I

107TH CONGRESS

1ST SESSION H. R. 2118

To establish a Tick-Borne Disorders Advisory Committee, and for other

purposes.

IN THE HOUSE OF REPRESENTATIVES

JUNE 8, 2001

Mr. GREENWOOD (for himself, Mrs. LOWEY, Mr. SIMMONS, Mr. BALDACCI,

Mr. MALONEY of Connecticut, Mr. KIRK, and Mr. LARSON of Connecticut) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To establish a Tick-Borne Disorders Advisory Committee,

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.

4 This Act may be cited as the ‘‘Lyme and Infectious

5 Disease Information and Fairness in Treatment (LIIFT)

6 Act’’.

7 SEC. 2. FINDINGS.

8 Congress makes the following findings:
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1 (1) Lyme disease is a common but frequently

2 misunderstood illness that, if not caught early and

3 treated properly, can cause serious health problems.

4 (2) Lyme disease is a bacterial infection that is

5 transmitted by a tick bite. Early signs of infection

6 may include a rash and flu-like symptoms such as

7 fever, muscle aches, headaches, and fatigue.

8 (3) Although Lyme disease can be treated with

9 antibiotics if caught early, the disease often goes un10 detected because it mimics other illnesses or may be

11 misdiagnosed.

12 (4) If an individual with Lyme disease does not

13 receive treatment, such individual can develop severe

14 heart, neurological, eye, and joint problems.

15 (5) Although Lyme disease accounts for 90 per16 cent of all vector-borne infections in the United

17 States, the ticks that spread Lyme disease also

18 spread other disorders, such as ehrlichiosis,

19 babesiosis, and other strains of Borrelia. All of these

20 diseases in 1 patient makes diagnosis and treatment

21 more difficult.

22 (6) According to the Centers for Disease Con23 trol and Prevention, cases of this tick-borne disease

24 have increased 25-fold since national surveillance of

25 it began in 1982. Although tick-borne disease cases
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1 have been reported in 49 States and the District of

2 Columbia, about 90 percent of the 15,000 cases have

3 been reported in the following 10 States: Con4 necticut, Pennsylvania, New York, New Jersey,

5 Rhode Island, Maryland, Massachusetts, Minnesota,

6 Delaware, and Wisconsin. Studies have shown that

7 the actual number of tick-borne disease cases are

8 approximately 10 times the amount reported due to

9 poor surveillance of the disease.

10 (7) According to studies, Lyme disease costs

11 our Nation between $1,000,000,000 to

12 $2,000,000,000 each year in increased medical

13 costs, lost productivity, prolonged pain and suf14 fering, unnecessary testing, and costly delays in di15 agnosis and inappropriate treatment.

16 (8) Patients with Lyme disease are increasingly

17 having difficulty obtaining diagnosis and treatment

18 for the disease, and being restored to health. Be19 cause of differences in medical and scientific opinion,

20 clinicians fear retaliation from insurance companies

21 and medical licensure boards based on their diag22 nosis and treatment of patients.

23 (9) A number of patients have difficulties in ob24 taining insurance coverage for treatment of Lyme

25 disease.
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1 (10) Despite 14 years of Federal funding, there

2 is still no test that can accurately determine infec3 tion so that proper treatment is adequately achieved.

4 Persistence of symptomatology in many patients

5 without reliable testing makes treatment of patients

6 more difficult.

7 (11) According to the General Accounting Of8 fice, over the past 10 years, the Centers for Disease

9 Control and Prevention has only increased its alloca10 tion for tick-borne research and education by 7 per11 cent, from $6,900,000 to $7,400,000. Over that

12 same period, the Centers for Disease Control and

13 Prevention’s expenditures for infectious diseases rose

14 318 percent, from $70,800,000 to $296,000,000.

15 (12) According to the General Accounting Of16 fice, over the past 10 years, the National Institutes

17 of Health have increased expenditures almost every

18 year, from $13,100,000 in fiscal year 1991 to

19 $26,000,000 in fiscal year 2000.

