Affordable Coronavirus Testing Act

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 fol- lowing 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Affordable Coronavirus 4 Testing Act’’. 5 SEC. 2. COVERAGE OF CORONAVIRUS ANTIBODY TESTS. 6 (a) COVERAGE.— 7 (1) IN GENERAL.—A group health plan and a 8 health insurance issuer offering group or individual 9 health insurance coverage (including a grandfathered 10 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4198 IS health plan (as defined in section 1251(e) of the Pa- 1 tient Protection and Affordable Care Act) shall pro- 2 vide coverage, and shall not impose any cost sharing 3 (including deductibles, copayments, and coinsurance) 4 requirements or prior authorization or other medical 5 management requirements, for eligible COVID–19 6 serology tests performed during any portion of the 7 2020 or 2021 plans years. 8 (2) ELIGIBLE TEST.—For purpose of para- 9 graph (1), an eligible COVID–19 serology test shall 10 include the following: 11 (A) A test that has been approved, cleared, 12 or authorized under section 510(k), 513, 515, 13 or 564 of the Federal Food, Drug, and Cos- 14 metic Act for the detection of the presence of 15 SARS–CoV–2 antibodies. 16 (B) A serology test kit that is made avail- 17 able within the 10-day grace period prior to an 18 emergency use authorization submission and 19 with respect to which such emergency use au- 20 thorization submission is under consideration, 21 except that this subparagraph shall not apply in 22 the case of a serology test kit where the emer- 23 gency use authorization submission request 24 under section 564 of the Federal Food, Drug, 25 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4198 IS and Cosmetic Act has been denied or not sub- 1 mitted within a reasonable timeframe. 2 (C) A serology laboratory developed test 3 that the Food and Drug Administration permits 4 for clinical use without an emergency use au- 5 thorization submission. 6 (D) Any other test the Secretary deter- 7 mines appropriate through guidance. 8 (b) ENFORCEMENT.—The provisions of this section 9 shall be applied by the Secretary of Health and Human 10 Services, Secretary of Labor, and Secretary of the Treas- 11 ury to group health plans and health insurance issuers of- 12 fering group or individual health insurance coverage as if 13 included in the provisions of part A of title XXVII of the 14 Public Health Service Act, part 7 of the Employee Retire- 15 ment Income Security Act of 1974, and subchapter B of 16 chapter 100 of the Internal Revenue Code of 1986, as ap- 17 plicable. 18 (c) IMPLEMENTATION.—The Secretary of Health and 19 Human Services, Secretary of Labor, and Secretary of the 20 Treasury may implement the provisions of this section 21 through sub-regulatory guidance, program instruction or 22 otherwise. 23 (d) RULE OF CONSTRUCTION.—Nothing in this Act, 24 or the amendments made by this Act, shall be construed 25 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4198 IS to limit the number of COVID–19 serology tests that will 1 be covered with respect to an individual under this Act 2 (or amendments). 3 (e) TERMS.—In this section: 4 (1) GENERAL TERMS.—The terms ‘‘group 5 health plan’’, ‘‘health insurance issuer’’, ‘‘group 6 health insurance coverage’’, and ‘‘individual health 7 insurance coverage’’ shall have the meanings given 8 such terms in section 2791 of the Public Health 9 Service Act (42 U.S.C. 300gg–91), section 733 of 10 the Employee Retirement Income Security Act of 11 1974 (29 U.S.C. 1191b), and section 9832 of the 12 Internal Revenue Code of 1986, as applicable. 13 (2) MEDICAL MANAGEMENT.—The term ‘‘med- 14 ical management’’ includes requirements relating to 15 clinical criteria for coverage, frequency limitations, 16 and similar restrictions as determined by the Sec- 17 retary of Health and Human Services, Secretary of 18 Labor, and Secretary of the Treasury. 19 (f) CONFORMING AMENDMENT.—Section 6001(d) of 20 the Families First Coronavirus Response Act (42 U.S.C. 21 1320b–5 note) is amended— 22 (1) by striking ‘‘The terms’’ and inserting the 23 following: 24 ‘‘(1) IN GENERAL.—The terms’’; and 25 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4198 IS (2) by adding at the end the following: 1 ‘‘(2) MEDICAL MANAGEMENT.—The term ‘med- 2 ical management’ includes requirements relating to 3 clinical criteria for coverage, frequency limitations, 4 and similar restrictions as determined by the Sec- 5 retary of Health and Human Services, Secretary of 6 Labor, and Secretary of the Treasury.’’