Smallpox Vaccine Injury Compensation Program: Administrative Implementation; Interim Final Rule
Federal
Register: December 16, 2003
(Volume 68, Number 241)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUMMARY:
The Smallpox Emergency Personnel Protection
Act of 2003 (SEPPA), authorizes the Secretary
of Health and Human Services (the Secretary),
to establish the Smallpox Vaccine Injury
Compensation Program (``the Program'').
This program is designed to provide benefits
and/or compensation to certain persons
harmed as a direct result of receiving
smallpox covered countermeasures, including
the smallpox vaccine, or as a direct result
of contracting vaccinia through certain
accidental exposures. In addition, the
Secretary may provide death benefits to
certain survivors of individuals who died
as the direct result of these injuries.
On
August 27, 2003, the Secretary published
an interim final rule that set out a Smallpox
(Vaccinia) Vaccine Injury Table (``the
Table''). The table includes adverse effects
(including injuries, disabilities, conditions,
and deaths) within specific time periods
that shall be presumed to result from
the receipt of, or exposure to, the smallpox
vaccine. The Secretary will use this table,
as well as the procedures set out in this
regulation, in deciding whether persons
are eligible to receive benefits under
the program. In this interim final rule,
the Secretary is setting out the administrative
policies, procedures, and requirements
governing the program, as authorized by
the SEPPA. The Secretary is seeking public
comment on this interim final rule.
DATES:
This regulation is effective on December
16, 2003. Written comments must be submitted
on or before February 17, 2004. The Secretary
will consider the comments received and
will decide whether to amend the current
procedures and requirements based on such
comments.
ADDRESSES:
All written comments concerning this interim
final rule should be submitted to the
Director, Smallpox Vaccine Injury Compensation
Program, Special Programs Bureau, Health
Resources and Services Administration,
Parklawn Building, Room 16C-17, 5600 Fishers
Lane, Rockville, MD 20857. Express and
courier mail should be sent to the Director,
Smallpox Vaccine Injury Compensation Program,
Special Programs Bureau, Health Resources
and Services Administration, 4350 East-West
Highway, 10th Floor, Bethesda, Maryland
20814. Electronic comments should be sent
to smallpox@hrsa.gov.
Comments received will be available for
public inspection at the Smallpox Vaccine
Injury Compensation Program Office, Special
Programs Bureau, Health Resources and
Services Administration, 4350 East-West
Highway, 10th Floor, Bethesda, Maryland
20814, between the hours of 8:30 a.m.
and 5 p.m. on Federal government workdays.
FOR
FURTHER INFORMATION CONTACT:
Paul T. Clark, Director, Smallpox Vaccine
Injury Compensation Program, telephone
1-888-496-0338. This is a toll-free number.
Electronic inquiries should be sent to
smallpox@hrsa.gov.
Interested parties may also wish to consult
the program's Web site at http://www.hrsa.gov/smallpoxinjury.
SUPPLEMENTARY
INFORMATION:
Background
Before it was eradicated, smallpox (variola)
was a serious illness that manifested
as outbreaks of either variola major with
death rates of greater than 20% or variola
minor with death rates of almost 1%. The
smallpox (vaccinia) vaccine (referred
to in this rule as the ``smallpox vaccine'')
contains a live vaccinia virus that induces
immunity to smallpox infection, but does
not lead to variola infection or disease.
Vaccinia virus is an orthopox type virus
that is different from, but related to,
the smallpox virus. The smallpox vaccine
was an essential tool for the successful
global eradication of the smallpox virus,
announced by the World Health Organization
in 1980.
Despite
such eradication, concern exists that
terrorists may have access to the smallpox
virus. On December 13, 2002, the President
announced a plan to protect the population
of the United States against the threat
of a possible smallpox attack. This plan
was based on heightened concerns, in the
wake of the attacks of September and October
2001, that terrorists may have access
to the smallpox virus and may attempt
to use it against the population of the
United States and government facilities
abroad. Under this plan, which the Secretary
is actively working to implement, State
and local governments have formed smallpox
emergency response plans to facilitate
the provision of critical services to
the population of the United States in
the event of a smallpox virus attack.
To
further the President's plan, the Secretary
issued a Declaration Regarding Administration
of Smallpox Countermeasures on January
24, 2003 (68 FR 4212). This Declaration
was issued pursuant to statutory authority,
42 U.S.C. 233(p)(2)(A), which was enacted
by the Homeland Security Act of 2002,
Pub. L. 107-296, 116 Stat. 2135. In this
Declaration, the Secretary stated that
``a potential bioterrorist incident makes
it advisable to administer, on a voluntary
basis, covered countermeasures specified
* * * for prevention or treatment of smallpox
or control or treatment of adverse events
related to smallpox vaccination, to [specified]
categories of individuals * * *.''
The
specific ``covered countermeasures'' described
in the Declaration are smallpox vaccines,
cidofovir and its derivatives, and Vaccinia
Immune Globulin. The categories of persons
to whom the Secretary recommended the
administration of such covered countermeasures,
on a voluntary basis, included certain
health care workers, certain public safety
personnel, other members of smallpox emergency
response plans identified by State or
local government entities or the Department
of Health and Human Services, and certain
personnel associated with specific Federal
facilities abroad. The Secretary recommended
that such persons receive the smallpox
vaccine to ensure the immediate mobilization
of smallpox emergency response personnel
who would provide critical services to
the population of the United States in
the event of a smallpox virus attack.
The
Secretary's Declaration became effective
on January 24, 2003, and will remain effective
until January 23, 2004, unless the Secretary
extends or shortens that time period by
amendment. Under the Smallpox Vaccine
Injury Compensation Program authorized
by the SEPPA, certain persons may be entitled
to benefits (defined as benefits and/or
compensation) for covered injuries, described
below, suffered as a direct result of
the administration of smallpox covered
countermeasures (including the smallpox
vaccine) or accidental vaccinia inoculation.
Specifically,
the SEPPA authorizes the Secretary to
make the benefits available to two categories
of eligible persons who sustained covered
injuries, provided they meet the legal
requirements (e.g., filing deadlines).
The first category, ``smallpox vaccine
recipients,'' includes certain persons
who volunteer for, and are selected to
be members of, a smallpox emergency response
plan, are vaccinated with a smallpox vaccine
under such a plan, and sustain covered
injuries. The second category, vaccinia
contacts, includes certain persons who
have covered injuries as the direct result
of exposure to vaccinia through contact
with certain persons who received the
smallpox vaccine or with the contacts
of such recipients. In addition, if a
person in either category dies, his or
her survivors or his or her estate may
be eligible for selected benefits under
this program in certain circumstances.
The
benefits available under the program include
compensation for medical care, lost employment
income, and survivor death benefits. To
be considered for program benefits, requesters
(i.e., smallpox vaccine recipients, vaccinia
contacts, survivors, or the representatives
of the estates of deceased smallpox vaccine
recipients or vaccinia contacts), or persons
filing on their behalf as their representatives,
must file a Request Form and the documentation
required under this regulation to show
that they are eligible. As mandated under
the SEPPA, the Secretary is herein, at
42 CFR part 102, establishing the procedures
and requirements governing the program.
At
this time, the Secretary is seeking public
comments on these procedures and requirements.
Summary of the Regulation Summary of Available
Benefits and Secondary Nature of Benefits
(Sec. 102.2, Sec. 102.84) The benefits
available under this program are medical
benefits, benefits for lost employment
income, and survivor death benefits. As
explained in Sec. 102.2(b), the SEPPA
establishes that the government is a secondary
payor for most benefits available under
the program. Thus, benefits paid under
this program are generally secondary to
any obligation of any third-party payor,
described in Sec. 102.3(aa), to pay for
or provide such benefits. Requesters generally
must provide the names of all other third-party
payors that have already provided benefits,
that are expected to do so in the future,
or that may have a duty to do so. These
payers include, but are not limited to:
insurance companies, workers' compensation
programs, the Federal Employees' Compensation
Act (FECA) Program, or the Public Safety
Officers' Benefit (PSOB) Program, a program
within the United States Department of
Justice that provides payments to public
safety officers and their survivors, including
death payments for officers killed in
the line of duty.
If
such a third-party payor has paid for
or provided the type of benefits requested
under this program, the Secretary will
only pay such benefits in an amount necessary
to supplement the payments already provided.
For example, if a requester were otherwise
entitled to $10,000 in medical benefits
from this program and the requester's
health insurance company (a third-party
payor) has paid $5,000 for the covered
medical benefits and services, the program
would pay the requester $5,000 (the amount
the requester is entitled to under this
program, reduced by the amount the requester
is entitled to from third-party payors).
As explained later in the preamble, upon
payment of benefits under the Smallpox
Vaccine Injury Compensation 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.
Description of Eligible Requesters
(Sec. 102.10(a))
(1)
Smallpox vaccine recipients, as defined
in Sec. 102.3(y).
A
person who has received a smallpox vaccine
is only considered a ``smallpox vaccine
recipient,'' for purposes of this program,
if he or she meets the criteria described
in this regulation. Specifically, he or
she must have been in a covered occupation
(including health care workers, law enforcement
officers, public safety personnel, and
supporting personnel), received a smallpox
vaccine as a participant in an approved
smallpox emergency response plan, and
sustained a covered injury, described
later in this preamble. The exact requirements
for smallpox vaccine recipients are set
forth in Sec. 102.3(x). For example, this
regulation provides that, in order to
be eligible, a smallpox vaccine recipient
must have received the smallpox vaccine
between January 24, 2003, and January
23, 2004, unless the period is extended
by the Secretary.
In
order to be covered by the program, a
smallpox vaccine recipient must also have
volunteered for and been selected to be
a member of a smallpox emergency response
plan before the time that the Secretary
publicly announces that an active case
of smallpox has been identified anywhere
in the world. For this reason, persons
who become members of smallpox emergency
response plans in order to respond to
a case of smallpox that has already occurred
will not be considered ``smallpox vaccine
recipients.'' Likewise, persons who receive
the smallpox vaccine as members of the
military or members of the public who
receive the smallpox vaccine voluntarily,
and not as part of an approved smallpox
emergency response plan, are not entitled
to benefits under the program.
(2)
Vaccinia contact, as defined in Sec. 102.3(bb).
The SEPPA imposes specific restrictions
as to which persons who have contracted
vaccinia from another person may be eligible
for benefits under this program. The specific
requirements pertaining to vaccinia contacts
are set forth in Sec. 102.3(bb). As explained
in that section, vaccinia contacts are
only eligible for benefits under this
program if they can show that they contracted
vaccinia as a result of contact with a
person who either meets the definition
of a smallpox vaccine recipient (except
that the vaccine recipient does not need
to sustain a covered injury) or who was
accidentally inoculated by such a person.
For this reason, if the source of a contact's
exposure to vaccinia is a person who received
a smallpox vaccine other than under an
approved smallpox emergency response plan,
the contact would not fall within the
regulation's definition of a ``vaccinia
contact'' and would not be eligible for
benefits under the program. For example,
the contacts of members of the military
and State Department personnel who receive
the smallpox vaccine for their employment,
but not as part of an approved smallpox
emergency response plan, would not be
entitled to benefits under this program.
Likewise,
the contacts of members of the general
public who receive the smallpox vaccine
voluntarily, and not as part of an approved
smallpox emergency response plan, would
not be covered under this program. In
addition, vaccinia contacts must have
contracted vaccinia during the effective
period of the Declaration (between January
24, 2003, and January 23, 2004, unless
extended by the Secretary), or within
30 days after the end of such period,
and must have sustained a covered injury.
(3)
Certain survivors of deceased smallpox
vaccine recipients or vaccinia contacts,
as defined in Sec. 102.3(z).
Categories of eligible survivors and the
priority of such survivors to receive
benefits from the program are discussed
in the section of this preamble concerning
death benefits (the only type of benefit
survivors are eligible to receive).
(4)
Representatives of estates of deceased
smallpox vaccine recipients or vaccinia
contacts. Representatives of
estates of deceased smallpox vaccine recipients
or vaccinia contacts may file Request
Packages with the program as long as they
are seeking benefits on behalf of the
deceased person's estate. Benefits Available
to Different Categories of Requesters
(Sec. 102.30) An eligible requester who
is a smallpox vaccine recipient or a vaccinia
contact may be entitled to receive either
medical benefits or benefits for lost
employment income or both as long as they
provide the proper documentation. For
example, such requesters must submit documentation
showing that they have out-of-pocket reasonable
and necessary medical expenses as a result
of a covered injury or its health complications
in order to receive medical benefits,
and documentation showing that they lost
employment income as a result of a covered
injury or its health complications in
order to receive benefits for lost employment
income. Such documentation requirements
are discussed later in this preamble.
