NATIONAL VACCINE INJURY
COMPENSATION PROGRAM

BHPr-2000/02
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Allow the Payment of Family Counseling Expenses

Allow for the inclusion of family counseling expenses in awards under the National Vaccine Injury Compensation Program (VICP)

Current Law: Section 2115(a) of the Public Health Service Act sets out the compensation which may be awarded under the Program to a petitioner for a vaccine-related injury or death. Awards may include payments for unreimbursable expenses for rehabilitation, developmental evaluation, special counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities. Compensation may not be for anything not included in this list unless it is specifically for the health, education, or welfare of the person who suffered the vaccine-related injury.

Proposal: Add payment of costs associated with family counseling to subsection (a) under (1)(A)(iii)(II) making compensation for such costs allowable.

Rationale: In its current form, the statute does not specifically allow for amounts to be awarded for purposes other than the immediate needs of the injured party. The Act does allow for counseling for the injured party as part of that person’s overall rehabilitation and development. The proposed change recognizes the importance of the family to the overall well-being of the injured party and allows for the award of expenses needed to help all family members cope with the aftermath of such a devastating event. Emotional conflicts among parents and siblings can irreparably damage relationships which are necessary to support and nurture the injured party. In such cases, expenses for counseling, which will ensure the best possible family environment for the injured party, are absolutely appropriate as they are expenses specifically related to the vaccine injury and are for the specific benefit of the injured party. Existing language in Section 2115 providing that expenses must be related to the vaccine injury and incurred on behalf of the injured person will still require that petitioners demonstrate that family counseling is reasonably necessary for the care of the vaccine-injured person, keeping with the intent of the statute. This amendment will make it easier to demonstrate the reasonableness of, and necessity for an award of compensation for family counseling expenses.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow compensation awards to include amounts for family counseling.

Effect on Beneficiaries: This change will improve the family relationships of vaccine-injured persons (mostly children) in family situations where counseling is needed.

Cost: The provision of counseling for other members of the injured party’s family is necessary in about 75 percent of the injury cases awarded each year. The annual number of awards is approximately 50 per year. The estimated average amount required for family counseling is $6,000 resulting in an annual estimate of $198,000.

(Dollars in Millions)

FY 2001-2005

$0.2

Other Data: Add the phrase “(including family counseling)” to Section 2115(a)(1)(A)(iii)(II) so that it will then read;

“(iii)(II) have been or will be for rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling (including family counseling), emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.”

BHPr-2000/03
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Clarify the Scope of “Factors Unrelated”

Clarify the Scope of the term “Factors Unrelated” as it applies to determining eligibility and compensation.

Current Law: Section 2113(a) of the Public Health Service Act (the Act) sets out the eligibility and compensation requirements of the National Vaccine Injury Compensation Program (VICP). Subsection(a)(1) specifies that compensation shall be awarded if the Special Master or the Court finds on the record as a whole that the illness, disability, injury, condition, or death described in the petition is not due to factors unrelated to the administration of the vaccine described in the petition. Subsection (a)(2) defines the term “factors unrelated to the administration of the vaccine”. This term does not include any idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor, injury, illness, or condition, and may include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death.

Proposal: Add genetic disorders and structural lesions to the list of factors identified in Subsection (2)(B) as potential “factors unrelated,” and state that these as well as the currently listed elements may be factors unrelated without regard to whether their cause is known.

Rationale: In order to award compensation, the Act provides that the Court must find by a preponderance of the evidence that the injury in question was not due to “factors unrelated” to the vaccine. Under existing statutory language, infection, toxins, trauma or metabolic disturbances which have no known relation to the vaccine but which are considered the principal cause of the claimed injury may be considered a “factor unrelated” to the immunization and serve as a basis to deny compensation. However, a factor unrelated cannot be an “idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor , injury, illness, or condition.” In several cases, the court has broadly interpreted this provision in holding that if the cause of the claimed injury is “idiopathic,” or unknown, it cannot be a “factor unrelated” even if it is a well-defined condition and known to be unrelated to immunization.

