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Congressional Record — Senate, August 4, 2020, Page S4865

Summary

Page S4865 of the Senate section of the Congressional Record for August 4, 2020, carrying amendment text in interleaved columns. One section would require Medicare coverage of COVID-19 antibody tests at no cost sharing, including through private plans under the program. Another provision, on Federal contracting, makes a contractor ineligible if an agency head finds it unreasonably failed to perform a contract to supply personal protective equipment. Further text directs a hazard evaluation with referrals to occupational safety officials, and sets an effective date one year after enactment for earlier prohibitions.

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“Congressional Record — Senate, August 4, 2020, Page S4865.” Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/crec-crec-2020-08-04-crec-2020-08-04-pt1-pgs4865-5960de3f36/, SHA-256 0e1f3af218019ff1ba4ff398731485fce3a2eca5ec233e11249916baa327e4c9.

Full text

                                               August 4, 2020                                    CONGRESSIONAL RECORD — SENATE                                                                       S4865
                                                 (c) EFFECTIVE DATE.—The prohibitions                  performed during any portion of the 2020 or            SEC. l03. COVERAGE OF CORONAVIRUS ANTI-
                                               under subsections (a) and (b) shall take ef-            2021 plans years.                                                 BODY TESTS AT NO COST SHARING
                                                                                                                                                                         UNDER MEDICARE.
                                               fect on the date that is one year after the               (2) ELIGIBLE TEST.—For purpose of para-
                                               date of the enactment of this Act.                      graph (1), an eligible COVID–19 serology test             (a) IN GENERAL.—Section 1833(cc)(1)(A)(iii)
                                               SEC. ll06. INELIGIBILITY FOR FEDERAL CON-               shall include the following:                           of the Social Security Act (42 U.S.C.
                                                          TRACTING AS RESULT OF UNREA-                   (A) A test that has been approved, cleared,          1395l(cc)(1)(A)(iii) is amended by inserting
                                                          SONABLE FAILURE TO PERFORM A                 or authorized under section 510(k), 513, 515, or       the following before the semicolon: ‘‘or a
                                                          CONTRACT FOR THE PROCUREMENT                 564 of the Federal Food, Drug, and Cosmetic            COVID–19 serology test described in section
                                                          OF PERSONAL PROTECTIVE EQUIP-                                                                       1852(a)(1)(B)(VII)’’.
                                                                                                       Act for the detection of the presence of
                                                          MENT.
                                                                                                       SARS–CoV–2 antibodies.                                    (b) COVERAGE UNDER MEDICARE ADVAN-
                                                 Any Federal contractor or subcontractor                 (B) A serology test kit that is made avail-          TAGE.—Section 1852(a)(1)(B) of the Social Se-
                                               determined by the head of an executive agen-            able within the 10-day grace period prior to           curity Act (42 U.S.C. 1395w–22(a)(1)(B)) is
                                               cy to have unreasonably failed to perform a             an emergency use authorization submission              amended—
                                               contract for the procurement of personal                and with respect to which such emergency                  (1) in clause (iv)—
                                               protective equipment shall be ineligible to             use authorization submission is under con-                (A) by redesignating subclause (VII) as sub-
                                               receive a Federal contract for a period of 10           sideration, except that this subparagraph              clause (VIII); and
                                               years following such determination.                     shall not apply in the case of a serology test            (B) by inserting after subclause (VI) the
                                               SEC. ll07. DEFINITIONS.                                 kit where the emergency use authorization              following new clause:
                                                  In this subtitle:                                    submission request under section 564 of the               ‘‘(VII) A COVID–19 serology test adminis-
                                                  (1) COVERED FOREIGN ENTITY.—The term                 Federal Food, Drug, and Cosmetic Act has               tered during any portion of the 2-year period
                                               ‘‘covered foreign entity’’ means—                       been denied or not submitted within a rea-             beginning on January 1, 2020, that begins on
                                                  (A) a covered entity designated by the Sec-          sonable timeframe.                                     or after the date of enactment of this sub-
                                               retary of Commerce;                                       (C) A serology laboratory developed test             clause, and the administration of such
                                                  (B) an entity included on the Consolidated           that the Food and Drug Administration per-             test.’’;
                                               Screening List;                                         mits for clinical use without an emergency                (2) in clause (v), by striking ‘‘and (VI)’’ and