An eligible requester who is the survivor
of a deceased smallpox vaccine recipient
or vaccinia contact may be entitled to
receive a death benefit. The estate of
a 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 direct result of
a covered injury or its health complications,
but were not paid during the deceased
person's lifetime. However, the estate
would not be eligible to receive payments
for benefits that were not accrued during
the deceased person's lifetime. For example,
the estate would not be entitled to benefits
for projected lost employment income that
the person might have accrued if he or
she had not died.
Covered
Injuries (Sec. 102.20--Sec. 102.21)
Covered injuries are defined in Sec. 102.3(g)
and set out in subpart C of this rule.
Covered injuries are those injuries in
smallpox vaccine recipients or vaccinia
contacts that the Secretary determines
are more likely than not (i.e., by a preponderance
of the evidence) the direct result of
the administration of a covered countermeasure
(including a smallpox vaccine) or of vaccinia
acquired through accidental vaccinia inoculation.
Because even survivors of, and representatives
of estates of, deceased smallpox vaccine
recipients and vaccinia contacts must
demonstrate that the deceased person sustained
a covered injury, a requester will not
be deemed eligible for benefits under
the program unless the Secretary determines
that an eligible smallpox vaccine recipient
or vaccinia contact sustained a covered
injury. One way that requesters can demonstrate
that they sustained a covered injury is
by demonstrating that they sustained an
injury listed on the Smallpox (Vaccinia)
Vaccine Injury Table (the table) within
the required time interval, as set out
in Sec. 102.21. In accordance with the
SEPPA, a smallpox vaccine recipient or
vaccinia contact shall be presumed to
have sustained a covered injury as the
direct result of the administration of,
or exposure to, the smallpox vaccine if
the requester submits sufficient documentation
demonstrating that he or she sustained
an injury included on the table, with
the onset of the first symptom or manifestation
within the time interval specified on
the table.
The
injury must also meet the table's definitions
and requirements, set forth in Sec. 102.21(b).
In such circumstances, the Secretary will
presume, solely for purposes of the program,
that the smallpox vaccine recipient or
vaccinia contact's injury was caused by
the smallpox vaccine or exposure to vaccinia.
Such a requester need not actually demonstrate
that the vaccine (or the vaccinia contracted
from accidental vaccinia inoculation)
caused the underlying injury, only that
an injury listed on the table was sustained
and that it first manifested itself within
the time interval listed. In directing
the Secretary to establish a table with
such a presumption, Congress did not direct
the Secretary to make this presumption
conclusive. In the Secretary's view, it
would be inconsistent with the purposes
of the SEPPA to make this presumption
absolutely conclusive. For this reason,
based on his review of the submitted documentation
and other relevant evidence, the Secretary
may determine that an injury meeting the
table requirements was more likely than
not (i.e., by a preponderance of the evidence)
caused by other factors and was not caused
by the smallpox vaccine or exposure to
vaccinia (e.g., if the Secretary determined
that the medical records demonstrated
that an individual's injury of encephalopathy
was caused by a car accident that occurred
post-vaccination and not by the smallpox
vaccine or exposure to vaccinia). In these
circumstances, which we expect to occur
rarely, the Secretary could rebut the
table presumption and decide that the
requester may not be entitled to benefits
under the program.
Requesters
who believe they sustained an injury included
on the table, but did not meet all the
table requirements (e.g., the first manifestation
of the injury did not become apparent
within the required time interval), or
requesters who believe they sustained
an injury not included on the table, may
still be able to demonstrate that the
injury is one that is covered under the
program. In order to establish a covered
injury, such requesters may need to submit
sufficient relevant medical documentation
(such as isolation of vaccinia from the
injured part of the body) or scientific
evidence (such as results of studies published
in peer-reviewed medical literature).
In order to establish a covered injury,
the Secretary, upon review of this evidence,
must conclude that, more likely than not,
the injury was actually caused by the
administration of a covered countermeasure
or by vaccinia through accidental inoculation
during the time periods set forth by law.
In other words, in evaluating such claims,
the Secretary will employ a preponderance
of the evidence standard, taking into
consideration all relevant medical and
scientific evidence, including all relevant
medical records.
As
provided under the SEPPA, this determination,
as with all other actions by the Secretary
under this Act, is not reviewable by any
court. Any injury that the Secretary considers
minor is not a covered injury. For example,
covered injuries do not include expected
skin reactions or expected minor scarring
at the vaccination or inoculation site.
No benefits will be paid for these reactions,
as stated in Sec. 102.20(b). Medical Benefits--Summary
and Calculation (Sec. 102.31 and Sec.
102.80) Medical benefits that may be available
under the program are described in Sec.
102.31. They include payment(s) or reimbursement
for medical services and medical items
that the Secretary determines are reasonable
and necessary for the diagnosis or treatment
of a covered injury or its direct health
complications (sequelae).
Past,
current, and expected future medical services
and items may be included in medical benefits.
In making determinations about which medical
services and items provided in the past
were reasonable and necessary, the Secretary
may consider whether those medical services
and items were prescribed or recommended
by a health care practitioner. In considering
benefits for future medical services and
items, the Secretary will consider statements
by health care practitioners with expertise
in the medical issues involved (for example,
a statement by a treating neurologist
concerning services and items likely to
be needed to address neurological issues)
concerning those services and items that
appear likely to be needed in the future
to diagnose or treat the covered injury
or its health complications. In order
for a requester to receive medical benefits
for a health complication, the health
complication must have resulted from the
covered injury and not be more likely
due to other factors or conditions. Examples
of health complications include 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 the injury.
If
a smallpox vaccine recipient or vaccinia
contact dies before filing for, or being
paid, benefits for the cost of medical
services or items accrued during his or
her lifetime as a result of a covered
injury or its health complications, the
deceased person's estate may be paid such
medical benefits. Because such payments
are for medical expenses accrued as a
result of a covered injury while the injured
person was alive, the cause of death does
not have to be related to the covered
injury for these medical benefits to be
paid. The calculation of medical benefits
is described in Sec. 102.80. There are
no caps on medical benefits. However,
the Secretary may limit the payment of
such benefits to the amounts he considers
reasonable for those services and items
he considers reasonable and necessary.
In addition, payment of medical benefits
or reimbursement of costs for medical
services and items by the program is secondary
to the obligations of any third-party
payor, such as the United States (except
for payment of benefits under this program),
State or local government entities, private
insurance carriers, employers, or any
other third- party payors that may have
a statutory or contractual obligation
to pay for or provide medical benefits.
When the Secretary has determined that
the requester is eligible for medical
benefits and that all of the documentation
is available by which he can compute the
amount, he will do the following, consistent
with the calculations described in Sec.
102.80:
(1)
Determine which medical expenses that
have been submitted are reasonable and
necessary to diagnose or treat a covered
injury or its health complications.
(2)
Compute all those reasonable medical expenses,
including medical services and items provided
in the past, and anticipated future medical
expenses.
(3)
Deduct from his computation the total
amount paid, or payable, by all other
third-party payors. This will be the basis
for the program's payment. For example:
An eligible, injured individual incurred
$5,000 in reasonable and necessary medical
expenses. If the individual's insurance
company paid $3,000, and the individual
is responsible for the $2,000 balance
(due to deductibles and co- payments),
then the Secretary will pay a medical
benefit of $2,000. As explained elsewhere
in the preamble, the Secretary may make
a payment of medical benefits and later
pursue such a payment from a third-party
payor with an obligation to pay for or
provide the medical services or items.
Lost
Employment Income--Summary and Calculation
(Sec. 102.32 and Sec. 102.81)
Lost employment income benefits that may
be available under the program are set
out in Sec. 102.32. The program will provide
benefits for lost employment income (secondary
to other benefits that may be available
to the requester) based on the number
of days of work that the injured person
lost as a result of the covered injury
or its health complications (including
diagnosis and treatment). These benefits
are a percentage of the employment income
lost and are based on the number of eligible
work days for which such income was lost.
Employment income includes the injured
person's gross employment income. The
lost work days do not have to be consecutive,
and partial days of lost work are included
in the calculation. For example, if an
individual's workday is eight hours and
he or she missed four hours a day for
doctors' appointments on two different
days, the eight hours of work missed will
be considered one total day of lost work.
As described in Sec. 102.32(c), a day
in which an individual used paid leave
(e.g., sick leave or vacation leave) in
order to be paid for lost work will not
be considered a day for which employment
income was lost and will not be used in
calculating benefits for lost employment
income.
The only exception to this rule is in
a case in which the injured person's employer
restores the paid leave taken and puts
the requester in the same position as
if he or she had not used paid leave on
the lost work day (i.e., treats the employee
as if he or she did not take paid leave
by taking back the payments made when
the leave was used and giving back the
leave to the employee for future use).
Under the SEPPA, the program cannot pay
for the first five days of lost employment
income resulting from a covered injury
or its health complications, unless the
injured individual lost employment income
for 10 or more work days (in which case,
all of the lost work days will be included
in the calculation). For this reason,
if an individual lost a total of four
days of employment income as a result
of a covered injury, he or she will not
be eligible for any benefits for lost
employment income. The calculation of
benefits for lost employment income is
described in Sec. 102.81. The annual cap
on benefits for lost employment income
for a requester is $50,000. A requester
may use documents such as pay slips, earning
and leave statements, and other documents
concerning the injured individual's salary
and benefits, to document his or her employment
income. The benefit terminates once the
requester reaches the age of 65. Benefits
that represent future lost employment
income will be adjusted to account for
inflation.
It
is important to remember that future lost
employment income will be calculated based
on an individual's employment income at
the time the covered injury was sustained
(except for the inflation adjustment provided
for in this regulation) and will not be
based on an individual's anticipated future
employment income. The lifetime cap for
this benefit is equal to the amount of
the death benefit available under the
PSOB Program in the same fiscal year in
which the lifetime cap is reached (currently
approximately $262,100, but subject to
change). However, this lifetime limitation
does not apply if the Secretary determines
that an individual has a covered injury
considered to be a total and permanent
disability under section 216(i) of the
Social Security Act. For this reason,
a requester deemed to have a permanent
and total disability by the Secretary
may be eligible to receive up to $50,000
a year until he or she reaches the age
of 65.
As
with medical benefits, if a smallpox vaccine
recipient or vaccinia contact dies before
filing for, or being paid, benefits for
lost employment income incurred during
his or her lifetime as a result of a covered
injury or its health complications, the
representative of that person's estate
may file for such benefits on behalf of
the estate. Because this payment is made
for loss of employment income that accrued
while the injured person was alive, the
death does not have to be related to the
covered injury for these benefits to be
paid. Once the Secretary has determined
that he has all the information necessary
to compute lost employment income, the
calculation will be made as follows, as
set out in Sec. 102.81:
(1)
If the eligible individual lost five days
or fewer of employment income, then there
will be no benefits for lost employment
income.
(2)
If the eligible individual lost six to
nine days of employment income, then the
Secretary will subtract five days from
the number of lost work days; if the eligible
individual lost 10 or more days of employment
income, then every lost work day will
be counted.
(3)
The Secretary will multiply the injured
individual's daily gross employment income
(including income from self-employment)
at the time of the covered injury by the
number of lost work days (as computed
above). This figure will be adjusted to
account for inflation, as appropriate.
(4)
The Secretary will compute 75% of the
lost employment income if the injured
individual had one or more dependents
(at the time of the covered injury) or
66 2/3% of the lost employment income
if there were no dependents (at the time
of the covered injury). This calculation
will serve as the basis for the lost employment
income benefit.
(5)
The amount of payment will be reduced
by any benefit that the requester is entitled
to receive from a third-party payor (e.g.,
a workers' compensation program). However,
the Secretary may make a payment of lost
employment income and later pursue such
a payment from a third-party payor with
an obligation to pay for or provide the
benefit (e.g., the Secretary can pay a
benefit for lost employment income to
a requester with a claim pending in a
State workers' compensation program, and
then has a right to recover such a payment
from the State if its program determines
that such a benefit is due the requester).
