VACCINES

[Title 42 CFR J]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter J - VACCINES]
[From the U.S. Government Printing Office]

42PUBLIC HEALTH12008-10-012008-10-01falseVACCINESJSUBCHAPTER JPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER J_VACCINES

PART 100_VACCINE INJURY COMPENSATION--Table of Contents

Sec.
100.1 Applicability.
100.2 Average cost of a health insurance policy.
100.3 Vaccine injury table.

Authority: Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782
(42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act (42 U.S.C.
300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act (42 U.S.C.
300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111 Stat. 873; sec.
1503 of Pub. L. 105-277, 112 Stat. 2681-741; and sec. 523(a) of Pub. L.
106-170, 113 Stat. 1927-1928.

Sec. 100.1 Applicability.

This part applies to the National Vaccine Injury Compensation
Program (VICP) under subtitle 2 of title XXI of the Public Health
Service (PHS) Act.

[60 FR 7693, Feb. 8, 1995]

Sec. 100.2 Average cost of a health insurance policy.

For purposes of determining the amount of compensation under the
VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C. 300aa-15(a)(3)(B),
provides that certain individuals are entitled to receive an amount
reflecting lost earnings, less certain deductions. One of the deductions
is the average cost of a health insurance policy, as determined by the
Secretary. The Secretary has determined that the average cost of a
health insurance policy is $363.12 for 2006. This figure is calculated
periodically (generally on an annual basis) using the most recent
Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data
available as the baseline for the average monthly cost of a health
insurance policy. This baseline is adjusted by the annual percentage
increase/decrease obtained from the most recent annual Kaiser Family
Foundation and Health Research and Educational Trust (KFF/HRET) Employer
Health Benefits survey or other authoritative source that may be more
accurate or appropriate in the future. The revised amount will be
effective upon its delivery by the Secretary to the United States Court
of Federal Claims, and the amount will be published as a notice in the
Federal Register periodically (generally on an annual basis).

[72 FR 36612, July 5, 2007]

Sec. 100.3 Vaccine injury table.

(a) In accordance with section 312(b) of the National Childhood
Vaccine Injury Act of 1986, title III of Pub. L. 99-660, 100 Stat. 3779
(42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health
Service Act (42 U.S.C. 300aa-14(c)), the following is a table of
vaccines, the injuries, disabilities, illnesses, conditions, and deaths
resulting from the administration of such vaccines, and the time period
in which the first symptom or manifestation of onset or of the
significant aggravation of such injuries, disabilities, illnesses,
conditions, and deaths is to occur after vaccine administration for
purposes of receiving compensation under the Program:

Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation after
vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing A. Anaphylaxis or 4 hours.
tetanus toxoid (e.g., DTaP, anaphylactic shock. 2-28 days.
DTP, DT, Td, or TT). B. Brachial Neuritis
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.

[[Page 613]]

II. Vaccines containing A. Anaphylaxis or 4 hours.
whole cell pertussis anaphylactic shock. 72 hours.
bacteria, extracted or B. Encephalopathy Not applicable.
partial cell pertussis (or encephalitis).
bacteria, or specific C. Any acute
pertussis antigen(s) (e.g., complication or
DTP, DTaP, P, DTP-Hib). sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
III. Measles, mumps, and A. Anaphylaxis or 4 hours.
rubella vaccine or any of anaphylactic shock. 5-15 days (not less
its components (e.g., MMR, B. Encephalopathy than 5 days and not
MR, M, R). (or encephalitis). more than 15 days).
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IV. Vaccines containing A. Chronic arthritis 7-42 days.
rubella virus (e.g., MMR, B. Any acute Not applicable.
MR, R). complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
V. Vaccines containing A. Thrombocytopenic 7-30 days.
measles virus (e.g., MMR, purpura. 6 months.
MR, M). B. Vaccine-Strain
Measles Viral
Infection in an
immunodeficient
recipient.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VI. Vaccines containing A. Paralytic Polio
polio live virus (OPV).
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain
Polio Viral
Infection
--in a non- 30 days.
immunodeficient
recipient.
--in an 6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
C. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
VII. Vaccines containing A. Anaphylaxis or 4 hours
polio inactivated virus anaphylactic shock.
(e.g., IPV).
B. Any acute Not applicable.
complication or
sequela (including
death of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed..
VIII. Hepatitis B. vaccines. A. Anaphylaxis or 4 hours.
anaphylactic shock.
B. Any acute Not applicable.
complication or
sequela (including
death) of an
illness,
disability, injury,
or condition
referred to above
which illness,
disability, injury,
or condition arose
within the time
period prescribed.
IX. Hemophilus influenzae No Condition Not applicable.
type b polysaccharide Specified.
conjugate vaccines.
X. Varicella vaccine........ No Condition Not applicable.
Specified.
XI. Rotavirus vaccine....... No condition Not applicable.
specified.

