[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3354 Introduced in House (IH)]
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117th CONGRESS
1st Session
H. R. 3354
To provide better care and outcomes for Americans living with
Alzheimer's disease and related dementias and their caregivers while
accelerating progress toward prevention strategies, disease modifying
treatments, and, ultimately, a cure.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 19, 2021
Ms. Sanchez (for herself, Mr. LaHood, Ms. Matsui, Mr. Upton, Ms.
Sherrill, Ms. Barragan, Mr. Posey, Ms. Stevens, Mr. Fitzpatrick, Mr.
Lowenthal, Ms. Norton, Mr. Welch, Mr. Kinzinger, Ms. Waters, Ms.
Newman, Mr. DeFazio, Mr. Cole, Mr. Suozzi, Mrs. Demings, Mr. Grothman,
Mr. Michael F. Doyle of Pennsylvania, Mr. Keating, Ms. Kuster, and Mr.
Grijalva) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To provide better care and outcomes for Americans living with
Alzheimer's disease and related dementias and their caregivers while
accelerating progress toward prevention strategies, disease modifying
treatments, and, ultimately, a cure.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS; FINDINGS.
(a) Short Title.--This Act may be cited as the ``Concentrating on
High-value Alzheimer's Needs to Get to an End Act of 2021'' or the
``CHANGE Act of 2021''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents; findings.
Sec. 2. Cognitive impairment detection benefit in the Medicare annual
wellness visit and initial preventive
physical examination.
Sec. 3. Medicare quality payment program.
Sec. 4. Report to Congress on implementation of this Act.
Sec. 5. Study and report on regulatory and legislative changes or
refinements that would accelerate
Alzheimer's disease research progress.
(c) Findings.--Congress finds as follows:
(1) It is estimated that 6.2 million Americans age 65 and
older are living with Alzheimer's disease in 2021. More than
one in nine people age 65 and older has Alzheimer's. By 2050,
the number of Americans age 65 and older with Alzheimer's
dementia is projected to reach 12.7 million.
(2) Alzheimer's disease disproportionately impacts women
and people of color.
(3) Almost two-thirds of Americans with Alzheimer's disease
are women.
(4) According to the Centers for Disease Control and
Prevention, among people ages 65 and older, African Americans
have the highest prevalence of Alzheimer's disease and related
dementias (13.8 percent), followed by Hispanics (12.2 percent),
and non-Hispanic Whites (10.3 percent), American Indian and
Alaska Natives (9.1 percent), and Asian and Pacific Islanders
(8.4 percent). This higher prevalence translates into a higher
death rate: Alzheimer's deaths increased 55 percent among all
Americans between 1999 and 2014, while the number was 107
percent for Latinos and 99 percent for African Americans.
(5) Currently available data shows that about half of
individuals age 65 and older with mild cognitive impairment
(MCI)--roughly 5 million Americans--have MCI due to Alzheimer's
disease. Approximately 15 percent of individuals with MCI
develop dementia after two years and 32 percent develop
Alzheimer's dementia within five years' follow-up.
(6) Addressing modifiable risk factors such as physical
activity, smoking, education, staying socially and mentally
active, blood pressure, and diet might prevent or delay up to
40 percent of dementia cases.
(7) An early, documented diagnosis, communicated to the
patient and caregiver, enables early access to care planning
services and available medical and nonmedical treatments, and
optimizes patients' ability to build a care team, participate
in support services, and enroll in clinical trials.
(8) Alzheimer's exacts an emotional and physical toll on
caregivers, resulting in higher incidence of heart disease,
cancer, depression, and other health consequences.
(9) More than 11 million Americans provide unpaid care for
people with Alzheimer's or other dementia and provided nearly
$257 billion in unpaid care to people living with Alzheimer's
and other dementias in 2020.
(10) In 2021, it is estimated that Alzheimer's and related
dementias will have cost Medicare and Medicaid programs $239
billion. By 2050, it is estimated that these direct costs will
increase to as much as $1.1 trillion.
SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN THE MEDICARE ANNUAL
WELLNESS VISIT AND INITIAL PREVENTIVE PHYSICAL
EXAMINATION.