(6) The payments made will be subject
to an annual cap of $50,000. The benefits
paid in lost employment income will be
subject to a lifetime cap, as discussed
above, unless the Secretary determines
that a requester has a covered injury
considered to be a total and permanent
disability under section 216(i) of the
Social Security Act. No State law workers'
compensation lien may be maintained on
any benefit for lost employment income
paid under this program. Death Benefits--Summary
and Calculation (Sec. 102.11, Sec. 102.33,
and Sec. 102.82) Certain survivors of
smallpox vaccine recipients or vaccinia
contacts who died as a direct result of
a covered injury or its health complications
may be eligible for death benefits, as
set out in Sec. 102.11 (eligible survivors
and their priority to receive death benefits),
Sec. 102.33 (general description of death
benefits) and Sec. 102.82 (calculation
of death benefits). The SEPPA provides
that death benefits under this program
may be available under two different calculations.
The ``standard calculation'' is a lump-sum
payment to eligible survivors and is described
in Sec. 102.82(c). In general, this method
is based on the death benefit available
under the PSOB Program. The ``alternative
calculation'' is only available to surviving
dependents who are younger than the age
of 18, as described in Sec. 102.82(d).
This method is based upon the deceased
person's employment income at the time
of the covered injury. Eligible Survivors
and Priorities for Receiving Death Benefits
With limited exceptions, the Smallpox
Vaccine Injury Compensation Program follows
the requirements of the PSOB Program with
respect to the categories of eligible
survivors (known in the PSOB Program as
beneficiaries) and the order of priority
for payments of death benefits to them.
The order of priority for survivors to
receive death benefits under the program
is subject to changes made in the future
under the PSOB Program concerning eligible
survivors and their priority to receive
death benefits.
Currently,
the categories of eligible survivors under
the PSOB Program are as follows:
(1)
Surviving spouses;
(2)
surviving eligible children;
(3)
individuals designated by the deceased
person as the beneficiaries under the
deceased person's most recently executed
life insurance policy; and
(4)
surviving parents.
Such
survivors, as defined under the PSOB Program,
are also eligible survivors under this
program. Currently, a surviving child
is considered eligible under the PSOB
Program if he or she is an individual
who is a natural, illegitimate, adopted,
or posthumous child, or stepchild, of
the deceased person, and is 18 years of
age or younger, or between 19 and 23 years
of age and a full-time student, or is
over 18 years of age and incapable of
self- support because of physical or mental
disability. The SEPPA included two additional
categories of survivors under this program
who are not eligible survivors under the
PSOB Program:
(5)
Legal guardians of deceased minors without
surviving parents; and
(6)
surviving dependents who are younger than
the age of 18 (some of whom may also fall
within the category of surviving eligible
children). As discussed below, special
criteria apply to the final category of
eligible survivors. Under current practices,
in the event that the deceased eligible
individual is survived by a spouse and
eligible children, the spouse will receive
50% of the death benefit and the children
will divide the remaining 50% equally.
If there are no surviving eligible children,
then the spouse receives the entire benefit;
if there is no surviving spouse, then
the children divide the benefit in equal
shares. In the event that the deceased
injured individual has no surviving spouse
or children, the individual designated
by the deceased individual as the beneficiary
under his or her most recently executed
life insurance policy will receive the
death benefit. If there is no life insurance
policy or no surviving designated beneficiary
under such a policy, the parents will
divide the death benefit in equal shares.
If none of these categories of survivors
exists, the legal guardian of a deceased
minor (who was a smallpox vaccine recipient
or vaccinia contact) with no living parent
will receive the death benefit, if applicable.
As
explained in Sec. 102.11(b)(5), surviving
dependents younger than the age of 18
will have the same priority as surviving
eligible children. Only the legal guardians
of persons qualifying both as surviving
eligible children under the PSOB Program
and as dependents younger than the age
of 18 can choose between a proportional
death benefit under the standard and the
alternative methods of payment. Survivors
eligible under the PSOB Program's categories
of survivors (e.g., spouses, parents,
certain insurance designees, and surviving
eligible children) who do not qualify
as dependent minors are only covered under
the standard calculation. Dependents who
are minors and who do not qualify under
another category of eligible survivors
(for example, eligible surviving children
of the deceased) are only covered by the
alternative method of payment. Death Benefits
Under the Standard Calculation, Described
in Sec. 102.82(c) Under the ``standard
calculation,'' the amount of the death
benefit that can be paid under the program
in a particular fiscal year will equal
the amount of the death benefit available
under the PSOB Program in the same fiscal
year (without regard to any reduction
in PSOB Program death benefits due to
a limitation in appropriations). The amount
of the PSOB Program death benefit, which
is subject to change, is currently approximately
$262,100.
Survivors
who already collected, or are eligible
to collect, death benefits under the PSOB
Program are not eligible to receive Smallpox
Vaccine Injury Compensation Program death
benefits under the standard calculation.
Survivors receiving a death benefit under
the standard calculation from this program
will receive the difference between any
disability benefit paid under the PSOB
Program and the death benefit available
under the standard calculation if the
PSOB Program disability benefit was underpaid
due to a limitation in appropriations.
Death
benefits under the standard calculation
will be reduced by the amount of lost
employment income benefits that were paid
under this program either to the deceased
individual during his or her lifetime,
or to his or her estate after death. For
example, if a smallpox vaccine recipient
received $40,000 from the program during
his lifetime in benefits for lost employment
income and later died, his survivors would
be entitled to receive a total of approximately
$222,100 in this fiscal year (the approximate
$262,100 death benefit, minus the $40,000
in benefits for lost employment income
paid to the injured person during his
lifetime).
Death
Benefits Under the Alternative Calculation,
Described in Sec. 102.82(d)
Payments
made under the ``alternative calculation''
of death benefits are based on the deceased
person's employment income at the time
he or she sustained the covered injury.
Under this calculation, 75% of the deceased
person's employment income (determined
in the same manner as employment income
for purposes of lost employment income
benefits) at the time he or she sustained
the covered injury resulting in death
will be paid annually until the youngest
of the dependents reaches the age of 18.
However, the maximum annual amount that
may be paid to dependents (in total) under
the alternative calculation is $50,000.
No lifetime caps apply to death benefits
under this alternative calculation. Death
benefits under this alternative calculation
are available only to surviving dependents
who are younger than the age of 18.
In
order for such surviving dependents to
receive payments under the alternative
calculation as opposed to the standard
calculation, the legal guardian of all
the dependents younger than the age of
18 must choose to receive a proportionate
share of the benefits under this calculation
on their behalf, as described in Sec.
102.82(d)(1). In the event that multiple
dependents have different legal guardians,
each legal guardian is responsible for
choosing the calculation of death benefits
on behalf of the dependents of whom he
or she is the legal guardian. For this
reason, the legal guardian of several
individuals who qualify both as surviving
dependents younger than the age of 18
and as surviving eligible children cannot
select a death benefit under the standard
calculation for some of those dependents
and a death benefit under the alternative
calculation for other dependents.
For
those survivors who are eligible for a
death benefit under both calculations,
the particular circumstances (e.g., the
age of the survivors, the employment income
of the deceased person at the time of
the covered injury) will determine which
method of calculation will provide the
greatest financial benefit. If dependent
survivors choose to receive death benefits
under the alternative calculation, no
death benefits will be paid to those dependents
under the standard calculation. However,
such payments would not preclude other
eligible survivors of equal priority from
receiving a proportionate death benefit
under the standard calculation. For example,
if a deceased smallpox recipient or vaccinia
contact is survived by two dependents
younger than the age of 18 from a prior
marriage and by a spouse who is not the
legal guardian of the dependents, the
legal guardian of the two dependents could
choose to receive a 50% share of the death
benefit for the dependent children under
the alternative calculation and the surviving
spouse would still be able to receive
his or her 50% share of the death benefit
under the standard calculation. As another
example, if a deceased smallpox recipient
is survived by two minor, dependent children,
one whose living parent is the deceased
person's surviving spouse and another
whose living parent is the deceased person's
former spouse, the surviving spouse could
receive a 50% share of the death benefit
under the standard calculation and each
of the dependent children would be eligible
for a proportionate share (25%) of the
death benefit available under the standard
calculation or the alternative calculation,
as determined by the children's respective
legal guardians. Although the Program
will generally apportion death benefits
among multiple eligible survivors, it
will not do so on behalf of dependents
receiving death benefits under the alternative
calculation if the dependents share the
same legal guardian (because such payments
would be made to the legal guardian on
behalf of all of the dependents for whom
he or she is the legal guardian).
The
legal guardian would be expected to apportion
the award appropriately. Death benefits
paid to survivors under this alternative
calculation are secondary to all payments
made, or expected to be made in the future,
by any third party payor for: (i) Compensation
for the deceased person's loss of employment
income on behalf of the dependents receiving
death benefits under the alternative calculation,
or their legal guardian(s); (ii) disability,
retirement, or death benefits in relation
to the deceased person on behalf of the
dependents receiving death benefits under
the alternative calculation, or their
legal guardian(s); and (iii) life insurance
benefits on behalf of the dependents receiving
death benefits under the alternative calculation.
Such secondary benefits are described
in Sec. 102.83(d)(3)(A). Reductions will
not be made if such benefits were paid
to other persons (for example, if a retirement
benefit was paid to the surviving spouse
who is not the dependents' legal guardian,
no deduction would be made to the dependents'
death benefit to account for the benefit
the spouse received). In calculating such
reductions, the Secretary will have discretion
to apportion over multiple years any lump-sum
third-party payments. The Secretary has
a right to recover benefits paid under
this program from third-party payors that
have an obligation to pay for or provide
such benefits. As with other determinations
made under this regulation, any determination
concerning the calculation and payment
of death benefits is not subject to any
judicial review.
Filing
a Request Package (Sec. 102.40-Sec. 102.41)
A Smallpox Vaccine Injury Compensation
Request Form (hereinafter ``Request Form'')
available from the program and all the
eligibility and benefits documentation
comprise the Smallpox Vaccine Injury Compensation
Request Package (hereinafter ``Request
Package''). In order for a requester to
have his or her request reviewed by the
program, the requester must submit, at
a minimum, a completed Request Form postmarked
within the filing deadlines established
by this regulation. If requesters choose
to use a commercial carrier such as Federal
Express, United Parcel Service, Emery,
etc., or a private delivery service, in
the absence of a postmark, the date that
the Request Form or Request Package is
marked as received by the delivery service
will be considered the equivalent of a
postmark. Requesters must send their Request
Forms and Request Packages to the applicable
address listed in Sec. 102.41.
Representatives
of Requesters (Sec. 102.44)
This program has been designed so that
requesters do not need to retain the services
of lawyers to pursue benefits under this
program. However, as provided in Sec.
102.44, requesters may have a legal or
personal representative submit the Request
Form and/or Request Package on their behalf.
A legally competent requester must certify
on the Request Form that he or she has
authorized the representative to submit
the Request Package on his or her behalf.
Requesters who are minors or legally incompetent
adults will require the assistance of
a representative (who does not need to
be a lawyer). Representatives of requesters
who are minors or adults determined by
a court to be legally incompetent are
required to submit specific documentation,
in addition to the documentation generally
required of requesters, which is described
in Sec. 102.63. The representative of
a requester is required to submit the
documents that would ordinarily be required
of the requester. For example, if this
regulation requires a requester to submit
his or her medical records, the requester's
representative would be required to submit
the same records on behalf of the requester.
The Secretary will direct all correspondence
to, and communicate exclusively with,
a requester's representative unless the
Secretary is advised that the representation
has stopped. As explained above, although
legal representation is permitted, it
is not needed for filing for program benefits.
As described in Sec. 102.44(d), the Secretary
will not be responsible for the payment
of any fees for the services of legal
or personal representatives or for any
associated costs.
Filing
Deadlines (Sec. 102.42)
Smallpox vaccine recipients who have a
covered injury have one year from the
date of a smallpox vaccination administered
during the effective period of the Declaration
(between January 24, 2003, and January
23, 2004, unless the Secretary extends
the time period) to submit a Request Form.
This deadline applies even if the requester's
injury was the direct result of a covered
countermeasure other than the smallpox
vaccine (e.g., cidofovir) that was administered
after the vaccine administration. Vaccinia
contacts have two years to submit their
Request Forms from the date of the onset
of the covered injury, as documented in
their medical records. Because the SEPPA,
in its discussion of filing deadlines,
refers to requests based on the administration
of the smallpox vaccine and requests based
on accidental vaccinia inoculation, the
filing deadlines that apply to Request
Forms filed by smallpox vaccine recipients
or vaccinia contacts are the same filing
deadlines that apply to Request Forms
filed by the survivors or the representatives
of the estates of deceased smallpox vaccine
recipients and vaccinia contacts.
