(b) Table definitions and requirements. The Table Definitions
that follow shall apply to, define and describe the scope of, and be
read in conjunction with paragraph (a) of this section.
(1) Significant local skin reaction—(i) Definition. Significant
local skin reaction is, for purposes of the Table, an unexpected
and extreme response at the vaccination or inoculation site that
results in a significant scar that is serious enough to require surgical
intervention. The onset of this injury is the initial skin lesion
at the vaccination or inoculation site that generally occurs with
smallpox vaccinations or inoculations. Minor scarring or minor local
reactions do not constitute a Table injury. Even a robust take, defined
as an area of redness at the vaccination site that exceeds 7.5 cm
in diameter with associated swelling, warmth and pain, in general
is considered an expected response to the vaccination or inoculation.
A robust take does not in itself constitute a Table injury, even
when the redness and swelling involves the entire upper arm with
associated enlargement and tenderness of the glands (lymph nodes)
in the underarm (axilla).
(ii) Table requirements. A Table injury for a significant
local skin reaction in a recipient or contact requires sufficient
evidence in the medical records of the occurrence of a significant
local skin reaction at the vaccination or inoculation site and a
permanent, disfiguring scar that resulted from the significant local
skin reaction. The scar must be of sufficient severity to require
surgical intervention to correct a significant cosmetic (e.g., keloid)
or functional (e.g., contracture) deformity and such surgery must
be included in the treatment plan documented in the medical records.
(2) Stevens-Johnson Syndrome (SJS)—(i) Definition. SJS
(sometimes called erythema multiforme major) is an acute hypersensitivity
reaction that affects skin, mucous membranes, and sometimes internal
organs (systemic toxicity). For purposes of the Table, both skin
and mucous membrane rash or lesions must be present and the rash
or lesions may not cover less than ten percent of body surface area.
In SJS, mucosal involvement generally predominates. Mucosal lesions
generally occur at more than one location and manifest as painful
lesions in sites such as the mouth or eyes. Skin rash or lesions
in SJS usually consist of red raised areas (erythematous macules),
blisters, and ulcerations.
(ii) Table requirements. A Table injury for SJS in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of SJS. The SJS, or related complications, must be
of sufficient severity to require inpatient hospitalization.
(3) Inadvertent Inoculation (II)—(i) Definition. II
is the spread of vaccinia virus from an existing vaccination or inoculation
site to a second location usually by scratching the vaccination or
inoculation site and subsequently spreading the virus, which produces
a new vaccinial lesion on the same person. Alternatively, II is the
spread of vaccinia virus from an existing vaccination or inoculation
site to another person usually by scratching an existing vaccination
or inoculation site and subsequently spreading the virus, resulting
in a contact case.
(ii) Table requirements. A Table injury for II in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of II and the occurrence of one of the following:
(A) Eye lesions, e.g., vaccinial keratitis or vaccinial blepharitis,
that resulted from II and that led to a permanent sequela, e.g.,
decrease in visual acuity;
(B) Permanent and disfiguring scar(s) that resulted from II. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the treatment
plan documented in the medical records; or
(C) Acute II or related complications of sufficient severity to
require inpatient hospitalization.
(4) Generalized Vaccinia (GV)—(i) Definition. GV
is a vaccinial infection that occurs from the spread of vaccinia
from an existing vaccination or inoculation site to otherwise normal
skin, resulting in multiple new areas of vaccinial rash or lesions.
The vaccinia is believed to be spread through the blood. The rash
or lesions are characterized by multiple blisters (vesicles or pustules)
that generally evolve in a similar sequence or manner as the original
vaccination or inoculation site.
(ii) Table requirements. A Table injury for GV in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of GV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from GV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the treatment
plan documented in the medical records; or
(B) Acute GV or related complications of sufficient severity to
require inpatient hospitalization.
(5) Eczema Vaccinatum (EV)—(i) Definition. EV
is the transmission or the spread of vaccinia virus from a vaccination
or inoculation site to skin that has been affected by, or is currently
affected with, eczema or atopic dermatitis. EV is characterized by
lesions that include multiple blisters (vesicles or pustules), which
generally evolve in a similar sequence or manner as the original
vaccination or inoculation site. The lesions may come together to
form larger lesions. Lesions may also spread to patches of skin that
have never been involved with eczema or atopic dermatitis. A person
with EV may be quite ill with signs and symptoms that involve the
whole body (systemic illness), such as fever, malaise, or enlarged
glands (lymph nodes).
(ii) Table requirements. A Table injury for EV in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of EV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from EV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the treatment
plan documented in the medical records; or
(B) Acute EV or related complications of sufficient severity to
require inpatient hospitalization.
(6) Progressive Vaccinia (PV)—(i) Definition. PV
is the failure to initiate the healing process in an initial vaccination
or inoculation site by 21 days after exposure to vaccinia with progressive
ulceration or necrosis at the vaccination or inoculation site leading
to a large destructive ulcer. PV is seen in people with an impaired
immune system (immunocompromised) and is characterized by a complete
or near complete lack of inflammation or absence of inflammatory
cells in the dermis of the skin at the vaccination or inoculation
site. The diagnosis of PV may be made before 21 days after exposure,
especially in a known immunocompromised individual who develops a
lesion at the vaccination or inoculation site. PV may spread through
the blood to any location in the body. Any person who initiates a
significant healing process of the vaccination or inoculation site
by 21 days after receipt of the smallpox vaccine or exposure to vaccinia
does not have PV.
(ii) Table requirements. A Table injury for PV in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of PV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from PV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the treatment
plan documented in the medical records; or
(B) Acute PV or related complications of sufficient severity to
require inpatient hospitalization.
(7) Postvaccinial Encephalopathy, Encephalitis or Encephalomyelitis
(PVEM)—(i) Definition. PVEM is, for the purposes
of the Table, an autoimmune central nervous system injury. In rare
cases, the vaccinia virus is isolated from the central nervous
system. Manifestations usually occur abruptly and may include fever,
vomiting, loss of appetite (anorexia), headache, general malaise,
impaired consciousness, confusion, disorientation, delirium, drowsiness,
seizures, language difficulties (aphasia), coma, muscular incoordination
(ataxia), urinary incontinence, urinary retention, and clinical
signs consistent with inflammation of the spinal cord (myelitis)
such as paralysis or meningismus. Long term central nervous system
impairments such as paralysis, seizure disorders, or developmental
delays are known to occur as sequelae of the acute PVEM. No clinical
criteria, radiographic findings, or laboratory tests are specific
for the diagnosis of PVEM.
(ii) Table requirements. A Table injury for PVEM in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of acute PVEM. The acute PVEM or related complications
must be of sufficient severity to require inpatient hospitalization.
(8) Fetal Vaccinia (FV)—(i) Definition. FV is
an intrauterine vaccinial infection subsequent to vaccinia vaccination
or inoculation of the mother that results from the placental transmission
of the vaccinia virus during any time in the pregnancy. FV manifests
as multiple skin lesions or organ involvement and may result in significant
scarring or death. FV skin lesions are similar to those seen in GV
or PV and the lesions may come together to form larger lesions. Congenital
malformations, other than those described above, are not Table injuries.
(ii) Table requirements. A Table injury for FV requires sufficient
evidence in the medical records of the occurrence of the FV. The
occurrence of the FV or related complications must be of sufficient
severity to require inpatient hospitalization or result in permanent
and disfiguring scar(s). In addition, a Table injury for FV requires
one of the following:
(A) A maternal history of vaccinial vaccination or inoculation,
with the occurrence of vaccinial skin or mucous membrane lesions
within the incubation period for vaccinia during the pregnancy in
a maternal recipient or contact; or
(B) Isolation of vaccinia from intrauterine or neonatal tissue.
