I

103D CONGRESS

1ST SESSION H. R. 1640

To provide for the immunization of all children in the United States against

vaccine preventable diseases, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

APRIL 1, 1993

Mr. WAXMAN (for himself, Mr. DINGELL, Ms. SLAUGHTER, Mrs. CLAYTON,

Mr. SYNAR, Mr. RICHARDSON, Mr. ROWLAND, Mr. SLATTERY, Mr.

WASHINGTON, Mr. BROWN of Ohio, Mr. KREIDLER, Ms. PELOSI, Mr.

MCDERMOTT, and Mr. WYDEN) introduced the following bill; which was

referred jointly to the Committees on Energy and Commerce and Ways

and Means

MAY 13, 1993

Additional sponsors: Mr. KLEIN, Mr. STUDDS, Mr. SWIFT, and Mr. RANGEL

OCTOBER 21, 1993

Additional sponsors: Mr. GUTIERREZ, Mr. BERMAN, and Mr. BISHOP

A BILL

To provide for the immunization of all children in the United

States against vaccine preventable diseases, and for other

purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND REFERENCES IN THE ACT.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Comprehensive Child Immunization Act of 1993’’.
2

•HR 1640 SC2

1 (b) REFERENCES IN ACT.—The amendments in this

2 Act apply to the Public Health Service Act unless other3 wise specifically stated.

4 SEC. 2. PURPOSE OF THE ACT.

5 The purpose of this Act is to ensure that all children

6 in the United States are protected against vaccine prevent7 able infectious diseases at the earliest appropriate age; to

8 establish a program to purchase vaccines and to distribute

9 them to all willing health care providers; to establish a

10 tracking program to monitor which children need to be

11 immunized and the results of immunizing children; and

12 to extend the National Childhood Vaccine Injury Com13 pensation Program.

14 SEC. 3. FINDINGS OF THE CONGRESS.

15 (a) CURRENT CIRCUMSTANCES.—The Congress

16 makes the following findings as to current circumstances:

17 (1) Immunizations are among the most cost-ef18 fective means of preventing disease.

19 (2) Although Federal support for childhood im20 munizations has been in existence since 1962, the

21 full potential of immunizations remains to be

22 achieved. Enactment and enforcement of school im23 munization requirements have resulted in excellent

24 immunization levels (96 percent or greater) in school

25 children. However, approximately 80 percent of vac-
3

•HR 1640 SC2

1 cine doses should be received before the second

2 birthday in order to protect children during their

3 most vulnerable periods. Many children do not re4 ceive their basic immunizations by that time, and in

5 some inner cities as few as 10 percent of 2-year olds

6 have received a complete series. This low level of im7 munizations has been reflected in recent years by

8 outbreaks of measles among inadequately immunized

9 pre-school children.

10 (3) The ‘‘infrastructure’’ to immunize children

11 is both public and private. There is considerable evi12 dence to suggest that the ‘‘private’’ infrastructure

13 has been damaged over the past decade as a result

14 of the significantly increased cost of privately pur15 chased vaccine.

16 (4) In some cases costs have risen over a ten17 year period by nearly 1400 percent, with private

18 rates exceeding the rates paid for like vaccines in

19 some other industrialized nations by over 2500 per20 cent.

21 (5) High costs, coupled with the growing num22 ber of uninsured and underinsured families, mean

23 that private physicians are increasingly referring

24 their private patients to overburdened public clinics

25 for vaccinations.
4

•HR 1640 SC2

1 (6) Eleven States now have programs that pro2 vide vaccines without charge to both public and pri3 vate health care providers. Some of these programs

4 have been in place for more than 20 years, with vir5 tually no burden or controversy. Other States that

6 have sought to establish such programs have been

7 denied additional discounted vaccines by manufac8 turers.

9 (7) There is no evidence to suggest that a nego10 tiated price that takes into account the reasonable

11 cost of production, marketing, research and develop12 ment, and distribution will not fairly compensate

13 vaccine manufacturers. Indeed, a recent report by

14 the Congressional Office of Technology Assessment

15 supports the proposition that negotiated rates can

16 assure fair compensation while holding down costs.