A statutory amendment is necessary to effectuate Congressional intent that compensation should not be afforded if the claimed injury is due to an alternative cause and not the vaccine. Such an amendment would reflect accurate medical science concerning what constitutes “factors unrelated” or alternative cause. Certain well-defined medical conditions, such as genetic disorders or structural lesions (malformations of the brain secondary to developmental abnormalities during fetal brain development), that are unrelated to immunization and are the known cause of a claimant’s condition should qualify as “factors unrelated” even if the cause of the alternative cause is unknown. Such a defined alternative cause is not “idiopathic” and should not be disregarded simply because the “cause of the cause” is unknown. In other words, when the vaccine has no known relation to the alternative cause, the alternative cause constitutes a factor unrelated, even if the precise cause of the alternative cause is unknown. With the current state of the decisional law, conditions which are clearly not vaccine related have been compensated, placing the medical integrity of the Program in question.

Additionally, the injury “encephalopathy” was redefined in the February 1995 regulations to clarify that an encephalopathy caused by infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder, shall not be considered a Table condition without regard to whether the cause of such condition is known. 42 C.F.R.§100.3(b)(2)(iii). For consistency, a similar clarification of what constitutes a compensable injury should be made applicable to all listed Table injuries. By redefining the term “factor unrelated” consistent with the clarification in the new regulations for encephalopathy, no longer will compensation be paid for injuries that are clearly not vaccine related. When an alternative cause is the known reason for an individual’s condition, vaccine compensation should not be paid, even though the cause of the alternative cause is unknown.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. By a vote of 5 to 2 the ACCV voted to recommend that the Secretary propose legislation which would add genetic disorders and structural lesions to the list of things which are clearly not related to the administration of vaccines.

Effect on Beneficiaries: This change will make it more likely that awards will be granted only to individuals with true vaccine injuries.

Cost: This change will result in the award of about 2 cases less each year. Average award amounts total approximately $1 million for each case. Savings from this change will amount to around $2 million per year.

(Dollars in Millions)

Other Data: Section 2113(a)(2)(B) would appear as follows:

“(B) may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), structural lesions, genetic disorders, or metabolic disturbances, without regard to whether the cause of the infection, toxin, trauma, structural lesion, genetic disorder or metabolic disturbance is known, but which have no known relation to the vaccine involved, but and which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death.”

BHPr-2000/04
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Allow Interim Payment of Costs

Authorize interim payment of costs incurred in adjudicating a post-1988 claim under the Program after a finding of entitlement is established.

Current Law: Section 2115 of the Public Health Service Act sets out the compensation which may be awarded at the conclusion of a vaccine-related injury or death case. Subsection (e) allows for compensation of “reasonable attorneys’ fees” and “other costs”. Because the payment of attorneys’ fees and other costs is included in the compensation awarded at the conclusion of the proceeding, petitioners and their attorneys must pay all costs of filing and presenting their cases out of pocket. As it is currently constructed, the Act does not allow for compensation to attorneys or petitioners for those expenditures required to gather, present, and support their case, prior to the final decision by the Special Master even though attorneys fees and costs ultimately may be paid regardless of the final decision as to whether entitlement is established.

Proposal: Add language to Section 2115 of the Public Health Service Act which would make available to petitioner, even though attorneys fees and costs may be paid regardless of the final decision as to whether entitlement is established, subsequent to a finding of entitlement in any case involving a vaccine administered on or after October 1, 1988, payment of actual costs involved in filing and adjudicating the claim up to the time that such a finding is made. The language would also include a requirement that the payment be based on submission of documentation verifying the expenditure of the amount requested, and that the payment may only be used for those costs allowed under 2115(e)(1)(B) “Other Costs”.

Rationale: In the process of filing a petition for compensation based on a suspected vaccine- related injury, the petitioner is often required to personally pay costs related to filing, such as expert witness costs and duplication of medical record costs. In those cases where a petitioner lacks the resources to pay such costs, the case might not be brought unless the petitioner is able to find an attorney who is willing to front those costs for the petitioner, and then carry that debt until the case is concluded. There is evidence that, on occasion, this may inhibit petitioner’s ability to obtain legal representation and medical expert witness testimony under the Program. Often, petitioners must provide payment for the up-front costs incurred in filing a claim under the Program, straining already tenuous financial situations. To reduce the hardship on petitioners under the Program and to expand the opportunity for all eligible parties to participate in the Program, this amendment would allow for the payment of actual costs (excluding attorneys’ fees) incurred in developing and documenting a vaccine-injury compensation case, much earlier in the process, i.e., at the time the initial determination of entitlement is made.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow for the interim payment of costs.

