retary is required to support such research by developing a national system for linking birth, infant death, and Medicaid data.

It is the committee's understanding that the structure for implementing such a system has already been developed and put into place by the National Center for Health Statistics (NCHS). Under the NCHS program, information found on birth certificates (such as infant birthweight, mother's receipt of prenatal care, and other risk factors) is linked with information recorded on infant death certificates. The purpose of this section of the committee's bill is to provide for the development of a national system that will allow HCFA Medicaid data to be integrated into the NHCS program.

Sec. 4308-Effective Dates

(a) In General. Except for the provisions relating to State applications for Title V funds (section 4303(a)) and to State and Secretarial Title V reports (section 4304), the amendments made under this subtitle of the committee bill are to apply to appropriations for fiscal years beginning with fiscal year 1990.

(b) Title V Applications and Reports. The amendments made under this subtitle relating to State applications for Title V funds (section 4303(a)) and to State and secretarial Title V reports (section 4304) are to apply for fiscal years beginning with fiscal year 1991.

SUBTITLE E-MISCELLANEOUS HEALTH-RELATED PROVISIONS

Sec. 4401-Congressional Access to Information

Section 301(j) of the Federal Food, Drug and Cosmetic Act prohibits the release of certain information. The committee's bill would amend that section to clarify that the section does not authorize the withholding of information from Congress. As amended, the section would simply restate the authority of the Congress to get information from the executive branch.

Sec. 4402-Vaccine Injury Compensation Technicals

The National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created a system for compensating children for injuries received from routine pediatric immunizations. The Vaccine Compensation Amendments of 1987 (Public Law 100-203) provided for a source of payment for such compensation and began the functioning of the system.

Since that time the U.S. Claims Court, which was designated as the forum for the resolution of these vaccine injury claims, has received more than a hundred petitions for compensation for injuries associated with vaccines administered before October 1, 1988, the effective date of the program. No claims for compensation for injuries associated with vaccines administered after the effective date have yet been received.

In addition, vaccine prices, which had skyrocketed as much as 2,000 percent before the enactment of the compensation system, have stabilized. Indeed, some manufacturers have demonstrated renewed interest in the U.S. vaccine market.

Several problems have, however, emerged in the system as it has been begun. Some are technical in nature and are easily corrected.

Others are problems created by unforeseen circumstance, such as the delay in initial receipt of claims. These difficulties, while not technical, are also easily corrected.

But most important are other, more fundamental problemsprincipally in the nature of the adjudication of petitions-which cannot be remedied by statutory change alone. Correction of these problems will require revision of the vaccine rules of the Claims Court and a re-dedication of all parties to the creation of an expeditious, non-adversarial, and fair system.

The committee proposes statutory amendments to address these difficulties with serious concern about the situation that has arisen since the receipt of the first claims. The Report accompanying the original Act makes clear that the committee intended a quick, flexible, and streamlined system. (H.Rept. No 99-908, 99th Cong., 2nd Sess., Sept. 26, 1986) That Report called for a compensation procedure that administered awards “quickly, easily, and with certainty and generosity." The system was intended to be “fair, simple, and easy to administer" and "to compensate persons with recognized vaccine injuries without requiring the difficult individual determinations of causation of injury." The powers of discovery within the proceeding were given over to the Master, with "neither party given power to cross-examine witnesses, file interrogatories, or take depositions" in order "to replace the usual rules of discovery in civil actions in Federal Courts."

...

The committee has come to understand that rather than establishing such a system, all participants have, to some degree, maintained their traditional adversarial litigation postures. The Claims Court has issued rules for vaccine proceedings that force proceedings to be formal and that virtually foreclose any opportunity for petitioners or respondents to proceed without litigators at their sides. Petitioners have failed to include adequate information in initial petitions and have pursued traditional rights of exclusion of evidence. Respondents have withheld sufficient personnel and administrative support and mounted defenses incompatible with a nofault system of compensation.

