Improving access to certain programs

(a) Procedures related to the transition of certain claims (1) Procedures for correcting submissions (A) Requests initially submitted under section 319F–4 (i) In general In the case of a request for compensation submitted under section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e) for an injury or death related to a medical product for active immunization to prevent coronavirus disease 2019 that the Secretary determines to be ineligible pursuant to subsection (b)(4)(B) of such section 319F–4, the Secretary shall, not later than 30 days after such determination, notify the individual submitting the request of such determination. (ii) Submission of petition An individual who receives a notification described in clause (i) shall be eligible to submit a petition to the United States Court of Federal Claims under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) with respect to the same medical product administration claimed in the request submitted under section 319F–4 of such Act (42 U.S.C. 247d–6e), provided such petition is submitted not later than the later of— (I) 1 year after receiving such notification under clause (i); or (II) the last date on which the individual otherwise would be eligible to submit a petition relating to such injury, as specified in section 2116 of such Act (42 U.S.C. 300aa–16). (iii) Eligibility To be eligible to submit a petition in accordance with clause (ii), the petitioner shall have submitted the request that was determined to be ineligible as described in clause (i) not later than the applicable deadline for filing a petition under such section 2116. (B) Requests initially submitted under section 2111 (i) In general If a special master determines that— (I) a petition submitted under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) related to a medical product for active immunization to prevent coronavirus disease 2019 that is ineligible for the program under subtitle 2 of title XXI of the Public Health Service Act (42 U.S.C. 300aa–10 et seq.) because it relates to a medical product administered at a time when the medical product was not included in the table under section 2114 of such Act (42 U.S.C. 300aa–14); and (II) the medical product was administered when it was a covered countermeasure subject to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)), the special master shall, not later than 30 days after such determination, notify the petitioner of such determination. (ii) Submission of request An individual who receives a notification described in clause (i) shall be eligible to submit a request for compensation under section 319F–4(b) of the Public Health Service Act (42 U.S.C. 247d–6e(b)) with respect to the same medical product administration claimed in the petition submitted under section 2111 of such Act (42 U.S.C. 300aa–11)— (I) not later than 1 year after receiving such notification; or (II) in the case that the notification is issued after judicial review of the petition under subsection (e) or (f) of section 2112 of such Act (42 U.S.C. 300aa–12), not later than 1 year after the judgment of the United States Court of Federal Claims or the mandate is issued by the United States Court of Appeals for the Federal Circuit pursuant to such subsection (e) or (f). (iii) Eligibility To be eligible to submit a request for compensation in accordance with clause (ii), the individual submitting the request shall have submitted the petition under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) that was determined to be ineligible not later than 1 year after the date of administration of the medical product. (2) Changes to certain programs (A) Section 319F–4 Section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e) is amended— (i) in subsection (b)(4)— (I) by striking Except as provided and inserting the following: (A) In general Except as provided; and (II) by adding at the end the following: (B) Exclusion of injuries eligible for petition under title XXI Notwithstanding any other provision of this section, no individual may be eligible for compensation under this section with respect to a vaccine that, at the time it was administered, was included in the Vaccine Injury Table under section 2114.; and (ii) in subsection (d)(3)— (I) by striking This section and inserting the following: (A) In general This section; and (II) by adding at the end the following: (B) Exhaustion of remedies A covered individual shall not be considered to have exhausted remedies as described in paragraph (1), nor be eligible to seek remedy under section 319F–3(d), unless such individual has provided to the Secretary all supporting documentation necessary to facilitate the determinations required under subsection (b)(4).. (B) Title XXI Title XXI of the Public Health Service Act (42 U.S.C. 300aa–1 et seq.) is amended— (i) in section 2111(a)(2)(A) (42 U.S.C. 300aa–11(a)(2)(A)), in the matter preceding clause (i), by inserting containing the information required under subsection (c) after unless a petition; (ii) in section 2112(d) (42 U.S.C. 300aa–12(d))— (I) by adding at the end of paragraph (1) the following: Such designation shall not occur until the petitioner has filed all materials required under section 2111(c).; and (II) in paragraph (3)(A)(ii), by striking the petition was filed and inserting on which the chief special master makes the designation pursuant to paragraph (1); (iii) in section 2114(e) (42 U.S.C. 300aa–14(e)), by adding at the end the following: (4) Licensure requirement Notwithstanding paragraphs (2) and (3), the Secretary may not revise the Vaccine Injury Table to include a vaccine for which the Centers for Disease Control and Prevention has issued a recommendation for routine use in children or pregnant women until at least one application for such vaccine has been approved under section 351. Upon such revision of the Vaccine Injury Table, all vaccines in a vaccine category on the Vaccine Injury Table, including vaccines authorized under emergency use pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, shall be considered included in the Vaccine Injury Table.; and (iv) in section 2116 (42 U.S.C. 300aa–16), by adding at the end the following: (d) Clarification Notwithstanding subsections (a) and (b), an injury or death related to a vaccine administered at a time when the vaccine was a covered countermeasure subject to a declaration under section 319F–3(b) shall not be eligible for compensation under the Program.. (b) Accelerating injury compensation program administration and ensuring program integrity (1) Petitions for compensation Section 2111(a)(2)(A)(i) of the Public Health Service Act (42 U.S.C. 300aa–11(a)(2)(A)(i)) is amended— (A) in subclause (I), by striking, and and inserting a semicolon; (B) in subclause (II)— (i) by moving the margin 2 ems to the right; and (ii) by striking, or and inserting; and; and (C) by adding at the end the following: (III) the judgment described in subclause (I) does not result from a petitioner's motion to dismiss the case; or. (2) Determination of good faith Section 2115(e)(1) of the Public Health Service Act (42 U.S.C. 300aa–15(e)(1)) is amended by adding at the end the following: When making a determination of good faith under this paragraph, the special master or court may consider whether the petitioner demonstrated an intention to obtain compensation on such petition and was not merely seeking to satisfy the exhaustion requirement under section 2121(b).. (c) Extension of deadlines To submit requests for compensation for certain injuries (1) In general With respect to claims filed under section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e) alleging a covered injury caused by the administration or use of a covered countermeasure pursuant to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) relating to coronavirus disease 2019, the following shall apply: (A) Notwithstanding the filing deadline applicable under such section 319F–4, the claim shall be filed within 3 years of the administration or use of the covered countermeasure, or 1 year after the date of enactment of this Act, whichever is later, and, if a claim filed under such section 319F–4 with respect to such administration or use was filed before the date of enactment of this Act and denied on the basis of having not been filed within the time period required under subsection (b)(4) of such section 319F–4, such claim may be refiled pursuant to this subparagraph. (B) With respect to a claim relating to the administration of a medical product for active immunization to prevent coronavirus disease 2019 such a claim may be filed under such section 319F–4 only if the administration of such vaccine occurred prior to the addition of the vaccine to the Vaccine Injury Table under section 2114 of the Public Health Service Act (42 U.S.C. 300aa–14).