Effect on Beneficiaries: This change will ease financial burdens currently borne by all petitioners and will be especially beneficial to financially disadvantaged petitioners.

Cost: There is no change in costs associated with this amendment.

Other Data: Add a new subsection to Section 2115(e) as follows:

“(4) Subsequent to a finding of entitlement in any case involving a vaccine administered on or after October 1, 1988, an award of compensation may be made to petitioner limited to actual costs incurred in proceeding on the petition (as defined under paragraph (1)(B), “other costs”), so long as petitioner provides documentation verifying the expenditure of the amount requested.”

BHPr-2000/05
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Allow the Payment of Guardianship Expenses

Allow for the payment of fees and costs associated with the establishment of guardianships.

Current Law: Section 2115(e) of the Public Health Service Act (the Act) sets out the compensation which may be awarded to pay for “reasonable attorneys’ fees” and “other costs”. Subsection 2115(e)(1)(B) allows for payment of other costs, but does not provide specific guidance on what may be included in these costs.

Proposal: Add a phrase which would specifically allow for the inclusion of reasonable fees and costs associated with the establishment of a guardianship or conservatorship in the definition of “other costs.”

Rationale: In its current form, the Act does not specifically allow for costs to be reimbursed for the establishment of a guardianship to oversee the use of funds awarded for the treatment and care of injured individuals. In fact, prevailing case law has reinforced that the statute does not allow compensation for such expenses. See Siegfried v. Secretary, HHS, 19 Cl.Ct. 323, 325 (1990); and Hulsey v. Secretary, HHS, 19 Cl. Ct. 331, 334 (1990). However, there have been cases which supported the opinion that such expenses should be compensable and have in fact awarded guardianship costs as in Thomas v. Secretary, HHS, No. 92-46V, 1997 WL 74664, at 3 (Fed. Cl. Spec. Mstr. Feb. 3, 1997).

Provisions for guardianships/conservatorships are routinely included in settlement stipulations because they are usually required by life insurance companies, and because it protects the integrity of the Program by protecting the award granted to the vaccine-injured individual (who is often legally incompetent). As with other attorneys’ fees and costs payable under the Program, permissible guardianship expenses will be limited to those that have already been incurred and documented as part of petitioners’ application of attorneys’ fees and costs. Fees associated with the future maintenance of a guardianship account would not be included.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would add the payment of costs associated with the establishment of guardianships to the list of “other costs” which may be paid under Section 2115(e)(1)(B) of the Act.

Effect on Beneficiaries: This change will enhance the protection of awards granted to injured individuals.

Cost: The average cost of establishing a guardianship is approximately $2,000 and guardianships are established in about 50 cases each year.

(Dollars in Millions)

Other Data: Change Section 2115(e)(1)(B) to read as follows:

“ (B) other costs, incurred in any proceeding on such petition, including reasonable fees and costs associated with the establishment of a guardianship or conservatorship. If the judgement of a Special Master...”

BHPr-2000/07
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Clarify the Calculation of Lost Earnings

Identifies a specific basis for calculating projected lost earnings resulting from a vaccine-related injury.

Current Law: Section 2115(a) of the Public Health Service Act sets out the compensation which may be awarded under the Program to a petitioner for a vaccine-related injury or death. Subsection (3)(B) specifies that if a person has sustained a vaccine-related injury before reaching the age of 18 and has an impaired earning capacity because of that injury which is likely to continue beyond age 18, compensation after attaining the age of 18 for loss of earnings will be determined on the basis of the average gross weekly earnings of workers in the private non-farm sector less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary of Health and Human Services (HHS).

Proposal: Specify in Section 2115(a)(3)(B) of the statute the use of the figure tabulated by the Bureau of Labor Statistics (BLS) from the Current Population Survey (CPS) based on specifications designed by the Department of Justice (DOJ) in consultation with a team of economic experts to best reflect the statutory criteria. This figure would be calculated annually at the request of the Secretary of HHS for use in the calculation of lost earnings under the VICP.

