[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2059 Reported in Senate (RS)]






                                                       Calendar No. 483
107th CONGRESS
  2d Session
                                S. 2059

   To amend the Public Health Service Act to provide for Alzheimer's 
               disease research and demonstration grants.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 21, 2002

 Ms. Mikulski (for herself, Mr. Kennedy, Mr. Hutchinson, Mr. Dodd, Mr. 
Torricelli, Mr. Miller, and Mr. Cochran) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                              July 3, 2002

  Reported under the authority of the order of the Senate of June 26, 
                2002, by Mr. Kennedy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to provide for Alzheimer's 
               disease research and demonstration grants.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Alzheimer's Disease 
Research, Prevention, and Care Act of 2002''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress makes the following findings:</DELETED>
        <DELETED>    (1) Alzheimer's disease is a disorder that 
        destroys cells in the brain. The disease is the leading cause 
        of dementia, a condition that involves gradual memory loss, 
        decline in the ability to perform routine tasks, 
        disorientation, difficulty in learning, loss of language 
        skills, impairment of judgment, and personality changes. As the 
        disease progresses, people with Alzheimer's disease become 
        unable to care for themselves. The loss of brain cells 
        eventually leads to the failure of other systems in the 
        body.</DELETED>
        <DELETED>    (2) In the United States, 4,000,000 people have 
        Alzheimer's disease and 19,000,000 people say that they have a 
        family member with the disease. By 2050, 14,000,000 people in 
        the United States will have Alzheimer's disease unless science 
        finds a way to prevent or cure the disease.</DELETED>
        <DELETED>    (3) One in 10 people over the age of 65, and 
        nearly half of those over the age of 85 have Alzheimer's 
        disease. Younger people also get the disease.</DELETED>
        <DELETED>    (4) The Alzheimer's disease process may begin in 
        the brain as many as 20 years before the symptoms of 
        Alzheimer's disease appear. A person will live an average of 8 
        years and as many as 20 once the symptoms of Alzheimer's 
        disease appear.</DELETED>
        <DELETED>    (5) The average lifetime cost of Alzheimer's 
        disease, per person, is $174,000. The total annual cost of 
        Alzheimer's disease care in the United States today is not less 
        than $100,000,000,000.</DELETED>
        <DELETED>    (6) In 2000, medicare alone spent $31,900,000,000 
        for the care of individuals with Alzheimer's disease and this 
        amount is projected to increase to $49,300,000,000 in 
        2010.</DELETED>
        <DELETED>    (7) Forty-nine percent of medicare beneficiaries 
        who have Alzheimer's disease also receive medicaid. Of the 
        total population dually eligible for medicare and medicaid, 22 
        percent have Alzheimer's disease.</DELETED>
        <DELETED>    (8) Seven in 10 people with Alzheimer's disease 
        live at home. While almost 75 percent of home care is provided 
        by family and friends, the average annual cost of paid care for 
        people with Alzheimer's disease at home is $12,500.</DELETED>
        <DELETED>    (9) At least half of all nursing home residents 
        have Alzheimer's disease or another dementia. The average 
        annual cost of Alzheimer's disease nursing home care is $42,000 
        but exceeds $70,000 in some areas. Medicaid pays nearly half of 
        the total nursing home bill and helps 2 out of 3 residents pay 
        for their care. Medicaid expenditures for nursing home care for 
        people with Alzheimer's disease are estimated to increase from 
        $18,200,000,000 in 2000 to $33,000,000,000 in 2010.</DELETED>
        <DELETED>    (10) In fiscal year 2002, the Federal Government 
        will spend an estimated $585,000,000 on Alzheimer's disease 
        research, a modest investment when compared with the annual 
        $100,000,000,000 cost of the disease. If science can find a way 
        to delay the onset of Alzheimer's disease symptoms for even 5 
        years, our Nation will save at least $50,000,000,000 in annual 
        health and long term care costs.</DELETED>
        <DELETED>    (11) Seventy percent of people with Alzheimer's 
        disease live at home where families provide at least 75 percent 
        of their care.</DELETED>
        <DELETED>    (12) A study commissioned by the United Hospital 
        Fund estimated that the annual value of this informal care 
        system is $196,000,000,000. Family caregiving comes at enormous 
        physical, emotional, and financial sacrifice, putting the whole 
        system at risk.</DELETED>
        <DELETED>    (13) One in 8 Alzheimer's disease caregivers 
        becomes ill or injured as a direct result of caregiving. One in 
        3 uses medication for problems related to caregiving. Older 
        caregivers are 3 times more likely to become clinically 
        depressed than others in their age group.</DELETED>
        <DELETED>    (14) Elderly spouses strained by caregiving are 63 
        percent more likely to die during a given 4-year period than 
        other spouses their age.</DELETED>
        <DELETED>    (15) Three of 4 caregivers are women. One in 3 has 
        children or grandchildren under the age of 18 living at home. 
        Caregiving leaves them less time for other family members and 
        they are much more likely to report family conflicts because of 
        their caregiving role.</DELETED>
        <DELETED>    (16) Most Alzheimer's disease caregivers work 
        outside the home before beginning their caregiving careers, but 
        caregiving forces them to miss work, cut back to part-time, 
        take less demanding jobs, choose early retirement, or give up 
        work altogether. As a result, in 2002, Alzheimer's disease will 
        cost American business an estimated $36,500,000,000 in lost 
        productivity, as well as an additional $24,600,000,000 in 
        business contributions to the total cost of care.</DELETED>