[[Page 614]]

XII. Vaccines containing Intussusception..... 0-30 days.
live, oral, rhesus-based
rotavirus.
XIII. Pneumococcal conjugate No condition Not applicable.
vaccines. specified..
XIV. Any new vaccine No Condition Not applicable.
recommended by the Centers Specified.
for Disease Control and
Prevention for routine
administration to children,
after publication by the
Secretary of a notice of
coverage.
------------------------------------------------------------------------

(b) Qualifications and aids to interpretation. The following
qualifications and aids to interpretation shall apply to the Vaccine
Injury Table to paragraph (a) of this section:
(1) Anaphylaxis and anaphylactic shock. For purposes of paragraph
(a) of this section, Anaphylaxis and anaphylactic shock mean an acute,
severe, and potentially lethal systemic allergic reaction. Most cases
resolve without sequelae. Signs and symptoms begin minutes to a few
hours after exposure. Death, if it occurs, usually results from airway
obstruction caused by laryngeal edema or bronchospasm and may be
associated with cardiovascular collapse. Other significant clinical
signs and symptoms may include the following: Cyanosis, hypotension,
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or
trachea and/or larynx with stridor and dyspnea. Autopsy findings may
include acute emphysema which results from lower respiratory tract
obstruction, edema of the hypopharynx, epiglottis, larynx, or trchea and
minimal findings of eosinophilia in the liver, spleen and lungs. When
death occurs within minutes of exposure and without signs of respiratory
distress, there may not be significant pathologic findings.
(2) Encephalopathy. For purposes of paragraph (a) of this section, a
vaccine recipient shall be considered to have suffered an encephalopathy
only if such recipient manifests, within the applicable period, an
injury meeting the description below of an acute encephalopathy, and
then a chronic encephalopathy persists in such person for more than 6
months beyond the date of vaccination.
(i) An acute encephalopathy is one that is sufficiently severe so as
to require hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a
significantly decreased level of consciousness lasting for at least 24
hours. Those children less than 18 months of age who present following a
seizure shall be viewed as having an acute encephalopathy if their
significantly decreased level of consciousness persists beyond 24 hours
and cannot be attributed to a postictal state (seizure) or medication.
(B) For adults and children 18 months of age or older, an acute
encephalopathy is one that persists for at least 24 hours and
characterized by at least two of the following:
(1) A significant change in mental status that is not medication
related; specifically a confusional state, or a delirium, or a
psychosis;
(2) A significantly decreased level of consciousness, which is
independent of a seizure and cannot be attributed to the effects of
medication; and
(3) A seizure associated with loss of consciousness.
(C) Increased intracranial pressure may be a clinical feature of
acute encephalopathy in any age group.
(D) A ``significantly decreased level of consciousness'' is
indicated by the presence of at least one of the following clinical
signs for at least 24 hours or greater (see paragraphs (b)(2)(i)(A) and
(b)(2)(i)(B) of this section for applicable timeframes):
(1) Decreased or absent response to environment (responds, if at
all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family
members or other individuals); or

[[Page 615]]

(3) Inconsistent or absent responses to external stimuli (does not
recognize familiar people or things).
(E) The following clinical features alone, or in combination, do not
demonstrate an acute encephalopathy or a significant change in either
mental status or level of consciousness as described above: Sleepiness,
irritability (fussiness), high-pitched and unusual screaming, persistent
inconsolable crying, and bulging fontanelle. Seizures in themselves are
not sufficient to constitute a diagnosis of encephalopathy. In the
absence of other evidence of an acute encephalopathy, seizures shall not
be viewed as the first symptom or manifestation of the onset of an acute
encephalopathy.
(ii) Chronic Encephalopathy occurs when a change in mental or
neurologic status, first manifested during the applicable time period,
persists for a period of at least 6 months from the date of vaccination.
Individuals who return to a normal neurologic state after the acute
encephalopathy shall not be presumed to have suffered residual
neurologic damage from that event; any subsequent chronic encephalopathy
shall not be presumed to be a sequela of the acute encephalopathy. If a
preponderance of the evidence indicates that a child's chronic
encephalopathy is secondary to genetic, prenatal or perinatal factors,
that chronic encephalopathy shall not be considered to be a condition
set forth in the Table.
(iii) An encephalopathy shall not be considered to be a condition
set forth in the Table if in a proceeding on a petition, it is shown by
a preponderance of the evidence that the encephalopathy was caused by an
infection, a toxin, a metabolic disturbance, a structural lesion, a
genetic disorder or trauma (without regard to whether the cause of the
infection, toxin, trauma, metabolic disturbance, structural lesion or
genetic disorder is known). If at the time a decision is made on a
petition filed under section 2111(b) of the Act for a vaccine-related
injury or death, it is not possible to determine the cause by a
preponderance of the evidence of an encephalopathy, the encephalopathy
shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition
set forth in the Table, the Court shall consider the entire medical
record.
(3) [Reserved]
(4) Seizure and convulsion. For purposes of paragraphs (b) (2) of
this section, the terms, ``seizure'' and ``convulsion'' include
myoclonic, generalized tonic-clonic (grand mal), and simple and complex
partial seizures. Absence (petit mal) seizures shall not be considered
to be a condition set forth in the Table. Jerking movements or staring
episodes alone are not necessarily an indication of seizure activity.
(5) Sequela. The term ``sequela'' means a condition or event which
was actually caused by a condition listed in the Vaccine Injury Table.
(6) Chronic Arthritis. (i) For purposes of paragraph (a) of this
section, chronic arthritis may be found in a person with no history in
the 3 years prior to vaccination of arthropathy (joint disease) on the
basis of:
(A) Medical documentation, recorded within 30 days after the onset,
of objective signs of acute arthritis (joint swelling) that occurred
between 7 and 42 days after a rubella vaccination;
(B) Medical documentation (recorded within 3 years after the onset
of acute arthritis) of the persistence of objective signs of
intermittent or continuous arthritis for more than 6 months following
vaccination; and
(C) Medical documentation of an antibody response to the rubella
virus.
(ii) For purposes of paragraph (a) of this section, the following
shall not be considered as chronic arthritis: Musculoskeletal disorders
such as diffuse connective tissue diseases (including but not limited to
rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus
erythematosus, systemic sclerosis, mixed connective tissue disease,
polymyositis/determatomyositis, fibromyalgia, necrotizing vascultitis
and vasculopathies and Sjogren's Syndrome), degenerative joint disease,
infectious agents other than rubella (whether by direct invasion or as
an immune reaction) metabolic and endocrine diseases, trauma, neoplasms,
neuropathic disorders, bone and cartilage disorders and arthritis
associated with

