II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Affordable Coronavirus 

5 Testing Act’’. 

6 SEC. 2. COVERAGE OF CORONAVIRUS ANTIBODY TESTS. 

7 (a) COVERAGE.— 

8 (1) IN GENERAL.—A group health plan and a 

9 health insurance issuer offering group or individual 

10 health insurance coverage (including a grandfathered 


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1 health plan (as defined in section 1251(e) of the Pa2 tient Protection and Affordable Care Act) shall pro3 vide coverage, and shall not impose any cost sharing 

4 (including deductibles, copayments, and coinsurance) 

5 requirements or prior authorization or other medical 

6 management requirements, for eligible COVID–19 

7 serology tests performed during any portion of the 

8 2020 or 2021 plans years. 

9 (2) ELIGIBLE TEST.—For purpose of para10 graph (1), an eligible COVID–19 serology test shall 

11 include the following: 

12 (A) A test that has been approved, cleared, 

13 or authorized under section 510(k), 513, 515, 

14 or 564 of the Federal Food, Drug, and Cos15 metic Act for the detection of the presence of 

16 SARS–CoV–2 antibodies. 

17 (B) A serology test kit that is made avail18 able within the 10-day grace period prior to an 

19 emergency use authorization submission and 

20 with respect to which such emergency use au21 thorization submission is under consideration, 

22 except that this subparagraph shall not apply in 

23 the case of a serology test kit where the emer24 gency use authorization submission request 

25 under section 564 of the Federal Food, Drug, 


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1 and Cosmetic Act has been denied or not sub2 mitted within a reasonable timeframe. 

3 (C) A serology laboratory developed test 

4 that the Food and Drug Administration permits 

5 for clinical use without an emergency use au6 thorization submission. 

7 (D) Any other test the Secretary deter8 mines appropriate through guidance. 

9 (b) ENFORCEMENT.—The provisions of this section 

10 shall be applied by the Secretary of Health and Human 

11 Services, Secretary of Labor, and Secretary of the Treas12 ury to group health plans and health insurance issuers of13 fering group or individual health insurance coverage as if 

14 included in the provisions of part A of title XXVII of the 

15 Public Health Service Act, part 7 of the Employee Retire16 ment Income Security Act of 1974, and subchapter B of 

17 chapter 100 of the Internal Revenue Code of 1986, as ap18 plicable. 

19 (c) IMPLEMENTATION.—The Secretary of Health and 

20 Human Services, Secretary of Labor, and Secretary of the 

21 Treasury may implement the provisions of this section 

22 through sub-regulatory guidance, program instruction or 

23 otherwise. 

24 (d) RULE OF CONSTRUCTION.—Nothing in this Act, 

25 or the amendments made by this Act, shall be construed 


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1 to limit the number of COVID–19 serology tests that will 

2 be covered with respect to an individual under this Act 

3 (or amendments). 

4 (e) TERMS.—In this section: 

5 (1) GENERAL TERMS.—The terms ‘‘group 

6 health plan’’, ‘‘health insurance issuer’’, ‘‘group 

7 health insurance coverage’’, and ‘‘individual health 

8 insurance coverage’’ shall have the meanings given 

9 such terms in section 2791 of the Public Health 

10 Service Act (42 U.S.C. 300gg–91), section 733 of 

11 the Employee Retirement Income Security Act of 

12 1974 (29 U.S.C. 1191b), and section 9832 of the 

13 Internal Revenue Code of 1986, as applicable. 

14 (2) MEDICAL MANAGEMENT.—The term ‘‘med15 ical management’’ includes requirements relating to 

16 clinical criteria for coverage, frequency limitations, 

17 and similar restrictions as determined by the Sec18 retary of Health and Human Services, Secretary of 

19 Labor, and Secretary of the Treasury. 

20 (f) CONFORMING AMENDMENT.—Section 6001(d) of 

21 the Families First Coronavirus Response Act (42 U.S.C. 