<DELETED>SEC. 3. PURPOSE OF THE NATIONAL INSTITUTE ON AGING.</DELETED>

<DELETED>     Section 443 of the Public Health Service Act (42 U.S.C. 
285e) is amended by inserting ``, Alzheimer's disease and related 
disorders,'' after ``aging process''.</DELETED>

<DELETED>SEC. 4. ALZHEIMER'S DISEASE PREVENTION INITIATIVE.</DELETED>

<DELETED>    Section 444 of the Public Health Service Act (42 U.S.C. 
285e-1) is amended--</DELETED>
        <DELETED>    (1) in subsection (d), by inserting ``and 
        training'' after ``conduct research''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(e) The Director of the Institute shall, in 
collaboration with the directors of the other relevant institutes and 
centers of the National Institutes of Health, and with volunteer 
organizations and other stakeholders, undertake an Alzheimer's Disease 
Prevention Initiative to--</DELETED>
        <DELETED>    ``(1) accelerate the discovery of new risk and 
        protective factors for Alzheimer's disease;</DELETED>
        <DELETED>    ``(2) rapidly identify candidate diagnostics, 
        therapies, or preventive interventions or agents for clinical 
        investigation and trials relating to Alzheimer's 
        disease;</DELETED>
        <DELETED>    ``(3) support or undertake such investigations and 
        trials; and</DELETED>
        <DELETED>    ``(4) implement effective prevention and treatment 
        strategies, including strategies to improve patient care and 
        alleviate caregiver burdens relating to Alzheimer's 
        disease.''.</DELETED>

<DELETED>SEC. 5. ALZHEIMER'S DISEASE CLINICAL RESEARCH.</DELETED>

<DELETED>    (a) Clinical Research.--Section 445F of the Public Health 
Service Act (42 U.S.C. 285e-8) is amended to read as follows:</DELETED>