(a) Annual Wellness Visit.--
(1) In general.--Section 1861(hhh)(2) of the Social
Security Act (42 U.S.C. 1395x(hhh)(2)) is amended--
(A) by striking subparagraph (D) and inserting the
following:
``(D) Detection of any cognitive impairment or
progression of cognitive impairment that shall--
``(i) be performed using a cognitive
impairment detection tool identified by the
National Institute on Aging as meeting its
criteria for selecting instruments to detect
cognitive impairment in the primary care
setting, and other validated cognitive
detection tools as the Secretary determines;
``(ii) include documentation of the tool
used for detecting cognitive impairment and
results of the assessment in the patient's
medical record; and
``(iii) take into consideration the tool
used, and results of, any previously performed
cognitive impairment detection assessment.'';
(B) by redesignating subparagraph (I) as
subparagraph (J); and
(C) by inserting after subparagraph (H) the
following new subparagraph:
``(I) Referral of patients with detected cognitive
impairment or potential cognitive decline to--
``(i) appropriate Alzheimer's disease and
dementia diagnostic services, including amyloid
positron emission tomography, and other
medically accepted diagnostic tests that the
Secretary determines are safe and effective;
``(ii) specialists and other clinicians
with expertise in diagnosing or treating
Alzheimer's disease and related dementias;
``(iii) available community-based services,
including patient and caregiver counseling and
social support services; and
``(iv) appropriate clinical trials.''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to annual wellness visits furnished on or after
January 1, 2022.
(b) Initial Preventive Physical Examination.--
(1) In general.--Section 1861(ww)(1) of the Social Security
Act (42 U.S.C. 1395x(ww)(1)) is amended by striking ``agreement
with the individual, and'' and inserting ``agreement with the
individual, detection of any cognitive impairment or
progression of cognitive impairment as described in
subparagraph (D) of subsection (hhh)(2) and referrals as
described in subparagraph (I) of such subsection, and''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to initial preventive physical examinations
furnished on or after January 1, 2022.
SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM.
Not later than January 1, 2022, the Secretary of Health and Human
Services shall implement Medicare policies under title XVIII of the
Social Security Act, including quality measures and Medicare Advantage
plan rating and risk adjustment mechanisms, that reflect the public
health imperative of--
(1) promoting healthy brain lifestyle choices;
(2) identifying and responding to patient risk factors for
Alzheimer's disease and related dementias; and
(3) incentivizing providers for--
(A) adequate and reliable cognitive impairment
detection in the primary care setting, that is
documented in the patient's electronic health record
and communicated to the patient;
(B) timely Alzheimer's disease diagnosis; and
(C) appropriate care planning services, including
identification of, and communication with patients and
caregivers about, the potential for clinical trial
participation.
SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION OF THIS ACT.
Not later than 3 years after the date of the enactment of this Act,
the Secretary of Health and Human Services shall submit a report to
Congress on the implementation of the provisions of, and amendments
made by, this Act, including--
(1) the increased use of validated tools for detection of
cognitive impairment and Alzheimer's disease;
(2) utilization of Alzheimer's disease diagnostic and care
planning services; and
(3) outreach efforts in the primary care and patient
communities.
SEC. 5. STUDY AND REPORT ON REGULATORY AND LEGISLATIVE CHANGES OR
REFINEMENTS THAT WOULD ACCELERATE ALZHEIMER'S DISEASE
RESEARCH PROGRESS.
(a) In General.--The Comptroller General of the United States (in
this section referred to as the ``Comptroller General'') shall conduct
a study on regulatory and legislative changes or refinements that would
accelerate Alzheimer's disease research progress. In conducting such
study, the Comptroller General shall consult with interested
stakeholders, including industry leaders, researchers, clinical
experts, patient advocacy groups, caregivers, patients, providers, and
State leaders. Such study shall include an analysis of innovative
public-private partnerships, innovative financing tools, incentives,
and other mechanisms to enhance the quality of care for individuals
diagnosed with Alzheimer's disease, reduce the emotional, financial,
and physical burden on familial care partners, and accelerate
development of preventative, curative, and disease-modifying therapies.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Comptroller General shall submit to Congress a report
containing the results of the study conducted under subsection (a),
together with recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
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