Countermeasure Injury Compensation Fund Amendment Act
Bill: S.3810 | Sponsor: Sen. Lee, Mike (R-UT)
Policy area: Health

Summary:
Countermeasure Injury Compensation Fund Amendment Act
This bill modifies a program that compensates individuals for injuries experienced due to medical countermeasures (e.g., vaccines) delivered during certain public health emergencies, including with respect to compensation for COVID-19 vaccine injuries.
The bill aligns award determination procedures and other aspects of the program with requirements under the Vaccine Injury Compensation Program, which provides compensation for injuries or deaths associated with routinely administered vaccines.
Additionally, the bill establishes a temporary commission to identify injuries caused by receipt of a COVID-19 vaccine. The Department of Health and Human Services (HHS) must list all identified injuries in a table of conditions that are presumed to be caused by a COVID-19 vaccine, provided there is sufficient scientific evidence linking the injury to the vaccine. If HHS does not include an identified injury in the table, it must publish an explanation of that decision.
The bill also allows individuals to resubmit their COVID-19 vaccine compensation claims, including the amounts of previously approved claims, for reconsideration under the provisions set out in the bill.

To amend the Countermeasure Injury Compensation Program with respect to 
                           COVID-19 vaccines.

    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 ``Countermeasure Injury Compensation 
Fund Amendment Act''.

SEC. 2. AMENDMENT TO THE COUNTERMEASURE INJURY COMPENSATION PROGRAM.

    Section 319F-4 of the Public Health Service Act (42 U.S.C. 247d-6e) 
is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1), by striking ``under 319F-
                3(b)'' and inserting ``under section 319F-3(b)'';
                    (B) in paragraph (2)--
                            (i) by striking ``and be in the same 
                        amount'' and all that follows through ``shall 
                        not apply'' and inserting ``be in the same 
                        amount, and be subject to the same conditions 
                        as is prescribed by section 2115'';
                    (C) by striking paragraphs (3) and (4) and 
                inserting the following:
            ``(3) Determination of eligibility and compensation.--
        Compensation shall be awarded under this section to eligible 
        individuals in accordance with the procedure set forth in 
        sections 2111, 2112, 2113, and 2121 for purposes of the 
        National Vaccine Injury Compensation Program, subject to the 
        other provisions of this section.'';
                    (D) by inserting before paragraph (5) the 
                following:
            ``(4) Time for filing petitions.--
                    ``(A) Previously submitted requests.--
                            ``(i) Pending claims.--In the case of a 
                        request for compensation submitted under this 
                        section before the date of enactment of the 
                        Countermeasure Injury Compensation Fund 
                        Amendment Act for which no compensation has 
                        been provided prior to such date of enactment, 
                        in order to be eligible for compensation under 
                        this section, not later than 28 months after 
                        such date of enactment, the individual shall 
                        submit a new petition under this section, 
                        consistent with the amendments made by the 
                        Countermeasure Injury Compensation Fund 
                        Amendment Act.
                            ``(ii) Previously paid claims.--In the case 
                        of a request for compensation submitted under 
                        this section and paid under this section before 
                        the date of enactment of the Countermeasure 
                        Injury Compensation Fund Amendment Act that 
                        relates to a COVID-19 countermeasure, the 
                        individual receiving such compensation may 
                        submit a subsequent petition under this section 
                        for additional compensation in the amount the 
                        individual would have received for such claim 
                        under this section after such date of 
                        enactment, less the amount already received by 
                        the individual.
                    ``(B) Subsequent petitions.--In the case of a an 
                injury or death resulting from the administration or 
                use of a covered countermeasure to which subparagraph 
                (A) does not apply, a petition for benefits or 
                compensation under this section shall be filed not 
                later than--
                            ``(i) subject to clause (ii)--
                                    ``(I) in the case of serious 
                                physical injury, 3 years after the 
                                first symptom or manifestation of onset 
                                of a significant aggravation of a 
                                covered injury; or
                                    ``(II) in the case of death--
                                            ``(aa) 2 years after death 
                                        from the administration or use 
                                        of the covered countermeasure; 
                                        and
                                            ``(bb) 4 years after the 
                                        occurrence of the first symptom 
                                        or manifestation of onset or of 
                                        the significant aggravation of 
                                        the injury from which the death 
                                        resulted; and
                            ``(ii) in the case that a covered 
                        countermeasure is added to the table under 
                        paragraph (5)(A) and the effect is to permit an 
                        individual who was not, before such addition, 
                        eligible to seek compensation under this 
                        section, such individual may file a petition 
                        for such compensation not later than 2 years 
                        after the effective date of the addition of 
                        such countermeasure.'';
                    (E) in paragraph (5), by striking subparagraphs (B) 
                and (C) and inserting the following:
                    ``(B) Amendment with respect to covid-19 
                vaccines.--
                            ``(i) In general.--Not later than 60 days 
                        after receipt of the report under subparagraph 
                        (C)(iii), the Secretary, taking into 
                        consideration such report, shall amend the 
                        covered countermeasure injury table established 
                        under subparagraph (A) to include all injuries 
                        related to COVID-19 vaccines that meet the 
                        standard described in subparagraph (A). In 
                        amending such table, the Secretary shall 
                        consider injuries caused by use of any vaccine 
                        that is, or was, the subject of an emergency 
                        use authorization under section 564 of the 
                        Federal Food, Drug, and Cosmetic Act.
                            ``(ii) Explanation of certain 
                        determinations.--With respect to any 
                        recommendation of the COVID-19 Vaccine 
                        Commission included in the report under 
                        subparagraph (C)(iii) that the Secretary does 
                        not adopt pursuant to this subparagraph, the 
                        Secretary, not later than 7 days after the 
                        covered countermeasure injury table has been 
                        amended pursuant to clause (i), shall publish a 
                        written explanation of the determination not to 
                        adopt such recommendation.
                    ``(C) COVID-19 vaccine commission.--
                            ``(i) In general.--There is established a 
                        commission to be known as the COVID-19 Vaccine 
                        Commission (referred to in this subparagraph as 
                        the `Commission') that is tasked with 
                        identifying covered injuries related to COVID-
                        19 vaccines, for purposes of recommending to 
                        the Secretary injuries for inclusion on the 
                        covered countermeasure injury table, as 
                        described in subparagraph (B).
                            ``(ii) Membership.--
                                    ``(I) In general.--The Commission 
                                shall be composed of the following:
                                            ``(aa) The Secretary, or a 
                                        designee of the Secretary, to 
                                        serve as an ex officio member.
                                            ``(bb) The following 
                                        members, selected, not later 
                                        than 30 days after the date of 
                                        enactment of the Countermeasure 
                                        Injury Compensation Fund 
                                        Amendment Act, in accordance 
                                        with subclause (II):

