Lyme and Tick-Borne Disease Prevention, Education, and Research Act

Upon July 18, 2011 …

Lyme and Tick-Borne Disease Prevention, Education, and Research Act (PDF download, S. 1381)

Here’s the Bill in the House (PDF, H.R. 2557)

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S.1381

112TH CONGRESS
1ST SESSION S. 1381
To provide for the expansion of Federal efforts concerning the prevention,
education, treatment, and research activities related to Lyme and other
tick-borne diseases, including the establishment of a Tick-Borne Diseases
Advisory Committee.
IN THE SENATE OF THE UNITED STATES
JULY 18, 2011
Mr. BLUMENTHAL (for himself, Mr. REED, Mrs. GILLIBRAND, Mr. WHITEHOUSE,
Mr. LIEBERMAN, and Mr. FRANKEN) introduced the following
bill; which was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
A BILL
To provide for the expansion of Federal efforts concerning
the prevention, education, treatment, and research activities
related to Lyme and other tick-borne diseases, including
the establishment of a Tick-Borne Diseases Advisory
Committee.
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 Tick-Borne
5 Disease Prevention, Education, and Research Act of
6 2011’’.
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1 SEC. 2. FINDINGS.
2 Congress makes the following findings:
3 (1) Lyme disease is a common but frequently
4 misunderstood illness that, if not caught early and
5 treated properly, can cause serious health problems.
6 (2) Lyme disease is caused by the bacterium
7 Borrelia burgdorferi, which belongs to the class of
8 spirochetes, and is transmitted to humans by the
9 bite of infected black-legged ticks. Early signs of in10
fection may include a rash and flu-like symptoms
11 such as fever, muscle aches, headaches, and fatigue.
12 (3) Although Lyme disease can be treated with
13 antibiotics if caught early, the disease often goes un14
detected because it mimics other illnesses or may be
15 misdiagnosed.
16 (4) If an individual with Lyme disease does not
17 receive treatment, such individual can develop severe
18 heart, neurological, eye, and joint problems.
19 (5) Although Lyme disease accounts for 90 per20
cent of all vector-borne infections in the United
21 States, the ticks that spread Lyme disease also
22 spread other diseases, such as anaplasmosis,
23 babesiosis, and tularemia, and carry Bartonella and
24 other strains of Borrelia. Other tick species, such as
25 the aggressive lone star, spread ehrlichiosis, Rocky
26 Mountain spotted fever, and southern tick-associated
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1 rash illness (STARI). Multiple diseases in 1 patient
2 make diagnosis and treatment more difficult.
3 (6) The Centers for Disease Control and Pre4
vention reported more than 38,000 confirmed and
5 probable Lyme disease cases in 2009. Over the past
6 decade, the incidence of Lyme disease has increased
7 by 84 percent.
8 (7) According to the Centers for Disease Con9
trol and Prevention, from 1992 to 2006, the inci10
dence of Lyme disease was highest among children
11 aged 5 to 14 years of age.
12 (8) Persistence of symptomatology in many pa13
tients without reliable testing makes diagnosis and
14 treatment of patients more difficult.
15 SEC. 3. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVI16
SORY COMMITTEE.