. 7 SEC. 3. COVERAGE OF CORONAVIRUS ANTIBODY TESTS AT 8 NO COST SHARING UNDER MEDICARE. 9 (a) IN GENERAL.—Section 1833(cc)(1)(A)(iii) of the 10 Social Security Act (42 U.S.C. 1395l(cc)(1)(A)(iii) is 11 amended by inserting the following before the semicolon: 12 ‘‘or a COVID–19 serology test described in section 13 1852(a)(1)(B)(VII)’’. 14 (b) COVERAGE UNDER MEDICARE ADVANTAGE.— 15 Section 1852(a)(1)(B) of the Social Security Act (42 16 U.S.C. 1395w–22(a)(1)(B)) is amended— 17 (1) in clause (iv)— 18 (A) by redesignating subclause (VII) as 19 subclause (VIII); and 20 (B) by inserting after subclause (VI) the 21 following new clause: 22 ‘‘(VII) A COVID–19 serology 23 test administered during any portion 24 of the 2-year period beginning on Jan- 25 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4198 IS uary 1, 2020, that begins on or after 1 the date of enactment of this sub- 2 clause, and the administration of such 3 test.’’; 4 (2) in clause (v), by striking ‘‘and (VI)’’ and in- 5 serting ‘‘(VI), and (VII)’’; and 6 (3) in clause (vi), by inserting ‘‘, or in the case 7 of a product or service described in subclause (VII) 8 of such clause that is administered or furnished dur- 9 ing any portion of the period described in such sub- 10 clause’’ after ‘‘this clause’’. 11 SEC. 4. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 12 UNDER MEDICAID AND CHIP. 13 (a) MEDICAID.— 14 (1) IN GENERAL.—Section 1905(a)(3) of the 15 Social Security Act (42 U.S.C. 1396d(a)(3)) is 16 amended— 17 (A) in subparagraph (A), by striking ‘‘; 18 and’’ and inserting a semicolon; 19 (B) in subparagraph (B), by inserting 20 ‘‘and’’ after the semicolon; and 21 (C) by adding at the end the following new 22 subparagraph: 23 ‘‘(C) COVID–19 serology tests administered 24 during any portion of the 2-year period beginning on 25 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4198 IS January 1, 2020, that begins on or after the date 1 of enactment of this subparagraph, and the adminis- 2 tration of such tests;’’. 3 (2) NO COST SHARING.— 4 (A) IN GENERAL.—Subsections (a)(2) and 5 (b)(2) of section 1916 of the Social Security 6 Act (42 U.S.C. 1396o) are each amended— 7 (i) in subparagraph (F), by striking 8 ‘‘or’’ at the end; 9 (ii) by redesignating subparagraph 10 (G) as subparagraph (H); and 11 (iii) by inserting after subparagraph 12 (F) the following new subparagraph: 13 ‘‘(G) any COVID–19 serology test de- 14 scribed in section 1905(a)(3)(C) that is per- 15 formed during any portion of the 2-year period 16 described in such section beginning on or after 17 the date of enactment of this subparagraph 18 (and the administration of such test), or’’. 19 (B) APPLICATION TO ALTERNATIVE COST 20 SHARING.—Section 1916A(b)(3)(B) of the So- 21 cial Security Act (42 U.S.C. 1396o–1(b)(3)(B)) 22 is amended by adding at the end the following 23 new clause: 24 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4198 IS ‘‘(xii) Any COVID–19 serology test 1 described in section 1905(a)(3)(C) that is 2 administered during any portion of the 2- 3 year period described in such section be- 4 ginning on or after the date of enactment 5 of this clause (and the administration of 6 such test).’’. 7 (C) CLARIFICATION.—The amendments 8 made in this paragraph shall apply with respect 9 to a State plan of a territory in the same man- 10 ner as a State plan of one of the 50 States. 11 (b) CHIP.— 12 (1) IN GENERAL.—Section 2103(c) of the So- 13 cial Security Act (42 U.S.C. 1397cc(c)) is amended 14 by adding at the end the following paragraph: 15 ‘‘(11) COVID–19 SEROLOGY TESTING.—The 16 child health assistance provided to a targeted low-in- 17 come child shall include coverage of any COVID–19 18 serology test described in section 1905(a)(3)(C) that 19 is administered during any portion of the 2-year pe- 20 riod described in such section beginning on or after 21 the date of the enactment of this subparagraph (and 22 the administration of such test).’’. 23 (2) PROHIBITION OF COST SHARING.—Section 24 2103(e)(2) of the Social Security Act (42 U.S.C. 25 VerDate Sep 11 2014 04:09 Jul 16, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4198 IS 1397cc(e)(2)) is amended by inserting ‘‘COVID–19 1 serology tests described in subsection (c)(11) (and 2 administration of such tests),’’ after ‘‘products),’’. 3 SEC. 5. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 4 UNDER THE TRICARE PROGRAM. 