<DELETED>``SEC. 445F. ALZHEIMER'S DISEASE COOPERATIVE STUDY 
              GROUP.</DELETED>

<DELETED>    ``(a) In General.--The Director of the Institute, pursuant 
to subsections (d) and (e) of section 444, shall establish and support 
a national consortium for cooperative clinical research regarding 
Alzheimer's disease. Such a consortium shall--</DELETED>
        <DELETED>    ``(1) investigate therapies, interventions, and 
        agents to detect, treat, slow the progression of, or prevent 
        Alzheimer's disease;</DELETED>
        <DELETED>    ``(2) enhance the national infrastructure for the 
        conduct of clinical trials;</DELETED>
        <DELETED>    ``(3) develop and test novel approaches to the 
        design and analysis of such trials;</DELETED>
        <DELETED>    ``(4) facilitate the enrollment of, and expand the 
        range of, patients for such trials, including patients from 
        diverse populations;</DELETED>
        <DELETED>    ``(5) develop improved diagnostics and means of 
        patient assessment for Alzheimer's disease; and</DELETED>
        <DELETED>    ``(6) include, as determined appropriate by the 
        Director of the Institute, the Alzheimer's Disease Centers and 
        Alzheimer's Disease Research Centers established under section 
        445.</DELETED>
<DELETED>    ``(b) Early Diagnosis and Detection Research.--</DELETED>
        <DELETED>    ``(1) In general.--The Director of the Institute, 
        in consultation with the directors of other relevant institutes 
        and centers of the National Institutes of Health, shall 
        conduct, or make grants for the conduct of, research related to 
        the early detection and diagnosis of Alzheimer's disease and of 
        mild cognitive impairment or other potential precursors to 
        Alzheimer's disease.</DELETED>
        <DELETED>    ``(2) Evaluation.--The research described in 
        paragraph (1) may include the evaluation of diagnostic tests 
        and imaging techniques.</DELETED>
<DELETED>    ``(c) Vascular Disease.--The Director of the Institute, in 
consultation with the directors of other relevant institutes and 
centers of the National Institutes of Health, shall, conduct or make 
grants for the conduct of, research related to the relationship of 
vascular disease and Alzheimer's disease, including clinical trials to 
determine whether drugs developed to prevent cerebrovascular disease 
can prevent the onset or progression of Alzheimer's disease.</DELETED>
<DELETED>    ``(d) National Alzheimer's Coordinating Center.--The 
Director of the Institute may establish a National Alzheimer's 
Coordinating Center to facilitate collaborative research among the 
Alzheimer's Disease Centers and Alzheimer's Disease Research Centers 
established under section 445.''.</DELETED>
<DELETED>    (b) Alzheimer's Disease Centers.--Section 445(a)(1) of the 
Public Health Service Act (42 U.S.C. 285e-2(a)(1)) is amended by 
inserting ``, and outcome measures and disease management'' after 
``treatment methods''.</DELETED>

<DELETED>SEC. 6. RESEARCH ON ALZHEIMER'S DISEASE CAREGIVING.</DELETED>

<DELETED>    Section 445C of the Public Health Service Act (42 U.S.C. 
285e-5) is amended--</DELETED>
        <DELETED>    (1) by striking ``Sec. 445C. (a)'' and inserting 
        the following:</DELETED>

<DELETED>``SEC. 445C. RESEARCH ON ALZHEIMER'S DISEASE SERVICES AND 
              CAREGIVING.</DELETED>

<DELETED>    ``(a) Services Research.--'';</DELETED>
        <DELETED>    (2) by striking subsections (b), (c), and 
        (e);</DELETED>
        <DELETED>    (3) by inserting after subsection (a) the 
        following:</DELETED>
<DELETED>    ``(b) Interventions Research.--The Director shall, in 
collaboration with the directors of the other relevant institutes and 
centers of the National Institutes of Health, conduct, or make grants 
for the conduct of, clinical, social, and behavioral research related 
to interventions designed to help caregivers of patients with 
Alzheimer's disease and related disorders.''; and</DELETED>
        <DELETED>    (4) in subsection (d) by striking ``(d) the 
        Director'' and inserting ``(c) Model Curricula and 
        Techniques.--The Director''.</DELETED>

<DELETED>SEC. 7. AUTHORIZATION OF APPROPRIATIONS.</DELETED>

<DELETED>    (a) In General.--Section 445J of the Public Health Service 
Act (42 U.S.C. 285e-11) is amended by striking ``$500,000,000 for 
fiscal year 1994, and such sums as may be necessary for each of the 
fiscal years 1995 and 1996.'' and inserting ``$1,500,000,000 for fiscal 
year 2003, and such sums as may be necessary for each of the fiscal 
years 2004 through 2007.''.</DELETED>
<DELETED>    (b) Aging Process Regarding Women.--Section 445H(b) of the 
Public Health Service Act (42 U.S.C. 285e-10(b)) is amended by striking 
``2003'' and inserting ``2007''.</DELETED>
<DELETED>    (c) Clinical Research and Training Awards.--Section 
445I(d) of the Public Health Service Act (42 U.S.C. 285e-10a(d)) is 
amended by striking ``2005'' and inserting ``2007''.</DELETED>

