Appendix B
| Jurisdiction | United States |
Part 110—Countermeasures Injury Compensation Program
Contents
Subpart A—General Provisions
§110.1 Purpose.
§110.2 Summary of available benefits.
§110.3 Definitions.
Subpart B—Persons Eligible to Receive Benefits
§110.10 Eligible requesters.
§110.11 Survivors.
Subpart C—Covered Injuries
§110.20 How to establish a covered injury.
Subpart D—Available Benefits
§110.30 Benefits available to different categories of requesters under this Program.
§110.31 Medical benefits.
§110.32 Benefits for lost employment income.
§110.33 Death benefits.
Subpart E—Procedures for Filing Request Packages
§110.40 How to obtain forms and instructions.
§110.41 How to file a Request Package.
§110.42 Deadlines for filing Request Forms.
§110.43 Deadlines for submitting documentation.
§110.44 Legal or personal representatives of requesters.
§110.45 Multiple survivors.
§110.46 Amending a Request Package.
Subpart F—Documentation Required for the Secretary to Determine Eligibility
§110.50 Medical records necessary for the Secretary to determine whether a covered injury was sustained.
§110.51 Documentation an injured countermeasure recipient must submit for the Secretary to make a determination of eligibility for Program benefits.
§110.52 Documentation a survivor must submit for the Secretary to make a determination of eligibility for death benefits.
§110.53 Documentation the executor or administrator of the estate of a deceased injured countermeasure recipient must submit for the Secretary to make a determination of eligibility for benefits to the estate.
Subpart G—Documentation Required for the Secretary to Determine Program Benefits
§110.60 Documentation a requester who is determined to be eligible must submit for the Secretary to make a determination of medical benefits.
§110.61 Documentation a requester who is determined to be eligible must submit for the Secretary to make a determination of lost employment income benefits.
§110.62 Documentation a requester who is determined to be an eligible survivor must submit for the Secretary to make a determination of death benefits.
§110.63 Documentation a legal or personal representative must submit when filing on behalf of a minor or on behalf of an adult who lacks legal capacity to receive payment of benefits.
Subpart H—Secretarial Determinations
§110.70 Determinations the Secretary must make before benefits can be paid.
§110.71 Insufficient documentation for eligibility and benefits determinations.
§110.72 Sufficient documentation for eligibility and benefits determinations.
§110.73 Approval of benefits.
§110.74 Disapproval of benefits.
Subpart I—Calculation and Payment of Benefits
§110.80 Calculation of medical benefits.
§110.81 Calculation of benefits for lost employment income.
§110.82 Calculation of death benefits.
§110.83 Payment of all benefits.
§110.84 The Secretary's right to recover benefits paid under this Program from third-party payers.
Subpart J—Reconsideration of the Secretary's Determinations
§110.90 Reconsideration of the Secretary's eligibility and benefits determinations.
§110.91 Secretary's review authority.
§110.92 No additional judicial or administrative review of determinations made under this part.
Subpart K—Covered Countermeasures Injury Tables
§110.100 Injury Tables.
Authority: 42 U.S.C. 247d-6e.
Source: 75 FR 63675, Oct. 15, 2010, unless otherwise noted.
Subpart A—General Provisions
§110.1 Purpose
This part implements the Public Readiness and Emergency Preparedness Act (PREP Act), which amended the Public Health Service Act (herein after "PHS Act" or "the Act") by including section 319F-3, and section 319F-4 entitled "Covered Countermeasure Process." Section 319F-4 of the PHS Act directs the Secretary of Health and Human Services, following issuance of a declaration under section 319F-3(b), to establish procedures for the Countermeasures Injury Compensation Program (herein after "CICP" or "the Program") to provide medical and lost employment income benefits to certain individuals who sustained a covered injury as the direct result of the administration or use of a covered countermeasure consistent with a declaration issued pursuant to section 319F-3(b), or in the good faith belief that administration or use of the covered countermeasure was consistent with a declaration. Also, if the Secretary determines that an individual died as a direct result of a covered injury, the Act provides for certain survivors of that individual to receive death benefits.