[[Page 616]]

ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's
syndrome, or blood disorders.
(iii) Arthralgia (joint pain) or stiffness without joint swelling
shall not be viewed as chronic arthritis for purposes of paragraph (a)
of this section.
(7) Brachial neuritis. (i) This term is defined as dysfunction
limited to the upper extremity nerve plexus (i.e., its trunks,
divisions, or cords) without involvement of other peripheral (e.g.,
nerve roots or a single peripheral nerve) or central (e.g., spinal cord)
nervous system structures. A deep, steady, often severe aching pain in
the shoulder and upper arm usually heralds onset of the condition. The
pain is followed in days or weeks by weakness and atrophy in upper
extremity muscle groups. Sensory loss may accompany the motor deficits,
but is generally a less notable clinical feature. The neuritis, or
plexopathy, may be present on the same side as or the opposite side of
the injection; it is sometimes bilateral, affecting both upper
extremities.
(ii) Weakness is required before the diagnosis can be made. Motor,
sensory, and reflex findings on physical examination and the results of
nerve conduction and electromyographic studies must be consistent in
confirming that dysfunction is attributable to the brachial plexus. The
condition should thereby be distinguishable from conditions that may
give rise to dysfunction of nerve roots (i.e., radiculopathies) and
peripheral nerves (i.e., including multiple monoeuropathies), as well as
other peripheral and central nervous system structures (e.g., cranial
neuropathies and myelopathies).
(8) Thrombocytopenic purpura. This term is defined by a serum
platelet count less than 50,000/mm3. Thrombocytopenic purpura does not
include cases of thrombocytopenia associated with other causes such as
hypersplenism, autoimmune disorders (including alloantibodies from
previous transfusions) myelodysplasias, lymphoproliferative disorders,
congenital thrombocytopenia or hemolytic uremic syndrome. This does not
include cases of immune (formerly called idiopathic) thrombocytopenic
purpura (ITP) that are mediated, for example, by viral or fungal
infections, toxins or drugs. Thrombocytopenic purpura does not include
cases of thrombocytopenia associated with disseminated intravascular
coagulation, as observed with bacterial and viral infections. Viral
infections include, for example, those infections secondary to Epstein
Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human
immunodeficiency virus (HIV), adenovirus, and dengue virus. An
antecedent viral infection may be demonstrated by clinical signs and
symptoms and need not be confirmed by culture or serologic testing. Bone
marrow examination, if performed, must reveal a normal or an increased
number of megakaryocytes in an otherwise normal marrow.
(9) Vaccine-strain measles viral infection. This term is defined as
a disease caused by the vaccine-strain that should be determined by
vaccine-specific monoclonal antibody or polymerase chain reaction tests.
(10) Vaccine-strain polio viral infection. This term is defined as a
disease caused by poliovirus that is isolated from the affected tissue
and should be determined to be the vaccine-strain by oligonucleotide or
polymerase chain reaction. Isolation of poliovirus from the stool is not
sufficient to establish a tissue specific infection or disease caused by
vaccine-strain poliovirus.
(c) Coverage provisions. (1) Except as provided in paragraph (c)(2),
(3) or (4) of this section, the revised Table of Injuries set forth in
paragraph (a) of this section and the Qualifications and Aids to
Interpretation set forth in paragraph (b) of this section apply to
petitions for compensation under the Program filed with the United
States Court of Federal Claims on or after March 24, 1997. Petitions for
compensation filed before such date shall be governed by section 2114(a)
and (b) of the Public Health Service Act as in effect on January 1,
1995, or by Sec. 100.3 as in effect on March 10, 1995 (see 60 FR 7678,
et seq., February 8, 1995), as applicable.
(2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X
of the Table) are included in the Table as of August 6, 1997.
(3) Rotavirus vaccines (Item XI of the Table) are included in the
Table as of October 22, 1998. Vaccines containing live, oral, rhesus-
based rotavirus (Item

[[Page 617]]

XII of the Table) are included in the Table as of October 22, 1998,
provided that they were administered on or before August 26, 2002.
(4) Pneumococcal conjugate vaccines (Item XIII of the Table) are
included in the Table as of December 18, 1999.
(5) Other new vaccines (Item XIV of the Table) will be included in
the Table as of the effective date of a tax enacted to provide funds for
compensation paid with respect to such vaccines. An amendment to this
section will be published in the Federal Register to announce the
effective date of such a tax.

[60 FR 7694, Feb. 8, 1995, as amended at 62 FR 7688, Feb. 20, 1997; 62
FR 10626, Mar. 7, 1997; 63 FR 25778, May 11, 1998; 64 FR 40518, July 27,
1999; 67 FR 48559, July 25, 2002]

PART 102_SMALLPOX COMPENSATION PROGRAM--Table of Contents

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.
102.22-102.29 [Reserved]

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 the 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 benefits
determinations.
102.91 Secretary's review authority.
102.92 No additional judicial or administrative review of determinations
made under this part.

