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Saturday, June 18, 2005

HR 2877 - ALERT Act (Introduced in House)

109th CONGRESS

1st Session

H . R . 2877

To provide for the expansion and intensification of efforts for prevention, education, and research activities with respect to Lyme and other tick-borne diseases, including the establishment of a Tick-Borne Diseases Advisory Committee.

IN THE HOUSE OF REPRESENTATIVES

June 14, 2005


Mr. SMITH of New Jersey (for himself, Mr. GILCHREST, and Mr. PLATTS) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To provide for the expansion and intensification of efforts for prevention, education, and research activities with respect to Lyme and other tick-borne diseases, including the establishment of a Tick-Borne Diseases Advisory Committee.

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 `Act for Lyme Education and Research and Tick-Borne Diseases' or the `ALERT Act'.

SEC. 2. FINDINGS.

The Congress finds as follows:

(1) The United States alone has 82 species of ticks causing at least 10 major diseases, which are Lyme disease, anaplasmosis, human monocytic ehrlichosis, babesiosis, tick paralysis, relapsing fever, tularemia, Rocky Mountain spotted fever, Colorado tick fever, and southern tick-associated rash illness (STARI) (also known as Masters' disease). New tick species continue to be classified, and new diseases continue to emerge.

(2) Lyme disease is the most prevalent vector-borne disease in the United States today.

(3) According to the Centers for Disease Control and Prevention, only 10 percent of cases that meet its surveillance criteria are reported; thus, an estimated 200,000 to 240,000 new cases occur each year.

(4) Tests to detect serum antibodies for Lyme disease can yield a high number of false-positive and false-negative results. False-negative results may delay diagnosis and treatment, which may lead to chronic, more debilitating, persistent and costly disease.

(5) The diagnosis and treatment picture of Lyme disease and other tick-borne diseases can be complicated because more than one tick-borne disease can be acquired by the bite of the same tick.

(6) If it is not diagnosed and treated early, Lyme disease can lead to chronic illness and can affect every system in the body, including the central nervous system. Diagnosis is complicated because Lyme disease can mimic diseases such as meningitis, multiple sclerosis, brain tumor, Alzheimer's disease, Parkinson's disease, ALS, and psychiatric illness.

(7) According to a study by the National Institutes of Health, patients with persistent Lyme disease suffer physical disability equivalent to that of congestive heart failure, severe pain equivalent to post-operative pain, and profound fatigue similar to multiple sclerosis.

SEC. 3. GOALS.

(a) Five-Year Plan- The Secretary of Health and Human Services, acting as appropriate through the Director of the Agency for Healthcare Research and Quality, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health, shall establish a plan that, for the five fiscal years following the date of the enactment of this Act, provides for activities to be carried out during such fiscal years toward achieving the goals described in paragraphs (1) through (4) of subsection (b). The plan shall, as appropriate to such goals, provide for the coordination of programs and activities regarding Lyme disease and other tick-borne diseases that are conducted or supported by the Federal Government.

(b) Goals-

(1) FIRST GOAL: DIAGNOSTIC TEST- The first goal under subsection (a) shall be--

(A) to develop a sensitive and definitive test for the diagnosis of Lyme disease capable of distinguishing active infection from past infection;

(B) to improve efficient utilization of diagnostic testing currently available to account for the multiple clinical manifestations of both acute and chronic Lyme disease; and

(C) to provide for the rapid evaluation and adoption of emerging test methods.

(2) SECOND GOAL: SURVEILLANCE AND REPORTING OF LYME DISEASE AND OTHER TICK-BORNE DISEASES- The second goal under subsection (a) shall be--

(A) to accurately determine the prevalence of Lyme disease and other tick-borne diseases in the United States;

(B) to evaluate the feasibility of developing a reporting system for collecting data on physician-diagnosed cases that do not meet the surveillance criteria of the Centers for Disease Control and Prevention in order to more accurately gauge disease outbreaks and incidence; and

(C) to evaluate the feasibility of creating a national uniform reporting system to include mandatory reporting by laboratories in each State.

(3) THIRD GOAL: PREVENTION OF LYME DISEASE AND OTHER TICK-BORNE DISEASES AND COMPLICATIONS DUE TO DELAYED DIAGNOSIS AND TREATMENT- The third goal under subsection (a) shall be--

(A) for the Director of the Agency for Healthcare Research and Quality, in coordination with the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, to provide and promote access to a comprehensive, up-to-date clearinghouse of peer-reviewed information on Lyme and other tick-borne diseases;

(B) to provide for public education by expanding the Community Based Education Programs of the Centers for Disease Control and Prevention to include expansion of information access points available to the public;

(C) to create a physician education program that includes the full spectrum of scientific research on Lyme and other tick-borne diseases; and

(D) for the Secretary to sponsor scientific conferences on Lyme and other tick-borne diseases, including reporting and consideration of the full spectrum of clinically-based knowledge, with the first of such conferences held within 24 months after the date of the enactment of this Act and with further conferences held as determined appropriate by the Secretary.

(4) FOURTH GOAL: CLINICAL OUTCOMES RESEARCH- The fourth goal under subsection (a) shall be--

(A) to establish epidemiological research goals to determine the long term course of illness for Lyme disease; and

(B) to establish treatment outcomes research goals to determine the effectiveness of different treatment modalities.

SEC. 4. STUDY BY INSTITUTE OF MEDICINE.