Rationale: The proposed amendment would codify the method of calculation that is currently in use by the government in vaccine cases. The current statutory language does not specify how average gross weekly earnings of workers in the private, non-farm sector are to be calculated in cases where an individual sustains a vaccine injury prior to age 18 which impairs his or her earning capacity. Until recently, projected lost earnings in such cases were determined based on a Bureau of Labor Statistics (BLS) figure published in the Current Employment Statistics (CES), which computes “the average weekly earnings of production or nonsupervisory workers on private non-farm payrolls”. This figure does not include statistics for supervisory workers, a fact which became the subject of legal challenges recently in several cases. As a result, DOJ requested that BLS prepare a special tabulation from data contained in another wage series known as the Current Population Survey (CPS). After consulting with a group of labor economists, the Department requested that this tabulation reflect the average gross weekly earnings of all workers in the private, non-farm sector, including supervisory and nonsupervisory workers, as well as part-year and part-time workers and full-year, full-time workers, and exclude the self-employed. This new calculation more accurately reflects the average weekly earnings of the group identified in the statute (the private, non-farm sector) than the CES figure, and is now being used by the government in pending vaccine cases to determine average gross weekly wages. Annual earnings data is calculated from the CPS in the first quarter of every year and BLS has agreed to provide an update of the special tabulation to the Secretary annually.

In keeping with the purpose of the Program, as stated in House Report No. 99-908, to provide compensation with certainty and generosity, it is appropriate to apply the special tabulation when calculating potential lost earnings. Codifying the use of this specific calculation would add certainty to the process of compensating injured persons while providing a more generous payment for lost earnings. In the past, the calculation did not include the salaries of supervisory personnel, and was therefore skewed to a lower level. This lower level of compensation has been challenged on the grounds that it unfairly assumes that none of these injured persons would attain a level of supervisory responsibility and the commensurate higher salary.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would establish a specific basis for the calculation of projected lost earnings from a vaccine-related injury.

Effect on Beneficiaries: Codifying the use of this calculation will not affect beneficiaries.

Cost: Enactment of this amendment will not increase Program costs because the method to be codified is the method currently in use. By standardizing the calculation, costs associated with litigation based on the lost earnings calculation method will be reduced. Each year about ten challenges are filed to the method used in calculating lost earnings. These cost about $2,000 each including attorney and financial expert costs. Costs to the VICP total approximately $20,000 per year which would be saved by standardizing the calculation method.

Other Data: Amend Section 2115(a)(3)(B) to include a specific description of the calculation used in arriving at an average weekly gross earnings figure so that it will then read:

“...for loss of earnings determined on the basis of the annual estimate of the average (mean) gross weekly earnings of wage and salary workers age 18 and over (excluding the incorporated self employed) in the private non-farm sector (which includes all industries other than agricultural production of crops and livestock), as calculated annually by the Bureau of Labor Statistics from the quarter sample data of the Current Population Survey, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary.”

BHPr-2000/08
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Change Advisory Commission Meeting Schedule Requirement

Eliminate the requirement that the Advisory Commission on Childhood Vaccines (ACCV) meet at least four times each year.

Current Law: Section 2119© of the Public Health Service Act specifies that the ACCV must meet “not less often than four times per year.”

Proposal: Delete from Section 2119© of the Public Health Service Act, the requirement that the ACCV meet at least four times per year.

Rationale: In its current form, the law limits the flexibility of the Commission to coordinate its meeting schedule with the schedules of related advisory committees which meet three times per year. This would bring the provisions governing the operation of the ACCV more in line with laws and regulations governing other advisory committees reporting to the Secretary of Health and Human Services, which do not have stated requirements for the number of annual meetings. For those years in which the Commission feels it can accomplish its business in less than four meetings, significant savings will be realized in reduced salary, travel, and meeting-related costs.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would eliminate the requirement that the ACCV meet at least four times per year.

Effect on Beneficiaries: This change will have no effect on beneficiaries.

Cost: Each meeting of the ACCV costs approximately $25,000. Should the frequency decline, there would be savings of $25,000 per meeting.

Other Data: Section 2119© would be changed to eliminate the phrase “not less often than four times per year” and would read as follows:

“(c) MEETINGS.--The Commission shall meet within 60 days after all members of the Commission are appointed, and thereafter shall meet not less often than four times per year and at the call of the chair. A quorum...”

BHPr-2000/09
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Change Advisory Commission Membership Criteria

Specify that the two seats on the Advisory Commission on Childhood Vaccines (ACCV) which are set aside for representatives of children injured by vaccines may also be filled by representatives of vaccine-injured adults or individuals who have suffered vaccine-related injuries.

Current Law: Section 2119(a)(1)(B) of the Public Health Service Act specifies that three members of the ACCV must be members of the general public and that of those three at least two must be legal representatives of children who have suffered a vaccine-related injury or death.