[[Page 618]]

Authority: 42 U.S.C. 216, 42 U.S.C. 239-239h.

Source: 68 FR 51497, Aug. 27, 2003, unless otherwise noted.

Subpart A_General Provisions

Source: 68 FR 70093, Dec. 16, 2003, unless otherwise noted.

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) Child means any natural, illegitimate, adopted, or posthumous
child or stepchild of a deceased smallpox vaccine recipient or vaccinia
contact who, at the time of the recipient or contact's death is:
(1) 18 years of age or under; or
(2) Over 18 years of age and a student as defined in section 8101 of
title 5, United States Code; or
(3) Over 18 years of age and incapable of self-support because of
physical or mental disability.
(f) Contact case means a case in which a person developed an initial
vaccinial lesion or vaccinial infection through an

[[Page 619]]

exposure other than being vaccinated him/herself.
(g) 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.
(h) 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:
(i) 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
(ii) 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.
(i) 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).
(j) Dependent means a person who would be considered a dependent by
the Internal Revenue Service.
(k) Disapproval means a decision by the Secretary that the requester
will not be paid benefits under the Program.
(l) Effective period of the Declaration means the time span
specified in the Declaration, as amended by the Secretary.
(m) 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.
(n) 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.
(o) Injury means an injury (including death), disability, illness,
or condition.
(p) Legally incompetent means a person who is considered to lack
legal capacity under applicable State law.
(q) Program means the Smallpox Vaccine Injury Compensation Program.
(r) 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.
(s) 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.
(t) Request Form means the form designated by the Secretary as the
request form for purposes of this part.
(u) 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.
(v) 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.
(w) 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.
(x) Smallpox (Vaccinia) Vaccine Injury Table or Table or Table of
Injuries means the table of injuries included at Sec. 102.21,

[[Page 620]]

including the definitions and requirements set forth at Sec. 102.21(b).
(y) 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.
(z) 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.
(aa) Survivor means a survivor of a deceased smallpox vaccine
recipient or vaccinia contact meeting the requirements of Sec. 102.11.
(bb) 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.
(cc) 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:
(i) 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
(ii) 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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004, as amended at 71
FR 29810, May 24, 2006]

Subpart B_Persons Eligible To Receive Benefits

Source: 68 FR 70093, Dec. 16, 2003, unless otherwise noted.

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

[[Page 621]]

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

[[Page 622]]

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., the first symptom or manifestation of 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.

[68 FR 70093, Dec. 16, 2003, as amended at 71 FR 29810, May 26, 2006]

[[Page 623]]

Sec. 102.21 Smallpox (Vaccinia) Vaccine Injury Table.

(a) Smallpox (Vaccinia) Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
Time interval for first symptom or manifestation of onset of injury
after: (1) administration of smallpox (vaccinia) vaccine in recipients
Injury (illness, disability, injury, (R); or (2) exposure to vaccinia in contacts (C). Please note that these
or condition) time intervals do not refer to time periods for the date of diagnosis of
the injury.
----------------------------------------------------------------------------------------------------------------
1. Significant Local Skin Reaction... R or C: 1-21 days.
2. Stevens-Johnson Syndrome.......... R or C: 1-21 days.
3. Inadvertent Inoculation........... R or C: 1-21 days.
4. Generalized Vaccinia.............. R or C: 1-21 days.
5. Eczema Vaccinatum................. R or C: 1-21 days.
6. Progressive Vaccinia.............. R or C: 1-21 days.
7. Postvaccinial Encephalopathy, R or C: 1-21 days.
Encephalitis or Encephalomyelitis.
8. Fetal Vaccinia.................... Maternal R or C: any time in gestation until 7 days after birth.
9. Secondary Infection............... R or C: 0-30 days.
10. Anaphylaxis or Anaphylactic Shock R: 0-4 hours.
C: Not Covered.
11. Vaccinial Myocarditis, R or C: 1-21 days.
Pericarditis, or Myopericarditis.
12. Death resulting from an injury R or C: No time interval specified.
referred to above in which the
injury arose within the time
interval referred to above (except
as specifically provided in
specified paragraph (b) of this
section).
----------------------------------------------------------------------------------------------------------------

(b) Table definitions and requirements. The Table Definitions that
follow shall apply to, define and describe the scope of, and be read in
conjunction with paragraph (a) of this section.
(1) Significant local skin reaction--(i) Definition. Significant
local skin reaction is, for purposes of the Table, an unexpected and
extreme response at the vaccination or inoculation site that results in
a significant scar that is serious enough to require surgical
intervention. The onset of this injury is the initial skin lesion at the
vaccination or inoculation site that generally occurs with smallpox
vaccinations or inoculations. Minor scarring or minor local reactions do
not constitute a Table injury. Even a robust take, defined as an area of
redness at the vaccination site that exceeds 7.5 cm in diameter with
associated swelling, warmth and pain, in general is considered an
expected response to the vaccination or inoculation. A robust take does
not in itself constitute a Table injury, even when the redness and
swelling involves the entire upper arm with associated enlargement and
tenderness of the glands (lymph nodes) in the underarm (axilla).
(ii) Table requirements. A Table injury for a significant local skin
reaction in a recipient or contact requires sufficient evidence in the
medical records of the occurrence of a significant local skin reaction
at the vaccination or inoculation site and a permanent, disfiguring scar
that resulted from the significant local skin reaction. The scar must be
of sufficient severity to require surgical intervention to correct a
significant cosmetic (e.g., keloid) or functional (e.g., contracture)
deformity and such surgery must be included in the treatment plan
documented in the medical records.
(2) Stevens-Johnson Syndrome (SJS)--(i) Definition. SJS (sometimes
called erythema multiforme major) is an acute hypersensitivity reaction
that affects skin, mucous membranes, and sometimes internal organs
(systemic toxicity). For purposes of the Table, both skin and mucous
membrane rash or lesions must be present and the rash or lesions may not
cover less than ten percent of body surface area. In SJS, mucosal
involvement generally predominates. Mucosal lesions generally occur at
more than one location and manifest as painful lesions in sites such as
the mouth or eyes. Skin rash or lesions in SJS usually consist of red
raised areas (erythematous macules), blisters, and ulcerations.
(ii) Table requirements. A Table injury for SJS in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of SJS.