However,
as explained later in the preamble, if
a smallpox vaccine recipient or vaccinia
contact filed a timely Request Form and
later died, his or her survivors (or the
representative of his or her estate) could
file an amendment to that Request Package
outside of the filing deadline. Because
the administration of smallpox covered
countermeasures other than the smallpox
vaccine (cidofovir and its derivatives
or Vaccinia Immune Globulin), in the context
of this program, generally relates back
to complications arising from the administration
of the smallpox vaccine or of accidental
vaccinia inoculation, the filing deadlines
set forth in Sec. 102.42 extend to the
administration of such other covered countermeasures.
In
the event that the Secretary amends the
Table of Injuries, requesters have an
extended filing deadline, based on the
effective date of the table amendment,
which will be published in the Federal
Register. However, the extended filing
deadline only applies if the table amendment
enables a person who could not establish
a table injury before the amendment to
establish such an injury. To speed the
review of eligibility, requesters should
file all documentation required for eligibility
determinations by the filing deadline.
However, a requester will meet the filing
deadline requirement by submitting only
the completed and signed Request Form
by that deadline, with documentation to
follow.
Request
Forms not filed within the governing filing
deadline will not be processed, and the
requester will not be considered for any
program benefits.
Amendments
to Request Packages (Sec. 102.46)
The filing of amendments to previously
filed Request Packages is discussed in
Sec. 102.46. As explained in that section,
if a smallpox vaccine recipient or vaccinia
contact filed a Request Package, but later
dies, his or her survivors or the representative
of his or her estate may amend the Request
Package. However, a requester filing such
an amended request will only be entitled
to benefits under the program if the original
Request Form (filed by the smallpox vaccine
recipient, vaccinia contact, or representative)
was filed within the applicable filing
deadline. If such an amendment is filed,
all of the documentation submitted with
the original Request Package will be considered
part of the amended Request Package and
the survivor or estate representative
need not resubmit such documentation.
Requesters
are responsible for notifying the program
of any changes in circumstances that may
have an impact on the Secretary's eligibility
and benefits determinations. Documentation
Needed for the Secretary To Determine
Eligibility (Sec. 102.50-Sec. 102.54)
Requesters or their representatives must
submit appropriate documentation to allow
the Secretary to determine if the requesters
are eligible for program benefits. The
documentation required will vary somewhat
depending on whether the requester is
filing as a smallpox vaccine recipient,
vaccinia contact, survivor, or representative
of an estate.
Medical
Records Required of All Requesters To
Establish a Covered Injury (Sec. 102.50)
Because all Request Packages filed with
the program, including those filed by
survivors or representatives of the estates
of deceased persons, must relate back
to a smallpox vaccine recipient or vaccinia
contact who sustained a covered injury,
all requesters must submit medical records
sufficient to demonstrate to the Secretary
that a covered injury was sustained by
a smallpox vaccine recipient or a vaccinia
contact. Section 102.50(a) describes the
medical records that are generally required
in order for a requester to establish
that a covered injury was sustained. The
Secretary will use the records submitted,
as well as any other available evidence,
to evaluate either whether an injury set
out in the table and meeting the table's
requirements was sustained or whether
an injury was sustained as the direct
result of receiving a covered countermeasure
(including a smallpox vaccine) or of contracting
vaccinia through accidental exposure.
The program will consider copies of medical
records to be the same as the original
records.
Although
the medical records described in Sec.
102.50(a) are those that will generally
be required for all requesters, requesters
may also submit additional documentation,
as provided for under Sec. 102.50(b).
As described in Sec. 102.50(d), the Secretary
may determine that particular records
described in Sec. 102.50(a) are not necessary
for particular requesters (for example,
if certain medical records provide the
exact same information as other records
that are submitted) or that additional
records may be required in order to make
a covered injury determination (for example,
in cases in which a preexisting condition
may be the cause of the current injury).
If certain medical records are unavailable
to a requester, the requester must submit
a statement describing the reasons for
the records' unavailability and the reasonable
efforts the requester has made to obtain
them. The Secretary may, at his discretion,
accept such a statement from the requester
instead of the required medical records,
if the circumstances so warrant, as set
forth in Sec. 102.50(c). If a smallpox
vaccine recipient or vaccinia contact
died and his or her survivors seek a death
benefit under the program, the Secretary
will need to review the medical records
to determine whether the death was the
direct result of a covered injury. As
explained in Sec. 102.53(d), the medical
records reviewed for this purpose may
be the same as those submitted for the
covered injury determination. In making
covered injury determinations, the Secretary
may consider all of the scientific evidence
available (e.g., published articles concerning
a relationship between the smallpox vaccine
and an injury) and consult with qualified
medical experts. Documentation a Smallpox
Vaccine Recipient Must Submit To Be Deemed
Eligible (Sec. 102.51) As described above,
a smallpox vaccine recipient must submit
medical records that are sufficient to
show that he or she sustained a covered
injury, including medical records produced
after the vaccination from all hospitals,
clinics, or providers. In order to show
eligibility, such a requester must also
submit a completed and signed Request
Form and the documentation described in
Sec. 102.51. As noted in Sec. 102.51(b),
a requester may submit a certification
form, available from the program, completed
by the entity (e.g., State government,
private employer) that participated in
the administration of the smallpox vaccine
or other covered countermeasure to the
smallpox vaccine recipient as part of
a smallpox emergency response plan in
place of documentation otherwise required
concerning the requester's participation
in, and receipt of the smallpox vaccine
under, an approved smallpox emergency
response plan. Documentation a Vaccinia
Contact Must Submit To Be Deemed Eligible
(Sec. 102.52) A requester who is a vaccinia
contact must submit a completed and signed
Request Form and the documentation described
in Sec. 102.52. Among the required documentation
is documentation identifying the individual
who was the source of the accidental vaccinia
inoculation. However, if such documentation
is unavailable, for example, if the source
of the exposure to vaccinia is unknown,
the Secretary has the discretion to accept
other documentation providing evidence
of the source of such exposure. For example,
the Secretary may accept an affidavit
signed by the requester explaining the
circumstances under which he or she contracted
the vaccinia. If this information is supportive
of the vaccinia contact contracting vaccinia
from a smallpox vaccine recipient (as
defined in this regulation, except that
the recipient need not sustain a covered
injury) or from the contact of such a
person, the Secretary may accept such
an affidavit in place of the required
documentation. Documentation a Survivor
Must Submit To Be Deemed Eligible (Sec.
102.53) A requester who is a survivor
of a deceased smallpox vaccine recipient
or vaccinia contact must submit a completed
and signed Request Form, the documentation
discussed above that the deceased person
would have had to submit if he or she
were alive at the time of filing, and
the documentation required of survivor
requesters. These requirements are described
in Sec. 102.53. Documentation a Representative
of a Deceased Person's Estate Must Submit
for the Estate To Be Deemed Eligible (Sec.
102.54) A requester who is the representative
of the estate of a deceased smallpox vaccine
recipient or vaccinia contact, seeking
benefits under the program on behalf of
the estate, must submit a completed and
signed Request Form, the documentation
discussed above that the deceased person
would have had to submit if he or she
were alive at the time of filing, and
the documentation required of requesters
who are estate representatives. These
requirements are described in Sec. 102.54.
Documentation
Needed for the Secretary To Calculate
Benefits (Sec. 102.60-Sec. 102.63)
In addition to the documentation requesters
must submit for the Secretary to make
eligibility determinations (including
the determination that a covered injury
was sustained), requesters must submit
documentation to enable the program to
calculate the type and amount of benefits
available. Because the benefits available
under the program are generally secondary
to benefits received from third-party
payors, it may be possible that certain
requesters who are deemed eligible will
not receive benefits from the program.
Sections 102.60- 102.63 describe the documentation
that is required for requesters seeking
particular types of benefits. Although
the program will accept such documentation
at any time after a Request Form is filed,
a requester need not submit any of the
documentation pertaining to benefits until
the Secretary has informed the requester
that he or she is eligible under the program.
The submission of benefits documentation
is described in Sec. 102.43(b) and is
designed to ease the documentary burden
on requesters who do not know whether
or not they will be deemed eligible. Requesters
need not submit benefits documentation
until they have been notified by the Secretary
that they are eligible.
In
order to calculate the amount of each
type of benefit available, the program
requires requesters to provide documentation
of every third-party payor that may have
paid for or provided the benefits requested,
or that may have an obligation to do so.
The information required concerning such
third-party payors with respect to each
type of benefit available under the program
is described in Sec. 102.60- Sec. 102.62.
Requesters
seeking medical benefits must also submit
documentation concerning the amount paid
or expected to be paid by such third-party
payors for the medical services or items
for which payment is being sought under
the program. Third-party payors of medical
benefits include, but are not limited
to, medical insurance, Medicaid, Medicare,
and any other source of medical recompense.
An example of the documentation necessary
to satisfy this requirement is an Explanation
of Benefits form issued by the requester's
health insurance company.
Third-party
payors of benefits for lost employment
income include, but are not limited to,
the requester's employer, disability insurance,
and workers' compensation programs. In
order to satisfy his or her obligations
under Sec. 102.61, a requester may need
to submit documentation including his
or her earnings and leave statements,
information concerning the number of hours
in the requester's standard work day,
as well as documentation concerning any
lost work benefits programs or payments.
Requesters seeking death benefits will
have to submit different documentation
concerning third-party payors depending
on whether they are seeking death benefits
under the standard calculation described
in Sec. 102.82(c) or are choosing a death
benefit under the alternative calculation
described in Sec. 102.82(d). For example,
survivors seeking a death benefit under
the standard calculation must submit documentation
concerning PSOB Program death and disability
benefits. The legal guardian of survivors
seeking a death benefit under the alternative
calculation must submit documentation
concerning a broader group of existing
or potential third-party payors (described
fully in the death benefits calculation
section of this preamble and set forth
in Sec. 102.83(d)(3)(A)). Requesters seeking
death benefits must submit other documentation
described in Sec. 102.62.
Before
payments will be made, the representatives
of requesters who are minors or legally
incompetent adults must submit additional
documentation described in Sec. 102.63.
Because some of this documentation may
be time-consuming to obtain (e.g., obtaining
a court decree establishing a guardianship
of the estate for a legally incompetent
adult), the requester can wait until a
benefits calculation has been made, and
a written approval has been issued, before
submitting such documentation.
Determinations
the Secretary Will Make (Sec. 102.70-Sec.
102.74)
When the Secretary receives a completed
and signed Request Form or Request Package
postmarked in the appropriate time frame,
he will conduct two separate reviews,
as described in Sec. 102.70. First, he
will determine whether the requester is
eligible. Second, the Secretary will determine
the type and amount of benefits that may
be paid (if any). If the Request Package
does not include sufficient documentation
to determine eligibility, the Secretary
will send written notice to the requester
(or his or her representative) identifying
the documentation that is needed, as provided
for in Sec. 102.71.
The
requester will be given 60 days to submit
the required documentation. If, after
reasonable efforts to obtain the documents,
the documentation remains unavailable,
the requester must submit a letter explaining
the circumstances to the Secretary. The
Secretary also has the discretion to accept
a letter meeting the requirements set
out in Sec. 102.71 as a substitute for
the unavailable documentation. Once the
Secretary has sufficient documentation
to make an eligibility determination,
he will make that decision in a timely
manner. If the Secretary determines that
a requester is not eligible for benefits
under the program, he will inform the
requester (or his or her representative)
of the disapproval in writing.
As described in Sec. 102.72(a), the Secretary
will provide information as to the options
available to the requester, including
the requester's right to seek reconsideration
of the eligibility decision. If the Secretary
determines that a requester meets the
eligibility requirements, he will notify
the requester in writing of this decision,
at which point the Secretary will review
the Request Package in order to calculate
the type and amount of the benefits. If
the Request Package does not have sufficient
documentation for the Secretary to calculate
the amount of the benefits, the Secretary
will notify the requester in writing of
the documentation he requires to complete
the calculation.
As
with the eligibility documentation, the
requester will be given 60 days to submit
the required documentation or provide
a letter setting forth the circumstances
that make the records unavailable. Again,
the Secretary may accept a letter meeting
the requirements set forth in Sec. 102.71
as a substitute for the unavailable documentation.
Once the Secretary has sufficient documentation
to calculate a requester's benefits, the
Secretary will complete this calculation
in a timely manner. As set out in Sec.
102.73, once the Secretary has calculated
the amount of the benefits and determined
that payment is to be made, he will inform
the requester of the approval in writing
and then initiate payment.