<DELETED>SEC. 8. ALZHEIMER'S DISEASE DEMONSTRATION GRANTS.</DELETED>

<DELETED>    Section 398B(e) of the Public Health Service Act (42 
U.S.C. 280c-5(e)) is amended--</DELETED>
        <DELETED>    (1) by striking ``and such'' and inserting 
        ``such''; and</DELETED>
        <DELETED>    (2) by inserting before the period ``, $25,000,000 
        for fiscal year 2003, and such sums as may be necessary for 
        each of the fiscal years 2004 through 2007''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Alzheimer's Disease Research, 
Prevention, and Care Act of 2002''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Alzheimer's disease is a disorder that destroys cells 
        in the brain. The disease is the leading cause of dementia, a 
        condition that involves gradual memory loss, decline in the 
        ability to perform routine tasks, disorientation, difficulty in 
        learning, loss of language skills, impairment of judgment, and 
        personality changes. As the disease progresses, people with 
        Alzheimer's disease become unable to care for themselves. The 
        loss of brain cells eventually leads to the failure of other 
        systems in the body.
            (2) In the United States, 4,000,000 people have Alzheimer's 
        disease and 19,000,000 people say that they have a family 
        member with the disease. By 2050, 14,000,000 people in the 
        United States will have Alzheimer's disease unless science 
        finds a way to prevent or cure the disease.
            (3) One in 10 people over the age of 65, and nearly half of 
        those over the age of 85 have Alzheimer's disease. Younger 
        people also get the disease.
            (4) The Alzheimer's disease process may begin in the brain 
        as many as 20 years before the symptoms of Alzheimer's disease 
        appear. A person will live an average of 8 years and as many as 
        20 once the symptoms of Alzheimer's disease appear.
            (5) The average lifetime cost of Alzheimer's disease, per 
        person, is $174,000. The total annual cost of Alzheimer's 
        disease care in the United States today is not less than 
        $100,000,000,000.
            (6) In 2000, medicare alone spent $31,900,000,000 for the 
        care of individuals with Alzheimer's disease and this amount is 
        projected to increase to $49,300,000,000 in 2010.
            (7) Forty-nine percent of medicare beneficiaries who have 
        Alzheimer's disease also receive medicaid. Of the total 
        population dually eligible for medicare and medicaid, 22 
        percent have Alzheimer's disease.
            (8) Seven in 10 people with Alzheimer's disease live at 
        home. While almost 75 percent of home care is provided by 
        family and friends, the average annual cost of paid care for 
        people with Alzheimer's disease at home is $12,500.
            (9) At least half of all nursing home residents have 
        Alzheimer's disease or another dementia. The average annual 
        cost of Alzheimer's disease nursing home care is $42,000 but 
        exceeds $70,000 in some areas. Medicaid pays nearly half of the 
        total nursing home bill and helps 2 out of 3 residents pay for 
        their care. Medicaid expenditures for nursing home care for 
        people with Alzheimer's disease are estimated to increase from 
        $18,200,000,000 in 2000 to $33,000,000,000 in 2010.
            (10) In fiscal year 2002, the Federal Government will spend 
        an estimated $585,000,000 on Alzheimer's disease research, a 
        modest investment when compared with the annual 
        $100,000,000,000 cost of the disease. If science can find a way 
        to delay the onset of Alzheimer's disease symptoms for even 5 
        years, our Nation will save at least $50,000,000,000 in annual 
        health and long term care costs.
            (11) Seventy percent of people with Alzheimer's disease 
        live at home where families provide at least 75 percent of 
        their care.
            (12) A study commissioned by the United Hospital Fund 
        estimated that the annual value of this informal care system is 
        $196,000,000,000. Family caregiving comes at enormous physical, 
        emotional, and financial sacrifice, putting the whole system at 
        risk.
            (13) One in 8 Alzheimer's disease caregivers becomes ill or 
        injured as a direct result of caregiving. One in 3 uses 
        medication for problems related to caregiving. Older caregivers 
        are 3 times more likely to become clinically depressed than 
        others in their age group.
            (14) Elderly spouses strained by caregiving are 63 percent 
        more likely to die during a given 4-year period than other 
        spouses their age.
            (15) Three of 4 caregivers are women. One in 3 has children 
        or grandchildren under the age of 18 living at home. Caregiving 
        leaves them less time for other family members and they are 
        much more likely to report family conflicts because of their 
        caregiving role.
            (16) Most Alzheimer's disease caregivers work outside the 
        home before beginning their caregiving careers, but caregiving 
        forces them to miss work, cut back to part-time, take less 
        demanding jobs, choose early retirement, or give up work 
        altogether. As a result, in 2002, Alzheimer's disease will cost 
        American business an estimated $36,500,000,000 in lost 
        productivity, as well as an additional $24,600,000,000 in 
        business contributions to the total cost of care.

