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This proposed rule would establish the COVID-19 Countermeasures Injury Table for the Countermeasures Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of covered injuries or their health complications. One way that an individual who was administered or used a covered countermeasure can show that they sustained a covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within the time interval set forth on the Table. The Table will list and explain injuries that, based on compelling, reliable, valid, medical, and scientific evidence, are presumed to be caused by covered COVID-19 countermeasures, and set forth the time periods in which the onset of these injuries must occur after the administration or use of these covered COVID-19 countermeasures.

Statement of Need:

The PREP Act directs the Secretary to establish, through regulations, a Table identifying serious physical injuries that are presumed to be directly caused by the administration or use of a covered countermeasure. The Secretary may only identify such injuries if it is determined based on compelling, reliable, valid, medical and scientific evidence'' that the administration or use of the covered countermeasure directly causes such covered injuries.  A Table creates a rebuttable presumption of causation, for compensation purposes, for eligible individuals whose injuries are listed on and meet the requirements of the Table. 

Summary of the Legal Basis:

Section 319F-4 of the Public Health Service Act, as amended, directs the Secretary, following issuance of a declaration under Section 319F-3(b), to establish procedures for the CICP to provide medical and lost employment benefits to certain individuals who sustained a covered injury as the direct result of the administration or use of a covered countermeasure consistent with a declaration issued pursuant to section 319F-3(b), or in good faith belief that administration or use of the covered countermeasure was consistent with a declaration.  The CICP’s regulations are set forth in 42 C.F.R. Part 110.  42 C.F.R. 110.20(a) states that individuals must establish that a covered injury occurred to be eligible for benefits under the Program.  A covered injury is death or a serious injury determined by the Secretary to be: (1) An injury meeting the requirements of a Table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or (2) an injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure.  Through this NPRM, the Secretary proposes to add the COVID-19 Countermeasures Injury Table to subpart K of 42 C.F.R. part 110, which lists Injury Tables for covered countermeasures, by adding sections (e) and (f).

Alternatives:

An alternative is to continue to review each claim and the associated medical records individually to ensure the requester has demonstrated that the injury occurred as the direct result of the administration or use of a covered countermeasure. This approach would be more time- and resource-intensive than providing an evidence-based presumption of causation by publishing a COVID-19 Countermeasures Injury Table for the CICP.

Anticipated Costs and Benefits:

This NPRM will allow requesters who were administered or used a covered COVID-19 countermeasure and whose alleged injuries are listed on the Table, but who missed the one-year filing deadline, to be able to file their claim within one year from the publication of the Table.  Also, future requesters, and previous requesters who were denied compensation, will be able to benefit from the presumption of causation afforded by their injuries being included on the Table, rather than needing to prove causation on a case-by-case basis. This will likely increase the number of claims filed and compensated. However, in rare instances that a COVID-19 countermeasure injury has occurred, this will decrease the burden on requesters allowing them to more easily receive compensation that may include reasonable unreimbursed medical expenses, lost employment income, and survivor death benefit.

Risks:

None