(a) In General- Not later than 90 days after the date of the enactment of this Act, the Secretary shall request the Institute of Medicine, National Academies of Sciences, to enter into an agreement with the Secretary for the conduct of a study of chronic Lyme disease. Such study shall include a systematic assessment of empirical evidence of treating physicians, as well as published peer-reviewed data, and shall include recommendations for addressing research gaps in diagnosis and treatment of chronic Lyme disease and an assessment of treatment guidelines, such as those of the Infectious Diseases Society of America and those of the International Lyme and Associated Diseases Society, and their utilization.

(b) Report- The Secretary shall ensure that, not later than one year after the Secretary enters into the agreement under subsection (a), a report providing the results of the study under such subsection is submitted to the Secretary and the Tick-Borne Diseases Advisory Committee under section 6.

SEC. 5. INCREASED FUNDING FOR RESEARCH AND EDUCATION.

(a) In General- For the purpose of providing for research and educational activities for Lyme and other tick-borne diseases, and for carrying out efforts to prevent Lyme and other tick-borne diseases, there is authorized to be appropriated $20,000,000 for each of the fiscal years 2006 through 2010. Such authorization is in addition to other authorizations of appropriations that are available for such purpose.

(b) Study- Of the amounts appropriated under subsection (a), the Secretary shall reserve not more than $500,000 for conducting the study under section 4.

SEC. 6. ESTABLISHMENT OF TICK-BORNE DISEASES ADVISORY COMMITTEE.

(a) Establishment- Not later than 180 days after the date of the enactment of this Act, the Secretary shall establish within the Office of the Secretary an advisory committee to be known as the Tick-Borne Diseases Advisory Committee (referred to in this section as the `Committee').

(b) Duties- The Committee shall advise the Secretary and the Assistant Secretary for Health regarding the manner in which such officials can--

(1) ensure interagency coordination and communication and minimize overlap regarding efforts to address tick-borne diseases;

(2) identify opportunities to coordinate efforts with other Federal agencies and private organizations addressing such diseases;

(3) ensure interagency coordination and communication with constituency groups;

(4) ensure that a broad spectrum of scientific viewpoints are represented in public health policy decisions and that information disseminated to the public and physicians is balanced; and

(5) advise relevant Federal agencies on priorities.

(c) Membership-

(1) APPOINTED MEMBERS-

(A) IN GENERAL- From among individuals who are not officers or employees of the Federal Government, the Secretary shall appoint to the Committee, as voting members, an equal number of individuals from each of the groups described in clauses (i) through (v), as follows:

(i) Scientific community members representing the broad spectrum of viewpoints held within the scientific community, such as members of the International Lyme and Associated Diseases Society.

(ii) Representatives of tick-borne disease voluntary organizations.

(iii) Health care providers who are full-time practicing physicians providing care for acute and chronic tick-borne diseases.

(iv) Patient representatives who are individuals who have been diagnosed with tick-borne diseases or who have had an immediate family member diagnosed with such a disease.

(v) Representatives of State and local health departments and national organizations that represent State and local health professionals.

(B) CERTAIN REQUIREMENT- In appointing members under subparagraph (A), the Secretary shall ensure that such members, as a group, represent a diversity of scientific perspectives relevant to the duties of the Committee.

(2) EX OFFICIO MEMBERS- The Secretary shall designate the Assistant Secretary for Health as a nonvoting, ex officio member of the Committee. In addition, the Secretary shall designate, as nonvoting members of the Committee, representatives from each of the following Federal agencies:

(A) The Agency for Healthcare Research and Quality.

(B) The National Institutes of Health.

(C) The Centers for Disease Control and Prevention.

(D) The Food and Drug Administration.

(E) The Office of the Assistant Secretary for Health.

(F) Such additional Federal agencies as the Secretary determines to be appropriate.

(3) CHAIR- The members of the Committee appointed under paragraph (1) shall select an individual from among such members to serve as the chair of the Committee. The term for serving as the chair shall be two years.

(4) TERM OF APPOINTMENT- The term of service for each member of the Committee, other than the Assistant Secretary for Health, shall be four years.

(5) VACANCY- A vacancy in the membership of the Committee shall be filled in the same manner as the original appointment. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term. Members may serve after the expiration of their terms until their successors have taken office.

(d) Meetings- The Committee shall hold public meetings, except as otherwise determined by the Secretary, giving notice to the public of such, and meet at least twice a year with additional meetings subject to the call of the Chair. Agenda items may be added at the request of members of the Committee, including the Chairs. Meetings shall be conducted, and records of the proceedings shall be maintained, as required by applicable law and by regulations of the Secretary.

(e) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $250,000 for each of the fiscal years 2006 and 2007. Amounts appropriated under the preceding sentence shall be used for the expenses and per diem costs incurred by the Committee under this section in accordance with the Federal Advisory Committee Act, except that no voting member of the Committee shall be a permanent salaried employee.

SEC. 7. REPORTS.

(a) In General- Not later than 24 months after the date of the enactment of this Act, and annually thereafter, the Secretary shall submit to the Congress a report on the activities carried out under this Act.

(b) Content- Reports under subsection (a) shall describe--

(1) progress in the development of accurate diagnostic tools and treatment modalities and their use in clinical settings;

(2) the promotion of public awareness and physician education initiatives to improve the knowledge of health care providers and the public regarding clinical and surveillance practices for Lyme disease and other tick-borne diseases; and

(3) other significant activities relating to surveillance, diagnosis, treatment, or prevention of Lyme and other tick-borne diseases.

SEC. 8. DEFINITION.

For purposes of this Act, the `Secretary' means the Secretary of Health and Human Services.

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