(9) Secondary Infection (SI)—(i) Definition. SI
is, for purposes of the Table, a non-vaccinial bacterial, fungal,
or viral infection at the site of a vaccinial skin or mucous membrane
lesion. SI occurs because the blister formation or ulceration that
is part of the normal progression of a vaccinial skin or mucous membrane
lesion disrupts the surface of the skin or mucous membrane, allowing
potential germs to invade and infect the vaccinial skin or mucous
membrane lesion leading to significant illness requiring hospitalization.
(ii) Table requirements. A Table injury for SI in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of SI. The acute SI or related complications must
be of sufficient severity to require inpatient hospitalization.
(10) Anaphylaxis or Anaphylactic shock—(i) Definition. Anaphylaxis
or anaphylactic shock is, for purposes of the Table, as an acute,
severe, and potentially lethal systemic allergic reaction to a component
of the smallpox vaccine.
(ii) Table requirements. A Table injury for anaphylaxis or
anaphylactic shock in a recipient requires sufficient evidence in
the medical records of the occurrence of an acute anaphylaxis or
anaphylactic shock. The anaphylaxis or anaphylactic shock must be
of sufficient severity to require inpatient hospitalization. Anaphylaxis
or anaphylactic shock is not a Table injury for contacts.
(11) Vaccinial Myocarditis, Pericarditis, or Myopericarditis
(MP)—(i) Definition. MP is, for purposes of the
Table, vaccinial myocarditis, pericarditis, or myopericarditis.
Myocarditis is defined as an inflammation of the heart muscle (myocardium).
Pericarditis is defined as an inflammation of the covering of the
heart (pericardium). Myopericarditis is defined as an inflammation
of both the heart muscle and its covering. The inflammation associated
with MP may range in severity from very mild (subclinical) to life
threatening. In many mild cases, myocarditis is diagnosed solely
by transient electrocardiographic (EKG) abnormalities (e.g., ST
segment and T wave changes), increased cardiac enzymes, or mild
echocardiographic abnormalities. Arrhythmias, abnormal heart sounds,
heart failure, and death may occur in more severe cases. Pericarditis
generally manifests with chest pain, abnormal heart sounds (pericardial
friction rub), EKG abnormalities (e.g., ST segment and T wave changes),
and/or increased fluid accumulation around the heart.
(ii) Table requirements. A Table injury for MP in a recipient
or contact requires sufficient evidence in the medical records of
the occurrence of acute MP. The acute MP (or related complications)
must be of sufficient severity to require inpatient hospitalization.
A death resulting from MP requires sufficient microscopic (histopathologic)
evidence of MP or its sequela in heart tissue.
(c) Glossary for purposes of this section.
(1) Blister or vesicle means a circumscribed, elevated skin
or mucous membrane lesion containing an accumulation of fluid.
(2) Contact means a person who developed a vaccinial lesion
or infection through inoculation (and not vaccination).
(3) Exposure period means the span of time during which vaccinia
virus can be transmitted from a vaccine recipient shedding vaccinia
or through a contact case shedding vaccinia.
(4) Inoculation means transmission of and infection with
the vaccinia virus through a means other than smallpox vaccination.
Spread (inoculation) of vaccinia virus may occur in two ways: either
self-inoculation in which the vaccinia virus is spread from the vaccinial
lesion at the vaccination site to one or more areas on the same person
or person-to-person inoculation when the vaccinia virus is spread
to another person, a contact.
(5) Inoculation site means the skin or mucous membrane surface
where the vaccinia virus entered the body through means other than
vaccination.
(6) Lesion means a pathologic change.
(7) Pustule means a circumscribed, elevated skin or mucous
membrane lesion containing an accumulation of white blood cells.
(8) Recipient means a person to whom the smallpox vaccine
was administered.
(9) Ulceration means a specific skin or mucous membrane lesion
characterized by erosion of the skin or mucous membrane surface.
(10) Vaccination means the administration and receipt of
the smallpox (vaccinia) vaccine, and not through contact.
(11) Vaccination site means the skin surface where the vaccinia
virus entered the body through vaccination.
 top
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
(a) Benefits available to smallpox vaccine recipients and vaccinia
contacts. A requester who is an eligible smallpox vaccine recipient
or vaccinia contact may be entitled to receive either medical benefits
or benefits for lost employment income, or both.
(b) Benefits available to survivors. A requester who is an
eligible survivor of a smallpox vaccine recipient or vaccinia contact
may be entitled to receive a death benefit.
(c) Benefits available to estates of deceased smallpox vaccine
recipients or vaccinia contacts. The estate of an otherwise
eligible deceased smallpox vaccine recipient or vaccinia contact
may be eligible to receive medical benefits or benefits for lost
employment income, or both, if such benefits were accrued during
the deceased person's lifetime as a result of a covered injury
or its health complications, but were not paid while the deceased
person was living. Such medical benefits and benefits for lost
employment income may be available regardless of whether the death
was the direct result of a covered injury or an unrelated factor.
The estate of a deceased smallpox vaccine recipient or vaccinia
contact may not receive a death benefit.
top
(a) Smallpox vaccine recipients and vaccinia contacts may receive
payments or reimbursements for medical services and items that the
Secretary determines to be reasonable and necessary to diagnose or
treat a covered injury or a health complication of a covered injury
(i.e., sequela). The Secretary may pay for such medical services
and items in an effort to cure, counteract, or minimize the effects
of any covered injury, or any health complication of a covered injury,
or to give relief, reduce the degree or the period of disability,
or aid in lessening the amount of monthly benefits to a requester
(e.g., a surgical procedure that lessens the amount of time and expense
for the treatment of a covered injury). The Secretary may make such
payments or reimbursements if the medical services and items have
already been provided or if they are likely to be provided in the
future. In making determinations about which medical services and
items are reasonable and necessary, the Secretary may consider whether
those medical services and items were prescribed or recommended by
a health care practitioner.
(b) To receive medical benefits for the health complications of
a covered injury, a requester must demonstrate that the complications
are the direct result of the covered injury. Examples of health complications
include, but are not limited to, complications of a covered injury
that occur as part of the natural course of the underlying disease,
an adverse reaction to a prescribed medication or diagnostic test
used in connection with a covered injury, or a complication of a
surgical procedure used to treat a covered injury.
(c) The calculation of medical benefits available under this Program
is described in §102.80. Although there are no caps on medical
benefits available under this Program, the Secretary may limit payments
to the amount he deems reasonable for those services and items he
considers reasonable and necessary. All payment or reimbursement
for medical services and items is secondary to any obligation of
any third-party payor to pay for or provide such services or items
to the requester. As provided in §102.84, the Secretary retains
the right to recover medical benefits paid to requesters by third-party
payors.
(d) The Secretary may make payments or reimbursements of medical
benefits to the estate of a deceased smallpox vaccine recipient or
vaccinia contact as long as such benefits were accrued during the
deceased person's lifetime as the result of a covered injury or its
health complications and were not paid during the deceased person's
lifetime.
top
(a) Requesters who are smallpox vaccine recipients or vaccinia contacts
may be able to receive benefits for loss of employment income incurred
as a result of a covered injury (or its health complications, as
described in §102.31(b)). These benefits are a percentage of
the employment income lost due to the covered injury or its health
complications.
(b) The method and amount of benefits for lost employment income
are described in §102.81. Benefits for lost employment income
will be adjusted if there are fewer than 10 days of lost employment
income. Benefits provided for lost employment income may also be
adjusted for annual and lifetime caps. Payment of benefits for lost
employment income is secondary to any obligation of any third-party
payor to pay for lost employment income or to provide disability
or retirement benefits to the requester. As provided in §102.84,
the Secretary retains the right to recover benefits for lost employment
income paid to requesters from third-party payors.
(c) The Secretary is not requiring an individual to use paid leave
(e.g., sick leave or vacation leave) to be paid for lost work days.
However, if an individual uses such paid leave in order to be paid
for lost work days, the Secretary will not consider the days in which
such leave was used to be days of lost employment income, unless
the individual's employer restores the leave that was used. By restoring
paid leave, an employer puts the individual in the same position
as if he or she had not used paid leave on the lost work day (i.e.,
takes back the payments made when the leave was taken and gives back
the leave to the employee for future use).