[[Page 624]]

The SJS, or related complications, must be of sufficient severity to
require inpatient hospitalization.
(3) Inadvertent Inoculation (II)--(i) Definition. II is the spread
of vaccinia virus from an existing vaccination or inoculation site to a
second location usually by scratching the vaccination or inoculation
site and subsequently spreading the virus, which produces a new
vaccinial lesion on the same person. Alternatively, II is the spread of
vaccinia virus from an existing vaccination or inoculation site to
another person usually by scratching an existing vaccination or
inoculation site and subsequently spreading the virus, resulting in a
contact case.
(ii) Table requirements. A Table injury for II in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of II and the occurrence of one of the following:
(A) Eye lesions, e.g., vaccinial keratitis or vaccinial blepharitis,
that resulted from II and that led to a permanent sequela, e.g.,
decrease in visual acuity;
(B) Permanent and disfiguring scar(s) that resulted from II. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the
treatment plan documented in the medical records; or
(C) Acute II or related complications of sufficient severity to
require inpatient hospitalization.
(4) Generalized Vaccinia (GV)--(i) Definition. GV is a vaccinial
infection that occurs from the spread of vaccinia from an existing
vaccination or inoculation site to otherwise normal skin, resulting in
multiple new areas of vaccinial rash or lesions. The vaccinia is
believed to be spread through the blood. The rash or lesions are
characterized by multiple blisters (vesicles or pustules) that generally
evolve in a similar sequence or manner as the original vaccination or
inoculation site.
(ii) Table requirements. A Table injury for GV in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of GV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from GV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the
treatment plan documented in the medical records; or
(B) Acute GV or related complications of sufficient severity to
require inpatient hospitalization.
(5) Eczema Vaccinatum (EV)--(i) Definition. EV is the transmission
or the spread of vaccinia virus from a vaccination or inoculation site
to skin that has been affected by, or is currently affected with, eczema
or atopic dermatitis. EV is characterized by lesions that include
multiple blisters (vesicles or pustules), which generally evolve in a
similar sequence or manner as the original vaccination or inoculation
site. The lesions may come together to form larger lesions. Lesions may
also spread to patches of skin that have never been involved with eczema
or atopic dermatitis. A person with EV may be quite ill with signs and
symptoms that involve the whole body (systemic illness), such as fever,
malaise, or enlarged glands (lymph nodes).
(ii) Table requirements. A Table injury for EV in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of EV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from EV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the
treatment plan documented in the medical records; or
(B) Acute EV or related complications of sufficient severity to
require inpatient hospitalization.
(6) Progressive Vaccinia (PV)--(i) Definition. PV is the failure to
initiate the healing process in an initial vaccination or inoculation
site by 21 days after exposure to vaccinia with progressive ulceration
or necrosis at the vaccination or inoculation site leading to a

[[Page 625]]