17 (8) The Secretary of Health and Human Serv18 ices has experience negotiating vaccine purchase

19 through the Federal contract system.

20 (9) The National Vaccine Injury Compensation

21 Program is an essential element in a comprehensive

22 immunization program and should be strengthened

23 and applied to additional vaccines recommended for

24 universal use in children.
5

•HR 1640 SC2

1 (b) NEEDED ACTIONS.—The Congress makes the fol2 lowing findings as to actions needed to ensure the full im3 munization of children at the earliest appropriate age:

4 (1) The Federal Government should purchase

5 and provide free of charge to health care providers

6 vaccines recommended for universal use in children.

7 This action will not only remove financial barriers to

8 immunization that impede children from being vac9 cinated at the appropriate time, but will also facili10 tate development of an immunization tracking sys11 tem.

12 (2) The Federal Government and the States

13 should develop linked registries to track the immuni14 zation status of the Nation’s children. The registries

15 should have the capability to notify parents of inad16 equately immunized children of the need to protect

17 their children with specific vaccines.

18 (2) The coordinated national information and

19 education outreach initiative inaugurated by the De20 partment of Health and Human Services in 1993

21 should be continued. This program brings needed in22 formation to parents and health care providers and

23 focuses their attention on the importance of achiev24 ing the full immunization of children at the earliest

25 appropriate age.
6

•HR 1640 SC2

1 (4) Private and public health insurers should be

2 encouraged to provide adequate reimbursement for

3 the administration of childhood vaccines.

4 (5) Volunteer community activities to promote

5 the full immunization of children at the earliest ap6 propriate age should be encouraged.

7 (6) The National Vaccine Injury Compensation

8 Program should be extended and improved. Vaccine

9 information materials should be simplified to ensure

10 that parents can understand the benefits and risks

11 of vaccines.

12 SEC. 4. FEDERAL PURCHASE AND TRACKING OF CHILD13 HOOD VACCINES.

14 (a) IN GENERAL.—Title XXI of the Public Health

15 Service Act is amended by adding at the end a new Sub16 title 3 as follows:

17 ‘‘Subtitle 3—Federal Purchase and Tracking of

18 Childhood Vaccines.

19 ‘‘SEC. 2141. PURCHASE BY THE SECRETARY.

20 ‘‘(a) RECOMMENDED CHILDHOOD VACCINES.—The

21 Secretary shall promulgate not later than October 1, 1994

22 (and periodically thereafter as the Secretary determines

23 appropriate in view of advances in scientific understanding

24 in the areas of immunization and disease control), a list

25 of vaccines that provide immunization against naturally
7

•HR 1640 SC2

1 occurring infectious diseases and are recommended for

2 universal use in children. The Secretary shall concurrently

3 promulgate recommendations regarding the appropriate

4 dosage for each vaccine and the age or ages of children

5 at which each vaccine should be administered.

6 ‘‘(b) CONSULTATION.—The Secretary shall, in order

7 to determine the amounts of vaccines to be purchased

8 under subsection (c), consult with Federal agencies in9 volved in research regarding, or the regulation, procure10 ment, or distribution of, recommended childhood vaccines.

11 The consultation may be effected through the establish12 ment of a Vaccine Requirements Panel, composed entirely

13 of representatives of the relevant Federal agencies, or

14 through such other means as the Secretary finds appro15 priate.

16 ‘‘(c) PURCHASE OF VACCINE.—

17 ‘‘(1) IN GENERAL.—The Secretary shall peri18 odically purchase recommended childhood vaccines in

19 amounts necessary for—

20 ‘‘(A) distribution under section 2142 to

21 meet anticipated needs for the routine and

22 catch-up immunization of children in the Unit23 ed States in accordance with the recommenda24 tions promulgated under subsection (a) and

25 foreseeable outbreak control activities, and
8

•HR 1640 SC2

1 ‘‘(B) maintenance of a reserve supply suf2 ficient for a six-month period.

3 The Secretary shall negotiate a reasonable price for

4 such vaccine that takes fairly into account the var5 ious costs described in paragraph (3).