                                                  (C) any entity that is subject to                    use authorization submission.                          inserting ‘‘(VI), and (VII)’’; and
                                               extrajudicial direction from a foreign gov-               (D) Any other test the Secretary deter-                 (3) in clause (vi), by inserting ‘‘, or in the
                                               ernment, as determined by the Secretary of              mines appropriate through guidance.                    case of a product or service described in sub-
                                               Homeland Security;                                                                                             clause (VII) of such clause that is adminis-
                                                  (D) any entity the Secretary of Homeland               (b) ENFORCEMENT.—The provisions of this
                                                                                                                                                              tered or furnished during any portion of the
                                               Security, in coordination with the Director             section shall be applied by the Secretary of
                                                                                                                                                              period described in such subclause’’ after
                                               of National Intelligence and the Secretary of           Health and Human Services, Secretary of
                                                                                                                                                              ‘‘this clause’’.
                                               Defense, determines poses a national secu-              Labor, and Secretary of the Treasury to
                                                                                                       group health plans and health insurance                SEC. l04. COVERAGE OF CORONAVIRUS ANTI-
                                               rity risk;                                                                                                                BODY TESTS UNDER MEDICAID AND
                                                  (E) any entity domiciled in the People’s             issuers offering group or individual health
                                                                                                                                                                         CHIP.
                                               Republic of China or subject to influence or            insurance coverage as if included in the pro-
                                                                                                       visions of part A of title XXVII of the Public           (a) MEDICAID.—
                                               control by the Government of the People’s                                                                        (1) IN GENERAL.—Section 1905(a)(3) of the
                                               Republic of China or the Communist Party                Health Service Act, part 7 of the Employee
                                                                                                       Retirement Income Security Act of 1974, and            Social Security Act (42 U.S.C. 1396d(a)(3)) is
                                               of the People’s Republic of China, as deter-                                                                   amended—
                                               mined by the Secretary of Homeland Secu-                subchapter B of chapter 100 of the Internal
                                                                                                       Revenue Code of 1986, as applicable.                     (A) in subparagraph (A), by striking ‘‘;
                                               rity; or                                                                                                       and’’ and inserting a semicolon;
                                                  (F) any subsidiary or affiliate of an entity           (c) IMPLEMENTATION.—The Secretary of                   (B) in subparagraph (B), by inserting ‘‘and’’
                                               described in subparagraphs (A) through (D).             Health and Human Services, Secretary of                after the semicolon; and
                                                  (2) EXECUTIVE AGENCY.—The term ‘‘execu-              Labor, and Secretary of the Treasury may                 (C) by adding at the end the following new
                                               tive agency’’ has the meaning given the term            implement the provisions of this section               subparagraph:
                                               in section 133 of title 41, United States Code.         through sub-regulatory guidance, program                 ‘‘(C) COVID–19 serology tests administered
                                                  (3) PERSONAL PROTECTIVE EQUIPMENT.—The               instruction or otherwise.                              during any portion of the 2-year period be-
                                               term ‘‘personal protective equipment’’ has                                                                     ginning on January 1, 2020, that begins on or
                                               the meaning given such term in section                    (d) RULE OF CONSTRUCTION.—Nothing in
                                                                                                       this title, or the amendments made by this             after the date of enactment of this subpara-
                                               319F–2(a)(6)(B) of the Public Health Service                                                                   graph, and the administration of such
                                               Act (as amended by this subtitle).                      title, shall be construed to limit the number
                                                                                                       of COVID–19 serology tests that will be cov-           tests;’’.