17 (a) ESTABLISHMENT.—Not later than 180 days after
18 the date of the enactment of this Act, the Secretary of
19 Health and Human Services (referred to in this Act as
20 the ‘‘Secretary’’) shall establish within the Office of the
21 Secretary an advisory committee to be known as the Tick-
22 Borne Diseases Advisory Committee (referred to in this
23 section as the ‘‘Committee’’).
24 (b) DUTIES.—The Committee shall—
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1 (1) advise the Secretary and the Assistant Sec2
retary for Health regarding the manner in which
3 such officials can—
4 (A) ensure interagency coordination and
5 communication and minimize overlap regarding
6 efforts to address tick-borne diseases;
7 (B) identify opportunities to coordinate ef8
forts with other Federal agencies and private
9 organizations addressing such diseases;
10 (C) ensure interagency coordination and
11 communication with constituency groups;
12 (D) ensure that a broad spectrum of sci13
entific viewpoints are represented in public
14 health policy decisions and that information dis15
seminated to the public and physicians is bal16
anced; and
17 (E) advise relevant Federal agencies on
18 priorities related to Lyme and other tick-borne
19 diseases; and
20 (2) in coordination with relevant agencies with21
in the Department of Health and Human Services,
22 regularly review published public and private treat23
ment guidelines and evaluate such guidelines for ef24
fective representation of a wide diversity of views.
25 (c) MEMBERSHIP.—
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1 (1) APPOINTED MEMBERS.—
2 (A) IN GENERAL.—From among individ3
uals who are not officers or employees of the
4 Federal Government, the Secretary shall ap5
point to the Committee, as voting members, the
6 following:
7 (i) Not less than 4 members from the
8 scientific community representing the
9 broad spectrum of viewpoints held within
10 the scientific community related to Lyme
11 and other tick-borne diseases.
12 (ii) Not less than 2 representatives of
13 tick-borne disease voluntary organizations.
14 (iii) Not less than 2 health care pro15
viders, including not less than 1 full-time
16 practicing physician, with relevant experi17
ence providing care for individuals with a
18 broad range of acute and chronic tick19
borne diseases.
20 (iv) Not less than 2 patient represent21
atives who are individuals who have been
22 diagnosed with a tick-borne disease or who
23 have had an immediate family member di24
agnosed with such a disease.
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1 (v) At least 2 representatives of State
2 and local health departments and national
3 organizations that represent State and
4 local health professionals.
5 (B) DIVERSITY.—In appointing members
6 under this paragraph, the Secretary shall en7
sure that such members, as a group, represent
8 a diversity of scientific perspectives relevant to
9 the duties of the Committee.
10 (2) EX OFFICIO MEMBERS.—The Secretary
11 shall designate, as nonvoting, ex officio members of
12 the Committee, representatives overseeing tick-borne
13 disease activities from each of the following Federal
14 agencies:
15 (A) The Centers for Disease Control and
16 Prevention.
17 (B) The National Institutes of Health.
18 (C) The Agency for Healthcare Research
19 and Quality.
20 (D) The Food and Drug Administration.
21 (E) The Office of the Assistant Secretary
22 for Health.
23 (F) Such additional Federal agencies as
24 the Secretary determines to be appropriate.
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1 (3) CO-CHAIRPERSONS.—The Secretary shall
2 designate the Assistant Secretary of Health as the
3 co-chairperson of the Committee. The appointed
4 members of the Committee shall also elect a public
5 co-chairperson. The public co-chairperson shall serve
6 a 2-year term.
7 (4) TERM OF APPOINTMENT.—The term of
8 service for each member of the Committee appointed
9 under paragraph (1) shall be 4 years.
10 (5) VACANCY.—A vacancy in the membership of
11 the Committee shall be filled in the same manner as
12 the original appointment. Any member appointed to
13 fill a vacancy for an unexpired term shall be ap14
pointed for the remainder of that term. Members
15 may serve after the expiration of their terms until
16 their successors have taken office.
17 (d) MEETINGS.—The Committee shall hold public
18 meetings, except as otherwise determined by the Sec19
retary, after providing notice to the public of such meet20
ings, and shall meet at least twice a year with additional
21 meetings subject to the call of the co-chairpersons. Agenda
22 items with respect to such meetings may be added at the
23 request of the members of the Committee, including the
24 co-chairpersons. Meetings shall be conducted, and records
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1 of the proceedings shall be maintained, as required by ap2
plicable law and by regulations of the Secretary.
3 (e) REPORT.—Not later than 1 year after the date
4 of enactment of this Act, and annually thereafter, the
5 Committee, acting through the members representing the
6 Centers for Disease Control and Prevention and the Na7
tional Institutes of Health, shall submit a report to the
8 Secretary. Each such report shall contain, at a min9
imum—
10 (1) a description of the Committee’s functions;
11 (2) a list of the Committee’s members and their
12 affiliations; and
13 (3) a summary of the Committee’s activities
14 and recommendations during the previous year, in15
cluding any significant issues regarding the func16
tioning of the Committee.
17 (f) AUTHORIZATION OF APPROPRIATIONS.—For the
18 purpose of carrying out this section, there is authorized
19 to be appropriated such sums a may be necessary for each
20 of the fiscal years 2012 through 2016. Amounts appro21
priated under the preceding sentence shall be used for the
22 expenses and per diem costs incurred by the Committee
23 under this section in accordance with the Federal Advisory
24 Committee Act (5 U.S.C. App.), except that no voting
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1 member of the Committee shall be a permanent salaried