22 1320b–5 note) is amended— 

23 (1) by striking ‘‘The terms’’ and inserting the 

24 following: 

25 ‘‘(1) IN GENERAL.—The terms’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(2) MEDICAL MANAGEMENT.—The term ‘med3 ical management’ includes requirements relating to 

4 clinical criteria for coverage, frequency limitations, 

5 and similar restrictions as determined by the Sec6 retary of Health and Human Services, Secretary of 

7 Labor, and Secretary of the Treasury.’’. 

8 SEC. 3. COVERAGE OF CORONAVIRUS ANTIBODY TESTS AT 

9 NO COST SHARING UNDER MEDICARE. 

10 (a) IN GENERAL.—Section 1833(cc)(1)(A)(iii) of the 

11 Social Security Act (42 U.S.C. 1395l(cc)(1)(A)(iii) is 

12 amended by inserting the following before the semicolon: 

13 ‘‘or a COVID–19 serology test described in section 

14 1852(a)(1)(B)(VII)’’. 

15 (b) COVERAGE UNDER MEDICARE ADVANTAGE.— 

16 Section 1852(a)(1)(B) of the Social Security Act (42 

17 U.S.C. 1395w–22(a)(1)(B)) is amended— 

18 (1) in clause (iv)— 

19 (A) by redesignating subclause (VII) as 

20 subclause (VIII); and 

21 (B) by inserting after subclause (VI) the 

22 following new clause: 

23 ‘‘(VII) A COVID–19 serology 

24 test administered during any portion 

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1 uary 1, 2020, that begins on or after 

2 the date of enactment of this sub3 clause, and the administration of such 

4 test.’’; 

5 (2) in clause (v), by striking ‘‘and (VI)’’ and in6 serting ‘‘(VI), and (VII)’’; and 

7 (3) in clause (vi), by inserting ‘‘, or in the case 

8 of a product or service described in subclause (VII) 

9 of such clause that is administered or furnished dur10 ing any portion of the period described in such sub11 clause’’ after ‘‘this clause’’. 

12 SEC. 4. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 

13 UNDER MEDICAID AND CHIP. 

14 (a) MEDICAID.— 

15 (1) IN GENERAL.—Section 1905(a)(3) of the 

16 Social Security Act (42 U.S.C. 1396d(a)(3)) is 

17 amended— 

18 (A) in subparagraph (A), by striking ‘‘; 

19 and’’ and inserting a semicolon; 

20 (B) in subparagraph (B), by inserting 

21 ‘‘and’’ after the semicolon; and 

22 (C) by adding at the end the following new 

23 subparagraph: 

24 ‘‘(C) COVID–19 serology tests administered 

25 during any portion of the 2-year period beginning on 


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1 January 1, 2020, that begins on or after the date 

2 of enactment of this subparagraph, and the adminis3 tration of such tests;’’. 

4 (2) NO COST SHARING.— 

5 (A) IN GENERAL.—Subsections (a)(2) and 

6 (b)(2) of section 1916 of the Social Security 

7 Act (42 U.S.C. 1396o) are each amended— 

8 (i) in subparagraph (F), by striking 

9 ‘‘or’’ at the end; 

10 (ii) by redesignating subparagraph 

11 (G) as subparagraph (H); and 

12 (iii) by inserting after subparagraph 

13 (F) the following new subparagraph: 

14 ‘‘(G) any COVID–19 serology test de15 scribed in section 1905(a)(3)(C) that is per16 formed during any portion of the 2-year period 

17 described in such section beginning on or after 

18 the date of enactment of this subparagraph 

19 (and the administration of such test), or’’. 

20 (B) APPLICATION TO ALTERNATIVE COST

21 SHARING.—Section 1916A(b)(3)(B) of the So22 cial Security Act (42 U.S.C. 1396o–1(b)(3)(B)) 

23 is amended by adding at the end the following 

24 new clause: 


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1 ‘‘(xii) Any COVID–19 serology test 

2 described in section 1905(a)(3)(C) that is 

3 administered during any portion of the 2- 

4 year period described in such section be5 ginning on or after the date of enactment 

6 of this clause (and the administration of 

7 such test).’’. 

