[Congressional Record Volume 144, Number 140 (Thursday, October 8, 1998)]
[Senate]
[Pages S11980-S11981]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DASCHLE (for himself and Mr. Johnson):
  S. 2585. A bill to amend the Public Health Service Act to eliminate a 
threshold requirement relating to unreimbursable expenses for 
compensation under the National Vaccine Injury Compensation Program; to 
the Committee on Finance.


     Amendment to the National Vaccine Injury Compensation Program

  Mr. DASCHLE. Mr. President, I am pleased to introduce, with my friend 
and colleague from South Dakota, Tim Johnson, legislation to make 
several common-sense changes to the National Vaccine Injury 
Compensation Program. This bill removes an unintended and unjustified 
barrier blocking certain children from qualifying for the compensation 
program. It also makes the necessary changes to allow new drugs to be 
incorporated into the program, including the newly-approved rotavirus 
vaccine.
  The Vaccine Act dates back to 1986, when Congress determined that a 
no-fault alternative to the tort system would best accommodate the dual 
objectives of ensuring proper compensation to victims of vaccine 
injuries and fostering continued development and broad-scale 
availability of lifesaving vaccines.
  Through the Vaccine Act, children seriously injured by a childhood 
vaccine can receive compensation for medical care, custodial or 
residential care, lifetime lost earnings, pain and suffering, and 
emotional distress--benefits comparable to those awarded through the 
judicial tort system.
  Tragically, some children have been unfairly denied the right to 
petition for benefits under the program because they did not incur 
$1,000 or more in out-of-pocket medical expenses.
  At first glance, the eligibility requirement of at least $1,000 in 
out-of-pocket medical expenses may seem like a reasonable way of 
deterring individuals from petitioning for benefits if they lack a 
material claim to compensation. In reality, however, the absence of 
out-of-pocket health care expenses does not mean a child has not been 
seriously injured, nor does it suggest they have access to other 
sources for recoupment of the losses their injury has exacted.
  Many children, including the children of military personnel, Native 
American children covered by the Indian Health Service, children with 
Medicaid coverage, and children covered under employer-sponsored health 
plans with minimal cost-sharing requirements, do not have high out-of-
pocket health care costs.
  While health insurance may remove the burden of high medical bills, 
it does not replace lost income or cover custodial and residential 
care. It cannot compensate for the toll these injuries have taken and 
will take on the lives of these children. Health care costs are just 
one component of the compensation for which a seriously injured child 
is eligible.
  I know of a Native American child in my own state who was profoundly 
injured after receiving a diptheria-pertussis-tetanus vaccination. 
Within hours of receiving the shot, this five-month-old child had a 
seizure and suffered severe brain damage because of the defective 
pertussis component of the shot.
  The doctors tell us that his disabilities will, throughout his 
lifetime, preclude this little boy from having a normal life. He will 
never live or work independently. But, because he receives health care 
from the Indian Health Service (IHS), he is not eligible for any 
benefits under the vaccine compensation program. Not only is this child 
barred from compensation for lost income and emotional trauma, he is 
denied financial support for his injury-related assisted living needs.
  Through legislation intended to foster continued improvements in 
public health, the federal government has obstructed this child's right 
to sue vaccine manufacturers. But the program's gate-keeping mechanism 
is off the mark. What we are saying--however unintentionally--to this 
particular child and others like him is: ``Fend for yourself.'' To deny 
this child the benefits available to other injured children is 
indefensible.
  The Vaccine Act contains other safeguards to prevent unjustified 
requests for compensation. For example, no benefits claim is accepted 
without a thorough review and significant medical proof of severe 
injury directly related to a childhood vaccination. The $1,000 
threshold is unnecessary.
  Senator Johnson and I certainly are not alone in calling for the 
repeal of the $1,000 threshold. In fact, we are in very good company. 
The Advisory Commission on Childhood Vaccines voted unanimously to 
recommend elimination of the $1,000 threshold.
  I hope this Congress will seize the opportunity to reconcile the 
intended and actual standards of fairness by which the National Vaccine 
Compensation Program fulfills its role in the public health system. In 
so doing, we will make a tremendous difference in the lives of children 
in desperate need of our support.
  There is also a disconnect between the Act's intended consequences 
and its actual effect in regard to enrollment of new vaccines. Several 
vaccines that have been approved by the Food and Drug Administration 
and have met the standards established in the Vaccine Act are still not 
fully integrated into the program.
  There are currently several vaccines Congress has approved for 
taxation and inclusion in the Vaccine Compensation Program that, 
because of a technical error in the legislation, were not authorized as 
compensable. This bill will fully integrate those vaccines into the 
program, and it will ensure that all new vaccines will be automatically 
compensable once the tax is levied.
  In addition, it initiates the 75 cents-per-vaccination tax on the 
rotavirus vaccine, which will ensure compensation for recipients of 
that vaccine. The rotavirus vaccine was approved by the FDA in August 
of this year to protect against rotavirus gastroenteritis, which causes 
about 125 deaths and 50,000 hospitalizations per year among infants in 
the United States. Initiation of the excise tax will help protect the 4 
million children who are expected to receive the vaccine annually.
  The changes proposed in this bill are not controversial. They are 
common-sense, and they are overdue. When Congress established the 
Vaccine Compensation Program, its intent was to protect the rights of 
victims without jeopardizing an invaluable weapon against childhood 
illnesses. The underpinning of this program is fairness, a standard 
that cannot be met until Congress makes these important changes.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.