2 employee.
3 SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS,
4 SURVEILLANCE, PREVENTION, AND RE5
SEARCH OF LYME AND OTHER TICK-BORNE
6 DISEASES.
7 (a) IN GENERAL.—The Secretary, acting as appro8
priate through the Director of the Centers for Disease
9 Control and Prevention, the Director of the National Insti10
tutes of Health, the Commissioner of Food and Drugs,
11 and the Director of the Agency for Healthcare Research
12 and Quality, as well as additional Federal agencies as the
13 Secretary determines to be appropriate, and in consulta14
tion with the Tick-Borne Diseases Advisory Committee,
15 shall provide for—
16 (1) the conduct or support of the activities de17
scribed in subsection (b); and
18 (2) the coordination of all Federal programs
19 and activities related to Lyme disease and other
20 tick-borne diseases.
21 (b) ACTIVITIES.—The activities described in this sub22
section are the following:
23 (1) DEVELOPMENT OF DIAGNOSTIC TESTS.—
24 Such activities include—
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1 (A) the development of sensitive and more
2 accurate diagnostic tools and tests, including a
3 direct detection test for Lyme disease capable
4 of distinguishing active infection from past in5
fection;
6 (B) improving the efficient utilization of
7 diagnostic testing currently available to account
8 for the multiple clinical manifestations of both
9 acute and chronic Lyme disease; and
10 (C) providing for the timely evaluation of
11 promising emerging diagnostic methods.
12 (2) SURVEILLANCE AND REPORTING.—Such ac13
tivities include surveillance and reporting of Lyme
14 and other tick-borne diseases—
15 (A) to accurately determine the prevalence
16 of Lyme and other tick-borne diseases;
17 (B) to evaluate the feasibility of developing
18 a reporting system for the collection of data on
19 physician-diagnosed cases of Lyme disease that
20 do not meet the surveillance criteria of the Cen21
ters for Disease Control and Prevention in
22 order to more accurately gauge disease inci23
dence; and
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1 (C) to evaluate the feasibility of creating a
2 national uniform reporting system including re3
quired reporting by laboratories in each State.
4 (3) PREVENTION.—Such activities include—
5 (A) the provision and promotion of access
6 to a comprehensive, up-to-date clearinghouse of
7 peer-reviewed information on Lyme and other
8 tick-borne diseases;
9 (B) increased public education related to
10 Lyme and other tick-borne diseases through the
11 expansion of the Community Based Education
12 Programs of the Centers for Disease Control
13 and Prevention to include expansion of informa14
tion access points to the public;
15 (C) the creation of a physician education
16 program that includes the full spectrum of sci17
entific research related to Lyme and other tick18
borne diseases, and, in coordination with the
19 Advisory Committee established under section
20 3, the publication of an annual report that eval21
uates published guidelines and current research
22 available on Lyme disease, in order to best edu23
cate health professionals on the latest research
24 and diversity of treatment options for Lyme
25 disease; and
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1 (D) the sponsoring of scientific conferences
2 on Lyme and other tick-borne diseases, includ3
ing reporting and consideration of the full spec4
trum of clinically based knowledge, with the
5 first of such conferences to be held not later
6 than 24 months after the date of enactment of
7 this Act.
8 (4) CLINICAL OUTCOMES RESEARCH.—Such ac9
tivities include—
10 (A) the establishment of epidemiological
11 research objectives to determine the long-term
12 course of illness for Lyme disease; and
13 (B) determination of the effectiveness of
14 different treatment modalities by establishing
15 treatment outcome objectives.
16 (c) AUTHORIZATION OF APPROPRIATIONS.—
17 (1) IN GENERAL.—For the purposes of carrying
18 out this section, and for the purposes of providing
19 for additional research, prevention, and educational
20 activities for Lyme and other tick-borne diseases,
21 there is authorized to be appropriated such sums as
22 may be necessary for each of the fiscal years 2012
23 through 2016.
24 (2) ADDITIONAL AMOUNTS.—The authorization
25 of appropriations under this subsection is in addition
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1 to any other authorization of appropriations avail2
able for the purposes described in paragraph (1).
3 SEC. 5. REPORTS ON LYME AND OTHER TICK-BORNE DIS4
EASES.
5 (a) IN GENERAL.—Not later than 18 months after
6 the date of enactment of this Act, and annually thereafter,
7 the Secretary shall submit to Congress a report on the
8 activities carried out under this Act.
9 (b) CONTENT.—Reports under subsection (a) shall
10 contain—
11 (1) significant activities or developments related
12 to the surveillance, diagnosis, treatment, education,
13 or prevention of Lyme or other tick-borne diseases,
14 including suggestions for further research and edu15
cation;
16 (2) a scientifically qualified assessment of Lyme
17 and other tick-borne diseases, including both acute
18 and chronic instances, related to the broad spectrum
19 of empirical evidence of treating physicians, as well
20 as published peer reviewed data, that shall include
21 recommendations for addressing research gaps in di22
agnosis and treatment of Lyme and other tick-borne
23 diseases and an evaluation of treatment guidelines
24 and their utilization;
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1 (3) progress in the development of accurate di2
agnostic tools that are more useful in the clinical
3 setting for both acute and chronic disease;
4 (4) the promotion of public awareness and phy5
sician education initiatives to improve the knowledge
6 of health care providers and the public regarding
7 clinical and surveillance practices for Lyme disease
8 and other tick-borne diseases; and
9 (5) a copy of the most

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