[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4198 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4198

   To require health plans to provide coverage for COVID-19 serology 
                                testing.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              July 2, 2020

   Mr. Scott of Florida (for himself and Ms. McSally) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To require health plans to provide coverage for COVID-19 serology 
                                testing.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Coronavirus Testing 
Act''.

SEC. 2. COVERAGE OF CORONAVIRUS ANTIBODY TESTS.

    (a) Coverage.--
            (1) In general.--A group health plan and a health insurance 
        issuer offering group or individual health insurance coverage 
        (including a grandfathered health plan (as defined in section 
        1251(e) of the Patient Protection and Affordable Care Act) 
        shall provide coverage, and shall not impose any cost sharing 
        (including deductibles, copayments, and coinsurance) 
        requirements or prior authorization or other medical management 
        requirements, for eligible COVID-19 serology tests performed 
        during any portion of the 2020 or 2021 plans years.
            (2) Eligible test.--For purpose of paragraph (1), an 
        eligible COVID-19 serology test shall include the following:
                    (A) A test that has been approved, cleared, or 
                authorized under section 510(k), 513, 515, or 564 of 
                the Federal Food, Drug, and Cosmetic Act for the 
                detection of the presence of SARS-CoV-2 antibodies.
                    (B) A serology test kit that is made available 
                within the 10-day grace period prior to an emergency 
                use authorization submission and with respect to which 
                such emergency use authorization submission is under 
                consideration, except that this subparagraph shall not 
                apply in the case of a serology test kit where the 
                emergency use authorization submission request under 
                section 564 of the Federal Food, Drug, and Cosmetic Act 
                has been denied or not submitted within a reasonable 
                timeframe.
                    (C) A serology laboratory developed test that the 
                Food and Drug Administration permits for clinical use 
                without an emergency use authorization submission.
                    (D) Any other test the Secretary determines 
                appropriate through guidance.
    (b) Enforcement.--The provisions of this section shall be applied 
by the Secretary of Health and Human Services, Secretary of Labor, and 
Secretary of the Treasury to group health plans and health insurance 
issuers offering group or individual health insurance coverage as if 
included in the provisions of part A of title XXVII of the Public 
Health Service Act, part 7 of the Employee Retirement Income Security 
Act of 1974, and subchapter B of chapter 100 of the Internal Revenue 
Code of 1986, as applicable.
    (c) Implementation.--The Secretary of Health and Human Services, 
Secretary of Labor, and Secretary of the Treasury may implement the 
provisions of this section through sub-regulatory guidance, program 
instruction or otherwise.
    (d) Rule of Construction.--Nothing in this Act, or the amendments 
made by this Act, shall be construed to limit the number of COVID-19 
serology tests that will be covered with respect to an individual under 
this Act (or amendments).
    (e) Terms.--In this section:
            (1) General terms.--The terms ``group health plan'', 
        ``health insurance issuer'', ``group health insurance 
        coverage'', and ``individual health insurance coverage'' shall 
        have the meanings given such terms in section 2791 of the 
        Public Health Service Act (42 U.S.C. 300gg-91), section 733 of 
        the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
        1191b), and section 9832 of the Internal Revenue Code of 1986, 
        as applicable.
            (2) Medical management.--The term ``medical management'' 
        includes requirements relating to clinical criteria for 
        coverage, frequency limitations, and similar restrictions as 
        determined by the Secretary of Health and Human Services, 
        Secretary of Labor, and Secretary of the Treasury.
    (f) Conforming Amendment.--Section 6001(d) of the Families First 
Coronavirus Response Act (42 U.S.C. 1320b-5 note) is amended--
            (1) by striking ``The terms'' and inserting the following:
            ``(1) In general.--The terms''; and
            (2) by adding at the end the following:
            ``(2) Medical management.--The term `medical management' 
        includes requirements relating to clinical criteria for 
        coverage, frequency limitations, and similar restrictions as 
        determined by the Secretary of Health and Human Services, 
        Secretary of Labor, and Secretary of the Treasury.''.

SEC. 3. COVERAGE OF CORONAVIRUS ANTIBODY TESTS AT NO COST SHARING UNDER 
              MEDICARE.

    (a) In General.--Section 1833(cc)(1)(A)(iii) of the Social Security 
Act (42 U.S.C. 1395l(cc)(1)(A)(iii) is amended by inserting the 
following before the semicolon: ``or a COVID-19 serology test described 
in section 1852(a)(1)(B)(VII)''.
    (b) Coverage Under Medicare Advantage.--Section 1852(a)(1)(B) of 
the Social Security Act (42 U.S.C. 1395w-22(a)(1)(B)) is amended--
            (1) in clause (iv)--
                    (A) by redesignating subclause (VII) as subclause 
                (VIII); and
                    (B) by inserting after subclause (VI) the following 
                new clause:
                                    ``(VII) A COVID-19 serology test 
                                administered during any portion of the 
                                2-year period beginning on January 1, 
                                2020, that begins on or after the date 
                                of enactment of this subclause, and the 
                                administration of such test.'';
            (2) in clause (v), by striking ``and (VI)'' and inserting 
        ``(VI), and (VII)''; and
            (3) in clause (vi), by inserting ``, or in the case of a 
        product or service described in subclause (VII) of such clause 
        that is administered or furnished during any portion of the 
        period described in such subclause'' after ``this clause''.