6 ‘‘(2) PRE-PROCUREMENT CONSULTATIONS.—

7 The Secretary may consult with representatives of

8 State governments, experts in vaccine delivery,

9 health care providers, and others with expertise in

10 purchasing and pricing pharmaceutical products

11 prior to soliciting bids or offers for recommended

12 childhood vaccines under this subtitle.

13 ‘‘(3) COST OR PRICING DATA.—A manufacturer

14 of recommended childhood vaccine shall provide cost

15 or pricing data in support of its proposed price at

16 the time it responds to a procurement instituted by

17 the Secretary under this section. A manufacturer

18 shall also provide such data upon the request of the

19 Secretary whenever the Secretary determines that

20 contract modifications are necessary. This informa21 tion shall include data related to the research and

22 development costs of the vaccine, production costs,

23 handling, shipping, and other costs associated with

24 delivering vaccine to health care providers and

25 States in accordance with the distribution plan of
9

•HR 1640 SC2

1 the Secretary (or a State, as the case may be) under

2 section 2142, marketing costs, profit levels sufficient

3 to encourage future investments in research and de4 velopment of new or improved vaccines, the cost of

5 maintaining adequate capacity for outbreak control,

6 and any other data the Secretary determines are

7 relevant.

8 ‘‘(4)(A) CONFIDENTIALITY OF DATA.—Informa9 tion provided to the Secretary under paragraph (3)

10 shall be treated as trade secret or confidential infor11 mation subject to section 552(b)(4) of title 5, United

12 States Code and section 1905 of title 18, United

13 States Code and shall not be revealed to any person

14 other than those authorized by the Secretary in con15 nection with carrying out official duties under this

16 section.

17 ‘‘(B) Subparagraph (A) does not authorize the

18 withholding of information provided under para19 graph (3) from any duly authorized subcommittee or

20 committee of the Congress. If the Secretary provides

21 such information to any subcommittee or committee,

22 the Secretary shall give written notice of this fact to

23 the manufacturer that provided the information.
10

•HR 1640 SC2

1 ‘‘(C) The Secretary shall establish written pro2 cedures to ensure the confidentiality of information

3 provided under paragraph (3).

4 ‘‘(5) PROHIBITION ON ADDITIONAL SHIPPING

5 OR HANDLING CHARGES.—Each contract for the

6 purchase of recommended childhood vaccine under

7 this section shall contain a provision by which the

8 manufacturer agrees to ship or otherwise arrange

9 for the delivery of such vaccine in accordance with

10 the distribution plan of the Secretary (or a State, as

11 the case may be) without imposing any additional

12 charge for shipping, handling, or any other cost on

13 the health care provider or State to which the

14 vaccine is shipped or delivered.

15 ‘‘(6) MULTIPLE SUPPLIERS.—To ensure a reli16 able and adequate supply of vaccine, the Secretary

17 may enter into contracts with multiple manufactur18 ers of the same recommended childhood vaccine,

19 under such terms and conditions and utilizing such

20 procurement processes as the Secretary deems ap21 propriate.

22 ‘‘(7) REPORTING REQUIREMENTS.—Each con23 tract for the purchase of recommended childhood

24 vaccine under this section shall require the manufac25 turer to report to the Secretary or the Secretary’s
11

•HR 1640 SC2

1 designee, at intervals determined by the Secretary,

2 data regarding the destination of vaccine by lot

3 number, and any other information the Secretary

4 may require.

5 ‘‘SEC. 2142. DISTRIBUTION OF VACCINES.

6 ‘‘(a) IN GENERAL.—The Secretary shall provide for

7 the distribution without charge of recommended childhood

8 vaccines purchased under this subtitle to health care pro9 viders who serve children and who (1) are members of a

10 uniformed service, or are officers or employees of the Unit11 ed States, (2) are health centers (as defined in section

12 2144(2)), (3) provide services under section 503 of the

13 Indian Health Care Improvement Act or pursuant to a

14 contract under section 102 of the Indian Self-Determina15 tion Act, or (4) are located in a State receiving a grant

16 under section 2143(b). The Secretary may provide for

17 such distribution through any State that receives a grant

18 under section 2143(b).