[[Page S11981]]

  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2585

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Vaccine Injury Compensation 
     Program Modification Act''.

     SEC. 2. ELIMINATION OF THRESHOLD REQUIREMENT OF 
                   UNREIMBURSABLE EXPENSES.

       Section 2111(c)(1)(D)(i) of the Public Health Service Act 
     (42 U.S.C. 300aa-11(c)(1)(D)(i)) is amended by striking ``and 
     incurred unreimbursable expenses due in whole or in part to 
     such illness, disability, injury, or condition in an amount 
     greater than $1,000''.

     SEC. 3. INCLUSION OF ROTAVIRUS GASTROENTERITIS AS A TAXABLE 
                   VACCINE.

       (a) In General.--Section 4132(1) of the Internal Revenue 
     Code of 1986 (defining taxable vaccine) is amended by adding 
     at the end the following new subparagraph:
       ``(K) Any vaccine against rotavirus gastroenteritis.''.
       (b) Effective Date.--
       (1) Sales.--The amendment made by this section shall apply 
     to sales after the date of the enactment of this Act.
       (2) Deliveries.--For purposes of paragraph (1), in the case 
     of sales on or before the date of the enactment of this Act 
     for which delivery is made after such date, the delivery date 
     shall be considered the sale date.

     SEC. 4. VACCINE INJURY COMPENSATION TRUST FUND.

       (a) Amendments Related to Section 904 of 1997 Act.--
       (1) Paragraph (1) of section 9510(c) of the 1986 Code is 
     amended to read as follows:
       ``(1) In general.--Amounts in the Vaccine Injury 
     Compensation Trust Fund shall be available, as provided in 
     appropriation Acts, only for--
       ``(A) the payment of compensation under subtitle 2 of title 
     XXI of the Public Health Service Act (as in effect on August 
     6, 1997) for vaccine-related injury or death with respect to 
     any vaccine--
       ``(i) which is administered after September 30, 1988, and
       ``(ii) which is a taxable vaccine (as defined in section 
     4132(a)(1)) at the time the vaccine was administered, or
       ``(B) the payment of all expenses of administration 
     incurred by the Federal Government in administering such 
     subtitle.''.
       (2) Section 9510(b) of the 1986 Code is amended by adding 
     at the end the following new paragraph:
       ``(3) Limitation on transfers to vaccine injury 
     compensation trust fund.--No amount may be appropriated to 
     the Vaccine Injury Compensation Trust Fund on and after the 
     date of any expenditure from the Trust Fund which is not 
     permitted by this section. The determination of whether an 
     expenditure is so permitted shall be made without regard to--
       ``(A) any provision of law which is not contained or 
     referenced in this title or in a revenue Act, and
       ``(B) whether such provision of law is a subsequently 
     enacted provision or directly or indirectly seeks to waive 
     the application of this paragraph.''.
       (b) Effective Date.--The amendments made by this section 
     shall take effect as if included in the provisions of the 
     Taxpayer Relief Act of 1997 to which they relate.
                                 ______