                                                                                                       ered with respect to an individual under this            (2) NO COST SHARING.—
                                                 SA 2552. Mr. SCOTT of Florida (for                                                                             (A) IN GENERAL.—Subsections (a)(2) and
                                                                                                       title (or amendments).
                                               himself, Ms. ERNST, and Ms. MCSALLY)                                                                           (b)(2) of section 1916 of the Social Security
                                               submitted an amendment intended to                         (e) TERMS.—In this section:                         Act (42 U.S.C. 1396o) are each amended—
                                               be proposed to amendment SA 2499 pro-                      (1) GENERAL TERMS.—The terms ‘‘group                  (i) in subparagraph (F), by striking ‘‘or’’ at
                                                                                                       health plan’’, ‘‘health insurance issuer’’,            the end;
                                               posed by Mr. MCCONNELL to the bill S.                   ‘‘group health insurance coverage’’, and ‘‘in-
                                               178, to condemn gross human rights                                                                               (ii) by redesignating subparagraph (G) as
                                                                                                       dividual health insurance coverage’’ shall             subparagraph (H); and
                                               violations of ethnic Turkic Muslims in                  have the meanings given such terms in sec-               (iii) by inserting after subparagraph (F)
                                               Xinjiang, and calling for an end to ar-                 tion 2791 of the Public Health Service Act (42         the following new subparagraph:
                                               bitrary detention, torture, and harass-                 U.S.C. 300gg–91), section 733 of the Employee            ‘‘(G) any COVID–19 serology test described
                                               ment of these communities inside and                    Retirement Income Security Act of 1974 (29             in section 1905(a)(3)(C) that is performed dur-
                                               outside China; which was ordered to lie                 U.S.C. 1191b), and section 9832 of the Internal        ing any portion of the 2-year period de-
                                               on the table; as follows:                               Revenue Code of 1986, as applicable.                   scribed in such section beginning on or after
                                                                                                          (2) MEDICAL MANAGEMENT.—The term                    the date of enactment of this subparagraph
                                                 At the appropriate place, insert the fol-             ‘‘medical management’’ includes require-
                                               lowing:                                                                                                        (and the administration of such test), or’’.
                                                                                                       ments relating to clinical criteria for cov-             (B) APPLICATION TO ALTERNATIVE COST
                                                TITLE ll—AFFORDABLE CORONAVIRUS                        erage, frequency limitations, and similar re-          SHARING.—Section 1916A(b)(3)(B) of the So-
                                                               TESTING                                 strictions as determined by the Secretary of           cial Security Act (42 U.S.C. 1396o–1(b)(3)(B))
                                               SEC. l01. SHORT TITLE.                                  Health and Human Services, Secretary of                is amended by adding at the end the fol-
                                                This title may be cited as the ‘‘Affordable            Labor, and Secretary of the Treasury.                  lowing new clause:
                                               Coronavirus Testing Act’’.                                (f)    CONFORMING     AMENDMENT.—Section               ‘‘(xii) Any COVID–19 serology test de-
                                               SEC. l02. COVERAGE OF CORONAVIRUS ANTI-                 6001(d) of the Families First Coronavirus Re-          scribed in section 1905(a)(3)(C) that is admin-
                                                           BODY TESTS.                                 sponse Act (42 U.S.C. 1320b–5 note) is amend-          istered during any portion of the 2-year pe-
                                                 (a) COVERAGE.—                                        ed—                                                    riod described in such section beginning on
                                                 (1) IN GENERAL.—A group health plan and a               (1) by striking ‘‘The terms’’ and inserting          or after the date of enactment of this clause
                                               health insurance issuer offering group or in-           the following:                                         (and the administration of such test).’’.