19 ‘‘(b) DUTIES OF HEALTH CARE PROVIDERS.—

20 ‘‘(1) FREE PROVISION TO CHILDREN.—A health

21 care provider receiving vaccine under this section

22 may use such vaccine only for administration to chil23 dren and may not impose a charge for such vaccine.

24 A provider may impose a fee for the administration

25 of such vaccine, except that a provider may not deny
12

•HR 1640 SC2

1 a child a vaccination due to inability of the child’s

2 parent or guardian to pay an administration fee.

3 ‘‘(2) REPORTING REQUIREMENTS.—A health

4 care provider receiving vaccine under this section

5 shall report to the applicable State registry operated

6 pursuant to a grant under section 2143(b) (or to the

7 Secretary if there is no such State registry) the data

8 described in section 2143(b)(1) for each dose of vac9 cine administered to a child. The provider shall addi10 tionally report to such State registry any occurrence

11 reported to the Secretary pursuant to section

12 2125(b). The provider shall also provide periodic es13 timates of the provider’s future dosage needs for rec14 ommended childhood vaccine distributed under this

15 section. All reports shall be made with such fre16 quency and in such detail as the Secretary may

17 prescribe.

18 ‘‘SEC. 2143. TRACKING OF CHILDHOOD IMMUNIZATIONS.

19 ‘‘(a) NATIONAL TRACKING SYSTEM.—The Secretary

20 shall establish a national system to track the immuniza21 tion status of children. The system shall be designed to

22 obtain timely information about the immunization status

23 of individual children and to monitor immunization rates

24 at the State and local levels. In addition, the system shall

25 be designed to monitor the safety and efficacy of vaccines,
13

•HR 1640 SC2

1 and to provide for the coordination of vaccine administra2 tion information with the information on adverse events

3 reported under section 2125(b). In addition, the Secretary

4 is authorized, in the case of inadequately immunized chil5 dren in States not receiving grants under subsection (b),

6 to notify the parents or guardians of those children of the

7 need to protect their children with specific vaccine.

8 ‘‘(b) STATE REGISTRY GRANTS.—

9 ‘‘(1) IN GENERAL.—The Secretary may make

10 grants to States to establish and operate State im11 munization tracking registries. A State receiving a

12 grant under this section shall maintain a registry

13 that includes the following information for each child

14 living within the State:

15 ‘‘(A) type and lot number of each rec16 ommended childhood vaccine administered after

17 September 30, 1996,

18 ‘‘(B) identification of the health care pro19 vider administering such vaccine,

20 ‘‘(C) address and other demographic data

21 needed to find the child,

22 ‘‘(D) notations of any adverse events asso23 ciated with each immunization, and

24 ‘‘(E) such other information as the Sec25 retary may prescribe.
14

•HR 1640 SC2

1 ‘‘(2) GRANT CONDITIONS.—A State, as a condi2 tion of receiving a grant under this subsection, shall

3 comply with the following requirements:

4 ‘‘(A) The State registry shall provide for

5 entry of the birth of each infant within the

6 State within six weeks following the birth, and

7 for timely entry thereafter of all information re8 ceived from health care providers pursuant to

9 section 2142(b)(2).

10 ‘‘(B) The State shall provide for the shar11 ing of appropriate information from the State’s

12 registry, including immunization status and re13 ports of adverse reactions, with health care pro14 viders who offer immunizations, for the purpose

15 of achieving the full immunization of all chil16 dren in accordance with the recommendations

17 of the Secretary under section 2141(a).

18 ‘‘(C) The State shall provide for notifica19 tion to the parents or guardian of an inad20 equately immunized child of the need to protect

21 the child with specific vaccine.

22 ‘‘(D) The State shall provide for the co23 ordination and exchange of information with

24 other State registries to allow the tracking of
15

•HR 1640 SC2

1 the immunization status of children changing

2 state of residence.

3 ‘‘(E) The State shall periodically furnish to

4 the Secretary, at such times and in such form

5 as the Secretary may prescribe, information

6 contained in the State registry.

