delays diagnosis, resulting in decreased opportunities 
for patients to access timely treatment options, in-
cluding clinical trial participation. 
(9) African Americans represent 13 percent of 
the U.S. population but only 5 percent of clinical 
trial participants and Latinos represent 17 percent 
of the U.S. population but less than one percent of 
clinical trial participants. Further, Latinos and Afri-
can Americans account for only 3.5 percent and 1.2 
percent, respectively, of principal investigators sup-
ported by the National Institutes of Health funding, 
limiting this perspective in research. Better recruit-
ment and trial designs are critical to addressing in-
novation in Alzheimer’s generally, including the 
underrepresentation of African Americans and 
Latinos. 
(10) Inability to identify eligible patients at the 
earliest stages of disease is a substantial impediment 
to efficient research toward Alzheimer’s disease pre-
vention, treatment, and cure. 
(11) Advancing treatment options to prevent, 
treat, or cure Alzheimer’s is an urgent national pri-
ority. 
(12) Continued Federal investment in Alz-
heimer’s research and the implementation of innova-
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tive programs, such as the breakthrough EUREKA 
prize competition authorized in the 21st Century 
Cures Act, are critical to advance the search to iden-
tify, treat, cure, and prevent Alzheimer’s disease. 
(13) Existing health care systems— 
(A) are costly; 
(B) do not adequately meet the needs of 
Alzheimer’s patients; 
(C) overburden familial caregivers; and 
(D) perpetuate hurdles to efficient Alz-
heimer’s research. 
(14) A paradigm shift to drive synergies be-
tween high-value patient care, caregiver support, and 
research initiatives is our best hope for preventing, 
treating, and curing Alzheimer’s disease. 
(15) Section 1115A of the Social Security Act, 
as amended by the PACE Innovation Act of 2015, 
enables identification of Alzheimer’s disease care 
models that focus on improving patient-centered out-
comes, reduce the burden on informal and familial 
caregivers, and facilitate clinical trial participation. 
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SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 
THE MEDICARE ANNUAL WELLNESS VISIT 
AND INITIAL PREVENTIVE PHYSICAL EXAM-
INATION. 
(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 in-
serting the following: 
‘‘(D) Detection of any cognitive impair-
ment 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 de-
tection tools as the Secretary determines; 
‘‘(ii) include documentation of the tool 
used for detecting cognitive impairment 
and results of the assessment in the pa-
tient’s medical record; and 
‘‘(iii) take into consideration the tool 
used, and results of, any previously per-
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formed cognitive impairment detection as-
sessment.’’; 
(B) by redesignating subparagraph (G) as 
subparagraph (H); and 
(C) by inserting after subparagraph (F) 
the following new subparagraph: 
‘‘(G) Referral of patients with detected 
cognitive impairment or potential cognitive de-
cline 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 serv-
ices, including patient and caregiver coun-
seling and social support services; and 
‘‘(iv) appropriate clinical trials.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to annual wellness vis-
its furnished on or after January 1, 2019. 
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(b) INITIAL
PREVENTIVE
PHYSICAL
EXAMINA-
TION.— 
(1) IN GENERAL.—Section 1861(ww)(1) of the 
Social Security Act (42 U.S.C. 1395x(ww)(1)) is 
amended by striking ‘‘paragraph (2) and’’ and in-
serting ‘‘paragraph (2), 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 
(G) 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, 2019. 
SEC. 3. TEST OF CARE DELIVERY MODELS OFFERING A 
CONTINUUM OF COMPREHENSIVE CARE, AND 
CAREGIVER SUPPORT SERVICES, FOR PA-
TIENTS WITH ALZHEIMER’S DISEASE AND 
OTHER DEMENTIAS. 
Section 1115A of the Social Security Act (42 U.S.C. 