large destructive ulcer. PV is seen in people with an impaired immune
system (immunocompromised) and is characterized by a complete or near
complete lack of inflammation or absence of inflammatory cells in the
dermis of the skin at the vaccination or inoculation site. The diagnosis
of PV may be made before 21 days after exposure, especially in a known
immunocompromised individual who develops a lesion at the vaccination or
inoculation site. PV may spread through the blood to any location in the
body. Any person who initiates a significant healing process of the
vaccination or inoculation site by 21 days after receipt of the smallpox
vaccine or exposure to vaccinia does not have PV.
(ii) Table requirements. A Table injury for PV in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of PV and the occurrence of one of the following:
(A) Permanent and disfiguring scar(s) that resulted from PV. The
scar(s) must be of sufficient severity to require surgical intervention
to correct a significant cosmetic (e.g., keloid) or functional (e.g.,
contracture) deformity and such surgery must be included in the
treatment plan documented in the medical records; or
(B) Acute PV or related complications of sufficient severity to
require inpatient hospitalization.
(7) Postvaccinial Encephalopathy, Encephalitis or Encephalomyelitis
(PVEM)--(i) Definition. PVEM is, for the purposes of the Table, an
autoimmune central nervous system injury. In rare cases, the vaccinia
virus is isolated from the central nervous system. Manifestations
usually occur abruptly and may include fever, vomiting, loss of appetite
(anorexia), headache, general malaise, impaired consciousness,
confusion, disorientation, delirium, drowsiness, seizures, language
difficulties (aphasia), coma, muscular incoordination (ataxia), urinary
incontinence, urinary retention, and clinical signs consistent with
inflammation of the spinal cord (myelitis) such as paralysis or
meningismus. Long term central nervous system impairments such as
paralysis, seizure disorders, or developmental delays are known to occur
as sequelae of the acute PVEM. No clinical criteria, radiographic
findings, or laboratory tests are specific for the diagnosis of PVEM.
(ii) Table requirements. A Table injury for PVEM in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of acute PVEM. The acute PVEM or related complications must
be of sufficient severity to require inpatient hospitalization.
(8) Fetal Vaccinia (FV)--(i) Definition. FV is an intrauterine
vaccinial infection subsequent to vaccinia vaccination or inoculation of
the mother that results from the placental transmission of the vaccinia
virus during any time in the pregnancy. FV manifests as multiple skin
lesions or organ involvement and may result in significant scarring or
death. FV skin lesions are similar to those seen in GV or PV and the
lesions may come together to form larger lesions. Congenital
malformations, other than those described above, are not Table injuries.
(ii) Table requirements. A Table injury for FV requires sufficient
evidence in the medical records of the occurrence of the FV. The
occurrence of the FV or related complications must be of sufficient
severity to require inpatient hospitalization or result in permanent and
disfiguring scar(s). In addition, a Table injury for FV requires one of
the following:
(A) A maternal history of vaccinial vaccination or inoculation, with
the occurrence of vaccinial skin or mucous membrane lesions within the
incubation period for vaccinia during the pregnancy in a maternal
recipient or contact; or
(B) Isolation of vaccinia from intrauterine or neonatal tissue.
(9) Secondary Infection (SI)--(i) Definition. SI is, for purposes of
the Table, a non-vaccinial bacterial, fungal, or viral infection at the
site of a vaccinial skin or mucous membrane lesion. SI occurs because
the blister formation or ulceration that is part of the normal
progression of a vaccinial skin or mucous membrane lesion disrupts the
surface of the skin or mucous membrane, allowing potential germs to
invade and infect the vaccinial skin or mucous

[[Page 626]]

membrane lesion leading to significant illness requiring
hospitalization.
(ii) Table requirements. A Table injury for SI in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of SI. The acute SI or related complications must be of
sufficient severity to require inpatient hospitalization.
(10) Anaphylaxis or Anaphylactic shock--(i) Definition. Anaphylaxis
or anaphylactic shock is, for purposes of the Table, as an acute,
severe, and potentially lethal systemic allergic reaction to a component
of the smallpox vaccine.
(ii) Table requirements. A Table injury for anaphylaxis or
anaphylactic shock in a recipient requires sufficient evidence in the
medical records of the occurrence of an acute anaphylaxis or
anaphylactic shock. The anaphylaxis or anaphylactic shock must be of
sufficient severity to require inpatient hospitalization. Anaphylaxis or
anaphylactic shock is not a Table injury for contacts.
(11) Vaccinial Myocarditis, Pericarditis, or Myopericarditis (MP)--
(i) Definition. MP is, for purposes of the Table, vaccinial myocarditis,
pericarditis, or myopericarditis. Myocarditis is defined as an
inflammation of the heart muscle (myocardium). Pericarditis is defined
as an inflammation of the covering of the heart (pericardium).
Myopericarditis is defined as an inflammation of both the heart muscle
and its covering. The inflammation associated with MP may range in
severity from very mild (subclinical) to life threatening. In many mild
cases, myocarditis is diagnosed solely by transient electrocardiographic
(EKG) abnormalities (e.g., ST segment and T wave changes), increased
cardiac enzymes, or mild echocardiographic abnormalities. Arrhythmias,
abnormal heart sounds, heart failure, and death may occur in more severe
cases. Pericarditis generally manifests with chest pain, abnormal heart
sounds (pericardial friction rub), EKG abnormalities (e.g., ST segment
and T wave changes), and/or increased fluid accumulation around the
heart.
(ii) Table requirements. A Table injury for MP in a recipient or
contact requires sufficient evidence in the medical records of the
occurrence of acute MP. The acute MP (or related complications) must be
of sufficient severity to require inpatient hospitalization. A death
resulting from MP requires sufficient microscopic (histopathologic)
evidence of MP or its sequela in heart tissue.
(c) Glossary for purposes of this section.
(1) Blister or vesicle means a circumscribed, elevated skin or
mucous membrane lesion containing an accumulation of fluid.
(2) Contact means a person who developed a vaccinial lesion or
infection through inoculation (and not vaccination).
(3) Exposure period means the span of time during which vaccinia
virus can be transmitted from a vaccine recipient shedding vaccinia or
through a contact case shedding vaccinia.
(4) Inoculation means transmission of and infection with the
vaccinia virus through a means other than smallpox vaccination. Spread
(inoculation) of vaccinia virus may occur in two ways: either self-
inoculation in which the vaccinia virus is spread from the vaccinial
lesion at the vaccination site to one or more areas on the same person
or person-to-person inoculation when the vaccinia virus is spread to
another person, a contact.
(5) Inoculation site means the skin or mucous membrane surface where
the vaccinia virus entered the body through means other than
vaccination.
(6) Lesion means a pathologic change.
(7) Pustule means a circumscribed, elevated skin or mucous membrane
lesion containing an accumulation of white blood cells.
(8) Recipient means a person to whom the smallpox vaccine was
administered.
(9) Ulceration means a specific skin or mucous membrane lesion
characterized by erosion of the skin or mucous membrane surface.
(10) Vaccination means the administration and receipt of the
smallpox (vaccinia) vaccine, and not through contact.
(11) Vaccination site means the skin surface where the vaccinia
virus entered the body through vaccination.