5 (a) IN GENERAL.—The Secretary of Defense shall 6 provide coverage under the TRICARE program, and shall 7 not impose any cost sharing (including deductibles, copay- 8 ments, and coinsurance) requirements or prior authoriza- 9 tion or other medical management requirements, for 10 COVID–19 serology tests performed for covered bene- 11 ficiaries during calendar year 2020 or 2021. 12 (b) DEFINITIONS.—In this section, the terms 13 ‘‘TRICARE program’’ and ‘‘covered beneficiary’’ have the 14 meanings given those terms in section 1072 of title 10, 15 United States Code. 16 SEC. 6. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 17 FROM DEPARTMENT OF VETERANS AFFAIRS. 18 (a) IN GENERAL.—The Secretary of Veterans Affairs 19 shall furnish a COVID–19 serology test to any enrolled 20 veteran, upon request by the veteran, during calendar 21 years 2020 and 2021 and shall not impose any cost shar- 22 ing (including deductibles, copayments, and coinsurance) 23 requirements or prior authorization or other medical man- 24 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4198 IS agement requirements for the receipt of such a test by 1 an enrolled veteran during such period. 2 (b) ENROLLED VETERAN DEFINED.—In this section, 3 the term ‘‘enrolled veteran’’ means a veteran enrolled in 4 the system of annual patient enrollment of the Depart- 5 ment of Veterans Affairs established and operated under 6 section 1705(a) of title 38, United States Code. 7 SEC. 7. COVERAGE OF CORONAVIRUS ANTIBODY TESTS 8 UNDER FEHBP. 9 Section 8902 of title 5, United States Code, is 10 amended by adding at the end the following: 11 ‘‘(p) A contract for a plan under this chapter shall— 12 ‘‘(1) require the carrier to provide coverage 13 for— 14 ‘‘(A) a COVID–19 serology test adminis- 15 tered on any date during the period beginning 16 on the date of enactment of this subsection and 17 ending on December 31, 2021; and 18 ‘‘(B) the administration of a test described 19 in subparagraph (A); and 20 ‘‘(2) prohibit the carrier from imposing any cost 21 sharing requirement (including a deductible, copay- 22 ment, or coinsurance requirement), or prior author- 23 ization or other medical management requirement, 24 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4198 IS with respect to a test described in paragraph 1 (1)(A).’’. 2 SEC. 8. REIMBURSEMENT FOR UNINSURED PATIENT 3 COSTS. 4 The Secretary of Health and Human Services shall 5 utilize amounts in the Public Health and Social Services 6 Emergency Fund (as established in the Coronavirus Aid, 7 Relief, and Economic Security Act (Public Law 116–136)) 8 to reimburse health care providers for the costs of pro- 9 viding health care services for the diagnosis and treatment 10 of COVID–19 for individuals who are not covered under 11 a group health plan or other health insurance coverage. 12 SEC. 9. ELECTRONIC REPORTING STANDARDS. 13 (a) COMMITTEE.— 14 (1) IN GENERAL.—Not later than 30 days after 15 the date of enactment of this Act, the Secretary of 16 Health and Human Services shall convene a com- 17 mittee to make recommendations to the Secretary on 18 the expedited adoption of private sector standards 19 (as defined in section 1171(7) of the Social Security 20 Act (42 U.S.C. 1320d(7))) and the platform de- 21 scribed in subsection (b). 22 (2) MEMBERSHIP.—The committee under para- 23 graph (1) shall include representatives of— 24 VerDate Sep 11 2014 23:29 Jul 15, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4198.IS S4198 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4198 IS (A) the Centers for Disease Control and 1 Prevention; 2 (B) the Office of Civil Rights of the De- 3 partment of Health and Human Services; 4 (C) the Office of the National Coordinator 5 for Health Information Technology; 6 (D) the Department of Defense; 7 (E) the Department of Veterans Affairs; 8 (F) the Centers for Medicare & Medicaid 9 Services; and 10 (G) standards development organizations 11 defined under section 1171(8) of the Social Se- 12 curity Act (42 U.S.C. 1320d(8)), including the 13 National Council for Prescription Drug Pro- 14 grams and Health Level 7. 15 (b) STANDARDS AND PLATFORM.—Not later than 60 16 days after the date of the convening of the committee in 17 subsection (a)(1), the committee shall recommend stand- 18 ards, implementation guidelines, and the attributes [Text truncated for display. 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