8 (C) CLARIFICATION.—The amendments 

9 made in this paragraph shall apply with respect 

10 to a State plan of a territory in the same man11 ner as a State plan of one of the 50 States. 

12 (b) CHIP.— 

13 (1) IN GENERAL.—Section 2103(c) of the So14 cial Security Act (42 U.S.C. 1397cc(c)) is amended 

15 by adding at the end the following paragraph: 

16 ‘‘(11) COVID–19 SEROLOGY TESTING.—The 

17 child health assistance provided to a targeted low-in18 come child shall include coverage of any COVID–19 

19 serology test described in section 1905(a)(3)(C) that 

20 is administered during any portion of the 2-year pe21 riod described in such section beginning on or after 

22 the date of the enactment of this subparagraph (and 

23 the administration of such test).’’. 

24 (2) PROHIBITION OF COST SHARING.—Section 

25 2103(e)(2) of the Social Security Act (42 U.S.C. 


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1 1397cc(e)(2)) is amended by inserting ‘‘COVID–19 

2 serology tests described in subsection (c)(11) (and 

3 administration of such tests),’’ after ‘‘products),’’. 

4 SEC. 5. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 

5 UNDER THE TRICARE PROGRAM. 

6 (a) IN GENERAL.—The Secretary of Defense shall 

7 provide coverage under the TRICARE program, and shall 

8 not impose any cost sharing (including deductibles, copay9 ments, and coinsurance) requirements or prior authoriza10 tion or other medical management requirements, for 

11 COVID–19 serology tests performed for covered bene12 ficiaries during calendar year 2020 or 2021. 

13 (b) DEFINITIONS.—In this section, the terms 

14 ‘‘TRICARE program’’ and ‘‘covered beneficiary’’ have the 

15 meanings given those terms in section 1072 of title 10, 

16 United States Code. 

17 SEC. 6. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 

18 FROM DEPARTMENT OF VETERANS AFFAIRS. 

19 (a) IN GENERAL.—The Secretary of Veterans Affairs 

20 shall furnish a COVID–19 serology test to any enrolled 

21 veteran, upon request by the veteran, during calendar 

22 years 2020 and 2021 and shall not impose any cost shar23 ing (including deductibles, copayments, and coinsurance) 

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1 agement requirements for the receipt of such a test by 

2 an enrolled veteran during such period. 

3 (b) ENROLLED VETERAN DEFINED.—In this section, 

4 the term ‘‘enrolled veteran’’ means a veteran enrolled in 

5 the system of annual patient enrollment of the Depart6 ment of Veterans Affairs established and operated under 

7 section 1705(a) of title 38, United States Code. 

8 SEC. 7. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 

9 UNDER FEHBP. 

10 Section 8902 of title 5, United States Code, is 

11 amended by adding at the end the following: 

12 ‘‘(p) A contract for a plan under this chapter shall— 

13 ‘‘(1) require the carrier to provide coverage 

14 for— 

15 ‘‘(A) a COVID–19 serology test adminis16 tered on any date during the period beginning 

17 on the date of enactment of this subsection and 

18 ending on December 31, 2021; and 

19 ‘‘(B) the administration of a test described 

20 in subparagraph (A); and 

21 ‘‘(2) prohibit the carrier from imposing any cost 

22 sharing requirement (including a deductible, copay23 ment, or coinsurance requirement), or prior author24 ization or other medical management requirement, 


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1 with respect to a test described in paragraph 

2 (1)(A).’’. 

3 SEC. 8. REIMBURSEMENT FOR UNINSURED PATIENT 

4 COSTS. 

5 The Secretary of Health and Human Services shall 

6 utilize amounts in the Public Health and Social Services 

7 Emergency Fund (as established in the Coronavirus Aid, 

8 Relief, and Economic Security Act (Public Law 116–136)) 

9 to reimburse health care providers for the costs of pro10 viding health care services for the diagnosis and treatment 

11 of COVID–19 for individuals who are not covered under 

12 a group health plan or other health insurance coverage. 