[68 FR 70093, Dec. 16, 2003, as amended at 71 FR 29808, May 24, 2006]

[[Page 627]]

Sec. Sec. 102.22-102.29 [Reserved]

Subpart D_Available Benefits

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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.

[[Page 628]]

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

[[Page 629]]

her legal guardian or life insurance benefits on behalf of the
dependent(s)).

Subpart E_Procedures for Filing Request Packages

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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, Healthcare Systems Bureau, Health Resources
and Services Administration, Parklawn Building, Room 11C-06, 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, Healthcare
Systems Bureau, Health Resources and Services Administration, Parklawn
Building, Room 11C-06, 5600 Fishers Lane, Rockville, Maryland 20857.
(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.''

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29810, May 24, 2006]

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, Healthcare Systems Bureau,
Health Resources and Services Administration, Parklawn Building, Room
11C-06, 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, Healthcare Systems Bureau, Health Resources and Services
Administration, Parklawn Building, Room 11C-06, 5600 Fishers Lane,
Rockville, Maryland 20857.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29810, May 24, 2006]

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

[[Page 630]]

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

[[Page 631]]

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 or reimbursement for representatives' fees or costs.
The Act does not authorize the Secretary to pay, or reimburse for, any
fees or costs associated with the requester's use of a personal
representative under this Program, including those of an attorney.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]

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

[[Page 632]]

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

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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:
(i) Is a health care worker, law enforcement officer, firefighter,
security personnel, emergency medical personnel, other public safety
personnel, or support personnel for such occupational specialties who
has volunteered and been selected to be a member of a smallpox emergency
response plan prior to the time at which the Secretary publicly
announces that an active case of smallpox has been identified within or
outside of the United States and that the requester is or will be
functioning in a role identified in a smallpox emergency response plan;
and
(ii) Was administered a smallpox vaccine pursuant to an approved
smallpox emergency response plan during the effective period of the
Declaration.

[[Page 633]]

(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)(i)-(ii) of this section (documentation concerning a vaccine
recipient's participation in, and receipt of the smallpox vaccine under,
an approved smallpox emergency response plan), a requester may submit a
certification, by a Federal, State, or local government entity or
private health care entity participating in the administration of
covered countermeasures through a smallpox emergency response plan, that
the requester is a person described in 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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]

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

[[Page 634]]

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 vaccinia 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

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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-

[[Page 635]]

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

[[Page 636]]

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 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

[[Page 637]]

requester's estate under applicable State law.

Subpart H_Secretarial Determinations

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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

[[Page 638]]

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

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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.
(i) For a smallpox vaccine recipient or vaccinia contact with no
dependents at the time the covered injury was sustained, the benefits
are 66\2/3\% of the individual's gross employment income at the time the
covered injury was sustained.
(ii) For a smallpox vaccine recipient or vaccinia contact with one
or more dependents at the time the covered injury was sustained, the
benefits are 75% of the individual's gross employment income at the time
the covered injury was sustained; and
(2) In the case of a smallpox vaccine recipient or vaccinia contact
who is a minor, the Secretary may consider the provisions of 5 U.S.C.
8113 (part of the statute authorizing the FECA Program), and any
implementing regulations, in determining the amount of payments under
this section and the circumstances under which such payments are
reasonable and necessary.
(b) Adjustment for inflation. Benefits for lost employment income
paid under the Program that represent future lost employment income will
be adjusted annually to account for inflation.

[[Page 639]]

(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.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]

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

[[Page 640]]

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:
(i) If no other eligible survivors are of equal priority to receive
death benefits, the Secretary will pay a death benefit in an amount
calculated under the alternative calculation to the aggregate of the
dependents on whose behalf the election was filed; and
(ii) If other eligible survivors are of equal priority to receive
death benefits as the dependents receiving death benefits under the
alternative calculation, the Secretary will pay the other eligible
survivors a proportionate amount of the death benefit available and
calculated under the standard calculation. In such circumstances, the
Secretary will pay the aggregate of the dependents receiving a death
benefit under the alternative calculation a proportionate share of the
benefits available under that calculation (in place of the proportionate
share of the death benefit that would be available under the standard
calculation). For example, if a deceased smallpox vaccine recipient is
survived by a dependent 10-year old child and a spouse who is not the
child's legal guardian (e.g., the dependent child's parents were the
deceased person and his or her former spouse), the surviving spouse
would be able to receive his or her share of the death benefit under the
standard calculation, and the dependent child's legal guardian, on
behalf of the minor, would receive either the child's proportionate
share of the death benefit under the standard calculation or the child's
proportionate share of the death benefit available under the alternative
calculation (if the legal guardian filed a written selection for such a
death benefit).
(c) Standard calculation of death benefits. (1) The maximum death
benefit available under the standard calculation of death benefits is
the amount of the comparable death benefit calculated under the PSOB
Program in the same fiscal year as the year in which the death benefit
under the standard calculation is paid under this Program (without
regard to any reduction under the PSOB Program attributable to a
limitation in appropriations), reduced by the total amount of benefits
for lost employment income paid under this Program to the deceased
person during his or her lifetime and to his or her estate after death.
(2) No death benefit will be paid under the standard calculation if
a death benefit has been paid, or if survivors are eligible to receive a
death benefit, under the PSOB Program with respect to the deceased
person.
(3) No death benefit will be paid under the standard calculation if
a disability benefit has been paid under the PSOB Program with respect
to the deceased person. However, if the PSOB Program disability benefit
paid was reduced because of a limitation on appropriations, a death
benefit will be available under the standard calculation to the extent
necessary to ensure that the total amount of disability benefits paid
under the PSOB Program, together with the amount of death benefits paid
under the standard calculation, equals the amount of the death benefit
described in paragraph (c)(1) of this section.
(4) Death benefits will be paid under the standard calculation in a
lump sum.
(d) Alternative calculation of death benefits available to surviving
dependents younger than the age of 18. If a deceased smallpox vaccine
recipient or vaccinia contact had at least one dependent who is younger
than the age of 18 (and will be younger than the age of 18 at the time
of the payment), the legal guardian(s) of all such dependents may
request benefits under the alternative