(d) The Secretary may pay benefits for lost employment income to
the estate of a deceased smallpox vaccine recipient or vaccinia contact
as long as such benefits were accrued during the deceased person's
lifetime as the result of a covered injury or its health complications
and were not paid to the deceased person during his or her lifetime.
top
(a) Eligible survivors may be able to receive a death benefit under
this Program if the Secretary determines that an otherwise eligible
deceased smallpox vaccine recipient or vaccinia contact sustained
a covered injury and died as a direct result of the injury. Annual
and lifetime caps may apply to the death benefits provided. The method
and amount of death benefits are described in §102.82. As provided
in §102.84, the Secretary retains the right to recover death
benefits paid to requesters from third-party payors. Death benefits
may be paid under two different calculations.
(b) The standard calculation, described in §102.82(c), is based
upon the death benefit available under the PSOB Program and is available
to all eligible survivors (except for surviving dependents younger
than the age of 18 who are not also surviving eligible children).
In the event that death benefits were paid under the PSOB Program
with respect to the deceased person, no death benefits may be paid
under the standard calculation. In addition, death benefits under
this standard calculation are secondary to disability benefits under
the PSOB Program. Any death benefit paid under the standard calculation
will be reduced by the total amount of benefits for lost employment
income paid to the smallpox vaccine recipient or vaccinia contact
during his or her lifetime and to his or her estate after death.
(c) The alternative calculation, described in §102.82(c), is
calculated based on the person's employment income at the time of
the covered injury. This calculation is only available to surviving
dependents who are younger than the age of 18. The legal guardian(s)
of such surviving dependents must select the death benefit as calculated
under this alternative calculation before it will be paid. The payment
of a death benefit as calculated under this alternative calculation
is secondary to other benefits received (compensation for loss of
employment income, death benefits (including PSOB Program death benefits),
disability benefits, or retirement benefits on behalf of the dependent(s)
or his or her legal guardian or life insurance benefits on behalf
of the dependent(s)).
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
Interested parties may obtain copies of all necessary forms and
instructions by sending a letter through the U.S. Postal Service,
commercial carrier, or private courier service, by telephone, or
by downloading them from the Program's website.
(a) If using the U.S. Postal Service, interested parties should
send letters asking for forms and instructions to the Smallpox Vaccine
Injury Compensation Program Office, Special Programs Bureau, Health
Resources and Services Administration, Parklawn Building, Room 16C–17,
5600 Fishers Lane, Rockville, MD 20857.
(b) If using a commercial carrier or private courier service, interested
parties should send letters asking for forms and instructions to
the Smallpox Vaccine Injury Compensation Program Office, Special
Programs Bureau, Health Resources and Services Administration, 4350
East-West Highway, 10th Floor, Bethesda, Maryland 20814.
(c) For forms and instructions, interested parties can call (888)
496–0338. This is a toll-free number.
(d) Interested parties can download forms and instructions from
the Internet at http://www.hrsa.gov/smallpoxinjury. Click
on the link to “Forms and Instructions.”
top
A Request Package comprises all the forms and documentation that
are submitted to enable the Secretary to determine eligibility and
calculate payments. Request Packages may be filed through the U.S.
Postal Service, commercial carrier, or private courier service. The
Smallpox Vaccine Injury Compensation Program Office will not accept
Request Packages electronically or by hand-delivery.
(a) If using the U.S. Postal Service, requesters (or their representatives)
should send all forms and documentation to the Smallpox Vaccine Injury
Compensation Program Office, Special Programs Bureau, Health Resources
and Services Administration, Parklawn Building, Room 16C–17,
5600 Fishers Lane, Rockville, MD 20857.
(b) If using a commercial carrier or private courier service, requesters
(or their representatives) should send all forms and documentation
to the Smallpox Vaccine Injury Compensation Program Office, Special
Programs Bureau, Health Resources and Services Administration, 4350
East-West Highway, 10th Floor, Bethesda, Maryland 20814.
top
(a) General. Filing deadlines vary depending on whether the
injured individual is a smallpox vaccine recipient or a vaccinia
contact. In all cases, the filing date is the date the Request Form
is postmarked. A legibly dated receipt from a commercial carrier,
a private courier service, or the U.S. Postal Service (e.g., the
date that a commercial carrier places on the package at the time
of drop-off) will be considered equivalent to a postmark. A Request
Form will not be considered filed unless it has been completed (to
the fullest extent possible) and signed by the requester or his or
her representative. After filing a Request Form within the governing
filing deadline, a requester can and should update the Request Form
to reflect new information.
(b) Request forms not filed within deadline. If the Secretary
determines that a Request Form was not filed within the governing
filing deadline set out in this section, the Request Form will not
be processed and the requester will not be entitled to any benefits
under this Program.
(c) Smallpox vaccine recipients. All Request Forms filed
by, or on behalf of, a smallpox vaccine recipient must be filed within
one year of the date of the administration of a smallpox vaccine
to the smallpox vaccine recipient. This deadline also applies to
a deceased smallpox vaccine recipient's survivor(s) and the representative
of his or her estate. This deadline applies to Request Forms concerning
injuries resulting from the administration of a smallpox vaccine
or other covered countermeasures.
(d) Vaccinia contacts. All Request Forms filed by, or on
behalf of, a vaccinia contact must be filed within two years after
the date of the first symptom or manifestation of onset of the covered
injury in the vaccinia contact. This deadline also applies to a deceased
vaccinia contact's survivor(s) and the representative of his or her
estate. This deadline applies to Request Forms concerning injuries
resulting from vaccinia contracted through accidental vaccinia inoculation
or from the administration of covered countermeasures (other than
the smallpox vaccine) as a result of such accidental vaccinia inoculation.
(e) Request forms (or amendments to request forms) based on modifications
to the table of injuries. The Secretary may amend the Table
set forth in §102.21. The effect of such an amendment may
enable a requester who previously could not establish a Table injury
to establish a Table injury. In such circumstances, the requester
must file a new Request Form or an amendment to a previously filed
Request Form as follows:
(1) If the injured person is a smallpox vaccine recipient, within
one year after the effective date of the amendment to the Table;
or
(2) If the injured person is a vaccinia contact, within two years
after the effective date of the amendment to the Table.
top
(a) Documentation for eligibility determinations. All eligibility
documentation required by the Program should be filed together with
the Request Form. However, if this is not possible, a requester will
satisfy the filing deadline as long as the signed Request Form is
completed (to the fullest extent possible) and submitted within the
governing filing deadline described in §102.42. The Secretary
will not generally begin his review of a requester's eligibility
until the documentation necessary for the Secretary to make this
determination has been submitted. All such documentation must be
submitted before the Program terminates.
(b) Documentation for benefits determinations. Although the
Secretary will accept documentation required to make benefits determinations
(i.e., calculate benefits available, if any) at the time the
Request Form is filed or any time thereafter, requesters need not
submit such documentation until they have been notified that the
Secretary has determined eligibility. The Secretary will not generally
begin his review of the benefits available to a requester until the
documentation necessary for the Secretary to make a benefits determination
has been submitted. All such documentation must be submitted before
the Program terminates.
top
(a) Persons other than a requester (e.g., a lawyer, guardian, friend)
may file a Request Package on a requester's behalf as his or her
representative. A requester need not use the services of a lawyer
to secure benefits under this Program. A representative (who does
not need to be a lawyer) is only required, as described in this section,
for requesters who are minors or legally incompetent adults. In the
event that a representative files on behalf of a requester, the representative
will be bound by the obligations and documentation requirements that
apply to the requester (e.g., if a requester is required to submit
employment records, the representative must file the requester's
employment records). The representative must also satisfy the requirements
specific to representatives set forth in this regulation. If a requester
has a representative, all communications from the Secretary will
be directed exclusively to the representative.