SEC. 4. COVERAGE OF CORONAVIRUS ANTIBODY TESTS UNDER MEDICAID AND CHIP.

    (a) Medicaid.--
            (1) In general.--Section 1905(a)(3) of the Social Security 
        Act (42 U.S.C. 1396d(a)(3)) is amended--
                    (A) in subparagraph (A), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subparagraph (B), by inserting ``and'' after 
                the semicolon; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(C) COVID-19 serology tests administered during any 
        portion of the 2-year period beginning on January 1, 2020, that 
        begins on or after the date of enactment of this subparagraph, 
        and the administration of such tests;''.
            (2) No cost sharing.--
                    (A) In general.--Subsections (a)(2) and (b)(2) of 
                section 1916 of the Social Security Act (42 U.S.C. 
                1396o) are each amended--
                            (i) in subparagraph (F), by striking ``or'' 
                        at the end;
                            (ii) by redesignating subparagraph (G) as 
                        subparagraph (H); and
                            (iii) by inserting after subparagraph (F) 
                        the following new subparagraph:
                    ``(G) any COVID-19 serology test described in 
                section 1905(a)(3)(C) that is performed during any 
                portion of the 2-year period described in such section 
                beginning on or after the date of enactment of this 
                subparagraph (and the administration of such test), 
                or''.
                    (B) Application to alternative cost sharing.--
                Section 1916A(b)(3)(B) of the Social Security Act (42 
                U.S.C. 1396o-1(b)(3)(B)) is amended by adding at the 
                end the following new clause:
                            ``(xii) Any COVID-19 serology test 
                        described in section 1905(a)(3)(C) that is 
                        administered during any portion of the 2-year 
                        period described in such section beginning on 
                        or after the date of enactment of this clause 
                        (and the administration of such test).''.
                    (C) Clarification.--The amendments made in this 
                paragraph shall apply with respect to a State plan of a 
                territory in the same manner as a State plan of one of 
                the 50 States.
    (b) CHIP.--
            (1) In general.--Section 2103(c) of the Social Security Act 
        (42 U.S.C. 1397cc(c)) is amended by adding at the end the 
        following paragraph:
            ``(11) COVID-19 serology testing.--The child health 
        assistance provided to a targeted low-income child shall 
        include coverage of any COVID-19 serology test described in 
        section 1905(a)(3)(C) that is administered during any portion 
        of the 2-year period described in such section beginning on or 
        after the date of the enactment of this subparagraph (and the 
        administration of such test).''.
            (2) Prohibition of cost sharing.--Section 2103(e)(2) of the 
        Social Security Act (42 U.S.C. 1397cc(e)(2)) is amended by 
        inserting ``COVID-19 serology tests described in subsection 
        (c)(11) (and administration of such tests),'' after 
        ``products),''.

SEC. 5. COVERAGE OF CORONAVIRUS ANTIBODY TESTS UNDER THE TRICARE 
              PROGRAM.

    (a) In General.--The Secretary of Defense shall provide coverage 
under the TRICARE program, and shall not impose any cost sharing 
(including deductibles, copayments, and coinsurance) requirements or 
prior authorization or other medical management requirements, for 
COVID-19 serology tests performed for covered beneficiaries during 
calendar year 2020 or 2021.
    (b) Definitions.--In this section, the terms ``TRICARE program'' 
and ``covered beneficiary'' have the meanings given those terms in 
section 1072 of title 10, United States Code.

SEC. 6. COVERAGE OF CORONAVIRUS ANTIBODY TESTS FROM DEPARTMENT OF 
              VETERANS AFFAIRS.

    (a) In General.--The Secretary of Veterans Affairs shall furnish a 
COVID-19 serology test to any enrolled veteran, upon request by the 
veteran, during calendar years 2020 and 2021 and shall not impose any 
cost sharing (including deductibles, copayments, and coinsurance) 
requirements or prior authorization or other medical management 
requirements for the receipt of such a test by an enrolled veteran 
during such period.
    (b) Enrolled Veteran Defined.--In this section, the term ``enrolled 
veteran'' means a veteran enrolled in the system of annual patient 
enrollment of the Department of Veterans Affairs established and 
operated under section 1705(a) of title 38, United States Code.