1315a) is amended— 
(1) in subsection (b)(2)(A), by adding at the 
end the following new sentence: ‘‘The models se-
lected under this subparagraph shall include the 
model described in subsection (h), which shall be im-
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plemented by not later than 6 months after the date 
of the enactment of the Concentrating on High- 
Value Alzheimer’s Needs to Get to an End 
(CHANGE) Act of 2018.’’; 
(2) by adding at the end the following new sub-
section: 
‘‘(h) DELIVERY MODELS OFFERING A CONTINUUM 
OF COMPREHENSIVE CARE, AND CAREGIVER SUPPORT 
SERVICES, FOR PATIENTS WITH ALZHEIMER’S DISEASE 
AND OTHER DEMENTIAS.— 
‘‘(1) IN
GENERAL.—The models described in 
this subsection are Medicare, Medicaid, or multi- 
payer models that incorporate a comprehensive con-
tinuum of care framework, such as that contained in 
the Program of All-Inclusive Care for the Elderly 
(PACE), to individuals diagnosed with Alzheimer’s 
disease or related dementia, at any stage. 
‘‘(2) REQUIREMENTS FOR MODELS.—The mod-
els described in this subsection shall include the fol-
lowing: 
‘‘(A) The enrollment of patients diagnosed 
with Alzheimer’s disease, at any stage, without 
regard to medical need for skilled nursing facil-
ity care or Medicaid eligibility. 
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‘‘(B) Through case management and care 
coordination services, the offering of a flexible 
menu of services, based upon identified patient 
needs over time, for high-quality, appropriate 
care from diagnosis through disease progres-
sion, including identification of appropriate clin-
ical trials. 
‘‘(C) The employment of a comprehensive 
approach to caring for patients with Alz-
heimer’s disease or related dementia that inte-
grates treatment of such patients with training 
and support services for their families and care-
givers, and facilitates participation in clinical 
trials. Such services may include— 
‘‘(i) day healthcare, including health 
care services and dementia-specific social, 
rehabilitative, recreational, memory, exer-
cise, nutritional counseling, occupational 
therapy, and personal care services; 
‘‘(ii) physician care, including referred 
specialists; 
‘‘(iii) respite care and, for clinical trial 
participants, care partner surrogate serv-
ices as needed; 
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‘‘(iv) 
medications 
and 
medication 
management, including for clinical trial 
compliance; 
‘‘(v) nursing care, and occupational, 
physical, and speech therapy as prescribed; 
‘‘(vi) identification and management 
of comorbidities; 
‘‘(vii) social worker services; 
‘‘(viii) meals at day health care and, 
if needed, at home; 
‘‘(ix) transportation to and from day 
health care and clinical trial study visits; 
and 
‘‘(x) personal care, skilled nursing 
services, and other services the Secretary 
determines appropriate that— 
‘‘(I) incorporate caregiver train-
ing, support, and counseling services 
successfully 
evaluated 
and 
imple-
mented in previous or existing models 
tested under such section 1115A and 
that are specific to Alzheimer’s dis-
ease patients and their caregivers; 
‘‘(II) 
maintain 
documentation 
and data likely to further scientific 
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understanding of Alzheimer’s disease 
natural history, taking into account 
gender, race, ethnicity, age of onset, 
and other factors; and 
‘‘(III) provide outreach activities 
to inform the public of the services of 
the program, and provide information 
on Alzheimer’s disease and related de-
mentias to the primary care commu-
nity and general public. 
‘‘(3) MODEL SELECTION AND EVALUATION.— 
‘‘(A) REQUESTS FOR PROPOSALS.—In im-
plementing the models described in this sub-
section, the Secretary shall seek requests for 
proposals from States, PACE programs (as de-
fined in section 1894(a)(2)), Alzheimer’s dis-
ease and dementia care centers, and specialized 
MA plans for special needs individuals (as de-
fined in section 1859(b)(6)) that have the dem-
onstrated ability to deliver the comprehensive 
continuum of dementia care described in para-
graph (2). 
‘‘(B) PHASE I MODELS.—In selecting mod-
els under this subsection to be tested under 
subsection (b), and in evaluating models, the 
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Secretary shall primarily focus on patient and 
caregiver outcomes, such as— 
‘‘(i) improved quality of life; 
‘‘(ii) maintaining functional or cog-
nitive performance; 
‘‘(iii) management of comorbidities 
and behavioral and safety concerns; and 
‘‘(iv) continued ability to remain in 
the community. 
