II 

115TH CONGRESS 

2D SESSION S. 2387 

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 SENATE OF THE UNITED STATES 

FEBRUARY 7, 2018 

Mrs. CAPITO (for herself, Ms. STABENOW, Mr. WICKER, and Mr. MENENDEZ) 

introduced the following bill; which was read twice and referred to the 

Committee on Finance 

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. 

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; TABLE OF CONTENTS; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Concentrating on High-value Alzheimer’s Needs to Get 

6 to an End (CHANGE) Act of 2018’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 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. Test of care delivery models offering a continuum of comprehensive 

care, and caregiver support services, for patients with Alzheimer’s disease and other dementias. 

Sec. 4. State innovation models for family caregivers of patients with Alzheimer’s and related dementias. 

Sec. 5. Medicare quality payment program. 

Sec. 6. Report to Congress on implementation of this Act. 

Sec. 7. Study and report on regulatory and legislative changes or refinements 

that would accelerate Alzheimer’s disease research progress. 

3 (c) FINDINGS.—Congress finds as follows: 

4 (1) The number of individuals in the United 

5 States with Alzheimer’s disease and related demen6 tias has more than doubled since 1980 and, based 

7 on the trajectory of Alzheimer’s, as many as 14 to 

8 16 million individuals in the United States will have 

9 Alzheimer’s by 2050. 

10 (2) Alzheimer’s is the only disease among the 

11 top 10 causes of death in the United States without 

12 an effective means of prevention, treatment, or cure. 

13 (3) In 2017, Alzheimer’s care will cost Medicare 

14 and Medicaid an estimated $175,000,000,000 and 

15 by 2050, Alzheimer’s disease will cost Medicare and 

16 Medicaid as much as $758,000,000,000. 

17 (4) Alzheimer’s exacts an emotional and phys18 ical toll on caregivers, resulting in higher incidence 

19 of heart disease, cancer, depression, and other health 

20 consequences. 


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1 (5) Alzheimer’s disease disproportionately im2 pacts women and people of color. Women are twice 

3 as likely to develop Alzheimer’s as they are breast 

4 cancer. African Americans are about two times more 

5 likely than White Americans to have Alzheimer’s dis6 ease and other dementias. Latinos are about one 

7 and one-half times more likely than White Ameri8 cans to have Alzheimer’s disease and other demen9 tias. This higher prevalence translates into a higher 

10 death rate: Alzheimer’s deaths increased 55 percent 

11 among all Americans between 1999 and 2014, while 

12 the number was 107 percent for Latinos and 99 per13 cent for African Americans. 

14 (6) As many as half of the estimated 5,100,000 

15 American seniors with Alzheimer’s disease and other 

16 dementias have never received a diagnosis. 

17 (7) An early, documented diagnosis, commu18 nicated to the patient and caregiver, enables early 

19 access to care planning services and available med20 ical and nonmedical treatments, and optimizes pa21 tients’ ability to build a care team, participate in 

22 support services, and enroll in clinical trials. 

23 (8) The lack of uniform, reliable cognitive im24 pairment detection methodologies in the Medicare 

25 annual wellness visit, and appropriate follow-up, 


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1 delays diagnosis, resulting in decreased opportunities 

2 for patients to access timely treatment options, in3 cluding clinical trial participation. 

4 (9) African Americans represent 13 percent of 

5 the U.S. population but only 5 percent of clinical 

6 trial participants and Latinos represent 17 percent 

7 of the U.S. population but less than one percent of 

8 clinical trial participants. Further, Latinos and Afri9 can Americans account for only 3.5 percent and 1.2 

10 percent, respectively, of principal investigators sup11 ported by the National Institutes of Health funding, 

12 limiting this perspective in research. Better recruit13 ment and trial designs are critical to addressing in14 novation in Alzheimer’s generally, including the 

15 underrepresentation of African Americans and 

16 Latinos. 

17 (10) Inability to identify eligible patients at the 

18 earliest stages of disease is a substantial impediment 

19 to efficient research toward Alzheimer’s disease pre20 vention, treatment, and cure. 

21 (11) Advancing treatment options to prevent, 

22 treat, or cure Alzheimer’s is an urgent national pri23 ority. 

24 (12) Continued Federal investment in Alz25 heimer’s research and the implementation of innovaVerDate Sep 11 2014 05:17 Feb 09, 2018 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2387.IS S2387

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1 tive programs, such as the breakthrough EUREKA 

2 prize competition authorized in the 21st Century 

3 Cures Act, are critical to advance the search to iden4 tify, treat, cure, and prevent Alzheimer’s disease. 

5 (13) Existing health care systems— 

6 (A) are costly; 

7 (B) do not adequately meet the needs of 

8 Alzheimer’s patients; 

9 (C) overburden familial caregivers; and 

10 (D) perpetuate hurdles to efficient Alz11 heimer’s research. 