Under
Sec. 102.74, if the Secretary disapproves
a request, which the Secretary may do
at any time, he will so notify the requester
(or his or her representative) in writing
and provide information as to the options
available to the requester, including
the requester's right to seek reconsideration
of the Secretary's decision. Payment of
All Benefits Under the Program (Sec. 102.83)
The Secretary's options in paying all
benefits under the program are described
in Sec. 102.83. If the Secretary determines
that there is a reasonable likelihood
that payments of medical benefits, benefits
for lost employment income, or death benefits
paid under the alternative calculation
(described in Sec. 102.82(d)) will be
required for a period in excess of a year
from the date the Secretary determines
that the requester is eligible for such
benefits, the Secretary may pay such benefits
through a lump-sum payment, annuity or
medical insurance policy, or appropriate
structured settlement agreement, as long
as the payment, annuity, policy, or agreement
is actuarially determined to have a value
equal to the present value of the projected
total amount of such benefits that the
requester is eligible to receive.
As
described in Sec. 102.83(b), lump sum
payments will generally be made through
electronic funds transfers to requesters'
accounts. If a requester is a minor, the
payment will be transferred to the account
of the minor's legal guardian (generally,
the minor's parent). The legal guardians
of minor requesters under this program
will be required to use the payments for
the benefit of the minor. Such legal guardians
are subject to applicable State law requirements
concerning payments made on behalf of
minors (e.g., become the guardian of the
minor's estate or establish an account
with State court supervision, if required
by State law).
In
administering this program, consistent
with the practice of the PSOB Program
in paying death benefits on behalf of
minors, the Secretary will not require
proof that the legal guardian has taken
such actions. Section 102.83(b) describes
the requirements pertaining to lump sum
payments made on behalf of adults considered
legally incompetent. As provided in Sec.
102.83(c), the Secretary may choose to
make interim payments of benefits under
the program (in other words, issue a payment
for a certain type or portion of program
benefit prior to making the final benefits
payment) in order to get certain benefits
to a requester more quickly than would
otherwise be possible. For example, the
Secretary may pay medical benefits for
past services or items to an eligible
requester whose covered injury has resulted
in substantial medical bills before making
the final determination concerning the
payment of future medical benefits. In
certain cases, the Secretary may make
an interim payment of benefits even before
a final eligibility or benefits determination
is made. The Secretary expects such instances
to be rare, and the requester in such
circumstances must agree to repay the
Secretary for any benefits later determined
to be improper.
The
Tax Consequences of Receiving Benefits
From the Program
The Secretary has asked the Internal Revenue
Service (IRS) to provide prompt guidance
on the tax consequences of receiving benefits
under SEPPA. The IRS intends to publish
guidance before the end of the year that
will give requesters who receive benefits
under the program the information they
would need to meet any Federal tax responsibilities.
The IRS has committed to working with
the Secretary to ensure that requesters
have ready access to the tax information
and assistance with any additional questions
they may have. The Secretary's Right To
Recover Benefits Paid Under the Program
From Third-Party Payors (Sec. 102.84)
As described elsewhere in this preamble,
the payment of benefits under this program
is generally secondary to benefits available
from other third-party payors. The category
of third-party payors that have primary
responsibility to pay for or provide such
benefits is different for each type of
benefit available under this program.
Such third-party payors are discussed
in the sections of the preamble concerning
the different types of benefits.
As
described in Sec. 102.84, after the Secretary
pays benefits under this program, he will
be subrogated to the rights of the requester,
meaning that the Secretary may assert
a claim against any third-party payor
with a legal or contractual obligation
to pay for, or provide, such benefits.
The Secretary may recover from such a
third-party payor the amount of benefits
the third- party payor has or had an obligation
to pay for or provide. For example, if
the Secretary pays a requester $10,000
in benefits for lost employment income
under this program and a State workers'
compensation program later determines
that it is obliged to pay the requester
$5,000 in workers' compensation benefits,
the Secretary may pursue a claim against
the State for the $5,000 (because the
Secretary, as the secondary payor, would
only be obligated to pay the requester
$5,000 in benefits for lost employment
income). Any benefits paid under this
program are not subject to any lien by
any primary third-party payor.
The
Reconsideration Process (Sec. 102.90)
Every individual who has filed a Request
Package and has received a determination
by the Secretary either denying eligibility
for benefits or denying a category or
amount of benefits requested, has a right
to seek reconsideration of the Secretary's
determination(s). Although such initial
determinations are characterized as Secretarial
determinations, this decision-making authority
will be delegated to the Smallpox Vaccine
Injury Compensation Program Office. The
requester or his or her representative
must send a letter seeking reconsideration
to the Associate Administrator, Special
Programs Bureau, Health Resources and
Services Administration, at the address
provided in Sec. 102.90(b). The letter
must be received by the Department within
60 calendar days of the date of the Department's
determination letter. The letter should
state the reasons why the Secretary should
reconsider his decision. No new documentation
can be included with this letter.
The
Associate Administrator, Special Programs
Bureau, will convene a panel to review
all cases seeking reconsideration. The
panel will consist of qualified individuals
who are independent of the Smallpox Vaccine
Injury Compensation Program Office. The
panel will review the Request Package
that was before the Secretary at the time
of the determination (and will not consider
any new documentation submitted by the
requester). After reviewing the case,
the panel will make a recommendation to
the Associate Administrator, Special Programs
Bureau, who will then make a final determination
as to whether or not the requester is
eligible for benefits or as to the type
and/or amount of benefits that may be
paid. The Associate Administrator will
inform the requester or his or her representative
in writing of the determination(s) and
of the reasons. This decision will be
considered the Secretary's final action
on the issue for which reconsideration
was sought. Requesters may not seek review
of such a decision. If the Associate Administrator's
final decision is that a requester who
was determined to be ineligible for benefits
is, in fact, eligible, then the Secretary
will make a determination as to the type
and amount of benefits to be paid. The
requester then has a right to seek reconsideration
of the Secretary's determination on that
issue.
Secretary's
Review Authority and No Further Review
of Determinations Made Under This Regulation
(Sec. 102.91, Sec. 102.92)
As described in Sec. 102.91, the SEPPA
authorizes the Secretary to review at
any time, and at his own motion or on
application, any determination made concerning
eligibility, entitlement to benefits,
and the calculation and payment of benefits
under the Program and authorizes the Secretary
to affirm, vacate, or modify such determination
in any manner the Secretary deems appropriate.
As explained in Sec. 102.92, once the
Secretary has made a final decision as
to eligibility or type or amount of benefits
and the requester has exercised his or
her right to reconsideration, section
262(f)(2) of the Public Health Service
Act does not allow any further review
of that decision by any court or administrative
body (unless the President specifically
directs further administrative review).
Given this broad statutory prohibition
against further review, no determination
made under this part (including, but not
limited to, eligibility determinations,
benefits calculations, payment decisions,
and reconsideration decisions) will be
subject to any review by Federal or State
courts.
Justification
for Omitting Notice of Proposed Rulemaking
and for Waiver of Delayed Effective Date
Through the enactment by the SEPPA of
part C, Title II of the Public Health
Service Act (PHS Act), the Secretary was
authorized to establish and administer
the Smallpox Vaccine Injury Compensation
Program. Congress authorized the Secretary
to issue regulations implementing the
SEPPA as the Secretary deems reasonable
and necessary, and provided that the initial
implementing regulations could be published
by interim final rule. In accordance with
that statutory authority, the Secretary
is herein establishing the procedures
and requirements to govern the program.
In addition, the Secretary has determined,
under 5 U.S.C. 553(b), that it is contrary
to the public interest to follow proposed
rulemaking procedures (i.e., issuing a
proposed rule, with an accompanying solicitation
of public comments) before issuance of
these regulations, because such a process
might delay the continuing implementation
of the President's plan to protect the
population of the United States against
the threat of a smallpox attack.
A
significant element of this plan, which
is also an important priority of the Secretary,
is the increased voluntary participation
of persons in smallpox emergency response
plans throughout the nation, which includes
voluntary immunization with the smallpox
vaccine. The sooner this regulation is
in effect, the sooner the program is implemented
and the sooner potential requesters will
be able to assess their eligibility to
receive benefits from the program. Once
this implementing regulation is in effect,
the Secretary expects individuals who
believe that they may be entitled to benefits
under the program will file requests for
such benefits within a short time frame.
In addition, publishing this regulation
promptly is necessary given that the governing
filing deadlines, as applied to particular
requesters, will begin to occur within
a short period of time. For the same reasons,
the Secretary has determined that there
is good cause to waive a delay in the
rule's effective date. Nonetheless, as
noted above, comments on the procedures
and requirements set forth in this interim
final rule will be accepted at the above
listed address for a period of 60 days
following the publication of the rule
in the Federal Register. Thus, although
the rule is effective immediately upon
publication, the Secretary will consider
the comments received and, based on them,
may amend the procedures and/or requirements
pertaining to this program.
Economic
and Regulatory Impact Regulatory Flexibility
Act and Executive Order 12866.
Executive Order 12866 directs agencies
to assess all costs and benefits of available
regulatory alternatives and, when rulemaking
is necessary, to select regulatory approaches
that provide the greatest net benefits
(including potential economic, environmental,
public health, safety distributive and
equity effects). In addition, under the
Regulatory Flexibility Act of 1980 (RFA),
if a rule has a significant economic effect
on a substantial number of small entities,
the Secretary must specifically consider
the economic effect of a rule on small
entities and analyze regulatory options
that could lessen the impact of the rule.
Executive Order 12866 requires that all
regulations reflect consideration of alternatives,
of costs, of benefits, of incentives,
of equity, and of available information.
Regulations
must meet certain standards, such as avoiding
an unnecessary burden. Regulations that
are ``significant'' because of cost, adverse
effects on the economy, inconsistency
with other agency actions, effects on
the budget, or novel legal or policy issues,
require special analysis. The Secretary
has determined that minimal resources
are required to implement the provisions
included in this regulation. Therefore,
in accordance with the RFA, and the Small
Business Regulatory Enforcement Fairness
Act of 1996, which amended the RFA, the
Secretary certifies that this rule will
not have a significant impact on a substantial
number of small entities. Specifically,
both the benefits and the burdens associated
with this interim final rule will go almost
entirely to individuals who are filing
as requesters with the program.
Any burdens on small entities associated
with the implementation of this final
rule (e.g., completing a certification
form concerning a smallpox vaccine recipient
who was vaccinated under the auspices
of a small entity as part of a smallpox
emergency response plan, providing records
to requesters seeking to comply with the
regulation's documentation requirements)
will be minimal in nature. Moreover, the
number of small entities affected in this
way will be very small in number. The
Secretary has also determined that this
proposed rule does not meet the criteria
for a major rule as defined by Executive
Order 12866 and would have no major effect
on the economy or Federal expenditures.
We have determined that the proposed rule
is not a ``major rule'' within the meaning
of the statute providing for Congressional
Review of Agency Rulemaking, 5 U.S.C.
801.
Nonetheless,
the Secretary believes that a discussion
of the factors that led to the creation
of the smallpox vaccination plan and of
the Smallpox Vaccine Injury Compensation
Program, as well as the likely impact
of both programs, is warranted. As described
earlier in this preamble, prior to its
eradication, smallpox (variola) was a
serious illness that manifested either
as outbreaks of variola major with death
rates of greater than 20% or variola minor
with death rates approaching 1%. Those
who survived were frequently left with
significant disabilities, such as blindness.
Smallpox vaccine was an essential tool
for the successful global eradication
of smallpox, announced by the World Health
Organization in 1980. Despite such eradication,
concern exists that terrorists may have
access to the smallpox virus.
On
December 13, 2002, the President announced
a plan to protect the population of the
United States against the threat of a
possible smallpox attack. This plan was
based on heightened concerns, in the wake
of the attacks of September and October
2001, that terrorists may have access
to the smallpox virus and may attempt
to use it against the population of the
United States and government facilities
abroad. Under this plan, which the Secretary
is actively working to implement, State
and local governments have formed volunteer
smallpox emergency response teams that
will be prepared to provide critical services
to the population of the United States
in the event of a smallpox virus attack.
In furtherance of the President's plan,
and as described earlier, the Secretary
issued a Declaration Regarding Administration
of Smallpox Countermeasures on January
24, 2003. In this Declaration, the Secretary
stated that ``a potential bioterrorist
incident makes it advisable to administer,
on a voluntary basis, covered countermeasures
specified * * * for prevention or treatment
of smallpox [(virus infection)] or control
or treatment of adverse events related
to smallpox vaccination, to [specified]
categories of individuals * * *.''