In proposing this legislation, the committee reiterates its intent that the vaccine injury compensation system be informal, flexible, and expeditious, and that all participants proceed accordingly. The re-invention of the adversarial process will serve neither to compensate injured children nor maintain the stability of the immunization programs of the United States.

The committee also reiterates its expectation that the Special Master and the powers given to the Master will allow the proceedings to be direct and straightforward. The Master should be able to require from petitioners and respondents information sufficient to evaluate the petition without resort to complex proceedings.

With such re-dedication to the original goals of the program, the committee anticipates that all participants will benefit. The system will provide compensation, eliminate the need for litigation, and assure the continued availability of and public confidence in immunizations in the United States.

(a) Reference. Section 4402(a) establishes that all references are made to the Public Health Service Act.

(b) Petitions. Paragraph (1) clarifies that certain information must be included in the original petition to the Claims Court in order to initiate a compensation proceeding. The committee has received reports from the Department of Health and Human Services (DHHS) and the Department of Justice (DOJ) that petitions have been accepted containing little or none of the information needed to review the claim for compensation. The committee has also heard from representatives of petitioners that the granting of the authority to initiate claims of compensation to the respondents would work a hardship on petitioners and could result in delay. The committee acknowledges that the current content required by all of Section 2111(c) could form the basis for delay. While the Court has been responsive in its promulgation of General Order 24, which allowed a suspension of proceedings while medical records were completed, the committee believes it necessary to set a clear standard of petition contents. The committee has, therefore, set forth a list of records (listed below at Paragraph (5) that must be included and has retained the broader list of records that should also be made available if needed for considering the petition for compensation. The committee anticipates that petitions for compensation can be reviewed by the Court for completeness under these standards and that the statutory time frame for compensation proceedings will commence from the receipt of a petition containing the specified materials. As specified below in Paragraph (4), materials not available to petitioners at the time of filing the petition may be described in lieu of provision, although the committee would expect respondents and the Court to evaluate the compensability of a petition on the basis of information received. The committee does not intend to preclude filings from being deemed adequate because of minor, inadvertent omissions or when material is unavailable to the petitioner.

Paragraph (2) provides technical clarification of the ability of a petitioner with a civil court action pending to enter the compensation system. Subparagraph (A) clarifies that a petitioner must petition to have his or her action dismissed and may not simply allow the action to lie dormant during the compensation proceeding. Subparagraph (B) clarifies that a plaintiff in such an action whose action is still pending may not enter the compensation system. In keeping with the purposes of the Act and this legislation, the committee intends that plaintiffs in pending actions who wish to have such actions dismissed without prejudice so that they may enter the compensation system be allowed to do so without prejudice or other disincentives.

Paragraph (3) amends the Act's restrictions on entry into the compensation system. The Act prohibits anyone who brings a civil action after the effective date (October 1, 1988) from entering the compensation system. The committee has received information, however, that the Claims Court did not accept petitions for compensation until November 15, 1988. Persons who chose between a civil action and a petition during that 6-week period did not, therefore, have a true choice. Rather than statutorily barring such persons from the system, the committee intends to allow such persons to petition to have their civil actions dismissed (as provided in Section 2111(a)(5)) and to enter into the compensation system.

Paragraph (4) inserts a new paragraph to allow petitions to be brought by persons who had appeals of civil actions pending on the effective date of the Act. Under the Act, plaintiffs in a civil action who were denied damages before October 1, 1988, are allowed to file petitions for compensation. Similarly, plaintiffs in a civil action pending on October 1, 1988, may petition to have such action dismissed before judgment and may file petitions for compensation. Conversely, plaintiffs who have civil actions pending on October 1, 1988 and do not have their civil actions dismissed may not file a compensation petition. Finally, if a person brings a civil action after deadline (originally October 1, 1988; amended by Paragraph (3) above to be November 15, 1988), he or she may not file a compensation petition. In crafting these original transition rules, the committee did not anticipate the situation in which a person had an appeal of a civil action pending on October 1, 1988, and did not have such action dismissed. The legislation would amend the Act to allow such a person to file a petition for compensation if damages were ultimately denied in the civil action (whether in the original trial verdict or in the appeals of the trial verdict).