                                               dividual health insurance coverage (includ-               ‘‘(1) IN GENERAL.—The terms’’; and                     (C) CLARIFICATION.—The amendments made




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                                               ing a grandfathered health plan (as defined               (2) by adding at the end the following:              in this paragraph shall apply with respect to
                                               in section 1251(e) of the Patient Protection              ‘‘(2) MEDICAL MANAGEMENT.—The term                   a State plan of a territory in the same man-
                                               and Affordable Care Act) shall provide cov-             ‘medical management’ includes require-                 ner as a State plan of one of the 50 States.
                                               erage, and shall not impose any cost sharing            ments relating to clinical criteria for cov-             (b) CHIP.—
                                               (including deductibles, copayments, and co-             erage, frequency limitations, and similar re-            (1) IN GENERAL.—Section 2103(c) of the So-
                                               insurance) requirements or prior authoriza-             strictions as determined by the Secretary of           cial Security Act (42 U.S.C. 1397cc(c)) is
                                               tion or other medical management require-               Health and Human Services, Secretary of                amended by adding at the end the following
                                               ments, for eligible COVID–19 serology tests             Labor, and Secretary of the Treasury.’’.               paragraph:




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                                               S4866                                             CONGRESSIONAL RECORD — SENATE                                                        August 4, 2020
                                                 ‘‘(11) COVID–19 SEROLOGY TESTING.—The                 SEC. l09. ELECTRONIC REPORTING STANDARDS.              limits on the timeframe for adoption of the
                                               child health assistance provided to a tar-                (a) COMMITTEE.—                                      standards) (42 U.S.C. 1320d–3).
                                               geted low-income child shall include cov-                 (1) IN GENERAL.—Not later than 30 days                 (d) ADOPTION OF PLATFORM.—Not later
                                               erage of any COVID–19 serology test de-                 after the date of enactment of this Act, the           than 90 days after receipt of the rec-
                                               scribed in section 1905(a)(3)(C) that is admin-         Secretary of Health and Human Services                 ommendations under subsection (b) on a
                                               istered during any portion of the 2-year pe-            shall convene a committee to make rec-                 common platform as described in subsection
                                               riod described in such section beginning on             ommendations to the Secretary on the expe-             (b)(4), the Secretary of Health and Human
                                               or after the date of the enactment of this              dited adoption of private sector standards (as         Services shall enter into a contract with a
                                               subparagraph (and the administration of                 defined in section 1171(7) of the Social Secu-         private sector entity to establish such plat-
                                               such test).’’.                                          rity Act (42 U.S.C. 1320d(7))) and the platform        form, which shall be available for use within
                                                 (2) PROHIBITION OF COST SHARING.—Section              described in subsection (b).                           180 days of the date of such contract.
                                               2103(e)(2) of the Social Security Act (42                 (2) MEMBERSHIP.—The committee under                    (e) REPORT.—Not later than 30 days after
                                               U.S.C. 1397cc(e)(2)) is amended by inserting            paragraph (1) shall include representatives            the date on which the committee established
                                               ‘‘COVID–19 serology tests described in sub-             of—                                                    under subsection (a) makes recommenda-
                                               section (c)(11) (and administration of such               (A) the Centers for Disease Control and              tions for standards and the platform under
                                               tests),’’ after ‘‘products),’’.                         Prevention;                                            subsection (b), the committee shall submit
                                               SEC. l05. COVERAGE OF CORONAVIRUS ANTI-                   (B) the Office of Civil Rights of the Depart-        to the appropriate committees of Congress a
                                                          BODY TESTS UNDER THE TRICARE                 ment of Health and Human Services;                     report on such standards and platform, in-
                                                          PROGRAM.                                       (C) the Office of the National Coordinator           cluding any legislative changes that would
                                                 (a) IN GENERAL.—The Secretary of Defense              for Health Information Technology;                     be necessary to implement such standards
                                               shall provide coverage under the TRICARE                  (D) the Department of Defense;                       and platform.