12 (14) A paradigm shift to drive synergies be13 tween high-value patient care, caregiver support, and 

14 research initiatives is our best hope for preventing, 

15 treating, and curing Alzheimer’s disease. 

16 (15) Section 1115A of the Social Security Act, 

17 as amended by the PACE Innovation Act of 2015, 

18 enables identification of Alzheimer’s disease care 

19 models that focus on improving patient-centered out20 comes, reduce the burden on informal and familial 

21 caregivers, and facilitate clinical trial participation. 


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1 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 

2 THE MEDICARE ANNUAL WELLNESS VISIT 

3 AND INITIAL PREVENTIVE PHYSICAL EXAM4 INATION. 

5 (a) ANNUAL WELLNESS VISIT.— 

6 (1) IN GENERAL.—Section 1861(hhh)(2) of the 

7 Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 

8 amended— 

9 (A) by striking subparagraph (D) and in10 serting the following: 

11 ‘‘(D) Detection of any cognitive impair12 ment or progression of cognitive impairment 

13 that shall— 

14 ‘‘(i) be performed using a cognitive 

15 impairment detection tool identified by the 

16 National Institute on Aging as meeting its 

17 criteria for selecting instruments to detect 

18 cognitive impairment in the primary care 

19 setting, and other validated cognitive de20 tection tools as the Secretary determines; 

21 ‘‘(ii) include documentation of the tool 

22 used for detecting cognitive impairment 

23 and results of the assessment in the pa24 tient’s medical record; and 

25 ‘‘(iii) take into consideration the tool 

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1 formed cognitive impairment detection as2 sessment.’’; 

3 (B) by redesignating subparagraph (G) as 

4 subparagraph (H); and 

5 (C) by inserting after subparagraph (F) 

6 the following new subparagraph: 

7 ‘‘(G) Referral of patients with detected 

8 cognitive impairment or potential cognitive de9 cline to— 

10 ‘‘(i) appropriate Alzheimer’s disease 

11 and dementia diagnostic services, including 

12 amyloid positron emission tomography, and 

13 other medically accepted diagnostic tests 

14 that the Secretary determines are safe and 

15 effective; 

16 ‘‘(ii) specialists and other clinicians 

17 with expertise in diagnosing or treating 

18 Alzheimer’s disease and related dementias; 

19 ‘‘(iii) available community-based serv20 ices, including patient and caregiver coun21 seling and social support services; and 

22 ‘‘(iv) appropriate clinical trials.’’. 

23 (2) EFFECTIVE DATE.—The amendments made 

24 by paragraph (1) shall apply to annual wellness vis25 its furnished on or after January 1, 2019. 


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1 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA2 TION.— 

3 (1) IN GENERAL.—Section 1861(ww)(1) of the 

4 Social Security Act (42 U.S.C. 1395x(ww)(1)) is 

5 amended by striking ‘‘paragraph (2) and’’ and in6 serting ‘‘paragraph (2), detection of any cognitive 

7 impairment or progression of cognitive impairment 

8 as described in subparagraph (D) of subsection 

9 (hhh)(2) and referrals as described in subparagraph 

10 (G) of such subsection, and’’. 

11 (2) EFFECTIVE DATE.—The amendments made 

12 by paragraph (1) shall apply to initial preventive 

13 physical examinations furnished on or after January 

14 1, 2019. 

15 SEC. 3. TEST OF CARE DELIVERY MODELS OFFERING A 

16 CONTINUUM OF COMPREHENSIVE CARE, AND 

17 CAREGIVER SUPPORT SERVICES, FOR PA18 TIENTS WITH ALZHEIMER’S DISEASE AND 

19 OTHER DEMENTIAS. 

20 Section 1115A of the Social Security Act (42 U.S.C. 

21 1315a) is amended— 

22 (1) in subsection (b)(2)(A), by adding at the 

23 end the following new sentence: ‘‘The models se24 lected under this subparagraph shall include the 

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1 plemented by not later than 6 months after the date 

2 of the enactment of the Concentrating on High-value 

3 Alzheimer’s Needs to Get to an End (CHANGE) 

4 Act of 2018.’’; 

5 (2) by adding at the end the following new sub6 section: 

7 ‘‘(h) DELIVERY MODELS OFFERING A CONTINUUM

8 OF COMPREHENSIVE CARE, AND CAREGIVER SUPPORT

9 SERVICES, FOR PATIENTS WITH ALZHEIMER’S DISEASE

10 AND OTHER DEMENTIAS.— 

11 ‘‘(1) IN GENERAL.—The models described in 

12 this subsection are Medicare, Medicaid, or multi13 payer models that incorporate a comprehensive con14 tinuum of care framework, such as that contained in 

15 the Program of All-Inclusive Care for the Elderly 

16 (PACE), to individuals diagnosed with Alzheimer’s 

17 disease or related dementia, at any stage. 