SEC. 7. COVERAGE OF CORONAVIRUS ANTIBODY TESTS UNDER FEHBP.

    Section 8902 of title 5, United States Code, is amended by adding 
at the end the following:
    ``(p) A contract for a plan under this chapter shall--
            ``(1) require the carrier to provide coverage for--
                    ``(A) a COVID-19 serology test administered on any 
                date during the period beginning on the date of 
                enactment of this subsection and ending on December 31, 
                2021; and
                    ``(B) the administration of a test described in 
                subparagraph (A); and
            ``(2) prohibit the carrier from imposing any cost sharing 
        requirement (including a deductible, copayment, or coinsurance 
        requirement), or prior authorization or other medical 
        management requirement, with respect to a test described in 
        paragraph (1)(A).''.

SEC. 8. REIMBURSEMENT FOR UNINSURED PATIENT COSTS.

    The Secretary of Health and Human Services shall utilize amounts in 
the Public Health and Social Services Emergency Fund (as established in 
the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116-
136)) to reimburse health care providers for the costs of providing 
health care services for the diagnosis and treatment of COVID-19 for 
individuals who are not covered under a group health plan or other 
health insurance coverage.

SEC. 9. ELECTRONIC REPORTING STANDARDS.

    (a) Committee.--
            (1) In general.--Not later than 30 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall convene a committee to make recommendations to 
        the Secretary on the expedited adoption of private sector 
        standards (as defined in section 1171(7) of the Social Security 
        Act (42 U.S.C. 1320d(7))) and the platform described in 
        subsection (b).
            (2) Membership.--The committee under paragraph (1) shall 
        include representatives of--
                    (A) the Centers for Disease Control and Prevention;
                    (B) the Office of Civil Rights of the Department of 
                Health and Human Services;
                    (C) the Office of the National Coordinator for 
                Health Information Technology;
                    (D) the Department of Defense;
                    (E) the Department of Veterans Affairs;
                    (F) the Centers for Medicare & Medicaid Services; 
                and
                    (G) standards development organizations defined 
                under section 1171(8) of the Social Security Act (42 
                U.S.C. 1320d(8)), including the National Council for 
                Prescription Drug Programs and Health Level 7.
    (b) Standards and Platform.--Not later than 60 days after the date 
of the convening of the committee in subsection (a)(1), the committee 
shall recommend standards, implementation guidelines, and the 
attributes of a health data platform that facilitates the real-time 
sharing of information for both public health and clinical health that 
allows for--
            (1) interoperable electronic reporting standards for the 
        sharing of electronic patient data, including case reports, 
        laboratory results, serology, immunology, and hospital capacity 
        data;
            (2) standardized electronic information reporting for the 
        automated e-reporting of COVID-19 or future epidemic 
        surveillance results from health care providers, laboratories, 
        and other sources to the Centers for Disease Control and 
        Prevention and State and local departments of health;
            (3) standardized immunization data that is shared with 
        immunization registries, medication history, and serology 
        available at the point of care for clinicians; and
            (4) a common platform for automated queries and responses 
        from hospitals, physicians, and other prescribers and 
        pharmacies to--
                    (A) collect, maintain, and provide to prescribers 
                and dispensers, in real-time and within ordinary 
                clinical workflow, information on patient prescription 
                and dispensing history, relevant clinical diagnoses, 
                laboratory test results, vaccinations through 
                pharmaceutical claims, and electronic prescribing data 
                transactions to treat patients; and
                    (B) allow for the relevant information to be 
                reported to public health officials for the purposes of 
                infectious disease surveillance, identification, and 
                containment consistent with any electronic case 
                reporting system.
        Such recommendations shall be prioritized in order of impact on 
        improvements to public and clinical health.
    (c) Adoption of Standards.--Not later than 90 days after receipt of 
the recommendations under subsection (b), and in consultation with 
American National Standards Institute Accredited Standards Development 
Organizations, the Secretary of Health and Human Services shall adopt 
priority standards and implementation specifications recommended by the 
committee under subsection (a) on an expedited basis without regard to 
the process described in section 1174 of the Social Security Act (with 
respect to limits on the timeframe for adoption of the standards) (42 
U.S.C. 1320d-3).
    (d) Adoption of Platform.--Not later than 90 days after receipt of 
the recommendations under subsection (b) on a common platform as 
described in subsection (b)(4), the Secretary of Health and Human 
Services shall enter into a contract with a private sector entity to 
establish such platform, which shall be available for use within 180 
days of the date of such contract.
    (e) Report.--Not later than 30 days after the date on which the 
committee established under subsection (a) makes recommendations for 
standards and the platform under subsection (b), the committee shall 
submit to the appropriate committees of Congress a report on such 
standards and platform, including any legislative changes that would be 
necessary to implement such standards and platform.
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