VITAL Act of 2020

II 116TH CONGRESS 2D SESSION S. 3512 To clarify the authority for regulating laboratory-developed testing procedures. IN THE SENATE OF THE UNITED STATES MARCH 17, 2020 Mr. PAUL introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To clarify the authority for regulating laboratory-developed testing procedures. 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 ‘‘Verified Innovative 4 Testing in American Laboratories Act of 2020’’ or the 5 ‘‘VITAL Act of 2020’’. 6 SEC. 2. LABORATORY-DEVELOPED TESTING PROCEDURES. 7 (a) FINDINGS.—Congress finds the following: 8 (1) Laboratory testing services are an integral 9 part of medical decision making, health manage- 10 ment, and public health surveillance. 11 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3512 IS (2) Provision of laboratory services is a profes- 1 sional health care activity, which is regulated under 2 the Public Health Service Act (42 U.S.C. 201 et 3 seq.). 4 (3) As witnessed with the 2020 COVID–19 5 pandemic, undue regulation of laboratory-developed 6 testing procedures may hamper the medical manage- 7 ment and public health response to infectious disease 8 outbreaks and pandemics, leading to delays in access 9 to testing and the ability to meet needed capacity to 10 stem community spread. 11 (b) SENSE OF CONGRESS.—It is the sense of Con- 12 gress that— 13 (1) the Federal Government should work to— 14 (A) ensure that patients receive the most 15 appropriate tests and procedures for medical 16 evaluations or treatment of clinical conditions; 17 (B) ensure that laboratory-developed test- 18 ing procedures are accurate, precise, clinically- 19 relevant, and monitored for continued quality 20 performance; 21 (C) enable laboratory professionals to pro- 22 vide professional services without undue restric- 23 tions; 24 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3512 IS (D) ensure that regulatory oversight of 1 laboratory tests does not limit patient access, 2 impede innovation, constrain flexibility or 3 adaptability, or limit a test’s sustainability as a 4 result of being unduly burdensome or beyond 5 the fiscal capacity of the laboratory to reason- 6 ably validate and perform, or the health care 7 system to financially support; 8 (E) preserve the ability of the laboratory 9 community to provide surge capacity in public 10 health emergencies, including biological, chem- 11 ical, radiological, and nuclear threats, infectious 12 disease outbreaks, or other emergent situations; 13 and 14 (F) safeguard, strengthen, and expand the 15 existing Laboratory Response Network, includ- 16 ing public health laboratories, sentinel labora- 17 tories, national laboratories, commercial ref- 18 erence laboratories, academic medical center 19 laboratories, and hospital-based laboratories; 20 and 21 (2) laboratories using laboratory-developed test- 22 ing procedures should adhere to personnel require- 23 ments required under section 353 of the Public 24 Health Service Act (42 U.S.C. 263a), including such 25 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3512 IS requirements relating to qualified professionals who 1 direct and supervise laboratories and consult on di- 2 agnosis, treatment, and management of patient care, 3 and render opinions to clients concerning diagnosis, 4 treatment, and management of patient care required 5 under such section 353. 6 (c) AUTHORITY OVER LABORATORY-DEVELOPED 7 TESTING PROCEDURES.—All aspects of a laboratory-de- 8 veloped testing procedures shall be regulated by the Sec- 9 retary of Health and Human Services under section 353 10 of the Public Health Service Act (42 U.S.C. 263a), and 11 no aspects of laboratory-developed testing procedures shall 12 be regulated under the Federal Food, Drug, and Cosmetic 13 Act (21 U.S.C. 301 et seq.), including during a public 14 health emergency declared under section 319 of the Public 15 Health Service Act (42 U.S.C. 247d). 16 (d) DEFINITION.—In this section, the term ‘‘labora- 17 tory-developed testing procedure’’ means a professional 18 medical service that utilizes a laboratory examination in 19 the context of clinical care or public health services and 20 that meets the standards for establishment of performance 21 specifications established by regulation under section 22 353(f) of the Public Health Service Act (42 U.S.C. 23 263a(f)) applicable to— 24 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3512 IS (1) laboratory modifications of test systems ap- 1 proved, cleared, or authorized by the Food and Drug 2 Administration under section 510(k), 513, 515, or 3 564 of the Federal Food, Drug, and Cosmetic Act 4 (21 U.S.C. 360(k), 360c, 360e, 360bbb–3); 5 (2) methods developed or performed, and re- 6 sults produced and interpreted, within a laboratory 7 or laboratories under common ownership or within 8 the same organization, certified as required under 9 section 353(c) of the Public Health Service Act (42 10 U.S.C. 263a(c)); 11 (3) standardized methods such as those that 12 are available in textbooks and peer-reviewed publica- 13 tions; or 14 (4) methods in which performance specifications 15 are not provided by the manufacturer of test sys- 16 tems or components. 17 (e) PUBLIC MEETING.—Not later than 90 days after 18 the date of enactment of this Act, the Administrator of 19 the Centers for Medicare & Medicaid Services shall hold 20 a public meeting to solicit recommendations on updating 21 the regulations under section 353 of the Public Health 22 Service Act (42 U.S.C. 263a). 23 (f) REPORT TO CONGRESS.—Not later than 180 days 24 after the date of enactment of this Act, the Secretary of 25 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 6 •S 3512 IS Health and Human Services shall report to the Committee 1 on Health, Education, Labor, and Pensions of the Senate 2 and the Committee on Energy and Commerce of the 3 House of Representatives, the following: 4 (1) Recommendations to update section 353 of 5 the Public Health Service Act (42 U.S.C. 263a) and 6 the regulations promulgated under such section, tak- 7 ing into consideration input and recommendations 8 from the Clinical Laboratory Improvement Advisory 9 Committee, to reflect the current state of the field 10 of clinical laboratory testing. 11 (2) An assessment of the availability and utili- 12 zation of laboratory-developed testing procedures 13 during the 2020 COVID–19 pandemic response that 14 includes— 15 (A) validation criteria and process, and av- 16 erage length of time from validation to achiev- 17 ing emergency use authorization under section 18 564 of the Federal Food, Drug, and Cosmetic 19 Act (21 U.S.C. 360bbb–3) before, and after, 20 February 29, 2020; 21 (B) the number of patients and samples 22 tested by laboratories using such testing proce- 23 dures; and 24 VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS 7 •S 3512 IS (C) recommendations to ensure that dur- 1 ing future infectious disease outbreaks, the pub- 2 lic health system and clinical laboratories do 3 not encounter delays to testing. 4 Æ VerDate Sep 11 2014 23:13 Apr 01, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S3512.IS S3512 kjohnson on DSK79L0C42PROD with BILLS