7 ‘‘(F) In designing its registry, the State

8 shall adhere to tracking models and systems

9 specifications prescribed by the Secretary for

10 the purpose of ensuring the mutual compatibil11 ity of the data systems and electronic informa12 tion technology utilized by the Secretary and

13 the various States in carrying out activities

14 under this subtitle.

15 ‘‘(G) The State shall monitor and enforce

16 compliance by health care providers with the re17 quirements of section 2142(b). The State shall

18 establishes procedures satisfactory to the Sec19 retary for terminating from participation in the

20 recommended childhood vaccine distribution

21 program any health care provider who fails to

22 comply with the requirements of section

23 2142(b), and for reinstating such provider to

24 program participation upon receiving from such

25 provider (i) the reports necessary to make cur-
16

•HR 1640 SC2

1 rent and complete the information that would

2 have been furnished to the State registry be3 tween the dates of the provider’s termination

4 and reinstatement, and (ii) satisfactory assur5 ances regarding the provider’s future compli6 ance.

7 ‘‘(H) If a State distributes recommended

8 childhood vaccines within the State on behalf of

9 the Secretary pursuant to section 2142(a), the

10 State shall compile data, including lot numbers,

11 on the vaccines distributed to each health care

12 provider, and shall furnish such data to the

13 Secretary in such form and at such intervals as

14 the Secretary may prescribe.

15 ‘‘(3) APPLICATIONS.—A State shall submit an

16 application for a grant under subsection (b) in such

17 form and containing such information as the Sec18 retary may prescribe. The application shall include a

19 description of the methods by which the State will

20 comply with the requirements of paragraph (2). The

21 application shall also include the assurances required

22 by paragraph (4) and a description of the expenses

23 that the State will incur in carrying out its respon24 sibilities under the grant.
17

•HR 1640 SC2

1 ‘‘(4) A State submitting an application for a

2 grant under this section shall provide assurances

3 satisfactory to the Secretary that—

4 ‘‘(A) the State’s tracking registry will be

5 fully operational not later than October 1,

6 1996;

7 ‘‘(B) the State’s tracking registry will ad8 here to any tracking models and systems speci9 fications prescribed by the Secretary pursuant

10 to paragraph (2)(F); and

11 ‘‘(C) as appropriate, the State is making

12 satisfactory and timely progress toward achiev13 ing the conditions described in subparagraphs

14 (A) and (B).

15 ‘‘(5) ALLOWABLE USES OF GRANT FUNDS.—A

16 State may use funds from a grant awarded under

17 this subsection for reasonable costs associated with

18 the development and operation of its registry, includ19 ing computer needs, technical assistance and train20 ing, education of health care providers, personnel

21 costs, travel expenses, and other appropriate activi22 ties.

23 ‘‘(6) STATE REPORTS TO THE SECRETARY.—A

24 State shall submit periodic reports to the Secretary

25 on the operation of the State’s registry and other ac-
18

•HR 1640 SC2

1 tivities under this subtitle. The reports shall be in

2 such form, contain such information, and be submit3 ted at such intervals as the Secretary may prescribe.

4 ‘‘(c) USE AND DISCLOSURE OF PERSONAL INFORMA5 TION.—

6 ‘‘(1) Notwithstanding any other provision of

7 this subtitle, no personally-identifiable information

8 relating to a child who receives recommended child9 hood vaccine under this subtitle or to the parent or

10 guardian of such a child that is collected or main11 tained by the National Tracking System established

12 under subsection (a), or a State immunization track13 ing registry established under subsection (b), may be

14 used or disclosed by any holder of such information

15 except as permitted by this subsection.

16 ‘‘(2) Information described in paragraph (1)

17 may be used or disclosed, without the consent of the

18 individual to whom it refers, or of the parent or

19 guardian of such individual, for—

20 ‘‘(A) the tracking of children’s immuniza21 tion status, and other purposes directly related

22 to the health of the children being tracked and

23 of their families;

24 ‘‘(B) oversight, audit, and evaluation of

25 the immunization delivery and tracking activi-
19

•HR 1640 SC2

1 ties, and the enforcement of the provisions of

2 this subtitle;

3 ‘‘(C) activities relating to establishing and

4 maintaining a safe and effective supply of rec5 ommended childhood vaccine (including activi6 ties to carry out part C of subtitle 2);

7 ‘‘(D) processing of insurance claims for

8 payment for vaccine administration (but only to

9 the extent necessary to process a claim);

10 ‘‘(E) administration of the National Vac11 cine Injury Compensation Program under sub12 title 2; or

13 ‘‘(F) health research, including research on

14 the delivery and financing of health services.