The
specific ``covered countermeasures'' described
in the Declaration are smallpox vaccines,
cidofovir and derivatives thereof, and
Vaccinia Immune Globulin. The categories
of persons to whom the Secretary recommended
the administration of such covered countermeasures,
on a voluntary basis, included certain
health care workers, members of smallpox
emergency response plans identified by
State or local government entities or
the Department of Health and Human Services,
certain public safety personnel, and certain
personnel associated with specific Federal
facilities abroad. The Secretary recommended
that such persons receive the smallpox
vaccine to ensure that essential personnel
would be able to mobilize immediately
and provide critical services to the population
of the United States in the event of a
smallpox virus attack. As already stated,
the SEPPA was enacted on April 30, 2003.
This statute authorized the Secretary
to establish the Smallpox Vaccine Injury
Compensation Program (the program). This
program has been appropriated $42 million
for the administration of the program
and the payment of benefits under the
program. The purpose of the program is
to provide benefits to eligible members
of smallpox emergency response plans who
sustain a covered injury as the result
of receiving the smallpox vaccine (or
other smallpox covered countermeasures).
In addition, certain persons who come
in contact with a vaccinated member of
a smallpox emergency response plan (or
the contact of such a person) and sustain
a covered injury may be eligible for benefits.
As noted above, death benefits are also
available to survivors of individuals
whose death resulted directly from a covered
injury. The availability of benefits to
injured persons (and certain survivors,
in the case of death) under this program
was considered an important step in the
implementation of the Administration's
smallpox vaccination plan and in the nation's
preparedness to face potential terrorist
events involving the smallpox virus.
Prior
to the enactment of the SEPPA, and the
establishment of this program, eligible
smallpox vaccine recipients and vaccinia
contacts were only entitled to benefits
for medical care or for lost employment
income related to covered injuries that
were otherwise available from other third-party
payors (e.g., State workers' compensation
programs). In addition, pursuant to the
Homeland Security Act of 2002, certain
smallpox vaccine recipients and vaccinia
contacts could pursue legal actions relating
to covered injuries under the Federal
Torts Claims Act (FTCA). The latter option
was limited insofar as awards under the
FTCA are available only to the extent
that negligence can be shown in relation
to the vaccine production or administration.
The SEPPA expanded the benefits available
to eligible smallpox vaccine recipients
and vaccinia contacts through the establishment
of a no-fault administrative compensation
program that supplements the benefits
available from other third-party payors.
The
Administration has worked to remove other
disincentives to smallpox vaccination
through approved smallpox emergency response
plans (e.g., providing appropriate guidelines
for pre-vaccination screening for potential
contraindications, engaging in post-vaccination
surveillance and data collection). Because
it is impossible to quantify the risk
of potential terrorist incidents involving
the smallpox virus, it is impossible to
assess the contribution that a group of
first responders vaccinated with the smallpox
vaccine through smallpox emergency response
plans will provide to the population of
the United States. In making benefits
available to eligible individuals, the
Administration is removing a disincentive
that may be a barrier against first responders
and others receiving the smallpox vaccination
as participants in approved smallpox emergency
response plans. In removing this disincentive,
the program is likely to increase the
nation's preparedness in the face of uncertainty.
In addition, the establishment of the
program ensures that individuals who sustain
covered injuries as the direct result
of such vaccinations (or of other smallpox
covered countermeasures) or of accidental
vaccinia inoculation will be afforded
appropriate benefits, including payment
for related medical services and items.
As
of September 2003, approximately 38,400
vaccinations have been administered to
civilians under approved smallpox emergency
response plans. Of those, approximately
800 have reported medical injuries to
the CDC through the Vaccine Adverse Events
Reporting System (VAERS). Such reports
have included three fatalities and 92
serious injuries. Some of those who have
reported injuries may not be eligible
for the Smallpox Vaccine Injury Compensation
Program, either because the injury is
not covered by the Act (e.g., because
the injury is excluded as a minor injury
or because the injury is neither listed
on the table nor is there evidence linking
the smallpox vaccine to the occurrence
of the injury) or because the individual
is not eligible under the SEPPA (e.g.,
the requester received the smallpox vaccine,
but not as a participant in an approved
smallpox emergency response plan).
Nevertheless,
these recorded injuries indicate a possible
injury rate of about 2% of the vaccinated
population. The $42 million appropriated
to the Program, in addition to covering
administrative costs, was projected by
Congress to cover the provision of benefits
to eligible requesters. This figure was
reached after consideration of the projected
number of covered injuries and related
deaths, projected medical costs related
to the covered injuries, and the projected
number of lost work days resulting from
such covered injuries.
The
fact that program benefits are generally
only available if such benefits are not
available from other third- party payors
(e.g., medical benefits will not be paid
for medical services or items if a requester's
health insurance company has an obligation
to pay for or provide such services or
items), or are generally only available
in an amount necessary to supplement benefits
available from third-party payors, was
also considered.
It
should be noted that the smallpox vaccination
program that was being considered by Congress
and the Administration when the $42 million
appropriation was made contemplated that
up to 2-3 million individuals could be
vaccinated through approved smallpox emergency
response plans if individuals representing
all of the occupations described in the
SEPPA (including health care workers,
firefighters, and public safety personnel)
fully participated in the smallpox vaccination
program. The number of individuals who
have received the smallpox vaccine under
approved smallpox emergency response plans
to date is substantially smaller than
the number of such vaccinees that were
considered possible if the smallpox vaccination
program reached full participation.
As
of September 2003, approximately 38,400
vaccinations were administered under approved
smallpox emergency response plans. For
this reason, the number of individuals
eligible to receive benefits under the
program may in fact be a small percentage
of the numbers originally considered.
Given that the number of individuals who
have volunteered to receive the smallpox
vaccine under approved smallpox emergency
response plans is significantly smaller
than the total number of potential vaccinees
likely considered in devising the $42
million appropriation, the program expects
the adverse events associated with the
smallpox vaccination program and the amount
of benefits paid by the program (which
will depend, on large part, upon the amount
of medical services and items, as well
as lost employment income, relating to
covered injuries) to be similarly smaller
than what was considered in calculating
the $42 million appropriation.
Of
course, this expectation may change over
time depending upon many factors, including
the number of volunteers who receive the
smallpox vaccine under approved smallpox
emergency response plans in the future,
as well as new scientific findings concerning
the existence of causal relationships
between particular medical conditions
and the smallpox vaccine (as well as other
covered countermeasures and vaccinia contracted
through accidental exposure). In establishing
the procedures described in this regulation,
the Secretary has made operational decisions
that will assist eligible requesters to
receive benefits in a prompt and fair
manner. For example, requesters are not
required to obtain the services of an
attorney in order to obtain benefits under
the program, but are permitted to appoint
a representative to assist them in filing
a Request Package if this will be helpful
to the requester.
In
addition, the Secretary has made an effort
to be flexible in circumstances in which
a requester is unable to submit documentation
that would otherwise be required in order
to establish eligibility and entitlement
to benefits. For example, if a requester
has made a good faith effort to obtain
medical records, but is unable to access
such records (e.g., if a physician's practice
is no longer in business), the Secretary
may choose to accept a statement by the
requester describing the reasons for the
records' unavailability and the reasonable
efforts the requester has made to obtain
them in place of the unavailable medical
records.
Likewise,
if a vaccinia contact is unable to identify
the source of his or her exposure to vaccinia,
this interim final rule enables the requester
to submit an affidavit explaining the
circumstances under which he or she contracted
the vaccinia. If this information is consistent
with the vaccinia contact contracting
vaccinia from an eligible vaccinee or
the contact of such a person (e.g., the
vaccinia contact works in a hospital and
was in close contact with several individuals
who received the smallpox vaccine under
an approved smallpox emergency response
plan and, to the best of his or her knowledge,
was not in close contact with any person
who received the smallpox vaccine outside
such a plan), the Secretary may accept
such an affidavit in place of the required
documentation.
Unfunded
Mandates Reform Act of 1995.
The Secretary has determined that this
interim final rule will not have effects
on State, local, and tribal governments
and on the private sector such as to require
consultation under the Unfunded Mandates
Reform Act of 1995. Federalism Impact
Statement. The Secretary has also reviewed
this rule in accordance with Executive
Order 13132 regarding federalism, and
has determined that it does not have ``federalism
implications.'' The rule does not ``have
substantial direct effects on the States,
or on the relationship between the national
government and the States, or on the distribution
of power and responsibilities among the
various levels of government.''
Impact
on Family Well-Being.
This interim final rule will not adversely
affect the following elements of family
well-being: Family safety, family stability,
marital commitment; parental rights in
the education, nurture and supervision
of their children; family functioning,
disposable income or poverty; or the behavior
and personal responsibility of youth,
as determined under section 654(c) of
the Treasury and General Government Appropriations
Act of 1999. In fact, this interim final
rule may have a positive impact on the
disposable income and poverty elements
of family well-being to the extent that
families of injured persons (and of other
persons deemed eligible to receive benefits
under this part) receive, or are helped
by, benefits paid under this part without
imposing a corresponding burden on them.
Impact
of the New Rule.
In this interim final rule, the Secretary
establishes the procedures and requirements
applicable to requesters filing for benefits
available under the program. This interim
final rule is based on the SEPPA. It will
have the effect of enabling certain eligible
individuals who sustained covered injuries
as the direct result of receiving a covered
countermeasure under the Secretary's Declaration,
or as a direct result of vaccinia contracted
through accidental vaccinia inoculation
in the case of certain vaccinia contacts,
to receive benefits under the program.
In the event that an otherwise eligible
smallpox vaccine recipient or vaccinia
contact has died, his or her estate and/or
survivors may be entitled to certain benefits.
This interim final rule sets out the eligibility
requirements that apply to the program,
and the documentation that must be submitted.
Paperwork Reduction Act of 1995. In accordance
with section 3506(c)(2)(A) of the Paperwork
Reduction Act (PRA) of 1995, the Department
is required to solicit public comments,
and receive final Office of Management
and Budget (OMB) approval, on any information
collection requirements set forth in rulemaking.
As indicated, in order to implement the
SEPPA, certain information is required
as set forth in Sec. Sec. 102.50-102.63
of this rule. In accordance with the PRA,
we have submitted and obtained OMB approval
on this data collection and reporting
of this information. An emergency review
was needed before the expiration of the
normal time limits under OMB's regulations
at 5 CFR part 1320, to ensure the timely
availability of data as necessary to ensure
the provision of benefits to eligible
petitioners.
Delaying
the data collection would delay implementation
of the statutory purpose of providing
benefits to eligible individuals who sustained
covered injuries, particularly because
the statutory filing deadlines for certain
eligible requesters may occur as early
as January 2004. Implementing this regulation
and providing benefits as soon as possible
will ensure that the intent of SEPPA in
making these benefits to eligible individuals
will be implemented, to the extent possible.
OMB has approved this collection, with
a 180-day approval period.
During
this period, we will publish a separate
Federal Register notice announcing the
initiation of an extensive 60-day agency
review and public comment period on the
requirements set forth.
Collection
of Information: The Smallpox Vaccine Injury
Compensation Program
Description of Respondents:
Individuals who are members of smallpox
emergency response plans who received
a smallpox vaccine and sustained a covered
injury from it or from other covered countermeasures.
Individuals who were injured by vaccinia
from contact with a vaccinated member
of a smallpox emergency response plan
or other vaccinia contacts also qualify.
In addition, some survivors of smallpox
vaccine recipients or of vaccinia contacts
may be eligible for death benefits and
the estates of such deceased persons may
receive certain benefits.
Estimated
Annual Reporting:
The estimated annual reporting for this
data collection is a total of six hours
for reviewing and completing the Smallpox
Vaccine Injury Compensation Request Form
as well as the time to obtain and provide
medical and financial documentation for
eligibility and the computation of benefits.
The estimated annual response burden is
as follows:
Number
of Responses per Total burden Form respondents
respondent Hourly response hours Wage
rate Total hour cost --------------------------------------------------------------------------------------------------------------------------------------------------------
Request Form and Supporting Documentation.........
1,250 1 5 6,250 $37.50 $234,375 Certification.....................................
1,250 1 1 1,250 37.50 46,875 -----------------------------------------------------------------------------------------------------
Total.........................................
2,500 ............... ...............