(b) Representatives of legally competent adults. A requester
who is a legally competent adult may use a representative
to submit a Request Package on his or her behalf. In such circumstances,
the requester must certify on the Request Form that he or she is
authorizing the representative to pursue benefits under this Program
on his or her behalf.
(c) Representatives of minors and legally incompetent adults. A
requester who is a minor or a legally incompetent adult must use
a representative to pursue benefits under this Program on his or
her behalf. In such circumstances, the representative must certify,
in the place provided on the Request Form, that the requester is
a minor or a legally incompetent adult and that the representative
is filing on behalf of the requester. In addition, before the requester
will be paid by the Program, the representative must submit the documentation
described in §102.63.
(d) No payment for attorneys' fees or costs. Because it is
not necessary to hire a lawyer to obtain benefits under this Program
and because attorneys' fees or other fees and costs to representatives
are not covered under the Act, the Secretary will not reimburse such
fees or costs.
top
Multiple survivors of the same smallpox vaccine recipient or vaccinia
contact may file Request Forms separately or together. Multiple survivors
may also submit one set of any required documentation on behalf of
all of the requesting survivors as long as such documentation is
identical for each survivor.
top
(a) Generally. All requesters may amend their documentation
concerning eligibility until the Secretary has made an eligibility
determination. Requesters also may amend their information or documentation
concerning the calculation of benefits until the Secretary has made
a benefits determination. The Secretary may, at his discretion, accept
eligibility or benefits documents even after eligibility or benefits
determinations have been made (e.g., the Secretary may accept new
documents concerning eligibility after determining that a requester
is ineligible and may use such documents to reevaluate the earlier
eligibility determination). However, such new documentation will
not be used in any reconsideration regarding the initial determination.
The Secretary will not consider any documentation submitted after
the Program terminates.
(b) Requesters who are survivors. If a smallpox vaccine recipient
or vaccinia contact submitted a Request Form within the filing deadline,
but subsequently dies, his or her survivor(s) may amend his or her
Request Package at any time before the Program terminates in order
to be considered eligible for death benefits. Such an amendment can
be filed regardless of whether the Secretary made an eligibility
determination or paid benefits with respect to the deceased person's
Request Package. However, a survivor filing an amendment to a previously
filed Request Package may only be entitled to benefits if the previously
filed Request Package was filed within the governing filing deadline.
All documentation that has already been submitted with respect to
the deceased person will be considered part of the survivor requester's
Request Package, and he or she is not required to resubmit such documentation.
Survivor requesters must also file an amendment to a Request Package
if there is a change in the order of priority of survivors, as described
in §102.11. Such an amendment may be filed at any time before
the Program terminates.
(c) Requests in which benefits are sought by the estate of a
deceased smallpox vaccine recipient or vaccinia contact. If
a smallpox vaccine recipient or vaccinia contact submitted a Request
Form within the filing deadline, but subsequently dies, a representative
of his or her estate may amend his or her Request Package at any
time before the Program terminates in order to be considered eligible
for benefits. Such an amendment can be filed regardless of whether
the Secretary made an eligibility determination or paid benefits
with respect to the deceased person's Request Package. However,
a representative of an estate filing an amendment to a previously
filed Request Package may only be entitled to benefits if the previously
filed Request Package was filed within the governing filing deadline.
All required documentation that has already been submitted with
respect to the deceased person will be considered part of the amended
Request Package, and the representative of the estate is not required
to resubmit such documentation.
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
(a) In order to establish that a smallpox vaccine recipient or vaccinia
contact sustained a covered injury, a requester must submit the following
medical records:
(1) All physician, clinic, or hospital outpatient medical records
documenting medical visits, consultations, and test results that
occurred on or after the date of the smallpox vaccination or exposure
to vaccinia; and
(2) All inpatient hospital medical records, including the admission
history and physical examination, the discharge summary, all physician
subspecialty consultation reports, all progress notes, and all test
results that occurred on or after the date of the smallpox vaccination
or exposure to vaccinia.
(b) A requester may submit additional medical documentation that
he or she believes will support the Request Package. Although generally
not required if a Table injury was sustained, a requester may need
to introduce additional medical documentation or scientific evidence
in order to establish that an injury was caused by a covered countermeasure
(including the smallpox vaccine) or vaccinia contracted through accidental
vaccinia inoculation.
(c) If certain medical records listed in paragraph (a) of this section
are unavailable to the requester after he or she has made reasonable
efforts to obtain the records, the requester must submit a statement
describing the reasons for the records' unavailability and the efforts
he or she has taken to obtain the records. The Secretary has the
discretion to accept such a statement in place of the unavailable
medical records. In this circumstance, the Secretary may require
an authorization from the requester (or his or her representative)
to try to obtain the records on his or her behalf.
(d) In certain circumstances, the Secretary may require additional
medical records to make a determination that a covered injury was
sustained (e.g., medical records prior to the date of vaccination
or accidental vaccinia exposure) or may determine that certain records
described in paragraph (a) of this section are not necessary for
an eligibility determination (e.g., records that are duplicative
of other records submitted). If the Program requests additional medical
records (or information) from a requester's health care practitioner,
then the requester may use a release form in order to have the medical
records sent directly to the Program.
top
(a) A smallpox vaccine recipient must submit the following documentation
in order to be deemed eligible by the Secretary:
(1) A completed (to the fullest extent possible) and signed Request
Form.
(2) Documentation demonstrating that the requester:
(i) Is a health care worker, law enforcement officer, firefighter,
security personnel, emergency medical personnel, other public safety
personnel, or support personnel for such occupational specialties
who has volunteered and been selected to be a member of a smallpox
emergency response plan prior to the time at which the Secretary
publicly announces that an active case of smallpox has been identified
within or outside of the United States and that the requester is
or will be functioning in a role identified in a smallpox emergency
response plan; and
(ii) Was administered a smallpox vaccine pursuant to an approved
smallpox emergency response plan during the effective period of the
Declaration.
(3) If the requester's injury relates to the administration of cidofovir
or its derivatives or Vaccinia Immune Globulin, and not the smallpox
vaccine, documentation demonstrating that the requester was administered
such a covered countermeasure during the effective period of the
Declaration.
(4) Medical records sufficient to demonstrate that the requester
sustained a covered injury, as described in §102.3(g), in accordance
with the requirements set forth in §102.50.
(b) As an alternative to the documentation described in paragraphs
(a)(2)(i)–(ii) of this section (documentation concerning a
vaccine recipient's participation in, and receipt of the smallpox
vaccine under, an approved smallpox emergency response plan), a requester
may submit a certification, by a Federal, State, or local government
entity or private health care entity participating in the administration
of covered countermeasures through a smallpox emergency response
plan, that the requester is a person described in §102.3(x)(1)–(3)
(a person meeting the definition of a smallpox vaccine recipient,
except for the requirement that the person sustained a covered injury).
A certification form that may be used for this purpose is available
from the Program.