13 SEC. 9. ELECTRONIC REPORTING STANDARDS. 

14 (a) COMMITTEE.— 

15 (1) IN GENERAL.—Not later than 30 days after 

16 the date of enactment of this Act, the Secretary of 

17 Health and Human Services shall convene a com18 mittee to make recommendations to the Secretary on 

19 the expedited adoption of private sector standards 

20 (as defined in section 1171(7) of the Social Security 

21 Act (42 U.S.C. 1320d(7))) and the platform de22 scribed in subsection (b). 

23 (2) MEMBERSHIP.—The committee under para24 graph (1) shall include representatives of— 


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1 (A) the Centers for Disease Control and 

2 Prevention; 

3 (B) the Office of Civil Rights of the De4 partment of Health and Human Services; 

5 (C) the Office of the National Coordinator 

6 for Health Information Technology; 

7 (D) the Department of Defense; 

8 (E) the Department of Veterans Affairs; 

9 (F) the Centers for Medicare & Medicaid 

10 Services; and 

11 (G) standards development organizations 

12 defined under section 1171(8) of the Social Se13 curity Act (42 U.S.C. 1320d(8)), including the 

14 National Council for Prescription Drug Pro15 grams and Health Level 7. 

16 (b) STANDARDS AND PLATFORM.—Not later than 60 

17 days after the date of the convening of the committee in 

18 subsection (a)(1), the committee shall recommend stand19 ards, implementation guidelines, and the attributes of a 

20 health data platform that facilitates the real-time sharing 

21 of information for both public health and clinical health 

22 that allows for— 

23 (1) interoperable electronic reporting standards 

24 for the sharing of electronic patient data, including 


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1 case reports, laboratory results, serology, immu2 nology, and hospital capacity data; 

3 (2) standardized electronic information report4 ing for the automated e-reporting of COVID–19 or 

5 future epidemic surveillance results from health care 

6 providers, laboratories, and other sources to the 

7 Centers for Disease Control and Prevention and 

8 State and local departments of health; 

9 (3) standardized immunization data that is 

10 shared with immunization registries, medication his11 tory, and serology available at the point of care for 

12 clinicians; and 

13 (4) a common platform for automated queries 

14 and responses from hospitals, physicians, and other 

15 prescribers and pharmacies to— 

16 (A) collect, maintain, and provide to pre17 scribers and dispensers, in real-time and within 

18 ordinary clinical workflow, information on pa19 tient prescription and dispensing history, rel20 evant clinical diagnoses, laboratory test results, 

21 vaccinations through pharmaceutical claims, 

22 and electronic prescribing data transactions to 

23 treat patients; and 

24 (B) allow for the relevant information to 

25 be reported to public health officials for the 


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1 purposes of infectious disease surveillance, iden2 tification, and containment consistent with any 

3 electronic case reporting system. 

4 Such recommendations shall be prioritized in order 

5 of impact on improvements to public and clinical 

6 health. 

7 (c) ADOPTION OF STANDARDS.—Not later than 90 

8 days after receipt of the recommendations under sub9 section (b), and in consultation with American National 

10 Standards Institute Accredited Standards Development 

11 Organizations, the Secretary of Health and Human Serv12 ices shall adopt priority standards and implementation 

13 specifications recommended by the committee under sub14 section (a) on an expedited basis without regard to the 

15 process described in section 1174 of the Social Security 

16 Act (with respect to limits on the timeframe for adoption 

17 of the standards) (42 U.S.C. 1320d–3). 

18 (d) ADOPTION OF PLATFORM.—Not later than 90 

19 days after receipt of the recommendations under sub20 section (b) on a common platform as described in sub21 section (b)(4), the Secretary of Health and Human Serv22 ices shall enter into a contract with a private sector entity 

23 to establish such platform, which shall be available for use 

24 within 180 days of the date of such contract. 


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1 (e) REPORT.—Not later than 30 days after the date 

2 on which the committee established under subsection (a) 

3 makes recommendations for standards and the platform 

4 under subsection (b), the committee shall submit to the 

5 appropriate committees of Congress a report on such 

6 standards and platform, including any legislative changes 

7 that would be necessary to implement such standards and 

8 platform. 

Æ 


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