7,500 ............... 281,250
According
to CDC's Vaccine Adverse Event Reporting
System (VAERS), there are reports of three
fatalities and 92 serious injuries (out
of approximately 800 total reported injuries)
based on the administration of approximately
38,400 smallpox vaccinations to volunteers
within the civilian sector (as of September
2003). The program recognizes the difficulty
inherent in predicting the number of individuals
who will file for benefits under approved
smallpox emergency response plans. Nonetheless,
with the anticipation of additional individuals
receiving the smallpox vaccine, plus a
number of potential contact cases, the
program predicts that there may be up
to 1,250 requesters. It is important to
note that a large number of such requesters
filing Request Forms with the program
may not be eligible for payments under
the program for a variety of reasons (e.g.,
they sustained minor injuries that do
not qualify as covered injuries, the Secretary
determines that their injuries do not
qualify as table injuries and that there
is insufficient evidence to establish
causation, they received the smallpox
vaccine outside of an approved smallpox
emergency response plan, or they did not
file their Request Form within the governing
filing deadlines).
The
annual burden estimate includes the time
required to review and complete the Request
Form as well as the time to obtain and
provide further documentation necessary
for eligibility and benefits determinations.
Comments on this information collection
activity should be sent to Lauren Wittenberg,
OMB Desk Officer, Office of Management
and Budget, Room 10235, New Executive
Office Building, 725 17th Street, NW.,
Washington, DC 20053; FAX: (202) 395-6974.
List
of Subjects in 42 CFR Part 102 Benefits,
Biologics, Compensation, Immunization,
Public health, Smallpox, Vaccinia.Dated:
October 27, 2003. Elizabeth M. Duke, Administrator,
Health Resources and Services Administration.
Approved: December 8, 2003.
Tommy G. Thompson, Secretary.
For the reasons stated above, the Department
of Health and Human Services amends part
102 of 42 CFR as follows: 0 1. The authority
section for part 102 is revised to read
as follows: Authority: 42 U.S.C. 216,
42 U.S.C. 239-239h. 0 2. In part 102,
add sections 102.1--102.20 to read as
follows: PART 102--SMALLPOX VACCINE INJURY
COMPENSATION PROGRAM Subpart A--General
Provisions Sec. 102.1 Purpose. 102.2 Summary
of available benefits. 102.3 Definitions.
Subpart B--Persons Eligible to Receive
Benefits 102.10 Eligible requesters. 102.11
Survivors. Subpart C--Covered Injuries
102.20 How to establish a covered injury.
102.21 Smallpox (Vaccinia) Vaccine Injury
Table. Subpart D--Available Benefits 102.30
Benefits available to different categories
of requesters under this program. 102.31
Medical benefits. 102.32 Benefits for
lost employment income. 102.33 Death benefits.
Subpart E--Procedures for Filing Request
Packages 102.40 How to obtain forms and
instructions. 102.41 How to file a request
package. 102.42 Deadlines for filing request
forms. 102.43 Deadlines for submitting
documentation. 102.44 Representatives
of requesters. 102.45 Multiple survivors.
102.46 Amending a request package. Subpart
F--Required Documentation To Be Deemed
Eligible 102.50 Medical records necessary
to establish that a covered injury was
sustained. 102.51 Documentation a smallpox
vaccine recipient must submit to be deemed
eligible by the Secretary. 102.52 Documentation
a vaccinia contact must submit to be deemed
eligible by the Secretary. 102.53 Documentation
a survivor must submit to be deemed eligible
by the Secretary. 102.54 Documentation
a representative of the estate of a deceased
smallpox vaccine recipient or vaccinia
contact must submit to be deemed eligible
by the Secretary. Subpart G--Required
Documentation for Eligible Requesters
to Receive Benefits 102.60 Documentation
an eligible requester seeking medical
benefits must submit. 102.61 Documentation
an eligible requester seeking benefits
for lost employment income must submit.
102.62 Documentation an eligible requester
seeking a death benefit must submit. 102.63
Documentation a representative filing
on behalf of an eligible requester who
is a minor or a legally incompetent adult
must submit. Subpart H--Secretarial Determinations
102.70 Determinations the Secretary must
make before benefits can be paid. 102.71
Insufficient documentation for eligibility
and benefits determinations. 102.72 Sufficient
documentation for eligibility and benefits
determinations. 102.73 Approval of benefits.
102.74 Disapproval of benefits. Subpart
I--Calculation and Payment of Benefits
102.80 Calculation of medical benefits.
102.81 Calculation of benefits for lost
employment income. 102.82 Calculation
of death benefits. 102.83 Payment of all
benefits. 102.84 The Secretary's right
to recover benefits paid under this program
from third-party payors. Subpart J--Reconsideration
of the Secretary's Determinations. 102.90
Reconsideration of the Secretary's eligibility
and/or benefits determinations. 102.91
Secretary's review authority. 102.92 No
additional judicial or administrative
review of determinations.
Subpart
A--General Provisions Sec. 102.1 Purpose.
This part implements Section 2 of the
Smallpox Emergency Personnel Protection
Act of 2003 (the Act). The Act directs
the Secretary of Health and Human Services
to establish procedures for providing
benefits to certain individuals who sustained
a covered injury as the direct result
of the administration of the smallpox
vaccine or other covered countermeasure,
and to certain individuals who sustained
a covered injury as the direct result
of accidental vaccinia inoculation through
contact with certain persons vaccinated
with the smallpox vaccine or with individuals
accidentally inoculated by them. Also,
if the Secretary determines that an individual
died as a result of a covered injury,
the Act provides for certain survivors
of that individual to receive death benefits.
Sec. 102.2 Summary of available benefits.
(a) The Act authorizes three forms of
benefits to requesters deemed eligible
by the Secretary:
(1)
Payment or reimbursement for reasonable
and necessary medical services and items
to diagnose or treat a covered injury
or its health complications, as described
in Sec. 102.31.
(2)
Lost employment income incurred as a result
of a covered injury, as described in Sec.
102.32.
(3)
Death payments to survivors if the Secretary
determines that the death of the smallpox
vaccine recipient or vaccinia contact
was the direct result of a covered injury,
as described in Sec. 102.33. (b) The benefits
paid under the Program, with the exception
of death benefits paid under Sec. 102.82(c),
are secondary to any obligation of any
third-party payor to pay for such benefits.
Death benefits paid under Sec. 102.82(c)
are secondary to death and disability
benefits under the PSOB Program. The benefits
paid under the Program usually will only
be paid after the requester has pursued
all other available coverage from all
third-party payors with an obligation
to pay for or provide such benefits (e.g.,
medical insurance for medical items, workers'
compensation program(s) for lost employment
income). However, as provided in Sec.
102.84, the Secretary has the discretion
to pay benefits under this Program before
a potential third- party payor makes a
determination on the availability of similar
benefits and has the right to later pursue
a claim against any third- party payor
with a legal or contractual obligation
to pay for, or provide, such benefits.
Sec. 102.3
Definitions.
This section defines certain words and
phrases found throughout this part. Words
and phrases that are used only in limited
situations are defined in specific sections
of this part.
(a)
Accidental vaccinia inoculation means
the transfer of vaccinia virus from an
existing vaccination site (the skin surface
where the vaccinia virus entered the body
through vaccination) or inoculation site
(the skin or mucous membrane surface where
the vaccinia virus entered the body through
means other than vaccination) on a person
to a second person, resulting in a contact
case.
(b)
Act means the Smallpox Emergency Personnel
Protection Act of 2003, Pub. L. 108-20,
117 Stat. 638.
(c)
Approval means a decision by the Secretary
that the requester will be paid benefits
under the Program.
(d)
Benefits means benefits and/or compensation.
(e)
Contact case means a case in which a person
developed an initial vaccinial lesion
or vaccinial infection through an exposure
other than being vaccinated him/herself.
(f)
Covered countermeasure means smallpox
(vaccinia) vaccines, cidofovir and its
derivatives, or Vaccinia Immune Globulin,
when used to prevent or treat the smallpox
disease or control or treat the adverse
effects of vaccinia vaccination or inoculation
or of the administration of another countermeasure.
(g)
Covered injury means an injury determined
by the Secretary, in accordance with subpart
C of this part, to be:
(1)
An injury meeting the requirements of
the Table, which is presumed to be the
direct result of the administration of
a smallpox vaccine or accidental vaccinia
inoculation; or
2)
More likely than not, the direct result
of:
(A)
The administration of a covered countermeasure
(including the smallpox vaccine) during
the effective period of the Declaration,
in the case of a smallpox vaccine recipient;
or
(B)
Vaccinia contracted through accidental
vaccinia inoculation (and not the result
of receiving a smallpox vaccine) during
the effective period of the Declaration
(or within 30 days after the end of such
period), in the case of a vaccinia contact.
(h)
Declaration means the Declaration Regarding
Administration of Smallpox Countermeasures
issued by the Secretary on January 24,
2003, and published in the Federal Register
on January 28, 2003 (68 FR 4212).
(i)
Dependent means a person who would be
considered a dependent by the Internal
Revenue Service.
(j)
Disapproval means a decision by the Secretary
that the requester will not be paid benefits
under the Program.
(k)
Effective period of the Declaration means
the time span specified in the Declaration
(January 24, 2003 until and including
January 23, 2004), unless extended by
the Secretary.
(l)
FECA Program means the workers' compensation
benefits program for civilian officers
and employees of the Federal Government
established under the Federal Employees'
Compensation Act (5 U.S.C. 8101 et seq.),
as amended, and implemented by the United
States Department of Labor in regulations
codified at 20 CFR Part 10, as amended.
(m)
Health care practitioner means a health
care provider licensed by a State and
authorized to diagnose and prescribe medications
and other treatments or authorized to
provide primary or specialty care.
(n)
Injury means an injury (including death),
disability, illness, or condition.
(o)
Legally incompetent means a person who
is considered to lack legal capacity under
applicable State law.
(p)
Program means the Smallpox Vaccine Injury
Compensation Program.
(q)
Public Safety Officers' Benefits Program
(PSOB Program) means the Program established
under subpart 1 of part L of title I of
the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3796 et seq.),
as amended, and implemented by the United
States Department of Justice in regulations
codified at 28 CFR Part 32, as amended.
(r)
Requester means a smallpox vaccine recipient,
vaccinia contact, survivor, or representative
of the estate of a deceased smallpox vaccine
recipient or vaccinia contact (on behalf
of the estate) who files a Request Package,
or on whose behalf a Request Package is
filed, under this part.
(s)
Request Form means the form designated
by the Secretary as the request form for
purposes of this part.
(t)
Request Package means the Request Form,
all documentation submitted by or on behalf
of the requester, and all documentation
obtained by the Secretary as authorized
by or on behalf of the requester for determinations
of eligibility and benefits under this
part.
(u)
Secretary means the Secretary of Health
and Human Services and any other officer
or employee of the Department of Health
and Human Services to whom the authority
involved has been delegated.
(v)
Smallpox emergency response plan means
a State, local, or Department of Health
and Human Services plan, approved by the
Secretary, detailing actions to be taken
in preparation for a possible smallpox-related
emergency during the period prior to the
identification of an active case of smallpox
either within or outside the United States.
(w)
Smallpox (Vaccinia) Vaccine Injury Table
or Table or Table of Injuries means the
table of injuries included at Sec. 102.21,
including the definitions and requirements
set forth at Sec. 102.21(b).
(x)
Smallpox vaccine recipient means a person:
(1) Who has been 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; (2) Who is or will be functioning
in a role identified in a smallpox emergency
response plan; (3) To whom a smallpox
vaccine is administered pursuant to a
smallpox emergency response plan during
the effective period of the Declaration;
and (4) Who sustained a covered injury.
(y)
State means any State of the United States
of America, the District of Columbia,
United States territories, commonwealths,
and possessions, the Republic of the Marshall
Islands, the Republic of Palau, and the
Federated States of Micronesia.
(z)
Survivor means a survivor of a deceased
smallpox vaccine recipient or vaccinia
contact meeting the requirements of Sec.
102.11. (aa) Third-party payor means the
United States (other than for payments
of benefits under this Program) or any
other third-party, including any State
or local governmental entity, private
insurance carrier, or employer, with a
legal or contractual obligation to pay
for or provide benefits. (bb)
Vaccinia
contact means an individual who:
(1)
Contracted vaccinia during the effective
period of the Declaration (or within 30
days after the end of such period);
(2)
Prior to contracting vaccinia, was accidentally
inoculated by a person: (A) Meeting the
criteria set forth in Sec. 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 (B) Who was accidentally
inoculated by a person meeting the criteria
set forth in Sec. 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);
and (3) Sustained a covered injury.
Subpart
B--Persons Eligible To Receive Benefits
Sec. 102.10
Eligible requesters.