15 ‘‘(3) Information described in paragraph (1)

16 may be used or disclosed with the written authoriza17 tion of the individual to whom it refers, or the par18 ent or guardian of such individual, and must, upon

19 the request of such individual, or parent or guard20 ian, be provided in writing to the individual.

21 ‘‘(4) The Secretary is authorized to issue regu22 lations governing the use, maintenance, and disclo23 sure, by any holder of information described in para24 graph (1), including appropriate administrative,
20

•HR 1640 SC2

1 technical and physical safeguards to ensure that only

2 authorized persons have access to the information.

3 ‘‘(5) ANY PERSON WHO KNOWINGLY—

4 ‘‘(A) uses or discloses information in viola5 tion of this subsection, or

6 ‘‘(B) requests or obtains any information

7 in violation of this subsection, and offers or

8 provides anything of value in exchange for the

9 provision of the information,

10 shall be fined as prescribed by title 18, United

11 States Code, or imprisoned not more than 3 years,

12 or both.’’

13 ‘‘(d) AUTHORITY TO USE SOCIAL SECURITY NUM14 BERS.—

15 ‘‘(1) IN GENERAL.—Notwithstanding section

16 205 of the Social Security Act or any other provision

17 of law, the Secretary and States receiving grants

18 under subsection (b) may utilize the social security

19 number of a child or of a parent or guardian of the

20 child for purposes of identification of a child in any

21 registry established under this section, and may re22 quire a child’s parent or guardian to furnish such

23 number (in any case where such a number has been

24 assigned by the Social Security Administration) as a
21

•HR 1640 SC2

1 condition of the child receiving recommended child2 hood vaccine under this subtitle.

3 ‘‘(2) AUTHORITY TO REDISCLOSE.—Notwith4 standing section 205(c)(2)(C)(vii)(I) of the Social

5 Security Act, a social security number obtained in

6 connection with activities under this subtitle may be

7 redisclosed if such redisclosure is otherwise in ac8 cordance with subsection (c) of this section.

9 ‘‘(e) REPORTS BY SECRETARY TO THE CONGRESS.—

10 The Secretary shall submit a report to Congress not later

11 than January 1, 1996, and biennially thereafter on the

12 operation of the national tracking system and the State

13 registries.

14 ‘‘SEC. 2144. DEFINITIONS.

15 ‘‘For purposes of this subtitle—

16 ‘‘(1) The term ‘recommended childhood vaccine’

17 is a vaccine on the list promulgated by the Secretary

18 pursuant to section 2141(a).

19 ‘‘(2) The term ‘health center’ means—

20 ‘‘(A) a federally qualified health center, as

21 defined in section 1905(l)(2) of the Social Secu22 rity Act; or

23 ‘‘(B) a public or nonprofit private entity

24 receiving Federal funds under—
22

•HR 1640 SC2

1 ‘‘(i) section 340A (relating to grants

2 for health services for residents of public

3 housing), or

4 ‘‘(ii) section 501(a)(2) of the Social

5 Security Act (relating to special projects of

6 regional and national significance).

7 ‘‘SEC. 2145. APPROPRIATIONS AND AUTHORIZATION.

8 ‘‘(a) VACCINE PURCHASES.—There shall be made

9 available for expenditure by the Secretary, out of the Com10 prehensive Child Immunization Account in the Treasury

11 established pursuant to section 6 of the Comprehensive

12 Child Immunization Act of 1993, such amounts as are re13 quired to carry out subsections (b) and (c) of section 2141

14 for fiscal year 1995 and for each fiscal year thereafter

15 during which such subsections remain in effect.

16 ‘‘(b) OTHER ACTIVITIES.—For carrying out this sub17 title other than subsections (b) and (c) of section 2141,

18 there are authorized to be appropriated $152,000,000 for

19 fiscal year 1995, $125,000,000 for fiscal year 1996, and

20 $35,000,000 for each of fiscal years 1997, 1998, and

21 1999.