Proposal: Expand the criteria for potential appointment to the two reserved general public seats on the ACCV under Section 2119(a)(1)(B) of the Public Health Service Act to include individuals who have suffered a vaccine-related injury either as children or as adults and to include legal representatives of adults injured by vaccines either as children or as adults.

Rationale: Current law specifies criteria for membership on the ACCV. The ACCV is made up of experts who either possess specific training, medical or legal, or who have personal experience gained as the legal representatives of vaccine-injured children. While this brings together a diverse group of very knowledgeable individuals, it ignores a pool of potential members who would provide the ACCV with a unique, and desired, viewpoint, i.e., that of an individual who has actually suffered an injury related to a vaccine. While the number of adults injured by vaccines is currently small, this pool of potential members will continue to expand as injured children mature to adulthood. In its current form, the law does not provide an opportunity for adult individuals who have suffered vaccine-related injuries to participate as members of the ACCV, or for the representatives of injured adults to participate. The opportunity to participate on the ACCV should be made available to these individuals in order to obtain their unique viewpoint on ACCV issues.

Effect on Beneficiaries: This change will broaden the scope of potential membership on the ACCV to make the membership more representative of the pool of injured individuals.

Cost: There will be no increase in costs as a result of this change.

Other Data: Section 2119(a)(1)(B) would be changed to include vaccine injured adults and the legal representatives of adults who have suffered a vaccine-related injury in the pool of potential ACCV members to be chosen from the general public as follows:

“(B) Three members from the general public of whom at least two shall be either legal representatives of individuals who have suffered a vaccine-related injury or death, or individuals who have themselves suffered a vaccine-related injury.”

BHPr-2000/10
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Changes to the Rulemaking Process for the Vaccine Injury Table

Change the rulemaking process for amending the Vaccine Injury Table (the Table) by reducing the period for public comment from 180 days to 60 days, and eliminating the requirement for a public hearing.

Current Law: Section 2114(c)(1) of the Public Health Service Act stipulates that in promulgating regulations to modify the Vaccine Injury Table, the Secretary (DHHS) shall provide for notice and opportunity for a public hearing and at least 180 days of public comment.

Proposal: Delete from Section 2114(c)(1) of the Public Health Service Act the phrase which stipulates that 180 days be allowed for comments on proposed changes to the Vaccine Injury Table (the Table) as well as that a public hearing be held. The period allowed for public comment will be changed to 60 days.

Rationale: In its current form, the law causes unnecessary delays and an unnecessarily onerous process for making changes to the Table. The shortened timeframe for comment will make it possible to reflect new scientific information relating to adverse events associated with the administration of childhood vaccines on the Table much sooner, and thus provide for a simplified claims adjudication process. Eliminating the requirement for a separate public hearing on proposed changes to the Table will not limit the opportunity of the public to comment and eliminates a requirement that in practice has had limited, if any added value . For example, at the last public hearing, held on September 11, 1997, no one appeared to provide testimony. Changes must still be discussed and acted on by the Advisory Commission on Childhood Vaccines (ACCV) at its meetings, which are open to the public. The public is provided with ample notice of the discussion of such items through publication of ACCV agendas in the Federal Register.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would streamline the rulemaking process for amending the Vaccine Injury Table.

Effect on Beneficiaries: This change will enhance the Program’s ability to provide appropriate compensation to beneficiaries by providing a simplified and streamlined process consistent with the general rulemaking process for the DHHS.

Cost: There will be no increase in costs associated with this proposal.

Other Data: Section 2114(c)(1) would be modified to change the requirement for a 180 day comment period to a 60 day comment period, and would delete the requirement to hold a public hearing when changes are proposed to the Vaccine Injury Table. The section would read:

“(c) ADMINISTRATIVE REVISION OF THE TABLE.--

(1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a public hearing and at least 180 60 days of public comment.”

BHPr-2000/11
9/15/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Extension of Current Statute of Limitations

Extend the current statute of limitations from 3 years for injury claims and 2 years for death claims, to 6 years for those claiming injury or death resulting from a covered vaccine.

Current Law: Section 2116(a) of the Public Health Service Act establishes timeframes governing the filing of petitions for compensation under the program. Subsection (a)(2) requires that a petition for compensation based on a claim of vaccine-related injury be filed no later than 36 months following the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury. Subsection (a)(3) requires that a petition for compensation based on a claim of vaccine-related death be filed no later than 24 months from the date of the death.