                                                    ``(AA) 3 members 
                                                appointed by the Chair 
                                                of the Committee on 
                                                Health, Education, 
                                                Labor, and Pensions of 
                                                the Senate.

                                                    ``(BB) 3 members 
                                                appointed by the 
                                                Ranking Member of the 
                                                Committee on Health, 
                                                Education, Labor, and 
                                                Pensions of the Senate.

                                                    ``(CC) 3 members 
                                                appointed by the Chair 
                                                of the Committee on 
                                                Energy and Commerce of 
                                                the House of 
                                                Representatives.

                                                    ``(DD) 3 members 
                                                appointed by the 
                                                Ranking Member of the 
                                                Committee on Energy and 
                                                Commerce of the House 
                                                of Representatives.

                                    ``(II) Eligibility.--Members 
                                selected to serve on the Commission 
                                pursuant to subclause (I)(bb) shall--
                                            ``(aa) be chosen on the 
                                        basis of their experience, 
                                        integrity, impartiality, and 
                                        good judgement;
                                            ``(bb) at the time of 
                                        appointment, not be elected or 
                                        appointed officers or employees 
                                        in the executive, legislative, 
                                        or judicial branch of the 
                                        Federal Government; and
                                            ``(cc) at the time of 
                                        appointment, not be a member of 
                                        the board or an employee of an 
                                        entity whose product is under 
                                        review, or expected to be under 
                                        review, by the Commission.
                                    ``(III) No compensation.--Members 
                                of the Commission shall not be 
                                compensated.
                                    ``(IV) Conflict of interest.--Each 
                                member of the Commission shall recuse 
                                themselves from advising on a covered 
                                countermeasure for which the member has 
                                a conflict of interest as described in 
                                section 208 of title 18, United States 
                                Code.
                            ``(iii) Report.--No later than one year 
                        after the date of enactment of the 
                        Countermeasure Injury Compensation Fund 
                        Amendment Act, the Commission shall submit to 
                        the Secretary and make publicly available a 
                        report identifying covered injuries considered 
                        for purposes of inclusion on the covered 
                        countermeasure injury table pursuant to 
                        subparagraph (B), and the vote counts and 
                        outcomes for each such injury.
                            ``(iv) Sunset.--The Commission established 
                        under this subparagraph shall be terminated 
                        upon publication of the report under clause 
                        (iii).'';
                    (F) by redesignating paragraph (6) as paragraph 
                (7);
                    (G) by inserting after paragraph (5) the following:
            ``(6) Electronic filing of petitions.--The clerk of the 
        United States Court of Federal Claims shall provide an option 
        for the electronic filing of a petition to initiate a 
        proceeding for compensation under this section.''; and
                    (H) in paragraph (7), as so redesignated--
                            (i) by striking ``sections 262, 263, 264, 
                        265, and 266'' and inserting ``sections 2111, 
                        2112, 2113, 2115, and 2121'';
                            (ii) in subparagraph (A), by striking 
                        ``terms `vaccine' and `smallpox vaccine''' and 
                        inserting ``term `vaccine''';
                            (iii) by amending subparagraph (B) to read 
                        as follows:
                    ``(B) the term `Vaccine Injury Table' shall be 
                deemed to mean the table established under paragraph 
                (5)(A);'';
                            (iv) by redesignating subparagraph (C) as 
                        subparagraph (F); and
                            (v) by inserting after subparagraph (B) the 
                        following:
                    ``(C) the term `factors unrelated to the 
                administration of the vaccine' shall be deemed to mean 
                factors unrelated to the administration or use of a 
                covered countermeasure;
                    ``(D)(i) the terms `petition', `petition under 
                section 2111', and `petition filed under section 2111' 
                shall be deemed to mean a request for compensation 
                under this section; and
                    ``(ii) the term `petitioner' shall be deemed to 
                mean a covered individual, as defined in subsection 
                (e), who makes a request for benefits or compensation 
                under this section;
                    ``(E) the term `vaccine-related injury or death' 
                shall be deemed to mean a covered injury, as defined in 
                subsection (e); and''; and
            (2) in subsection (d)--
                    (A) in paragraph (1), by striking ``, or if the 
                Secretary fails'' and all that follows through ``319F-
                3(d)'' and inserting a period; and
                    (B) in paragraph (5), by striking ``under 
                subsection (a) the Secretary determines that a covered 
                individual qualifies for compensation'' and inserting 
                ``a covered individual is determined under subsection 
                (a) to be eligible for compensation under this 
                section''.
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