22 ‘‘(c) In addition to other amounts available for carry23 ing out title III and subtitle 1 of title XXI, there are au24 thorized to be appropriated for fiscal years 1993 and 1994

25 such additional sums as may be necessary for activities
23

•HR 1640 SC2

1 related to and preparatory to implementation of this sub2 title, including infrastructure improvements, information

3 and education, surveillance and response, and vaccine

4 safety.’’.

5 (b) REQUIREMENTS CONCERNING IMMUNIZATIONS

6 OF CHILDREN UNDER STATE MEDICAID PROGRAMS.—

7 (1) Coverage of immunizations under early and

8 periodic screening, diagnosis, and testing

9 (EPSDT).—Section 1905(r)(1)(B)(iii) of the Social

10 Security Act is amended to read as follows:

11 ‘‘(iii) appropriate immunizations ac12 cording to the recommendations of the

13 Secretary promulgated under section

14 2141(a) of the Public Health Service Act,

15 taking into account the health history of

16 the individual,’’.

17 (2) REIMBURSEMENT RATES FOR IMMUNIZA18 TIONS WITH RECOMMENDED CHILDHOOD VAC19 CINES.—Section 1902(a)(13) of the Social Security

20 Act is amended—

21 (A) by striking ‘‘and’’ and the end of sub22 paragraph (E),

23 (B) by inserting ‘‘and’’ at the end of sub24 paragraph (F), and
24

•HR 1640 SC2

1 (C) by adding at the end the following new

2 subparagraph:

3 ‘‘(G) that payments to providers shall in4 clude amounts, as appropriate, as reimburse5 ment for administration of recommended child6 hood vaccines (as defined in section 2144 of the

7 Public Health Service Act) in accordance with

8 section 1905(r)(i)(B)(iii);’’.

9 (3) EFFECTIVE DATE.—(A) IN GENERAL.—Ex10 cept as provided in subparagraph (B), the amend11 ments made by this subsection shall be effective with

12 respect to calendar quarters beginning on or after

13 October 1, 1994.

14 (B) EXTENSION FOR STATE LAW AMEND15 MENT.—In the case of a State plan under title XIX

16 of the Social Security Act which the Secretary of

17 Health and Human Services determines requires

18 State legislation in order for the plan to meet the

19 additional requirements imposed by the amendments

20 made by paragraph (2), the State plan shall not be

21 regarded as failing to comply with the requirements

22 of such title solely on the basis of its failure to meet

23 these additional requirements before the first day of

24 the first calendar quarter beginning after the close

25 of the first regular session of the State legislature
25

•HR 1640 SC2

1 that begins after the date of enactment of this Act.

2 For purposes of the previous sentence, in the case

3 of a State that has a two-year legislative session,

4 each year of such session shall be deemed to be a

5 separate regular session of the State legislature.

6 (c) TERMINATION OF PURCHASE PROGRAM.—Sub7 sections (b) and (c) of section 2141 of the Public Health

8 Service Act (as added by subsection (a) of this section)

9 shall cease to be in effect beginning on such date as may

10 be prescribed in Federal law providing for immunization

11 services for all children as part of a broad-based reform

12 of the national health care system.

13 SEC. 5. NATIONAL VACCINE INJURY COMPENSATION PRO14 GRAM AMENDMENTS.

15 (a) USE OF VACCINE INJURY COMPENSATION TRUST

16 FUND.—

17 (1) Section 9510(c)(1) of the Internal Revenue

18 Code of 1986 is amended by striking out ‘‘, and be19 fore October 1, 1992,’’.

20 (2) Section 6601(r) of the Omnibus Budget

21 Reconciliation Act of 1989 is amended by striking

22 out ‘‘$2,500,000 for each of fiscal years 1991 and

23 1992’’ each place it appears and inserting in lieu

24 thereof ‘‘$3,000,000 for fiscal year 1994 and each

25 fiscal year thereafter’’ (in three places).
26

•HR 1640 SC2

1 (b) PERMANENT EXTENSION OF AUTHORITY TO IM2 POSE TAXES FOR THE VACCINE INJURY COMPENSATION

3 TRUST FUND.—

4 (1) PERMANENT EXTENSION OF TAX.—Section

5 4131(c) of the Internal Revenue Code of 1986 is re6 pealed.