[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]
top
A requester who is a vaccinia contact must submit the following
documentation in order to be deemed eligible by the Secretary:
(a) A completed (to the fullest extent possible) and signed Request
Form;
(b) Documentation identifying the individual who was the source
of the accidental vaccinia inoculation. This documentation must demonstrate
that the source of the vaccinia was an individual described in §102.3(x)(1)–(3)
(a person meeting the definition of a smallpox vaccine recipient,
except for the requirement that the person sustained a covered injury)
or an individual who was accidentally inoculated by an individual
described in §102.3(x)(1)–(3) (a person meeting the definition
of a smallpox vaccine recipient, except for the requirement that
the person sustained a covered injury). If the requester is unable
to provide the identity of the person who was the source of the accidental
exposure, he or she must explain in writing both why this criterion
cannot be met and the circumstances of the accidental vaccinia inoculation
that support an individual described above as the source of the accidental
vaccinia inoculation. The Secretary has the discretion to accept
the requester's statement as evidence of the requester's source of
exposure; and
(c) Medical records sufficient to demonstrate that the requester
contracted vaccinia during the effective period of the Declaration
(or within 30 days thereafter) and sustained a covered injury, as
described in §102.3(g), in accordance with the requirements
set forth in §102.50. These records must be consistent with
the requester contracting vaccinia after the accidental vaccinia
inoculation described in paragraph (b) of this section.
top
A requester who is a survivor must submit the following documentation
in order to be deemed eligible by the Secretary:
(a) A completed (to the fullest extent possible) and signed Request
Form;
(b) All of the documentation required in:
(1) Section 102.51(a)(2)–(4) (documentation requirements for
smallpox vaccine recipients), in the case of a deceased smallpox
vaccine recipient. The survivor requester may submit a certification,
as described in §102.51(b) in the place of the documentation
described in §102.51(a)(2) (documentation concerning a vaccine
recipient's participation in, and receipt of the smallpox vaccine
under, an approved smallpox emergency response plan); or
(2) Section 102.52(b)–(d) (documentation requirements for
vaccinia contacts), in the case of a deceased vaccinia contact;
(c) A death certificate for the deceased smallpox vaccine recipient
or vaccinia contact. If a death certificate is unavailable, the requester
must submit a letter providing the reasons for its unavailability.
The Secretary has the discretion to accept other documentation as
evidence that the smallpox recipient or vaccinia contact is deceased;
(d) Medical records sufficient to demonstrate that the deceased
smallpox vaccine recipient or vaccinia contact died as the result
of the covered injury. Such medical records may be the same as those
required under §102.50. If an autopsy was performed on the deceased
smallpox vaccine recipient or vaccinia contact, the requester must
submit a complete copy of the final autopsy report.
(e) Documentation showing that the requester is an eligible survivor,
pursuant to §102.11 (e.g., birth certificate or marriage certificate);
and
(f) A certification, on the place provided on the Request Form,
either that there are no other eligible survivors (e.g., for surviving
eligible children, a certification that there is no surviving spouse,
no other surviving eligible children, and no other surviving dependents
younger than the age of 18 who may be eligible for the death benefit
under the alternative calculation) or that other eligible survivors
exist (along with the information known about such survivors). Section
102.11 lists eligible survivors and the priorities of survivorship.
top
A requester who is the representative of the estate of a deceased
smallpox vaccine recipient or vaccinia contact must submit the following
documentation in order for the estate to be deemed eligible by the
Secretary:
(a) A completed (to the fullest extent possible) and signed Request
Form;
(b) All of the documentation required in:
(1) Section 102.51(a)(2)–(4) (documentation requirements for
smallpox vaccine recipients), in the case of a deceased smallpox
vaccine recipient. The requester may submit a certification, as described
in §102.51(b) in the place of the documentation described in §102.51(a)(2)
(documentation concerning a vaccine recipient's participation in,
and receipt of the smallpox vaccine under, an approved smallpox emergency
response plan); or
(2) Section 102.52(b)–(d) (documentation requirements for
vaccinia contacts), in the case of a deceased vaccinia contact;
(c) A death certificate for the deceased smallpox vaccine recipient
or vaccinia contact. If a death certificate is unavailable, the requester
must submit a letter providing the reasons for its unavailability.
The Secretary has the discretion to accept other documentation as
evidence that the smallpox recipient or vaccinia contact is deceased;
and
(d) Documentation showing that the requester is the representative
of the estate of the deceased smallpox vaccine recipient or vaccinia
contact.
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
A requester deemed eligible by the Secretary who seeks payment or
reimbursement for medical services or items must submit the following,
in addition to the documentation submitted under subpart F:
(a) List of third-party payors. The requester must submit
a list of all third-party payors that may have an obligation to pay
for or provide any medical services or items for which payment or
reimbursement is being sought under this Program. Such third-party
payors may include, but are not limited to, health maintenance organizations,
health insurance companies, Medicare, Medicaid, and other entities
obligated to provide medical services or items or recompense individuals
for medical expenses. Such a list must include the individual's account
numbers and other applicable information. If the requester knows
of no such third-party payor, he or she must certify to that fact.
If the requester becomes aware that a third-party payor may have
such an obligation, the requester must inform the Secretary within
10 business days of becoming aware of this information.
(b) Documents for medical services or items provided in the past. A
requester seeking payment or reimbursement for medical services or
items provided in the past must submit an itemized statement from
each health care entity (e.g., clinic, hospital, doctor, or pharmacy)
and third-party payor listing the services or items provided to diagnose
or treat the covered injury or its health complications and the amounts
paid or expected to be paid by third parties for such services or
items (e.g., an Explanation of Benefits from the individual's health
insurance company). If no third-party payor has an obligation to
pay for or provide such services or items, the requester must certify
to that fact and submit an itemized list of the services or items
provided (including the total cost of such services or items). To
assist the Secretary in making a determination as to whether such
services or items were reasonable and necessary to diagnose or treat
a covered injury or its health complications, the requester may submit,
in addition to the required medical records, documentation showing
that a health care practitioner prescribed or recommended such services
or items. The medical records must support the requested services
and items;
(c) Documents for medical services and items expected to be provided
in the future. A requester seeking payments for medical services
or items expected to be provided in the future must submit a statement
from one or more health care practitioner(s) (e.g., a treating
neurologist for neurologic issues and a treating cardiologist for
cardiologic issues) describing those services and items that appear
likely to be needed to diagnose or treat the covered injury or
its health complications in the future. The medical records must
support the requested services and items. A requester must submit
documentation, if available, concerning the likely cost of, and
the amount expected to be paid by third-party payors for, such
services or items.
top
A requester deemed eligible by the Secretary who seeks benefits
for lost employment income from the Program must submit, in addition
to the documentation submitted under subpart F, documentation describing:
(a) The number of days (including partial days) of work missed by
the smallpox vaccine recipient or vaccinia contact as a result of
the covered injury or its health complications for which employment
income was lost (e.g., time sheet from pay period reflecting work
days missed). As stated in §102.32(c), days for which an individual
used paid leave in order to be paid for lost work will be considered
days of work for which employment income was received (unless the
individual's employer restores the leave that was used by putting
the individual in the same position as if he or she had not used
paid leave);
(b) The smallpox vaccine recipient or vaccinia contact's gross employment
income at the time the covered injury was sustained (e.g., the individual's
most recent Federal tax return or a pay stub from the time of the
covered injury);
(c) Whether the smallpox vaccine recipient or vaccinia contact had
one or more dependents at the time the covered injury was sustained
(e.g., the individual's most recent Federal tax return); and
(d) All third-party payors that have paid for or that may be required
to pay the requester benefits for loss of employment income or provide
disability and retirement benefits for which payment or reimbursement
is being sought under this Program (e.g., State workers' compensation
programs, disability insurance programs, etc.). A requester must
submit documentation, if available, concerning the amount of such
payments or benefits expected to be paid by third-party payors. If
the requester knows of no such third-party payor, he or she must
certify to that fact. If, at any time, the requester becomes aware
that a third-party payor may have such an obligation, the requester
must inform the Secretary within 10 business days of becoming aware
of this information.
top
(a) A requester deemed an eligible survivor by the Secretary who
seeks a death benefit under §102.82(c) must submit, in addition
to the documentation submitted under subpart F, a certification informing
the Secretary whether a disability or death benefit was paid under
the PSOB Program with respect to the deceased smallpox vaccine recipient
or vaccinia contact. If such a benefit(s) was provided, the requester
must submit documentation showing the amount of the benefit(s) provided
by the PSOB Program. If no such benefits were provided, the certification
must explain whether any survivors are eligible for a death benefit
under the PSOB Program and, if so, whether death benefits have been
sought under the PSOB Program.