20 (13) The Lyme disease vaccine gained approval

21 from the Food and Drug Administration in 1998.

22 Since that time, the Food and Drug Administration

23 has received over 1,000 adverse event reports on the

24 vaccine, including reports of severe arthritic symp25 toms and even Lyme disease.
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1 SEC. 3. PURPOSE.

2 The purpose of this Act is to establish a Tick-Borne

3 Disorders Advisory Committee that will—

4 (1) provide a public voice regarding the direc5 tion and activities of the governmental agencies that

6 deal with Lyme disease in order to create a better

7 understanding and response by the government to

8 the public need regarding the disease;

9 (2) assure communication and coordination re10 garding tick-borne disorder issues between agencies

11 of the Department of Health and Human Services,

12 the biomedical community, and voluntary organiza13 tions concerned; and

14 (3) promote coordination of activities with the

15 Social Security Administration and Department of

16 Defense.

17 SEC. 4. TICK-BORNE DISORDERS ADVISORY COMMITTEE.

18 (a) ESTABLISHMENT OF COMMITTEE.—Not later

19 than 180 days after the date of enactment of this Act,

20 there shall be established an advisory committee to be

21 known as the Tick-Borne Disorders Advisory Committee

22 (referred to in this Act as the ‘‘Committee’’) organized

23 in the Office of the Secretary of Health and Human Serv24 ices.
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1 (b) DUTIES.—The Committee shall advise the Sec2 retary of Health and Human Services (in this Act referred

3 to as the ‘‘Secretary’’) regarding how to—

4 (1) provide public input on the public’s needs

5 regarding tick-borne disorders, so that government

6 agencies can more effectively plan and execute their

7 activities, thus improving the response to public

8 need;

9 (2) assure interagency coordination and com10 munication and minimize overlap regarding tick11 borne disorder issues;

12 (3) identify opportunities to coordinate efforts

13 with other Federal agencies and tick-borne disorder

14 national nonprofits; and

15 (4) develop informed responses to constituency

16 groups regarding the efforts and progress of the De17 partment of Health and Human Services.

18 (c) MEMBERSHIP.—

19 (1) IN GENERAL.—The Secretary shall appoint

20 11 voting members to the Committee of which—

21 (A) 3 shall be scientific community mem22 bers, including a researcher or public health of23 ficial, with demonstrated achievement in tick24 borne education, research, or advocacy, and ex25 tensive experience in working with a diverse
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1 range of patients, patient groups, and tick2 borne non-profits;

3 (B) 3 shall be representatives of national

4 tick-borne disorder voluntary organizations that

5 advocate for the public, as well as those suf6 fering from or providing medical care to pa7 tients with tick-borne disorders;

8 (C) 3 shall be clinicians with extensive ex9 perience in the diagnoses and treatment of tick10 borne diseases and with long-term experience,

11 independent of an individual practice or re12 search, in working with patients, patient

13 groups, and tick-borne non-profits; and

14 (D) 2 shall be patient representatives who

15 are individuals who have been diagnosed with

16 tick-borne illnesses or who have had an imme17 diate family member diagnosed with such ill18 ness.

19 (2) EX-OFFICIO REPRESENTATIVES.—The Com20 mittee shall have nonvoting ex-officio members of

21 which—

22 (A) 2 shall be from the Centers for Disease

23 Control and Prevention, 1 of which shall be

24 from the Viral and Rickettsial Diseases Division

25 of the Viral and Rickettsial Zoonoses Branch;
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1 (B) 1 shall be from the Food and Drug

2 Administration, Office of Special Health Issues,

3 in the Office of the Commissioner;

4 (C) 3 shall be from the National Institutes

5 of Health—

6 (i) 1 of which shall be from the Rocky

7 Mountain Laboratories Microscopy

8 Branch; and

9 (ii) 1 of which shall be a pathologist

10 with the National Institutes of Health who

11 has extensive experience in Lyme disease

12 research and a demonstrated ability to

13 work well with diverse groups in the pa14 tient, public, and health care provider com15 munities;

16 (D) 1 shall be from the Health Resources

17 and Services Administration;