[[Page 641]]

calculation described in this paragraph. To receive such a benefit, the
legal guardian, on behalf of all such dependents for whom he or she is
the legal guardian, must file a selection to receive benefits under the
alternative calculation, as described in paragraph (d)(1) of this
section. If multiple dependents have different legal guardians, each
legal guardian is responsible for requesting benefits under the standard
calculation or for filing a selection for a death benefit under the
alternative calculation. If a single dependent has more than one legal
guardian, one legal guardian may file the selection. Payments made under
the alternative calculation will be made to the legal guardian(s) of all
of the dependents on behalf of all of those dependents until they reach
the age of 18.
(1) Selection of benefits under alternative calculation. Before a
payment of a death benefit will be approved under the alternative
calculation, the legal guardian(s) of the dependents for whom he or she
is the legal guardian must file a written selection, on behalf of all
such dependents, to receive a death benefit under the alternative
calculation. If such a selection is approved by the Secretary, these
dependents will be paid a proportionate share of the death benefit under
the alternative calculation in place of the proportionate share of
benefits that would otherwise be available to them under the standard
calculation.
(2) Amount of payments. The maximum death benefit available under
this paragraph is 75% of the deceased person's income (including income
from self-employment) at the time he or she sustained the covered injury
that resulted in death, adjusted to account for inflation (as
appropriate), except as follows:
(i) The maximum payment of death benefits that may be made on behalf
of the aggregate of the dependents in any one year is $50,000;
(ii) All payments made under this paragraph will stop once the
youngest of the dependents reaches the age of 18.
(3) Reductions for other coverage. The total amount of death
benefits provided under the alternative calculation will be reduced so
that the total amount of payments made (or expected to be made) under
obligations described in paragraph (d)(3)(i) of this section, together
with the death benefits paid under the alternative calculation, is not
greater than the amount of payments described in paragraph (d)(2) of
this section. In other words, the total amount of death benefits paid to
dependents under the alternative calculation may be reduced if third-
party payors have paid (or are expected to pay) for certain benefits so
that such dependents will receive a total sum (combining the death
benefit paid under the alternative calculation and the actual and
expected benefits paid for by third-party payors) that is not greater
than the death benefit that would be available under the alternative
calculation if no third-party payor existed to pay such benefits.
(i) The amount of death benefits paid under the alternative
calculation will be reduced for all payments made, or expected to be
made in the future, by any third-party payor for:
(A) Compensation for the deceased person's loss of employment income
on behalf of the dependents or their legal guardian(s);
(B) Disability, retirement, or death benefits in relation to the
deceased person (including, but not limited to, death and disability
benefits under the PSOB Program) on behalf of the dependents or their
legal guardian(s); and
(C) Life insurance benefits on behalf of the dependents.
(ii) In calculating such reductions, the Secretary will deem any
lump-sum payment made by a third-party payor under any obligation
described in paragraph (d)(3)(A) of this section, as received over a
period of years, rather than in a single year. The Secretary has
discretion as to how to apportion such payments over multiple years.
(4) Timing of payments. Payments made under this paragraph will be
made on an annual basis, beginning at the time of the initial payment,
to the legal guardian(s) on behalf of the aggregate of the dependents
receiving the payment. In the year in which the youngest dependent
reaches the age of 18, payments under this section will be paid on a pro
rata basis for the period of time before that dependent reaches the age
of 18. Once a dependent reaches

[[Page 642]]

the age of 18, the payments under this alternative calculation will no
longer be made on his or her behalf. Because payments under the
alternative calculation are to be made on behalf of dependents who are
younger than the age of 18, if a dependent meets this requirement at the
time of filing of the Request Form, but reaches the age of 18 (or is
older than 18 years of age) at the time of the initial payment, no
payment will be made to the dependent's legal guardian on his or her
behalf under the alternative calculation.

[68 FR 70093, Dec. 16, 2003; 69 FR 7376, Feb. 17, 2004]

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 Secretary. 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.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]

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

[[Page 643]]

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

Source: 68 FR 70096, Dec. 16, 2003, unless otherwise noted.

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, Healthcare Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, Room 12-105, Rockville,
Maryland 20857.
(2) Letters sent through a commercial carrier or private courier
service must be sent to the Associate Administrator, Healthcare Systems
Bureau, Parklawn Building, Room 12-105, 5600 Fishers Lane, Rockville,
Maryland 20857.
(c) Reconsideration process. When the Associate Administrator of the
Healthcare Systems 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.

[68 FR 70096, Dec. 16, 2003, as amended at 71 FR 29811, May 24, 2006]

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

[[Page 644]]

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.

PART 110 [RESERVED]

[[Page 645]]