(b) A representative seeking a death benefit under §102.82(d)
on behalf of a dependent requester younger than the age of 18 deemed
an eligible survivor by the Secretary must submit, in addition to
the documentation submitted under subpart F, the following:
(1) Documentation showing that the deceased smallpox vaccine recipient
or vaccinia contact is survived by one or more dependents younger
than the age of 18. Such documentation must show the date of birth
of all such dependents (e.g., copies of birth certificates);
(2) A written selection by each legal guardian, on behalf of all
of the dependents described in paragraph (b)(1) of this section for
whom he or she is the legal guardian, to receive proportional death
benefits under the alternative calculation as described in §102.82(d),
in place of proportional benefits available under the standard calculation
as described in §102.82(c). Written selections are described
in §102.82(d)(1).
(3) Documentation showing that the requester is the legal guardian
of all of the dependents described in paragraph (b)(1) of this section,
as required under §102.63(b). If multiple dependents have different
legal guardians, the legal guardian of each dependent(s) must submit
such documentation;
(4) Documentation showing the deceased smallpox vaccine recipient
or vaccinia contact's gross employment income at the time the covered
injury was sustained (e.g., the decedent's most recent Federal tax
return or a pay stub from the time of the covered injury); and
(5) A description of all third-party payors that have paid for or
that may be required to pay for the benefits described in §102.82(d)(3)(A).
This description must include the amount of such benefits that have
been paid or that may be authorized to be paid in the future. If
the representative knows of no such third-party payor, he or she
must certify to that fact. If, at any time, the representative becomes
aware that a third-party payor may have such an obligation, he or
she must inform the Secretary within 10 business days of becoming
aware of this information.
top
Before benefits will be paid under by the Program to an eligible
requester who is a minor or legally incompetent adult, his or her
representative must submit, in addition to the documentation submitted
under subpart F and under §§102.60–102.62, the following:
(a) Documentation showing that the requester is:
(1) A minor (e.g., birth certificate); or
(2) A legally incompetent adult (e.g., court decree of incompetency);
and
(b) Documentation showing that:
(1) In the case of a minor, the requester is the legal guardian
of the minor (e.g., birth certificates for parents who are legal
guardians or, for other legal guardians, a decree by a court of competent
jurisdiction establishing the legal guardianship of a person other
than the minor's parents under applicable State law). If a minor
has more than one legal guardian, this information is required only
of one legal guardian; or
(2) In the case of a legally incompetent adult, a decree by a court
of competent jurisdiction establishing a guardianship or conservatorship
of the requester's estate under applicable State law.
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
(a) Before reviewing a Request Package, the Secretary will assign
a Program number to the Request Package and so inform the requester
(or his or her representative) in writing. All correspondence to
the requester (or his or her representative) about a specific Request
Package will be referenced by this Program number.
(b) Before the Secretary will pay benefits under this Program, he
must determine that:
(1) The requester or his or her representative submitted a completed
(to the fullest extent possible) and signed Request Form within the
governing filing deadline;
(2) The requester meets the eligibility requirements set out in
this part (including a determination that a covered injury was sustained);
and
(3) The requester is entitled to receive benefits from the Program.
In making this determination, the Secretary will decide the type(s)
and amounts of benefits that will be paid to the requester.
(c) Once the Secretary has sufficient documentation to make an eligibility
or benefits determination, he will make the decision in a timely
manner.
top
In the event that there is insufficient documentation in the Request
Package for the Secretary to make the applicable determinations under
this part, the Secretary will notify the requester, or his or her
representative. The requester will be given 60 calendar days from
the date of the Secretary's notification to submit the required documentation.
If the requester is unable to provide the additional documentation,
he or she may write to the Secretary and explain the reason that
the requested documentation is unavailable and the efforts the requester
has taken to obtain the documents. The Secretary may accept such
a letter in place of the required documentation or disapprove the
request due to insufficient documentation. If no documentation is
submitted in response to the Secretary's letter, the Secretary may
disapprove the request. The Secretary also may require an authorization
from the requester (or his or her representative) to try to obtain
required documentation on his or her behalf.
top
(a) Eligibility determinations. When the Secretary determines
that there is sufficient documentation in the Request Package to
conduct an evaluation of a requester's eligibility, he will begin
the review to determine whether the requester is eligible. If the
Secretary determines that the requester is not eligible, the Secretary
will inform the requester (or his or her representative) in writing
of the disapproval and the options available to the requester, including
reconsideration.
(b) Benefits determinations. If the Secretary determines
that the requester is eligible for benefits, he will, after receiving
documentation from the requester for a benefits determination, either
calculate the amount and types of benefits, as described in subpart
I of this part, or request additional documentation in order to calculate
the benefits that can be paid (e.g., an Explanation of Benefits from
the requester's insurance company if none was provided).
(c) Additional documentation required. At any time after
a Request Form has been filed, the Secretary may direct a requester
to supplement or amend the Request Package by providing additional
information or documentation.
top
When the Secretary has determined that benefits will be paid to
a requester and has calculated the type and amount of such benefits,
he will notify the requester (or his or her representative) in writing.
The Secretary will make payments in accordance with §102.83.
top
(a) If the Secretary determines that a requester is not eligible
for payments under the Program, the Secretary will disapprove the
request and provide the requester, or his or her representative,
with a written notice of the basis for the disapproval and the options
available to the requester, including reconsideration.
(b) The Secretary may disapprove a request at any time, even before
the requester has submitted required documentation (e.g., the Secretary
may determine that a requester did not meet the filing deadline,
even before required documentation is submitted or reviewed).
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
In calculating medical benefits, the Secretary will take into consideration
all reasonable costs for those medical items and services that are
reasonable and necessary to diagnose or treat a smallpox vaccine
recipient or vaccinia contact's covered injury or its health complications,
as described in §102.31. The Secretary will consider and may
rely upon benefits documentation submitted by the requester (e.g.,
bills, Explanation of Benefits, and cost-related documentation to
support the expenses relating to the covered injury or its health
complications), as required by §102.60. The Secretary will make
such payments only to the extent that such costs were not, and will
not be, paid by any third-party payor and only if no third-party
payor had or has an obligation to provide such services or items
to the requester, except as provided in §103.83(c) and §103.84.
There are no caps on medical benefits that may be provided under
the Program.
top
(a) Primary calculation. Benefits under this section may
be paid for days of work lost as a result of a covered injury or
its health complications if the smallpox vaccine recipient or vaccinia
contact lost employment income for the lost work days. As described
in §102.32(c), days in which an individual used paid leave (including
vacation and sick leave) for lost work days will not be considered
days for which the individual lost employment income (unless the
individual's employer restores the leave taken by putting the employee
in the same position as if he or she had not used paid leave).
(1) The Secretary will calculate the rate of benefits to be paid
for the lost work days based on the smallpox vaccine recipient or
vaccinia contact's gross employment income, which includes income
from self-employment, at the time he or she sustained the covered
injury. The Secretary may not, except with respect to injured individuals
who are minors, consider projected future earnings in this calculation.
(i) For a smallpox vaccine recipient or vaccinia contact with no
dependents at the time the covered injury was sustained, the benefits
are 66 2/3% of the individual's gross employment income
at the time the covered injury was sustained.
(ii) For a smallpox vaccine recipient or vaccinia contact with one
or more dependents at the time the covered injury was sustained,
the benefits are 75% of the individual's gross employment income
at the time the covered injury was sustained; and
(2) In the case of a smallpox vaccine recipient or vaccinia contact
who is a minor, the Secretary may consider the provisions of 5 U.S.C.
8113 (part of the statute authorizing the FECA Program), and any
implementing regulations, in determining the amount of payments under
this section and the circumstances under which such payments are
reasonable and necessary.
(b) Adjustment for inflation. Benefits for lost employment
income paid under the Program that represent future lost employment
income will be adjusted annually to account for inflation.