7 (2) REINSTATEMENT OF TAX.—The tax im8 posed by section 4131 of the Internal Revenue Code

9 of 1986 is hereby reinstated effective April 1, 1993.

10 (c) AMENDMENT OF VACCINE INJURY TABLE.—(1)

11 Section 2114 is amended by adding at the end thereof the

12 following new subsection:

13 ‘‘(f) ADDITION OF VACCINES TO TABLE.—The Vac14 cine Injury Table set out in subsection (a) also includes

15 any recommended childhood vaccine included in the list

16 promulgated by the Secretary under section 2141(a). The

17 Secretary may modify the Table with respect to any vac18 cine added by operation of the preceding sentence only in

19 accordance with subsection (c). For purposes of section

20 2116(b), the addition of a vaccine to the Table by oper21 ation of the subsection shall constitute a revision of this

22 Table.’’.

23 (2) Section 2116(b) is amended by striking out ‘‘such

24 person may file’’ and inserting in lieu thereof ‘‘or to sig25 nificantly increase the likelihood of obtaining compensa-
27

•HR 1640 SC2

1 tion, such person may, notwithstanding section

2 2111(b)(2), file’’.

3 (d) EXTENSION OF TIME FOR DECISION.—Section

4 2112(d)(3)(D) is amended by striking out ‘‘540 days’’ and

5 inserting in lieu thereof ‘‘30 months (but for no more than

6 6 months at a time)’’.

7 (e) SIMPLIFICATION OF VACCINE INFORMATION MA8 TERIALS.—

9 (1) Section 2126 (b) is amended—

10 (A) by striking out ‘‘by rule’’ in the matter

11 preceding paragraph (1);

12 (B) by striking out, in paragraph (1), ‘‘,

13 opportunity for a public hearing, and 90’’ and

14 inserting in lieu thereof ‘‘and 30’’; and

15 (C) by striking out, in paragraph (2), ‘‘,

16 appropriate health care providers and parent

17 organizations’’.

18 (2) Section 2126(c) is amended—

19 (A) by inserting ‘‘shall be based on avail20 able data and information,’’ immediately after

21 ‘‘such materials’’ in the matter preceding para22 graph (1), and

23 (B) by striking out paragraphs (1) through

24 (10) and inserting in lieu thereof the following:
28

•HR 1640 SC2

1 ‘‘(1) a concise description of the bene2 fits of the vaccine,

3 ‘‘(2) a concise description of the risks

4 associated with the vaccine, and

5 ‘‘(3) a statement of the availability of

6 the National Vaccine Injury Compensation

7 Program.’’.

8 (3) Subsections (a) and (d) of section 2126 are

9 each amended by inserting ‘‘or to any other individ10 ual’’ immediately after ‘‘to the legal representative

11 of any child’’.

12 (4) Subsection (d) of section 2126 is amend13 ed—

14 (A) by striking out all after ‘‘subsection

15 (a),’’ the second place it appears in the first

16 sentence and inserting in lieu thereof ‘‘supple17 mented with visual presentations or oral expla18 nations, in appropriate cases.’’, and

19 (B) by striking ‘‘or other information’’ in

20 the last sentence.

21 SEC. 6. FUNDING FOR CHILD IMMUNIZATION PROGRAM.

22 (a) MAINTENANCE OF SEPARATELY IDENTIFIABLE

23 ACCOUNT.—There shall be established in the Treasury of

24 the United States the Comprehensive Child Immunization

25 Account for the purpose of funding activities under sub-
29

•HR 1640 SC2

1 sections (b) and (c) of section 2141 of the Public Health

2 Service Act.

3 (b) SOURCE OF RECEIPTS.—Receipts shall be cred4 ited to the Account established under subsection (a) as

5 may be provided in Federal law.

Æ

HR 1640 SC2——2

HR 1640 SC2——3