SEC. 3. PRIORITY TO ALZHEIMER'S DISEASE RESEARCH.

     Section 443 of the Public Health Service Act (42 U.S.C. 285e) is 
amended--
            (1) by striking ``The general'' and inserting ``(a) In 
        General.--The general''; and
            (2) by adding at the end the following:
    ``(b) Priorities.--The Director of the Institute shall, in 
expending amounts appropriated under this subpart, give priority to 
conducting and supporting Alzheimer's disease research.''.

SEC. 4. ALZHEIMER'S DISEASE PREVENTION INITIATIVE.

    Section 444 of the Public Health Service Act (42 U.S.C. 285e-1) is 
amended--
            (1) in subsection (d), by inserting ``and training'' after 
        ``conduct research''; and
            (2) by adding at the end the following:
    ``(e) The Director of the National Institutes of Health shall, in 
collaboration with the Director of the Institute, the directors of 
other relevant institutes, and with volunteer organizations and other 
stakeholders, undertake an Alzheimer's Disease Prevention Initiative 
to--
            ``(1) accelerate the discovery of new risk and protective 
        factors for Alzheimer's disease;
            ``(2) rapidly identify candidate diagnostics, therapies, or 
        preventive interventions or agents for clinical investigation 
        and trials relating to Alzheimer's disease;
            ``(3) support or undertake such investigations and trials; 
        and
            ``(4) implement effective prevention and treatment 
        strategies, including strategies to improve patient care and 
        alleviate caregiver burdens relating to Alzheimer's disease.''.

SEC. 5. ALZHEIMER'S DISEASE CLINICAL RESEARCH.

    (a) Clinical Research.--Section 445F of the Public Health Service 
Act (42 U.S.C. 285e-8) is amended to read as follows:

``SEC. 445F. ALZHEIMER'S DISEASE CLINICAL RESEARCH.