(c) Limitations on benefits paid. The Secretary will reduce
the benefits calculated under paragraphs (a) and (b) of this section,
according to the limitations described in this paragraph:
(1) Annual limitation. The maximum amount that a requester
can receive in any one year in benefits for lost employment income
under this Program is $50,000;
(2) Lifetime limitation. The maximum amount that a requester
can receive during his or her lifetime in benefits for lost employment
income under this Program is the amount of the death benefit calculated
under the PSOB Program in the same fiscal year as the year in which
this lifetime cap is reached. This amount is the maximum death benefit
payable to survivors under this Program using the standard calculation
described in §102.82(c). However, this lifetime cap does not
apply if the Secretary determines that the smallpox vaccine recipient
or vaccinia contact has a covered injury (or injuries) meeting the
definition of “disability” in section 216(i) of the Social
Security Act, 42 U.S.C. 416(i); and
(3) Number of lost work days. A requester will be compensated
for ten or more days of work lost if he or she lost employment income
for those days as a result of the covered injury (or its health complications).
If the number of days of lost employment income due to the covered
injury (or its health complications) is fewer than ten, the Secretary
will reduce the number of lost work days by 5 days. If the smallpox
vaccine recipient or vaccinia contact lost employment income for
a period of 5 days or fewer, no benefits for lost employment income
will be paid. Lost work days do not need to be consecutive. Partial
days of lost employment income may be aggregated to calculate the
total number of lost work days. The Secretary has the discretion
to consider the reasonableness of work days (or partial work days)
lost as a result of a covered injury or its health complications
in this calculation.
(d) Reductions for other coverage. From the amount of benefits
calculated under paragraphs (a), (b), and (c) of this section, the
Secretary will make reductions:
(1) For all payments made, or expected to be made in the future,
to the requester for compensation of lost employment income or disability
or retirement benefits, by any third-party payor in relation to the
covered injury or its health complications, consistent with §102.32(b);
and
(2) So that the total amount of benefits for lost employment income
paid to a requester under this Program, together with the total amounts
paid (or payable) by third-party payors, as described in paragraph
(d)(1) of this section, does not exceed 66 2/3% (or 75%,
if the smallpox vaccine recipient or vaccinia contact had at least
one dependent at the time the covered injury was sustained) of his
or her employment income at the time of the covered injury for the
lost work days. If a requester receives a lump-sum payment from any
third-party payor, under any obligation described in paragraph (d)(1)
of this section, the Secretary will deem such a payment to be received
over a period of years, rather than in a single year. The Secretary
has discretion as to how to apportion such payments over multiple
years; and
(e) Termination of payments. The Secretary will not pay benefits
for lost employment income after the requester reaches the age of
65.
[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]
top
(a) Definitions. For purposes of this section:
(1) Alternative calculation means the calculation used under
paragraph (d) of this section for the death benefit available to
dependents.
(2) Deceased person means an otherwise eligible deceased
smallpox vaccine recipient or vaccinia contact; and
(3) Dependent means a person whom the Internal Revenue Service
would have considered the deceased person's dependent at the time
the covered injury was sustained, and who is younger than the age
of 18 at the time of filing the Request Form.
(4) Standard calculation means the calculation used under
paragraph (c) of this section for the death benefit available to
all eligible survivors (other than dependents who do not meet another
category of eligible survivors, such as surviving eligible children).
(b) General. (1) If the legal guardian(s) of dependents younger
than 18 years of age does not file a written selection to receive
death benefits under the alternative calculation, as described in
paragraph (d)(1) of this section, or if the Secretary does not approve
such a selection, the Secretary will pay proportionate death benefits
under the standard calculation to all of the eligible survivors with
priority to receive death benefits under the standard calculation,
as described in §102.11(b).
(2) If the Secretary approves a written selection to receive benefits
under the alternative calculation, as described in paragraph (d)(1)
of this section:
(i) If no other eligible survivors are of equal priority to receive
death benefits, the Secretary will pay a death benefit in an amount
calculated under the alternative calculation to the aggregate of
the dependents on whose behalf the election was filed; and
(ii) If other eligible survivors are of equal priority to receive
death benefits as the dependents receiving death benefits under the
alternative calculation, the Secretary will pay the other eligible
survivors a proportionate amount of the death benefit available and
calculated under the standard calculation. In such circumstances,
the Secretary will pay the aggregate of the dependents receiving
a death benefit under the alternative calculation a proportionate
share of the benefits available under that calculation (in place
of the proportionate share of the death benefit that would be available
under the standard calculation). For example, if a deceased smallpox
vaccine recipient is survived by a dependent 10-year old child and
a spouse who is not the child's legal guardian (e.g., the dependent
child's parents were the deceased person and his or her former spouse),
the surviving spouse would be able to receive his or her share of
the death benefit under the standard calculation, and the dependent
child's legal guardian, on behalf of the minor, would receive either
the child's proportionate share of the death benefit under the standard
calculation or the child's proportionate share of the death benefit
available under the alternative calculation (if the legal guardian
filed a written selection for such a death benefit).
(c) Standard calculation of death benefits. (1) The maximum
death benefit available under the standard calculation of death benefits
is the amount of the comparable death benefit calculated under the
PSOB Program in the same fiscal year as the year in which the death
benefit under the standard calculation is paid under this Program
(without regard to any reduction under the PSOB Program attributable
to a limitation in appropriations), reduced by the total amount of
benefits for lost employment income paid under this Program to the
deceased person during his or her lifetime and to his or her estate
after death.
(2) No death benefit will be paid under the standard calculation
if a death benefit has been paid, or if survivors are eligible to
receive a death benefit, under the PSOB Program with respect to the
deceased person.
(3) No death benefit will be paid under the standard calculation
if a disability benefit has been paid under the PSOB Program with
respect to the deceased person. However, if the PSOB Program disability
benefit paid was reduced because of a limitation on appropriations,
a death benefit will be available under the standard calculation
to the extent necessary to ensure that the total amount of disability
benefits paid under the PSOB Program, together with the amount of
death benefits paid under the standard calculation, equals the amount
of the death benefit described in paragraph (c)(1) of this section.
(4) Death benefits will be paid under the standard calculation in
a lump sum.
(d) Alternative calculation of death benefits available to surviving
dependents younger than the age of 18. If a deceased smallpox
vaccine recipient or vaccinia contact had at least one dependent
who is younger than the age of 18 (and will be younger than the
age of 18 at the time of the payment), the legal guardian(s) of
all such dependents may request benefits under the alternative
calculation described in this paragraph. To receive such a benefit,
the legal guardian, on behalf of all such dependents for whom he
or she is the legal guardian, must file a selection to receive
benefits under the alternative calculation, as described in paragraph
(d)(1) of this section. If multiple dependents have different legal
guardians, each legal guardian is responsible for requesting benefits
under the standard calculation or for filing a selection for a
death benefit under the alternative calculation. If a single dependent
has more than one legal guardian, one legal guardian may file the
selection. Payments made under the alternative calculation will
be made to the legal guardian(s) of all of the dependents on behalf
of all of those dependents until they reach the age of 18.
(1) Selection of benefits under alternative calculation. Before
a payment of a death benefit will be approved under the alternative
calculation, the legal guardian(s) of the dependents for whom he
or she is the legal guardian must file a written selection, on behalf
of all such dependents, to receive a death benefit under the alternative
calculation. If such a selection is approved by the Secretary, these
dependents will be paid a proportionate share of the death benefit
under the alternative calculation in place of the proportionate share
of benefits that would otherwise be available to them under the standard
calculation.
(2) Amount of payments. The maximum death benefit available
under this paragraph is 75% of the deceased person's income (including
income from self-employment) at the time he or she sustained the
covered injury that resulted in death, adjusted to account for inflation
(as appropriate), except as follows:
(i) The maximum payment of death benefits that may be made on behalf
of the aggregate of the dependents in any one year is $50,000;
(ii) All payments made under this paragraph will stop once the youngest
of the dependents reaches the age of 18.
(3) Reductions for other coverage. The total amount of death
benefits provided under the alternative calculation will be reduced
so that the total amount of payments made (or expected to be made)
under obligations described in paragraph (d)(3)(i) of this section,
together with the death benefits paid under the alternative calculation,
is not greater than the amount of payments described in paragraph
(d)(2) of this section. In other words, the total amount of death
benefits paid to dependents under the alternative calculation may
be reduced if third-party payors have paid (or are expected to pay)
for certain benefits so that such dependents will receive a total
sum (combining the death benefit paid under the alternative calculation
and the actual and expected benefits paid for by third-party payors)
that is not greater than the death benefit that would be available
under the alternative calculation if no third-party payor existed
to pay such benefits.