18 ‘‘(2) REQUIREMENTS FOR MODELS.—The mod19 els described in this subsection shall include the fol20 lowing: 

21 ‘‘(A) The enrollment of patients diagnosed 

22 with Alzheimer’s disease, at any stage, without 

23 regard to medical need for skilled nursing facil24 ity care or Medicaid eligibility. 


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1 ‘‘(B) Through case management and care 

2 coordination services, the offering of a flexible 

3 menu of services, based upon identified patient 

4 needs over time, for high-quality, appropriate 

5 care from diagnosis through disease progres6 sion, including identification of appropriate clin7 ical trials. 

8 ‘‘(C) The employment of a comprehensive 

9 approach to caring for patients with Alz10 heimer’s disease or related dementia that inte11 grates treatment of such patients with training 

12 and support services for their families and care13 givers, and facilitates participation in clinical 

14 trials. Such services may include— 

15 ‘‘(i) day healthcare, including health 

16 care services and dementia-specific social, 

17 rehabilitative, recreational, memory, exer18 cise, nutritional counseling, occupational 

19 therapy, and personal care services; 

20 ‘‘(ii) physician care, including referred 

21 specialists; 

22 ‘‘(iii) respite care and, for clinical trial 

23 participants, care partner surrogate serv24 ices as needed; 


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1 ‘‘(iv) medications and medication 

2 management, including for clinical trial 

3 compliance; 

4 ‘‘(v) nursing care, and occupational, 

5 physical, and speech therapy as prescribed; 

6 ‘‘(vi) identification and management 

7 of comorbidities; 

8 ‘‘(vii) social worker services; 

9 ‘‘(viii) meals at day health care and, 

10 if needed, at home; 

11 ‘‘(ix) transportation to and from day 

12 health care and clinical trial study visits; 

13 and 

14 ‘‘(x) personal care, skilled nursing 

15 services, and other services the Secretary 

16 determines appropriate that— 

17 ‘‘(I) incorporate caregiver train18 ing, support, and counseling services 

19 successfully evaluated and imple20 mented in previous or existing models 

21 tested under such section 1115A and 

22 that are specific to Alzheimer’s dis23 ease patients and their caregivers; 

24 ‘‘(II) maintain documentation 

25 and data likely to further scientific 


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1 understanding of Alzheimer’s disease 

2 natural history, taking into account 

3 gender, race, ethnicity, age of onset, 

4 and other factors; and 

5 ‘‘(III) provide outreach activities 

6 to inform the public of the services of 

7 the program, and provide information 

8 on Alzheimer’s disease and related de9 mentias to the primary care commu10 nity and general public. 

11 ‘‘(3) MODEL SELECTION AND EVALUATION.— 

12 ‘‘(A) REQUESTS FOR PROPOSALS.—In im13 plementing the models described in this sub14 section, the Secretary shall seek requests for 

15 proposals from States, PACE programs (as de16 fined in section 1894(a)(2)), Alzheimer’s dis17 ease and dementia care centers, and specialized 

18 MA plans for special needs individuals (as de19 fined in section 1859(b)(6)) that have the dem20 onstrated ability to deliver the comprehensive 

21 continuum of dementia care described in para22 graph (2). 

23 ‘‘(B) PHASE I MODELS.—In selecting mod24 els under this subsection to be tested under 

25 subsection (b), and in evaluating models, the 


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1 Secretary shall primarily focus on patient and 

2 caregiver outcomes, such as— 

3 ‘‘(i) improved quality of life; 

4 ‘‘(ii) maintaining functional or cog5 nitive performance; 

6 ‘‘(iii) management of comorbidities 

7 and behavioral and safety concerns; and 

8 ‘‘(iv) continued ability to remain in 

9 the community. 

10 ‘‘(C) PHASE II.—Subject to the require11 ments under subsection (c), in determining 

12 which models under this subsection to expand 

13 under subsection (c), the Secretary shall take 

14 into account— 

15 ‘‘(i) any recommendations or strate16 gies identified in the report under section 

17 8 of the Concentrating on High-value Alz18 heimer’s Needs to Get to an End 

19 (CHANGE) Act of 2018; and 

20 ‘‘(ii) whether the model incorporates 

21 care delivery, payment, and evaluation 

22 strategies that are likely to demonstrate 

23 improved patient outcomes, including the 

24 outcomes described in subparagraph (B) 

25 and reduced hospitalizations, emergency 


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1 room visits, and skilled nursing facility 

2 stays, without increasing spending under 

3 the applicable title.’’. 

