United States of America Covid Vaccine NFCS

Introduction

The US had an existing no-fault compensation scheme for standard vaccines including childhood vaccines, the National Vaccine Injury Compensation Program (VCIP).

Covid Vaccines were not included in VCIP. Instead, they were included the Countermeasures Injury Compensation Program (CICP). The provisions to create the CICP were effective from 30 December 2005, and covid-19 vaccines were incorporated from 17 March 2020.

The CICP was created under federal legislation; the Public Readiness and Emergency Preparedness Act, or PREP Act, (as defined in section 319F-3(i)(2) of the Public Health Service Act (PHS Act)). The PREP Act established the CICP to provide compensation to eligible individuals for serious physical injuries or death directly caused by the administration or use of pandemic, epidemic, or security countermeasures identified in declarations issued by the Secretary pursuant to section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d).

It is administered by the Health Resources & Services Administration, who are an Agency of the U.S. Department of Health and Human Services.

The funding for the scheme comes from the Federal Government.

Vaccines Covered

This NFCS includes vaccines approved for emergency use and standard approvals. To be a covered countermeasure a vaccine must be:-

administered in the US, and
must be

approved or cleared under the Food Drug & Cosmetics Act;
licensed under the Public Health Service Act (PHS); or
authorized for emergency use under Sections 564, 564A, or 564B of the Food Drug & Cosmetics Act

Injuries Covered

This NFCS covers both temporary and permanent injuries. Under this NFCS only eligible injuries are covered. Eligible injuries are serious physical injuries or death. A serious physical injury is defined as an injury that (a) is life threatening; (b) results in permanent impairment of a body function or permanent damage to a body structure; or (c) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure (section 319F-3(i)(10) of the PHS Act (42 U.S.C. 247d-6d(i)(10)).

The PREP Act makes provision for a Table of injuries where a rebuttable presumption of causation exists. As at February 2023 there is not a Countermeasures Injury Table for Covid-19 vaccines. All non-table injuries require that the injury must be a direct result of the administration of the vaccine. Proof must be based on compelling, reliable, valid, medical and scientific evidence.

Charges for making a claim

There is no charge for making a claim under this scheme. It is the responsibility of the claimant to provide medical records to the scheme, no funding is provided for this.

Claimants

Under this scheme the following categories of individuals are permitted to make a claim.

Live vaccine recipient/their authorised representative
Eligible Survivors/Beneficiaries of a deceased vaccine recipient/their authorised representative
The estate of a deceased vaccine recipient

Under this scheme the claimant is allowed to nominate a personal or a legal representative to make their claim. Funding for the personal or legal representation is not provided by the scheme.

The priority order for Eligible survivors is:-

Priority	Category
1	Spouse and no surviving child(ren) of the vaccine recipient - A spouse will qualify for CICP benefits if he or she qualifies as a spouse under the Public Safety Officers’ Benefits (PSOB) Program
2	Spouse, child(ren), and minor dependent(s) - if there is at least one surviving child of the vaccine recipient and a surviving spouse: The spouse may receive 50% of the death benefit and the child(ren) and minor dependent(s) may receive a percentage. A surviving child will qualify under this category if he or she is a natural, illegitimate, adopted, or posthumous child, or stepchild of a vaccine recipient who, at the time of the vaccine recipient’s death, is: 18 years old or younger, or between 19 and 22 years of age and a full-time student, or incapable of self-support due to a physical or mental disability, regardless of age
3	Child(ren) and no surviving spouse - If there is at least one surviving child (as defined in category two above) but no surviving spouse, the surviving child (or surviving children in equal shares) receives the death benefit.
4	Named Beneficiary and no surviving spouse or child(ren) – If the vaccine recipient dies without a spouse, child, or dependent minor, then the person(s) named in a beneficiary designation form supplied by an employer or, if no such form exists, the most recently executed insurance policy may be eligible for death benefits. The individual(s) may receive the entire death benefit.
5	Parents and no spouse, no child, no minor dependent, and no named beneficiary - If there is no spouse, no child, no minor dependent, and no named beneficiary, then the two parents may divide the death benefit into equal shares. If there is only one surviving parent, then he or she would receive the entire benefit.
6	Legal guardian of a deceased minor without surviving parents - If the deceased vaccine recipient was a minor, then his or her legal guardian if other than a parent (such as a grandparent) may receive the death benefit if there are no other survivors as listed above under the standard calculation.
7	Adult Children - if none of the above: If there is no spouse, no child as defined under category two above, no minor dependent, no named Beneficiary, and no surviving parent, then the death benefit may be paid to the individual(s) who would qualify as surviving child(ren) under category two above, but for age

Under the CICP there is an additional category of survivors who may be eligible for the alternative calculation of the death benefit.

Dependent(s) younger than the age of 18: A person whom the Internal Revenue Service would consider to be the deceased vaccine recipient’s dependent at the time the covered injury was sustained and who is younger than the age of 18 at the time of the filing of the Request Form. This category may include individuals who would also qualify as a surviving minor child (as defined under category two in the section above) as well as dependents other than the decedent’s children, such as nieces, nephews, foster children, or other minors. Surviving dependents younger than the age of 18 under this category have the same priority as surviving children as described under category two in the section above (2. Spouse, child(ren), and minor dependent(s)).