(i) The amount of death benefits paid under the alternative calculation
will be reduced for all payments made, or expected to be made in
the future, by any third-party payor for:
(A) Compensation for the deceased person's loss of employment income
on behalf of the dependents or their legal guardian(s);
(B) Disability, retirement, or death benefits in relation to the
deceased person (including, but not limited to, death and disability
benefits under the PSOB Program) on behalf of the dependents or their
legal guardian(s); and
(C) Life insurance benefits on behalf of the dependents.
(ii) In calculating such reductions, the Secretary will deem any
lump-sum payment made by a third-party payor under any obligation
described in paragraph (d)(3)(A) of this section, as received over
a period of years, rather than in a single year. The Secretary has
discretion as to how to apportion such payments over multiple years.
(4) Timing of payments. Payments made under this paragraph
will be made on an annual basis, beginning at the time of the initial
payment, to the legal guardian(s) on behalf of the aggregate of the
dependents receiving the payment. In the year in which the youngest
dependent reaches the age of 18, payments under this section will
be paid on a pro rata basis for the period of time before that dependent
reaches the age of 18. Once a dependent reaches the age of 18, the
payments under this alternative calculation will no longer be made
on his or her behalf. Because payments under the alternative calculation
are to be made on behalf of dependents who are younger than the age
of 18, if a dependent meets this requirement at the time of filing
of the Request Form, but reaches the age of 18 (or is older than
18 years of age) at the time of the initial payment, no payment will
be made to the dependent's legal guardian on his or her behalf under
the alternative calculation.
[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]
top
(a) The Secretary may pay any benefits under this Program through
lump-sum payments. If the Secretary determines that there is a reasonable
likelihood that the payments of medical benefits, benefits for lost
employment income, or death benefits paid under the alternative calculation
(described in §102.82(d)) will be required for a period in excess
of one year from the date the Secretary determines the requester
is eligible for such benefits, the Secretary may make a lump-sum
payment, purchase an annuity or medical insurance policy, or execute
an appropriate structured settlement agreement, provided that such
payment, annuity, policy, or agreement is actuarially determined
to have a value equal to the present value of the projected total
amount of benefits that the requester is eligible to receive under §§102.80,
102.81, and 102.82(d).
(b) Lump sum payments will be made through an electronic funds transfer
to an account of the requester. However, if the requester is a minor,
the payment will be made to the account of his or her legal guardian
on behalf of the minor. In accepting such payments, the legal guardian
of a minor requester is obliged to use the funds for the benefit
of the minor and to take any actions necessary to comply with state
law requirements pertaining to such payments. If the requester is
a legally incompetent adult, the legal guardian must establish a
guardianship or conservatorship of the estate account with court
oversight, in accordance with State law, and payment will be made
to that account.
(c) The Secretary may, at his discretion, make interim payments
of benefits under this Program, even before he makes a final determination
as to the total type and total amount of benefits that will be paid.
The Secretary may, for example, make an interim payment of medical
benefits that have been calculated before a final determination on
benefits for lost employment income is completed, or of past medical
benefits that have been calculated before a final calculation of
future medical benefits is completed. The Secretary may, in his discretion,
make an interim payment even before a final eligibility or benefits
determination is made (e.g., if a piece of documentation has not
been obtained because a person with a severe vaccine-related injury
is hospitalized, but all other documentation is consistent with the
requester meeting the eligibility requirements). If such a requester's
documentation is incomplete, the requester must submit the required
documentation within the time-frame determined by the requester.
Such a requester must agree that he or she will be obliged to repay
the Secretary such benefits in the event that such payments are later
determined to be inappropriate. Any payments made on an interim basis
will not entitle a requester to seek reconsideration of the Secretary's
decision on these benefits until the Secretary makes a complete benefits
determination.
top
Upon payment of benefits under this program, the Secretary will
be subrogated to the rights of the requester and may assert a claim
against any third-party payor with a legal or contractual obligation
to pay for (or provide) such benefits and may recover from such third-party
payor(s) the amount of benefits paid up to the amount of benefits
the third-party payor has or had an obligation to pay for (or provide).
In other words, the Secretary may pay benefits before the requester
receives a payment from a third-party payor in specific circumstances.
In those circumstances, the Secretary has a right to be reimbursed
by the third-party payor. The circumstances in which the Secretary
may assert this right include those in which the Secretary pays benefits
under this Program to a requester before a final decision is made
that a third-party payor has an obligation to pay such benefits to
the requester. Requesters receiving benefits under this Program (or
their representatives) shall assist the Secretary in recovering such
benefits. In the event that a requester receives a benefit from a
third-party payor after receiving the same type of benefits from
the Secretary under this Program, the Secretary has a right to recover
the amount of the benefits awarded from the requester.
top
Source: 68 FR 70096, Dec.
16, 2003, unless otherwise noted.
top
(a) Right of reconsideration. A requester has the right to
seek reconsideration of the Secretary's determination that he or
she is not eligible for payment. In addition, a requester who asserts
that the amount of the benefits paid by the Secretary (or the fact
that certain benefits were not paid or payable) is incorrect may
also seek reconsideration. Letters seeking reconsideration must be
in writing, describe the reason(s) why the decision should be reconsidered,
and be postmarked within 60 calendar days of the date of the Secretary's
decision on the request. Because no new documentation will be considered
in the reconsideration process, the letter seeking reconsideration
may not include or refer to any documentation that was not before
the Secretary at the time of his initial determination.
(b) Letters seeking reconsideration. A requester, or his
or her representative, may send a letter seeking reconsideration
through the U.S. Postal Service, commercial carrier, or a private
courier service. The Secretary will not accept letters seeking reconsideration
electronically or by hand-delivery.
(1) Letters sent through the U.S. Postal Service must be sent to
the Associate Administrator, Special Programs Bureau, Health Resources
and Services Administration, 5600 Fishers Lane, Room 16C–17,
Rockville, Maryland 20857.
(2) Letters sent through a commercial carrier or private courier
service must be sent to the Associate Administrator, Special Programs
Bureau, Health Resources and Services Administration, 4350 East-West
Highway, 10th Floor, Bethesda, Maryland 20814.
(c) Reconsideration process. When the Associate Administrator
of the Special Programs Bureau (the Associate Administrator), receives
a letter seeking reconsideration, a qualified panel will be convened,
independent of the Program, to review the Secretary's initial determination.
The panel will base its recommendation on the documentation before
the Secretary when the initial determination(s) was made. The panel
will perform its own review and make its own findings, which will
be submitted to the Associate Administrator. The Associate Administrator
will then review the panel's recommendation(s) and make a final determination,
which will be sent to the requester (or his or her representative).
This will be the Secretary's final action on the letter seeking reconsideration
and will be considered the Secretary's final determination on the
request. Requesters may not seek review of a decision made on reconsideration.
top
Under section 262(f)(1) of the Public Health Service Act (42 U.S.C.
239a(f)(1)), the Secretary may, at any time, review on his own motion
or on application, any determination made under this part (including,
but not limited to, determinations concerning eligibility, entitlement
to benefits, and the calculation and payment of benefits under the
Program). Upon review of such a determination, the Secretary may
affirm, vacate, or modify the determination in any manner the Secretary
deems appropriate.
top
Under section 262(f)(2) of the Public Health Service Act (42 U.S.C.
239a(f)(2)), no further judicial review of the Secretary's actions
under this part (including, but not limited to, eligibility determinations,
the calculation of benefits, and determinations about the method
of payment of benefits) is permitted. In addition, no further administrative
review of the Secretary's actions under this part is permitted unless
the President specifically directs otherwise.
|