4 SEC. 4. STATE INNOVATION MODELS FOR FAMILY CARE5 GIVERS OF PATIENTS WITH ALZHEIMER’S 

6 AND RELATED DEMENTIAS. 

7 Section 1115A(b)(2)(B) of the Social Security Act 

8 (42 U.S.C. 1315(b)(2)(B)) is amended by adding the fol9 lowing new clause: 

10 ‘‘(xxv) Allowing States to develop and 

11 test programs that increase an Alzheimer’s 

12 disease patient’s ability to remain in the 

13 community by reducing the financial bur14 den to family caregivers, and that in15 clude— 

16 ‘‘(I) familial caregiver support 

17 services, including training necessary 

18 to enable such caregivers to provide 

19 services at the level of a home health 

20 aide; 

21 ‘‘(II) certification of familial 

22 caregiver training and satisfactory 

23 completion of testing or other require24 ments demonstrating caregiver com25 petence; 


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1 ‘‘(III) appropriate familial care2 giver oversight, including home visits 

3 or other activities; and 

4 ‘‘(IV) for familial caregivers of 

5 Alzheimer’s disease and other demen6 tia patients for whom a care plan in7 cludes home health aide services, pay8 ment to the caregiver for the hours of 

9 one-on-one services provided in the 

10 care plan, and performed by the fa11 milial caregivers, in an amount that is 

12 not below the then-applicable min13 imum wage in that State and does not 

14 exceed the prevailing hourly rate paid 

15 to a home health aide.’’. 

16 SEC. 5. MEDICARE QUALITY PAYMENT PROGRAM. 

17 Not later than January 1, 2019, the Secretary of 

18 Health and Human Services shall implement Medicare 

19 policies under title XVIII of the Social Security Act, in20 cluding quality measures and Medicare Advantage plan 

21 rating and risk adjustment mechanisms, that reflect the 

22 public health imperative of— 

23 (1) promoting healthy brain lifestyle choices; 


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1 (2) identifying and responding to patient risk 

2 factors for Alzheimer’s disease and related demen3 tias; and 

4 (3) incentivizing providers for— 

5 (A) adequate and reliable cognitive impair6 ment detection in the primary care setting, that 

7 is documented in the patient’s electronic health 

8 record and communicated to the patient; 

9 (B) timely Alzheimer’s disease diagnosis; 

10 and 

11 (C) appropriate care planning services, in12 cluding identification of, and communication 

13 with patients and caregivers about, the poten14 tial for clinical trial participation. 

15 SEC. 6. REPORT TO CONGRESS ON IMPLEMENTATION OF 

16 THIS ACT. 

17 Not later than 3 years after the date of the enact18 ment of this Act, the Secretary of Health and Human 

19 Services shall submit a report to Congress on the imple20 mentation of the provisions of, and amendments made by, 

21 this Act, including— 

22 (1) the increased use of validated tools for de23 tection of cognitive impairment and Alzheimer’s dis24 ease; 


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1 (2) models undergoing testing and evaluation 

2 under the provisions of, and amendments made by, 

3 sections 3 and 4; 

4 (3) utilization of Alzheimer’s disease diagnostic 

5 and care planning services; and 

6 (4) outreach efforts in the primary care and pa7 tient communities. 

8 SEC. 7. STUDY AND REPORT ON REGULATORY AND LEGIS9 LATIVE CHANGES OR REFINEMENTS THAT 

10 WOULD ACCELERATE ALZHEIMER’S DISEASE 

11 RESEARCH PROGRESS. 

12 (a) IN GENERAL.—The Comptroller General of the 

13 United States (in this section referred to as the ‘‘Comp14 troller General’’) shall conduct a study on regulatory and 

15 legislative changes or refinements that would accelerate 

16 Alzheimer’s disease research progress. In conducting such 

17 study, the Comptroller General shall consult with inter18 ested stakeholders, including industry leaders, researchers, 

19 clinical experts, patient advocacy groups, caregivers, pa20 tients, providers, and State leaders. Such study shall in21 clude an analysis of— 

22 (1) innovative public-private partnerships, inno23 vative financing tools, incentives and other mecha24 nisms to enhance the quality of care for individuals 

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1 tional, financial, and physical burden on familial 

2 care partners, and accelerate development of pre3 ventative, curative, and disease-modifying therapies; 

4 and 

5 (2) the results of any models under the provi6 sions of, and amendments made by, sections 3 and 

7 4 and the feasibility of incorporating into such mod8 els innovative arrangements with research sponsors, 

9 through a user fee or otherwise, to facilitate budget 

10 neutrality or incentivize providers through a shared11 savings approach. 

12 (b) REPORT.—Not later than 1 year after the date 

13 of the enactment of this Act, the Comptroller General shall 

14 submit to Congress a report containing the results of the 

15 study conducted under subsection (a), together with rec16 ommendations for such legislation and administrative ac17 tion as the Comptroller General determines appropriate. 

Æ 


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