18 (E) 1 shall be from the Social Security Ad19 ministration;

20 (F) 1 shall be from the Department of De21 fense, United States Army Center for Health

22 Promotion and Preventive Medicine;

23 (G) 1 shall be from the Health Care Fi24 nancing Administration; and
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1 (H) any additional members shall be added

2 from other Departments if necessary to aid the

3 Committee in its overall goals.

4 (d) CHAIRPERSON.—The Assistant Secretary for

5 Health (Department of Health and Human Services) shall

6 serve as the co-chairperson of the Committee with a public

7 co-chairperson chosen by the members described under

8 subsection (c)(1). The public co-chairperson shall serve a

9 2-year term and retain all voting rights.

10 (e) TERM OF APPOINTMENT.—All members shall be

11 appointed to serve on the Committee for 4 year terms.

12 (f) VACANCY.—If there is a vacancy on the Com13 mittee, such position shall be filled in the same manner

14 as the original appointment. Any member appointed to fill

15 a vacancy for an unexpired term shall be appointed for

16 the remainder of that term. Members may serve after the

17 expiration of their terms until their successors have taken

18 office.

19 (g) MEETINGS.—The Committee shall hold public

20 meetings, except as otherwise determined by the Sec21 retary, giving notice to the public of such, and meet at

22 least twice a year with additional meetings subject to the

23 call of the Chairperson. Agenda items can be added at the

24 request of the Committee members, as well as the Chair25 person. Meetings shall be conducted, and records of the
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1 proceedings kept as required by applicable laws and De2 partmental regulations.

3 (h) REPORTS.—

4 (1) IN GENERAL.—Not later than 18 months

5 after the date of enactment of this Act, and annually

6 thereafter, the Secretary shall submit to Congress a

7 report on the activities carried out under this Act.

8 (2) CONTENT.—Such reports shall describe—

9 (A) progress in the development of more

10 accurate diagnostic tools and tests;

11 (B) the development of the other seven

12 categories of case definitions;

13 (C) the promotion of public awareness and

14 physician education initiatives to improve the

15 knowledge of health care providers and the pub16 lic regarding the best and most effective meth17 ods to prevent, diagnose and treat tick-borne

18 disorders;

19 (D) the improved access to disability bene20 fits policies for people living with tick-borne dis21 orders; and

22 (E) recommendations for resolving dif23 ferences in medical and scientific opinion that

24 have resulted in the exceptional number of re-
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1 views of Lyme disease clinicians by insurance

2 companies and State medical licensure boards.

3 (i) AUTHORIZATION OF APPROPRIATIONS.—There is

4 authorized to be appropriated to carry out this Act,

5 $250,000 for each of the fiscal years 2002 and 2003.

6 SEC. 5. CENTERS FOR DISEASE CONTROL AND PREVEN7 TION.

8 There are authorized to be appropriated for the Cen9 ters for Disease Control and Prevention—

10 (1) $14,500,000 for each of the fiscal years

11 2002 and 2003 to enable such Centers to focus on

12 developing better diagnostic tools and tests, expand13 ing educational efforts regarding other tick-borne

14 disorders beyond Lyme disease, and re-educating cli15 nicians, medical licensure boards, and health care in16 surers about the inappropriate uses of the Lyme dis17 ease case surveillance definition in the diagnosis and

18 treatment of patients; and

19 (2) $7,000,000 for each of the fiscal years 2002

20 and 2003 to collaborate with the National Institutes

21 of Health, the Department of Defense, and other ap22 propriate agencies for further research on tick-borne

23 disorders, including the study of preventive methods

24 to decrease exposure to such disorders.
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1 SEC. 6. NATIONAL INSTITUTES OF HEALTH.

2 The Director of the National Institutes of Health, in

3 working with the Tick-Borne Disorders Advisory Com4 mittee established under this Act, and recognizing that

5 tick-borne disorders affect multiple systems of the body,

6 shall coordinate activities and research regarding tick7 borne diseases across Institutes to encourage collaborative

8 research.

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