                                               program, and shall not impose any cost shar-              (E) the Department of Veterans Affairs;
                                               ing (including deductibles, copayments, and               (F) the Centers for Medicare & Medicaid                SA 2553. Mr. ENZI submitted an
                                               coinsurance) requirements or prior author-              Services; and                                          amendment intended to be proposed to
                                               ization or other medical management re-                   (G) standards development organizations              amendment SA 2499 proposed by Mr.
                                               quirements, for COVID–19 serology tests per-            defined under section 1171(8) of the Social Se-        MCCONNELL to the bill S. 178, to con-
                                               formed for covered beneficiaries during cal-            curity Act (42 U.S.C. 1320d(8)), including the         demn gross human rights violations of
                                               endar year 2020 or 2021.                                National Council for Prescription Drug Pro-            ethnic Turkic Muslims in Xinjiang, and
                                                 (b) DEFINITIONS.—In this section, the terms           grams and Health Level 7.                              calling for an end to arbitrary deten-
                                               ‘‘TRICARE program’’ and ‘‘covered bene-                   (b) STANDARDS AND PLATFORM.—Not later
                                               ficiary’’ have the meanings given those                                                                        tion, torture, and harassment of these
                                                                                                       than 60 days after the date of the convening
                                               terms in section 1072 of title 10, United               of the committee in subsection (a)(1), the             communities inside and outside China;
                                               States Code.                                            committee shall recommend standards, im-               which was ordered to lie on the table;
                                               SEC. l06. COVERAGE OF CORONAVIRUS ANTI-                 plementation guidelines, and the attributes            as follows:
                                                          BODY TESTS FROM DEPARTMENT OF                of a health data platform that facilitates the           At the appropriate place, insert the fol-
                                                          VETERANS AFFAIRS.                            real-time sharing of information for both              lowing:
                                                 (a) IN GENERAL.—The Secretary of Vet-                 public health and clinical health that allows          SEC. l. VOLUNTARY PROTECTION PROGRAM.
                                               erans Affairs shall furnish a COVID–19 serol-           for—                                                     (a) COOPERATIVE RELATIONSHIPS.—The Sec-
                                               ogy test to any enrolled veteran, upon re-                (1) interoperable electronic reporting               retary of Labor shall establish a program of
                                               quest by the veteran, during calendar years             standards for the sharing of electronic pa-            entering into cooperative relationships with
                                               2020 and 2021 and shall not impose any cost             tient data, including case reports, laboratory         employers to encourage the establishment of
                                               sharing (including deductibles, copayments,             results, serology, immunology, and hospital            comprehensive safety and health manage-
                                               and coinsurance) requirements or prior au-              capacity data;                                         ment systems that include—
                                               thorization or other medical management                   (2) standardized electronic information re-             (1) requirements for systematic assessment
                                               requirements for the receipt of such a test by          porting for the automated e-reporting of               of hazards;
                                               an enrolled veteran during such period.                 COVID–19 or future epidemic surveillance re-              (2) comprehensive hazard prevention, miti-
                                                 (b) ENROLLED VETERAN DEFINED.—In this                 sults from health care providers, labora-              gation, and control programs;
                                               section, the term ‘‘enrolled veteran’’ means            tories, and other sources to the Centers for              (3) active and meaningful management
                                               a veteran enrolled in the system of annual              Disease Control and Prevention and State               leadership and employee participation in the
                                               patient enrollment of the Department of                 and local departments of health;                       voluntary program described in subsection
                                               Veterans Affairs established and operated                 (3) standardized immunization data that is           (b); and
                                               under section 1705(a) of title 38, United               shared with immunization registries, medi-                (4) employee safety and health training.