Proposal: Revise the references to filing limits in Section 2116(a)(2) and (a)(3) of the Public Health Service Act by replacing them with one standard limit of six years.

Rationale: For vaccines included in the original Vaccine Injury Table (the Table), petitions must be filed within 24 months for deaths and 36 months for injuries. For vaccines and injuries subsequently added to the Table, petitions may be filed for injuries or deaths resulting from vaccines administered up to eight years prior to the effective date of the change which adds the vaccine or injury to the Table. The proposal to increase the timeframe during which petitions for both injuries and deaths related to vaccines currently on the Table to 6 years takes into consideration the significant difference between the time allowed for filing related to vaccines covered in the current Table and filing related to vaccines and conditions added to the table. Setting the revised standard at six years brings it into conformance with the basic standard established by 28 U.S.C.A. § 2501 for claims unrelated to vaccines filed with the U.S. Court of Federal Claims (the Court). In addition to making the standard consistent with the Court’s existing standard, lengthening the period in which petitions may be filed will allow for the more accurate determination of life care needs of the injured party prior to filing. The current situation provides an incentive for petitioners’ attorneys to delay litigation proceedings in order to allow for more time to adequately assess the future medical needs of an injured child.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would extend the statute of limitations governing when a petition alleging injury or death related to administration of a covered vaccine may be filed with the Court.

Effect on Beneficiaries: The proposed change will allow petitioners sufficient time to evaluate the long-term effects of the alleged injury from covered childhood vaccines and develop a better estimate of the life-long needs of the petitioner prior to filing a claim. This will allow cases to move more rapidly through the entire process rather than having to remain on hold while such cost estimates are developed subsequent to the filing of the petition. This change will also reduce the chances that anyone entitled to participate will be excluded due to failure to file within established timeframes.

Cost: Approximately $500,000 per year. The change proposed might result in the receipt of a few petitions which would otherwise be barred. At most, two additional cases might be filed each year by individuals who did not become aware of the VICP until after the original timeframe had expired. Since only about one out of three cases is compensated, this would result in one award every other year.

Other Data: Change Section 2116(a)(2) and (3) to remove references to 36, 24, and 48 month periods and replace them with a standard 6 year period.

“(2) ...no petition may be filed for compensation under the Program for such injury after the expiration of 36 months 6 years after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury, and

(3) a vaccine set forth in the Vaccine Injury Table which is administered after the effective date of this part, if a death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such death after the expiration of 24 months from the date of the death and no such petition may be filed more than 48 months more than 6 years after the date of the death, or more than 6 years after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted.”

BHPr-2000/13
12/14/98

HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Injury Compensation Program:
Exceptional Circumstances for Payment of Attorneys’ Fees and Costs

Allow the U. S. Court of Federal Claims (the Court) the discretion to provide for a check for attorneys’ fees and costs awarded under section 2115(e) to be made payable solely to the attorney for the petitioner.

Current Law: Section 2115 of the Public Health Service Act sets out the compensation which may be awarded to a petitioner under Section 2111. Existing statutory language requires that all compensation be paid to petitioner.

Proposal: Add language to Section 2115(e) of the Public Health Service Act which would allow the Court, in exceptional circumstances and with good cause shown, to provide for a check for the fees and costs incurred by an attorney in a claim filed under the National Vaccine Injury Compensation Program to be made payable solely to the attorney for the petitioner.

Rationale: In its current form the statute requires that all compensation awarded under the program, including attorneys’ fees and costs, be made to the petitioner. This does not provide an avenue for the petitioner’s attorney to be compensated in the exceptional event that a petitioner, whose name is on the check issued for payment of attorneys’ fees and costs, cannot be located or refuses to sign the check making payment to the attorney. The legislative history contained in Committee Report 99-908 indicates that Congress clearly intended that petitioners’ ability to obtain qualified assistance should not be limited. To ensure the greatest interest possible on the part of attorneys in representing vaccine cases before the Court, Congress’ direction was that “the court make adequate provision for attorneys’ time and that the court exercise its discretion to award fees in non-prevailing, good-faith claims.” This intent is contravened if attorneys who have faithfully executed their duties and fully represented petitioners before the Court, can be denied the compensation which Congress intended them to receive. Instances have been documented in which attorneys went unpaid for their time because petitioners whose names are on all checks by law, could not be located or refused to endorse payments which their legal representatives had earned.