§110.2 Summary of Available Benefits
(a) The Act authorizes three forms of benefits to, or on behalf of, requesters determined to be eligible by the Secretary:
(1) Payment or reimbursement for reasonable and necessary medical services and items to diagnose or treat a covered injury, or to diagnose, treat, or prevent its health complications, as described in §110.31.
(2) Lost employment income incurred as a result of a covered injury, as described in §110.32.
(3) Death benefits to certain survivors if the Secretary determines that the death of the injured countermeasure recipient was the direct result of a covered injury, as described in §110.33.
(b) In general, the benefits paid under the Program, are secondary to any obligation of any third-party payer to provide or pay for such benefits. The benefits available under the CICP usually will be paid only after the requester has in good faith attempted to obtain all other available coverage from all third-party payers with an obligation to pay for or provide such benefits (e.g., medical insurance for medical services or items, workers' compensation program(s) for lost employment income). However, as provided in §110.84, the Secretary has the discretion to pay benefits under this Program before a potential third-party payer makes a determination on the availability of similar benefits and has the right to later pursue a claim against any third-party payer with a legal or contractual obligation to pay for, or provide, such benefits.
§110.3 Definitions
This section defines certain words and phrases found throughout this part.
(a) Act or PHS Act means the Public Health Service Act, as amended.
(b) Alternative calculation means the calculation used in §110.82(c) of this part for the death benefit available to dependents younger than 18 years old at the time of payment.
(c) Approval means a decision by the Secretary or her designee that the requester is eligible for benefits under the Program.
(d) Benefits means payments and/or compensation for reasonable and necessary medical expenses or provision of services described in §110.31, lost employment income described in §110.32, and/or payment to certain survivors of death benefits described in §110.33.
(e) (1) Child means any natural, illegitimate, adopted, posthumous child, or stepchild of a deceased injured countermeasure recipient who, at the time of the countermeasure recipient's death is:
(i) 18 years of age or younger; or(3) Stepchild means a child of an injured countermeasure recipient's spouse but who is not the child of the injured countermeasure recipient. For a stepchild to be eligible for survivor death benefits under the Program, the stepchild's parent must have been married to the injured countermeasure recipient at the time of that injured countermeasure recipient's death, and the stepchild must have been supported by the injured countermeasure recipient.
(ii) Between 19 and 22 years of age and a full-time student; or
(iii) Incapable of self-support due to a physical or mental disability.
(2) Posthumous child means a child born after the death of the parent.
(f) Covered Countermeasure means the term that is defined in section 319F-3(i) (1) of the PHS Act and described in a declaration issued under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(i)(I), (b)). To be a covered countermeasure for purposes of this part, the countermeasure must have been administered or used pursuant to the terms of a declaration, or in a good faith belief of such; and
(1) Administered or used within a State (as defined in §110.3(bb)), or otherwise in the territory of the United States; or
(2) Administered to, or used by, otherwise eligible individuals—
(i) At American embassies or military installations abroad (such as military bases, ships, and camps); or
(ii) At North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status Agreement) where American servicemen and servicewomen are stationed.
(g) Covered Injury means death, or a serious injury as described in §110.3(z), and determined by the Secretary in accordance with §110.20 of this part to be:
(1) An injury meeting the requirements of a Covered Countermeasures Injury Table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or
(2) An injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure. This includes serious aggravation caused by a covered countermeasure of a pre-existing condition.
(h) Declaration means a recommendation issued by the Secretary under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(b)), for the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, following her determination that a specific disease, condition, or threat represents a public health emergency or a credible risk of a future public health emergency.
(i) Dependent means, for purposes of lost employment income benefits, a person whom the Internal Revenue Service would consider to be the injured countermeasure recipient's dependent at the time the covered injury was sustained. For purposes of survivor death benefits, dependent means a person whom the Internal Revenue Service would consider to be the deceased injured countermeasure recipient's dependent...
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