Title: VITAL Act of 2021
Policy area: Health

Summary:
Verified Innovative Testing in American Laboratories Act of 2021 or the VITAL Act of 2021
This bill expressly shifts the regulation of laboratory-developed testing procedures from the Food and Drug Administration (FDA) to the Centers for Medicare & Medicaid Services (CMS). Under current law, the FDA regulates the safety and effectiveness, as well as quality of design and manufacture, of laboratory-developed tests, while the CMS regulates clinical laboratories and testing processes. Historically, the FDA has exercised enforcement discretion and not enforced certain statutory and regulatory requirements with respect to these tests.
The CMS must hold a public meeting to solicit recommendations to update existing regulations related to clinical laboratories, and the Department of Health and Human Services must report specified information to Congress, including an assessment of the availability and use of laboratory-developed testing procedures during the COVID-19 (i.e., coronavirus disease 2019) response.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1666 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 1666

 To clarify the authority for regulating laboratory-developed testing 
                              procedures.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 18, 2021

   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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Verified Innovative Testing in 
American Laboratories Act of 2021'' or the ``VITAL Act of 2021''.

SEC. 2. LABORATORY-DEVELOPED TESTING PROCEDURES.

    (a) Findings.--Congress finds the following:
            (1) Laboratory testing services are an integral part of 
        medical decision making, health management, and public health 
        surveillance.
            (2) Provision of laboratory services is a professional 
        health care activity, which is regulated under the Public 
        Health Service Act (42 U.S.C. 201 et seq.).
            (3) As witnessed with the 2020 COVID-19 pandemic, undue 
        regulation of laboratory-developed testing procedures may 
        hamper the medical management and public health response to 
        infectious disease outbreaks and pandemics, leading to delays 
        in access to testing and the ability to meet needed capacity to 
        stem community spread.
    (b) Sense of Congress.--It is the sense of Congress that--
            (1) the Federal Government should work to--
                    (A) ensure that patients receive the most 
                appropriate tests and procedures for medical 
                evaluations or treatment of clinical conditions;
                    (B) ensure that laboratory-developed testing 
                procedures are accurate, precise, clinically-relevant, 
                and monitored for continued quality performance;
                    (C) enable laboratory professionals to provide 
                professional services without undue restrictions;
                    (D) ensure that regulatory oversight of laboratory 
                tests does not limit patient access, impede innovation, 
                constrain flexibility or adaptability, or limit a 
                test's sustainability as a result of being unduly 
                burdensome or beyond the fiscal capacity of the 
                laboratory to reasonably validate and perform, or the 
                health care system to financially support;
                    (E) preserve the ability of the laboratory 
                community to provide surge capacity in public health 
                emergencies, including biological, chemical, 
                radiological, and nuclear threats, infectious disease 
                outbreaks, or other emergent situations; and
                    (F) safeguard, strengthen, and expand the existing 
                Laboratory Response Network, including public health 
                laboratories, sentinel laboratories, national 
                laboratories, commercial reference laboratories, 
                academic medical center laboratories, and hospital-
                based laboratories; and
            (2) laboratories using laboratory-developed testing 
        procedures should adhere to personnel requirements required 
        under section 353 of the Public Health Service Act (42 U.S.C. 
        263a), including such requirements relating to qualified 
        professionals who direct and supervise laboratories and consult 
        on diagnosis, treatment, and management of patient care, and 
        render opinions to clients concerning diagnosis, treatment, and 
        management of patient care required under such section 353.
    (c) Authority Over Laboratory-Developed Testing Procedures.--All 
aspects of a laboratory-developed testing procedures shall be regulated 
by the Secretary of Health and Human Services under section 353 of the 
Public Health Service Act (42 U.S.C. 263a), and no aspects of 
laboratory-developed testing procedures shall be regulated under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including 
during a public health emergency declared under section 319 of the 
Public Health Service Act (42 U.S.C. 247d).
    (d) Definition.--In this section, the term ``laboratory-developed 
testing procedure'' means a professional medical service that utilizes 
a laboratory examination in the context of clinical care or public 
health services and that meets the standards for establishment of 
performance specifications established by regulation under section 
353(f) of the Public Health Service Act (42 U.S.C. 263a(f)) applicable 
to--
            (1) laboratory modifications of test systems approved, 
        cleared, or authorized by the Food and Drug Administration 
        under section 510(k), 513, 515, or 564 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb-
        3);
            (2) methods developed or performed, and results produced 
        and interpreted, within a laboratory or laboratories under 
        common ownership or within the same organization, certified as 
        required under section 353(c) of the Public Health Service Act 
        (42 U.S.C. 263a(c));
            (3) standardized methods such as those that are available 
        in textbooks and peer-reviewed publications; or
            (4) methods in which performance specifications are not 
        provided by the manufacturer of test systems or components.
    (e) Public Meeting.--Not later than 90 days after the date of 
enactment of this Act, the Administrator of the Centers for Medicare & 
Medicaid Services shall hold a public meeting to solicit 
recommendations on updating the regulations under section 353 of the 
Public Health Service Act (42 U.S.C. 263a).
    (f) Report to Congress.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
report to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the House of 
Representatives, the following:
            (1) Recommendations to update section 353 of the Public 
        Health Service Act (42 U.S.C. 263a) and the regulations 
        promulgated under such section, taking into consideration input 
        and recommendations from the Clinical Laboratory Improvement 
        Advisory Committee, to reflect the current state of the field 
        of clinical laboratory testing.
            (2) An assessment of the availability and utilization of 
        laboratory-developed testing procedures during the 2020 COVID-
        19 pandemic response that includes--
                    (A) validation criteria and process, and average 
                length of time from validation to achieving emergency 
                use authorization under section 564 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) 
                before, and after, February 29, 2020;
                    (B) the number of patients and samples tested by 
                laboratories using such testing procedures; and
                    (C) recommendations to ensure that during future 
                infectious disease outbreaks, the public health system 
                and clinical laboratories do not encounter delays to 
                testing.
                                 <all>