This change would make it possible for attorneys to receive payment even when the petitioner refuses to sign the check without getting HHS involved. By allowing the Court to review exceptional cases and make a determination regarding issuance of a new check directly to an attorney, this change would ensure that implementation of the Program is in accordance with the original intent regarding payment of attorney fees and costs.

The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow the Court, under exceptional circumstances and with good cause shown, to provide for issuance of a check for attorneys’ fees and costs directly to the attorney for the petitioner.

Effect on Beneficiaries: This change will not have a direct effect on beneficiaries.

Cost: There is no cost associated with this change.

Other Data: Suggested legislative language attached.

(BHPr-2000/13)

Appendix

Add a new subsection to Section 2115(e) as follows:

“(4)(A) With a petitioner’s express consent, the special master or court may order that attorneys’ fees and costs awarded under paragraph (1) be made payable solely to the attorney for a petitioner.

(B) In the absence of a petitioner’s express consent, the special master or court may order that attorneys’ fees and costs awarded under paragraph (1) be made payable solely to the attorney for a petitioner only in exceptional circumstances for good cause shown.

(C) In determining whether to order that attorneys’ fees and costs be made payable solely to the attorney for a petitioner in accordance with subparagraph (B), the special master shall afford all interested persons, including the petitioner, the Secretary, and the attorney for petitioner, an opportunity to submit relevant information. If the petitioner cannot be located, or refuses to respond to the special master’s request for information, the special master may order that attorneys’ fees and costs be made payable solely to the petitioner’s attorney if the special master determines that there is no practical alternative means to ensure that petitioner’s attorney will be promptly reimbursed for fees and costs incurred in proceeding upon the petition.”

OPHS-2001/01
4/13/00

OFFICE OF PUBLIC HEALTH AND SCIENCE
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL

National Vaccine Program

Reauthorize the National Vaccine Program.

Current Law: Section 2106 of the Public Health Service Act provides appropriation authority for the conduct of a broad range of activities for the National Vaccine Program, as defined in sections 2101-2105 and 2125-2128 of the Act; and in sections 312-316 of P.L. 99-660, as amended, the National Childhood Vaccine Injury Act of 1986. The existing authority has expired.

Proposal: Reauthorize National Vaccine Program activities for five years.

Rationale: The National Vaccine Program’s legislative mandate of “optimal prevention of human infectious diseases through immunization and optimal prevention against adverse reactions to vaccines” is achieved through coordination and direction of vaccine research and development, vaccine safety assurance, and immunization activities that are brought together in the National Vaccine Plan. The Plan describes the principal policy directions and objectives for programs carried out in the Centers for Disease Control and Prevention (CDC), Department of Defense (DoD), Food and Drug Administration (FDA), Health Care Financing Administration (HCFA), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), and U.S. Agency for International Development (USAID).

In P.L. 99-660, Congress created the National Vaccine Program–a cross departmental, multi- agency collaboration led by the National Vaccine Program Office (NVPO)–as a vehicle for coordination and intervention to meet public health needs in the prevention of infectious diseases. While each agency has its own separate focus and goals, the National Vaccine Program has successfully created the framework and opportunity, through the Inter-Agency Vaccine Group (IAG), to make collective public health decisions and policy recommendations regarding vaccines and immunizations. This process not only facilitates agency focus and cooperation, but increases the effectiveness of the Federal role in the implementation of a coordinated vaccine policy as the national public health policy leader. The NVPO convenes the IAG composed of major agencies concerned with both vaccine development and use; and an Inter-Agency Vaccine Communications Group (IAVCG) composed of communication and technical experts from the IAG agencies. The IAG membership consists of senior policy and program officials from CDC, DoD, FDA, HCFA, HRSA, NIH, USAID, and NVPO. The IAVCG focuses on enhancing immunization communication efforts across Federal agencies to effectively inform the public about vaccines, encourage appropriate and optimal use of vaccines, and ensure public trust in immunization programs.

The National Vaccine Program and the IAG, in consultation with the National Vaccine Advisory Committee (NVAC), continue to establish new priorities and assess existing ones as emergent issues unfold. It identifies gaps in national efforts in disease prevention, particularly those that can only be addressed by cross-agency collaboration, e.g., development and use of safe and effective vaccines.

Authorization: Such sums as necessary.

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