Losses covered

This scheme is secondary of other collateral sources of payment, such as health insurance and other statutory entitlements. Collateral sources should be exhausted before a claim will be paid by the scheme.

The scheme pays the following

Live Vaccine Recipient	Survivors/Beneficiaries of a Deceased Vaccine Recipient	Estate of a Deceased Vaccine Recipient
Only eligible economic losses are compensated	Compensation payments are for general categories and are not broken down into economic and non-economic losses.	Only eligible economic losses are compensated

The following categories of benefits and reimbursements are available.

Live Vaccine recipients

medical expenses – where reasonable and necessary and not paid by insurance/Government programs such as Medicaid or Veterans Benefits
Lost income – this is only available for those who have been unable to work for more than five days.

Survivors of a deceased vaccine recipient

Death Benefits – these are capped at the standard maximum death benefit under the Public Safety Officers’ Benefits program (this is updated annually, for eligible deaths and disabilities that occurred on or after 1 October 2022 it is $422,035).

Estate of a deceased Vaccine recipients

medical expenses – If an individual injured as a result of a covered vaccine dies (regardless of the cause of death) before CICP has paid all medical and/or lost employment income benefits due, the individual’s estate may be eligible to receive those benefits
Lost income – as per medical expenses above.

Payments consist of a mixture of periodic payments and a lump sum payment.

Funeral expenses are not available under this NFCS.

Compensation for live vaccine recipients and Estates is fully individualised under this scheme.

Loss of earnings are paid under this scheme. They are quantified on an individual basis set out in Section 239d(a)(B). Lost earnings calculated at 66.67 % of their income at the time of the injury. If the injured vaccine recipient has one or more dependents this is augmented by 8.33%.

The total value of benefits paid has a top cap of $50,000 a year and a lifetime cap equivalent to the standard maximum death benefit under the Public Safety Officers’ Benefits. Section 239d(c)(3)(A)(ii) states that the lifetime cap does not apply to those under a disability as defined in Section 416(i) of the Public Health and Welfare Act. Section 416(i) defines a disability as (A) inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or has lasted or can be expected to last for a continuous period of not less than 12 months, or (B) blindness; and the term ‘‘blindness’’ means central visual acuity of 20/200 or less in the better eye with the use of a correcting lens. An eye which is accompanied by a limitation in the fields of vision such that the widest diameter of the visual field subtends an angle no greater than 20 degrees shall be considered for purposes of this paragraph as having a central visual acuity of 20/200 or less.

There is no minimum claim value under this NFCS, but loss of earnings cannot be claimed for the first five work days of lost employment. This does not apply if the individual is claiming for lost employment for 10 or more work days. Lost earnings can only be claimed until the vaccine recipient reaches the age of 65.

Time limits for claims

For Table injuries an injury will only be eligible for compensation if it occurs within a set time of the vaccination, which is specified on the Table. There is currently no table for Covid-19 vaccine injuries.

A claim under the scheme must be brought within 1 year from vaccination.

Evaluating claims – standard of proof required

Claims are assessed using an administrative process described in the:-

Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule (A Rule by the Health and Human Services Department on 21 October 2010), and
Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule (A Rule by the Health and Human Services Department on 7 October 2011),

Briefly, it is the responsibility of the claimant to ensure that CICP has received the information required in the Request for Benefits package, which includes:-

Request for Benefits form
Authorisation for Use or Disclosure of Health Information Form (a separate form is needed for each healthcare provider who treated the vaccine recipient)
Proof of administration of a covered vaccine, for example a Covid-19 vaccine card.
Medical records. These can be submitted either by the claimant/their representative or the health care provider(s). The CICP prefers that medical records are sent directly to the program by the health care provider(s). Medical records must include:-

All medical records documenting medical visits, procedures, consultations, and test results that occurred on or after the date of administration of the Covid-19 Vaccine.
All hospital records, including the admission history and physical examination, the discharge summary, all physician subspecialty consultation reports, all physician and nursing progress notes, and all test results that occurred on or after the date of administration of the Covid-19 Vaccine.
All medical records for one year prior to the Covid-19 vaccination, as necessary, to show any pre-existing medical history.

The Request for Benefits Package must be submitted either via the HRSA Injury Compensation Programs Website or by mail. Once received the Request for Benefits Package is reviewed by CICP medical staff to determine eligibility for benefits. The standard of proof required by the scheme varies depending on whether the injury is a Table Injury or a non-Table injury.

For injuries included in the Table of injuries a rebuttable presumption of causation exists. As at February 2023 there is not a Countermeasures Injury Table for Covid-19 vaccines.

All non-table injuries require that the injury must be a direct result of the administration of the vaccine. Proof must be based on compelling, reliable, valid, medical and scientific evidence.

Appeals and the right to litigate

This scheme is a removes the right to litigate.

There is an internal appeals process where the NFCS itself reconsiders the decision. Requests for reconsideration must be received in writing within 60 days of the CICP’s decision that the claim was not eligible for compensation. Judicial review of the NFCS decision is not permitted.