‘‘(C) PHASE II.—Subject to the require-
ments under subsection (c), in determining 
which models under this subsection to expand 
under subsection (c), the Secretary shall take 
into account— 
‘‘(i) any recommendations or strate-
gies identified in the report under section 
8 of the Concentrating on High-Value Alz-
heimer’s Needs to Get to an End 
(CHANGE) Act of 2018; and 
‘‘(ii) whether the model incorporates 
care delivery, payment, and evaluation 
strategies that are likely to demonstrate 
improved patient outcomes, including the 
outcomes described in subparagraph (B) 
and reduced hospitalizations, emergency 
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room visits, and skilled nursing facility 
stays, without increasing spending under 
the applicable title.’’. 
SEC. 4. STATE INNOVATION MODELS FOR FAMILY CARE-
GIVERS OF PATIENTS WITH ALZHEIMER’S 
AND RELATED DEMENTIAS. 
Section 1115A(b)(2)(B) of the Social Security Act 
(42 U.S.C. 1315(b)(2)(B)) is amended by adding the fol-
lowing new clause: 
‘‘(xxv) Allowing States to develop and 
test programs that increase an Alzheimer’s 
disease patient’s ability to remain in the 
community by reducing the financial bur-
den to family caregivers, and that in-
clude— 
‘‘(I) familial caregiver support 
services, including training necessary 
to enable such caregivers to provide 
services at the level of a home health 
aide; 
‘‘(II) 
certification 
of 
familial 
caregiver training and satisfactory 
completion of testing or other require-
ments demonstrating caregiver com-
petence; 
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‘‘(III) appropriate familial care-
giver oversight, including home visits 
or other activities; and 
‘‘(IV) for familial caregivers of 
Alzheimer’s disease and other demen-
tia patients for whom a care plan in-
cludes home health aide services, pay-
ment to the caregiver for the hours of 
one-on-one services provided in the 
care plan, and performed by the fa-
milial caregivers, in an amount that is 
not below the then-applicable min-
imum wage in that State and does not 
exceed the prevailing hourly rate paid 
to a home health aide.’’. 
SEC. 5. MEDICARE QUALITY PAYMENT PROGRAM. 
Not later than January 1, 2019, the Secretary of 
Health and Human Services shall implement Medicare 
policies under title XVIII of the Social Security Act, in-
cluding quality measures and Medicare Advantage plan 
rating and risk adjustment mechanisms, that reflect the 
public health imperative of— 
(1) promoting healthy brain lifestyle choices; 
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(2) identifying and responding to patient risk 
factors for Alzheimer’s disease and related demen-
tias; and 
(3) incentivizing providers for— 
(A) adequate and reliable cognitive impair-
ment 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, in-
cluding identification of, and communication 
with patients and caregivers about, the poten-
tial for clinical trial participation. 
SEC. 6. REPORT TO CONGRESS ON IMPLEMENTATION OF 
THIS ACT. 
Not later than 3 years after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit a report to Congress on the imple-
mentation of the provisions of, and amendments made by, 
this Act, including— 
(1) the increased use of validated tools for de-
tection of cognitive impairment and Alzheimer’s dis-
ease; 
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(2) models undergoing testing and evaluation 
under the provisions of, and amendments made by, 
sections 3 and 4; 
(3) utilization of Alzheimer’s disease diagnostic 
and care planning services; and 
(4) outreach efforts in the primary care and pa-
tient communities. 
SEC. 7. STUDY AND REPORT ON REGULATORY AND LEGIS-
LATIVE 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 ‘‘Comp-
troller 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 inter-
ested stakeholders, including industry leaders, researchers, 
clinical experts, patient advocacy groups, caregivers, pa-
tients, providers, and State leaders. Such study shall in-
clude an analysis of— 
(1) innovative public-private partnerships, inno-
vative financing tools, incentives and other mecha-
nisms to enhance the quality of care for individuals 
diagnosed with Alzheimer’s disease, reduce the emo-
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tional, financial, and physical burden on familial 
care partners, and accelerate development of pre-
ventative, curative, and disease-modifying therapies; 
and 
(2) the results of any models under the provi-
sions of, and amendments made by, sections 3 and 
4 and the feasibility of incorporating into such mod-
els innovative arrangements with research sponsors, 
through a user fee or otherwise, to facilitate budget 
neutrality or incentivize providers through a shared- 
savings approach. 
(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 rec-
ommendations for such legislation and administrative ac-
tion as the Comptroller General determines appropriate. 
Æ 
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