(a)
The following requesters may, as determined
by the Secretary, be eligible to receive
benefits from this Program:
(1)
Smallpox vaccine recipients, as described
in Sec. 102.3(x);
(2)
Vaccinia contacts, as described in Sec.
102.3(bb); or
(3)
Survivors, as described in Sec. 102.3(z)
and Sec. 102.11.
(4)
Representatives of the estates of deceased
smallpox vaccine recipients or vaccinia
contacts (i.e., individuals authorized
to act on behalf of the deceased person's
estate under applicable state law, such
as an executor). (b) If a smallpox vaccine
recipient or vaccinia contact dies, his
or her survivor(s) or the representative
of his or her estate may file a new Request
Package (or Request Package(s)) or amend
a previously filed Request Package. A
new Request Package may be filed whether
or not a Request Package was previously
submitted by or on behalf of the deceased
person, but must be filed within the filing
deadlines described in Sec. 102.42.
Amendments
to previously filed Request Packages and
the filing deadlines for such amendments
are described in Sec. 102.46. (c) The
benefits available to different categories
of requesters are described in Sec. 102.30.
Sec. 102.11 Survivors. (a) Survivors of
individuals who died as the direct result
of a covered injury. If the Secretary
determines that a smallpox vaccine recipient
or vaccinia contact died as the direct
result of a covered injury (or injuries),
his or her survivor(s) may be eligible
for death benefits. (b) Survivors who
may be eligible to receive benefits and
order of priority for benefits.
(1)
The Act uses the same categories of survivors
and order of priority for benefits as
established and defined by the PSOB Program,
except as provided in paragraphs (b)(3),
(b)(4), and (b)(5) of this section.
(2)
The PSOB Program's categories of survivors
(known in the PSOB Program as beneficiaries)
and order of priority for receipt of death
benefits are detailed under subpart 1
of part L of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42
U.S.C. 3796 et seq.), as amended, as implemented
in 28 CFR Part 32, as amended.
(3)
In the PSOB Program, the person who is
survived must satisfy the eligibility
requirements for a deceased public safety
officer, whereas the person who is survived
under this Program must be a deceased
smallpox vaccine recipient or vaccinia
contact who would otherwise have been
eligible under this part.
(4)
Unlike the PSOB Program, if there are
no survivors eligible to receive death
benefits under the PSOB Program (as set
forth in paragraph (b)(2) of this section),
the legal guardian of a deceased minor
who was a smallpox vaccine recipient or
vaccinia contact may be eligible as a
survivor under this Program. Such legal
guardianship must be determined by a court
of competent jurisdiction under applicable
State law.
(5)
A surviving dependent younger than the
age of 18 whose legal guardian opts to
receive a death benefit under the alternative
calculation on the dependent's behalf
will have the same priority as surviving
eligible children under the PSOB Program
(consistent with paragraph (b)(2) of this
section) even if the dependent is not
the surviving eligible child of the deceased
person for purposes of the PSOB Program.
However, such a dependent may only be
eligible to receive benefits under the
alternative death benefits calculation,
described in Sec. 102.82(d), and is not
eligible to receive death benefits under
the standard calculation described in
Sec. 102.82(c). Because death benefits
paid under the alternative calculation
will be paid to the dependents' legal
guardian(s) on behalf of all such dependents,
the Secretary will not divide or apportion
such benefits among the dependents.
(6)
Any change in the order of priority of
survivors or of the eligible category
of survivors under the PSOB Program shall
apply to requesters seeking death benefits
under this Program on the effective date
of the change, even prior to any corresponding
amendment to this part. Such changes will
apply to Request Packages pending with
the Program on the effective date of the
change, as well as to requests filed after
that date.
Subpart
C--Covered Injuries Sec. 102.20
How to establish a covered injury.
(a) General. In order to receive benefits
under the Program, a requester must submit
documentation showing that a covered injury,
as described in Sec. 102.3(g), was sustained.
A requester can establish that a covered
injury was sustained by demonstrating
to the Secretary that a Table injury occurred,
as described in paragraph (c) of this
section. In the alternative, a requester
can establish that an injury was actually
caused by a covered countermeasure or
accidental vaccinia inoculation, as described
in paragraph (d) of this section. The
Secretary will consider all relevant medical
and scientific evidence, such as medical
records and documentation submitted by
the requester, when determining whether
a covered injury was established. In addition,
the Secretary may obtain the views of
qualified medical experts in making determinations
concerning covered injuries. As set forth
in the definition of covered countermeasures,
if a covered injury is related to the
administration of a covered countermeasure,
the countermeasure must have been administered
to prevent or treat the smallpox disease
or to control or treat the adverse effects
of vaccinia vaccination or inoculation
or of the administration of another countermeasure.
The time periods described in this part
for receiving a covered countermeasure
(during the effective period of the Declaration)
or for vaccinia contracted from accidental
vaccinia inoculation (during the effective
period of the Declaration or within 30
days after the end of such period) in
relation to a covered injury must also
be met.
(b) Minor injuries. Any injuries that
the Secretary deems minor will not be
considered covered injuries. Minor injuries
include expected and routine responses
to the smallpox vaccine, other covered
countermeasures, or accidental vaccinia
inoculation that are not severe (e.g.,
minor scarring or minor local reactions,
for instance a mild systemic illness with
a generalized maculopapular rash that
resolves quickly).
(c) Table injuries. A requester may establish
that a covered injury occurred by demonstrating
that a smallpox vaccine recipient or vaccinia
contact sustained an injury listed on
the Smallpox (Vaccinia) Vaccine Injury
Table, set forth in Sec. 120.21, within
the time interval listed on the Table
and as defined by the Table's Definitions
and Requirements, set forth in Sec. 120.21(b).
In such circumstances, the requester need
not demonstrate the cause of the injury
because the Secretary will presume, only
for purposes of making determinations
under this subpart, that the injury was
the direct result of the administration
of a smallpox vaccine or exposure to vaccinia.
Even if the Table requirements are satisfied,
however, an injury will not be considered
a covered injury if the Secretary determines,
based upon his review of the evidence,
that a source other than the smallpox
vaccine or exposure to vaccinia more likely
than not caused the injury. In such circumstances,
the Table presumption will be rebutted.
(d) Injuries for which causation must
be proven. If an injury is not included
on the Table or if a requester is unable
to meet all of the Table requirements
with respect to an injury included on
the Table (e.g., onset of the injury within
the time interval included on the Table),
a requester may establish a covered injury
by proving causation.
To
establish that a covered countermeasure
or accidental vaccinia inoculation caused
an injury, the requester must demonstrate,
by a preponderance of the evidence (more
likely than not), that:
(1)
In the case of a smallpox vaccine recipient,
he or she sustained an injury as the direct
result of the administration of a covered
countermeasure (including the smallpox
vaccine) during the effective period of
the Declaration; or
(2)
In the case of a vaccinia contact, he
or she sustained an injury as the direct
result of vaccinia contracted through
accidental vaccinia inoculation from a
person described in Sec. 102.3(bb)(2)
(a person meeting the definition of a
smallpox vaccine recipient, except that
the person need not sustain a covered
injury, or the contact of such a person),
and not as the result of receiving a smallpox
vaccine. Such vaccinia must have been
contracted during the effective period
of the Declaration (or within 30 days
after the end of such period). The Secretary
will consider an injury that resulted
from the administration of a covered countermeasure
(other than the smallpox vaccine) to be
the direct result of vaccinia contracted
through accidental vaccinia inoculation
if the covered countermeasure was administered
as a result of such vaccinia.
Sec.
Sec. 102.22-102.29 [Reserved] 3. In part
102, reserve Sec. Sec. 102.22-102.29.
Sec. Sec. 102.30-102.91 [Added] 4. In
part 102, add sections 102.30-102.91 to
read as follows:
Subpart D--Available Benefits Sec. 102.30
Benefits available to different categories
of requesters under this Program.
(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.
Sec.
102.31 Medical benefits. (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 Sec. 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 Sec.
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.
Sec.
102.32 Benefits for lost employment income.
(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 Sec. 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 Sec. 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 Sec. 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.
Sec.
102.33 Death benefits. (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 Sec. 102.82. As provided in Sec. 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 Sec. 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 Sec. 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)).
Subpart
E--Procedures for Filing Request Packages
Sec. 102.40
How to obtain forms and instructions.
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.''
Sec.
102.41 How to file a Request Package.
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.
Sec.
102.42 Deadlines for Filing Request Forms.
(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 Sec. 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. Sec. 102.43 Deadlines for
submitting documentation. (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 Sec. 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.
Sec.
102.44 Representatives of requesters.
(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 Sec. 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. Sec. 102.45
Multiple survivors. 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.
Sec.
102.46 Amending a request package.
(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 Sec. 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.
Subpart
F--Required Documentation To Be Deemed
Eligible Sec. 102.50
Medical records necessary to establish
that a covered injury was sustained.
(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.
Sec.
102.51 Documentation a smallpox vaccine
recipient must submit to be deemed eligible
by the Secretary.
(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:
(A) 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 (B) 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 Sec. 102.3(g),
in accordance with the requirements set
forth in Sec. 102.50. (b) As an alternative
to the documentation described in paragraphs
(a)(2)(A)-(B) 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 Sec. 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.
Sec. 102.52 Documentation a vaccinia contact
must submit to be deemed eligible by the
Secretary. 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 Sec. 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 Sec. 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 Sec. 102.3(g), in accordance with the
requirements set forth in Sec. 102.50.
These records must be consistent with
the requester contracting vaccinia after
the accidental vaccinia inoculation described
in paragraph (b) of this section. Sec.
102.53 Documentation a survivor must submit
to be deemed eligible by the Secretary.
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 Sec. 102.51(b) in the
place of the documentation described in
Sec. 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 Sec. 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 Sec.
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.
Sec.
102.54 Documentation the representative
of the estate of a deceased smallpox vaccine
recipient or vaccine contact must submit
to be deemed eligible by the Secretary.
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 Sec. 102.51(b)
in the place of the documentation described
in Sec. 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.
Subpart
G--Required Documentation for Eligible
Requesters to Receive Benefits Sec. 102.60
Documentation an eligible requester seeking
medical benefits must submit.
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.
Sec.
102.61 Documentation an eligible requester
seeking benefits for lost employment income
must submit.
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 Sec. 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.
Sec.
102.62 Documentation an eligible requester
seeking a death benefit must submit.
(a) A requester deemed an eligible survivor
by the Secretary who seeks a death benefit
under Sec. 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 Sec. 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 Sec. 102.82(d), in place
of proportional benefits available under
the standard calculation as described
in Sec. 102.82(c). Written selections
are described in Sec. 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 Sec. 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 Sec. 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.
Sec. 102.63 Documentation a representative
filing on behalf of an eligible requester
who is a minor or a legally incompetent
adult must submit. 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 Sec.
Sec. 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 [[Page 70102]] 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.
Subpart
H--Secretarial Determinations Sec. 102.70
Determinations the Secretary must make
before benefits can be paid.
(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. Sec. 102.71
Insufficient
documentation for eligibility and benefits
determinations. 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.
Sec.
102.72 Sufficient documentation for eligibility
and benefits determinations.
(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. Sec. 102.73 Approval of
benefits. 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 Sec. 102.83. Sec. 102.74 Disapproval
of benefits. (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).
Subpart
I--Calculation and Payment of Benefits
Sec. 102.80 Calculation of medical benefits.
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 Sec. 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
Sec. 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 Sec.
103.83(c) and Sec. 103.84. There are no
caps on medical benefits that may be provided
under the Program. Sec. 102.81 Calculation
of benefits for lost employment income.
(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 Sec. 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. (A) 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.
(B) 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 Sec.
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 Sec. 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.
Sec.
102.82 Calculation of death benefits.
(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 Sec. 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: (A) 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
(B) 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: (A)
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;
(B) 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)(A) 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. (A) 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: (i) Compensation
for the deceased person's loss of employment
income on behalf of the dependents or
their legal guardian(s); (ii) 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 (iii) Life insurance benefits on behalf
of the dependents. (B) 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.
Sec. 102.83 Payment of all benefits. (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 Sec. 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 Sec. Sec. 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. Sec. 102.84
The Secretary's right to recover benefits
paid under this program from third-party
payors. 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. Subpart J--Reconsideration
of the Secretary's Determinations Sec.
102.90 Reconsideration of the Secretary's
eligibility and benefits determinations.
(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.
Sec.
102.91 Secretary's review authority.
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.
Sec. 102.92 No additional judicial or
administrative review of determinations
made under this part. 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. |