                                               States Code.                                            cation history, and serology available at the             (b) VOLUNTARY PROTECTION PROGRAM.—
                                               SEC. l07. COVERAGE OF CORONAVIRUS ANTI-                 point of care for clinicians; and                         (1) IN GENERAL.—The Secretary of Labor
                                                          BODY TESTS UNDER FEHBP.                        (4) a common platform for automated que-             shall establish and carry out a voluntary
                                                 Section 8902 of title 5, United States Code,          ries and responses from hospitals, physi-              protection program (consistent with sub-
                                               is amended by adding at the end the fol-                cians, and other prescribers and pharmacies            section (a)) to encourage excellence and rec-
                                               lowing:                                                 to—                                                    ognize the achievement of excellence in both
                                                 ‘‘(p) A contract for a plan under this chap-            (A) collect, maintain, and provide to pre-           the technical and managerial protection of
                                               ter shall—                                              scribers and dispensers, in real-time and              employees from occupational hazards.
                                                 ‘‘(1) require the carrier to provide coverage         within ordinary clinical workflow, informa-               (2) PROGRAM REQUIREMENTS.—The vol-
                                               for—                                                    tion on patient prescription and dispensing            untary protection program shall include the
                                                 ‘‘(A) a COVID–19 serology test adminis-               history, relevant clinical diagnoses, labora-          following:
                                               tered on any date during the period begin-              tory test results, vaccinations through phar-             (A) APPLICATION.—Employers who volun-
                                               ning on the date of enactment of this sub-              maceutical claims, and electronic pre-                 teer under the program shall be required to
                                               section and ending on December 31, 2021; and            scribing data transactions to treat patients;          submit an application to the Secretary of
                                                 ‘‘(B) the administration of a test described          and                                                    Labor demonstrating that the worksite with
                                               in subparagraph (A); and                                  (B) allow for the relevant information to            respect to which the application is made
                                                 ‘‘(2) prohibit the carrier from imposing any          be reported to public health officials for the         meets such requirements as the Secretary of
                                               cost sharing requirement (including a de-               purposes of infectious disease surveillance,           Labor may require for participation in the
                                               ductible, copayment, or coinsurance require-            identification, and containment consistent             program.
                                               ment), or prior authorization or other med-             with any electronic case reporting system.                (B) ONSITE EVALUATIONS.—
                                               ical management requirement, with respect               Such recommendations shall be prioritized                 (i) IN GENERAL.—There shall be onsite eval-
                                               to a test described in paragraph (1)(A).’’.             in order of impact on improvements to pub-             uations by representatives of the Secretary
                                               SEC. l08. REIMBURSEMENT FOR UNINSURED PA-               lic and clinical health.                               of Labor to ensure a high level of protection
                                                           TIENT COSTS.                                  (c) ADOPTION OF STANDARDS.—Not later                 of employees.
                                                 The Secretary of Health and Human Serv-               than 90 days after receipt of the rec-                    (ii) TREATMENT OF HAZARDS.—Any rep-
                                               ices shall utilize amounts in the Public                ommendations under subsection (b), and in              resentative of the Secretary of Labor who is
                                               Health and Social Services Emergency Fund               consultation with American National Stand-             conducting an onsite evaluation under clause




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                                               (as established in the Coronavirus Aid, Re-             ards Institute Accredited Standards Develop-           (i)—
                                               lief, and Economic Security Act (Public Law             ment Organizations, the Secretary of Health               (I) shall not issue, or recommend the
                                               116–136)) to reimburse health care providers            and Human Services shall adopt priority                issuance of, citations under the Occupational
                                               for the costs of providing health care serv-            standards and implementation specifications            Safety and Health Act of 1970 (29 U.S.C. 651
                                               ices for the diagnosis and treatment of                 recommended by the committee under sub-                et seq.) related to any of the hazards identi-
                                               COVID–19 for individuals who are not cov-               section (a) on an expedited basis without re-          fied during the evaluation; and
                                               ered under a group health plan or other                 gard to the process described in section 1174             (II) may refer any hazard identified during
                                               health insurance coverage.                              of the Social Security Act (with respect to            the evaluation to the Assistant Secretary of




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