    ``(a) In General.--The Director of the Institute, pursuant to 
subsections (d) and (e) of section 444, shall conduct and support 
cooperative clinical research regarding Alzheimer's disease. Such 
research shall include--
            ``(1) investigating therapies, interventions, and agents to 
        detect, treat, slow the progression of, or prevent Alzheimer's 
        disease;
            ``(2) enhancing the national infrastructure for the conduct 
        of clinical trials;
            ``(3) developing and testing novel approaches to the design 
        and analysis of such trials;
            ``(4) facilitating the enrollment of patients for such 
        trials, including patients from diverse populations;
            ``(5) developing improved diagnostics and means of patient 
        assessment for Alzheimer's disease; and
            ``(6) as determined appropriate by the Director of the 
        Institute, the Alzheimer's Disease Centers and Alzheimer's 
        Disease Research Centers established under section 445.
    ``(b) Early Diagnosis and Detection Research.--
            ``(1) In general.--The Director of the Institute, in 
        consultation with the directors of other relevant institutes 
        and centers of the National Institutes of Health, shall 
        conduct, or make grants for the conduct of, research related to 
        the early detection and diagnosis of Alzheimer's disease and of 
        mild cognitive impairment or other potential precursors to 
        Alzheimer's disease.
            ``(2) Evaluation.--The research described in paragraph (1) 
        may include the evaluation of diagnostic tests and imaging 
        techniques.
    ``(c) Vascular Disease.--The Director of the Institute, in 
consultation with the directors of other relevant institutes and 
centers of the National Institutes of Health, shall conduct or make 
grants for the conduct of, research related to the relationship of 
vascular disease and Alzheimer's disease, including clinical trials to 
determine whether drugs developed to prevent cerebrovascular disease 
can prevent the onset or progression of Alzheimer's disease.
    ``(d) National Alzheimer's Coordinating Center.--The Director of 
the Institute may establish a National Alzheimer's Coordinating Center 
to facilitate collaborative research among the Alzheimer's Disease 
Centers and Alzheimer's Disease Research Centers established under 
section 445.''.
    (b) Alzheimer's Disease Centers.--Section 445(a)(1) of the Public 
Health Service Act (42 U.S.C. 285e-2(a)(1)) is amended by inserting ``, 
and outcome measures and disease management'' after ``treatment 
methods''.

SEC. 6. RESEARCH ON ALZHEIMER'S DISEASE CAREGIVING.

    Section 445C of the Public Health Service Act (42 U.S.C. 285e-5) is 
amended--
            (1) by striking ``Sec. 445C. (a)'' and inserting the 
        following:

``SEC. 445C. RESEARCH ON ALZHEIMER'S DISEASE SERVICES AND CAREGIVING.

    ``(a) Services Research.--'';
            (2) by striking subsections (b), (c), and (e);
            (3) by inserting after subsection (a) the following:
    ``(b) Interventions Research.--The Director shall, in collaboration 
with the directors of the other relevant institutes and centers of the 
National Institutes of Health, conduct, or make grants for the conduct 
of, clinical, social, and behavioral research related to interventions 
designed to help caregivers of patients with Alzheimer's disease and 
related disorders and improve patient outcomes.''; and
            (4) in subsection (d), by striking ``(d) the Director'' and 
        inserting ``(c) Model Curricula and Techniques.--The 
        Director''.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--Section 445J of the Public Health Service Act (42 
U.S.C. 285e-11) is amended by striking ``$500,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal years 
1995 and 1996.'' and inserting ``$1,100,000,000 for fiscal year 2003, 
$1,200,000,000 for fiscal year 2004, $1,300,000,000 for fiscal year 
2005, $1,400,000,000 for fiscal year 2006, and $1,500,000,000 for 
fiscal year 2007.''.
    (b) Aging Process Regarding Women.--Section 445H(b) of the Public 
Health Service Act (42 U.S.C. 285e-10(b)) is amended by striking 
``2003'' and inserting ``2007''.
    (c) Clinical Research and Training Awards.--Section 445I(d) of the 
Public Health Service Act (42 U.S.C. 285e-10a(d)) is amended by 
striking ``2005'' and inserting ``2007''.

SEC. 8. ALZHEIMER'S DISEASE DEMONSTRATION GRANTS.

    Section 398B(e) of the Public Health Service Act (42 U.S.C. 280c-
5(e)) is amended--
            (1) by striking ``and such'' and inserting ``such''; and
            (2) by inserting before the period ``, $20,000,000 for 
        fiscal year 2003, and such sums as may be necessary for each of 
        the fiscal years 2004 through 2007''.




                                                       Calendar No. 483

107th CONGRESS

  2d Session

                                S. 2059

_______________________________________________________________________

                                 A BILL

   To amend the Public Health Service Act to provide for Alzheimer's 
               disease research and demonstration grants.

_______________________________________________________________________

                              July 3, 2002

  Reported under the authority of the order of the Senate of June 26, 
                        2002, with an amendment