Paragraph (5) adds a new paragraph to the Act to specify (as described above at Paragraph (1) the minimum supportive materials that must be supplied in order to initiate a compensation proceeding. Minimum materials include maternal and infant doctor and hospital records and, if applicable, autopsy results. The legislation would also add a new paragraph to allow petitioners to submit an identification of records that are unavailable (and the reasons for their unavailability) in lieu of submitting the materials. The committee intends for the parties and the Court to construe this provision broadly so as to require the submission of a meaningful file of information but not so as to hold up proceedings unreasonably if petitioner makes a good faith effort to supply records and name unavailable ones. The committee intends that petitioner also make every effort to continue to obtain unavailable records and that petitioners submit records as they become available.

Paragraph (6) adds a new subsection to Section 2111(c) of the Act regarding the timing of submissions and the bifurcation of proceedings. The committee intends that the Special Master and the Court make efforts to allow compensation proceedings to begin on the issue of whether compensation is to be awarded without requiring petitioners to submit information that is needed only to decide how much compensation is to be awarded and without requiring respondents to evaluate such information, and the committee expects that the Master will initially restrict inquiry to the question of whether to award compensation. The committee believes that this structure, similar to that established for vaccine civil actions by the Act, will serve petitioners, respondents, and the Court well by allowing all participants to avoid needless documentation of issues that may never arise.

Paragraph (7) is a technical amendment.

Paragraph (8) makes a conforming amendment to make a reference parallel to that established by Paragraph (2) above.

(c) Special Masters. Section 4402(c) revises the provisions of the Act regarding the authorities of Special Masters. The Act provides the Master with powers to require such evidence as he or she may

need to determine whether compensation should be awarded and, if so, the amount of compensation to be awarded. The Act, however, provided these powers in a non-parallel fashion, giving all authorities in determining whether to award and not explicitly providing some in determining how much the award should be and setting a standard of "appropriate" in one authority and "reasonable and necessary" in others.

The legislation revises these authorities to make them parallel and consistent. All authority granted to the Master may be exercised in the determination of whether compensation should be awarded and in the determination of how much the award should be. All authority is to be used when reasonable and necessary to achieve these results.

In addition to these changes, the legislation also makes two substantive changes in the authorities of the Masters. First, the legislation has limited hearings to those requested by one of the parties and found to be reasonable and necessary by the Master. The committee does not intend to restrict the Master's ability to gather relevant oral and written materials and has made no similar limitation on the authority to require evidence, information, or testimony. The committee is, however, concerned that the routine use of hearings as a method of gathering such information may produce unnecessary formality in the gathering of such information and may tend to create an adversary process rather than a no-fault compensation proceeding.

Second, the legislation amends the Act to require-rather than simply permit-the Master to prepare and submit proposed findings of fact and conclusions of law to the Court.

The committee reiterates its concern that these authorities not be used to re-create an adversarial process before the Special Masters. The system is intended to allow the proceedings to be conducted in what has come to be known as an "inquisitorial" format, with the Master conducting discovery (as needed), cross-examination (as needed), and investigation. As was stated in the Report accompanying the original Act, "In order to expedite the proceedings, the power of the Special Master is intended to replace the usual rules of discovery in civil actions in Federal courts." The parties are, of course, free to request that the Master develop the record by obtaining necessary information. (For example, the Master might be asked to subpoena further records.)

The committee also believes that the Masters may, in some cases, be well-advised to retain independent medical experts to assist in the evaluation of medical issues associated with eligibility for compensation and the amounts of compensation to be awarded. In cases where petitioners assert a theory of vaccine causation of injury and respondents claim other causation, the Master may find it most expeditious to receive outside advice rather than attempt a full adversarial proceeding on the questions of causation. The Act authorizes such action by the Master and the committee would encourage its use as appropriate.

(d) De Novo Proceedings. Section 4402(d) clarifies that the Claims Court, in acting upon the recommendations of the Master, may receive further evidence in addition to that contained in the Master's report. The committee recognizes that the regrettable lack of repre