II 

116TH CONGRESS 

1ST SESSION S. 1126 

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 

APRIL 10, 2019 

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 2019’’. 


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

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. Medicare quality payment program. 

Sec. 4. Report to Congress on implementation. 

3 (c) FINDINGS.—Congress finds the following: 

4 (1) It is estimated that 5,800,000 million 

5 Americans are living with Alzheimer’s disease in 

6 2019. This includes an estimated 5,600,000 million 

7 people age 65 and older and approximately 200,000 

8 individuals under age 65 who have younger-onset 

9 Alzheimer’s. By 2050, the number of people age 65 

10 and older with Alzheimer’s dementia is projected to 

11 increase to 13,800,000 Americans. 

12 (2) As many as half of the estimated 5,100,000 

13 American seniors with Alzheimer’s disease and other 

14 dementias have never received a diagnosis. 

15 (3) In 2019, it is expected that Alzheimer’s and 

16 related dementias will cost Medicare and Medicaid 

17 $195,000,000,000. By 2050, it is estimated that 

18 overall Alzheimer’s costs will increase to more than 

19 $1,100,000,000,000. 

20 (4) Alzheimer’s exacts an emotional and phys21 ical toll on caregivers, resulting in higher incidence 

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

23 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 2 times more 

5 likely than White Americans to have Alzheimer’s disease and other dementias. Latinos are about 11 6 ⁄2

7 times more likely than White Americans to have Alz8 heimer’s disease and other dementias. According to 

9 the Centers for Disease Control, among people ages 

10 65 and older, African Americans have the highest 

11 prevalence of Alzheimer’s disease and related demen12 tias (13.8 percent), followed by Hispanics (12.2 per13 cent), and non-Hispanic Whites (10.3 percent), 

14 American Indian and Alaska Natives (9.1 percent), 

15 and Asian and Pacific Islanders (8.4 percent). This 

16 higher prevalence translates into a higher death 

17 rate: Alzheimer’s deaths increased 55 percent among 

18 all Americans between 1999 and 2014, while the 

19 number was 107 percent for Latinos and 99 percent 

20 for African Americans. 

21 (6) The latest science reveals there are actions 

22 that can be taken both now and across the lifespan 

23 of an individual to help optimize brain health, reduce 

24 the risk of cognitive decline, and help mitigate symp25 toms. There are also important behavioral and social 


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1 dimensions that could delay cognitive decline and 

2 build a resilient brain. For example, a 2016 study 

3 supported by the National Institutes of Health 

4 found that a diet high in natural plant-based foods 

5 and limited in saturated fats was associated with re6 duced cognitive decline. A 2017 study published by 

7 the Lancet Commission found that physical activity 

8 had a significant protective effect against cognitive 

9 decline. A study supported by the National Insti10 tutes of Health which was published in 2018 found 

11 a connection between lower blood pressure and de12 creased cognitive impairment. An American Acad13 emy of Neurology study recently published found 

14 that physical activity and cognitive activity were 

15 both associated with reduced risk of total dementia. 

16 (7) There are evidence-based, reliable, and Na17 tional Institutes of Health-identified cognitive im18 pairment detection tools that are available on the 

19 Alzheimer’s and Dementia Resources website of the 

20 National Institute on Aging that must replace detec21 tion by direct observation in the Medicare Annual 

22 visits and Welcome to Medicare visits. The National 

23 Institutes of Health-identified tools will allow for ap24 propriate follow-up instead of delaying diagnosis or 

25 impeding opportunities for patients to access timely 


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1 treatment options, including clinical trial participa2 tion. 

3 (8) An early, documented diagnosis, commu4 nicated to the patient and caregiver, enables early 

5 access to care planning services and available med6 ical and nonmedical treatments, and optimizes the 

7 ability of patients to build a care team, participate 

8 in support services, and enroll in clinical trials. 

9 (9) African Americans represent 13 percent of 

10 the United States population, but only 5 percent of 

11 clinical trial participants, and Latinos represent 17 

12 percent of the United States population, but less 

13 than 1 percent of clinical trial participants. Further, 

14 Latinos and African Americans account for only 3.5 

15 percent and 1.2 percent, respectively, of principal in16 vestigators supported by the National Institutes of 

17 Health funding, limiting this perspective in research. 

18 Better recruitment and trial designs are critical to 

19 addressing innovation in Alzheimer’s generally, in20 cluding the underrepresentation of African Ameri21 cans and Latinos. 

22 (10) Inability to identify eligible patients at the 

23 earliest stages of disease is a substantial impediment 

24 to efficient research toward Alzheimer’s disease pre25 vention, treatment, and cure. 


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1 (11) Advancing treatment options to prevent, 

2 treat, or cure Alzheimer’s is an urgent national pri3 ority. 

4 (12) A paradigm shift to drive synergies be5 tween high-value patient care, caregiver support, 

6 brain health promotion, and research initiatives is 

7 our best hope for preventing, treating, and curing 

8 Alzheimer’s disease. 

9 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 

10 THE MEDICARE ANNUAL WELLNESS VISIT 

11 AND INITIAL PREVENTIVE PHYSICAL EXAM12 INATION. 

13 (a) ANNUAL WELLNESS VISIT.— 

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

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

16 amended— 

17 (A) by striking subparagraph (D) and in18 serting the following: 

19 ‘‘(D) Detection of any cognitive impairment or 

20 progression of cognitive impairment that shall— 

21 ‘‘(i) be performed using a cognitive impairment 

22 detection tool identified by the National Institute on 

23 Aging as meeting its criteria for selecting instru24 ments to detect cognitive impairment in the primary 


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1 care setting, and other validated cognitive detection 

2 tools as the Secretary determines; 

3 ‘‘(ii) include documentation of the tool used for 

4 detecting cognitive impairment and results of the as5 sessment in the medical record of the patient; and 

6 ‘‘(iii) take into consideration the tool used, and 

7 results of, any previously performed cognitive im8 pairment detection assessment.’’; 

9 (B) by moving subparagraphs (G) and (H) 

10 two ems to the left; 

11 (C) by redesignating subparagraph (I) as 

12 subparagraph (J); and 

13 (D) by inserting after subparagraph (H) 

14 the following new subparagraph: 

15 ‘‘(I) Referral of patients with detected cognitive 

16 impairment or potential cognitive decline to— 

17 ‘‘(i) appropriate Alzheimer’s disease and 

18 dementia diagnostic services, including amyloid 

19 positron emission tomography, and other medi20 cally accepted diagnostic tests that the Sec21 retary determines are safe and effective; 

22 ‘‘(ii) specialists and other clinicians with 

23 expertise in diagnosing or treating Alzheimer’s 

24 disease and related dementias; 


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1 ‘‘(iii) available community-based services, 

2 including patient and caregiver counseling and 

3 social support services; and 

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

5 (2) EFFECTIVE DATE.—The amendments made 

6 by paragraph (1) shall apply to annual wellness vis7 its furnished on or after January 1, 2020. 

8 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA9 TION.— 

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

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

12 amended by inserting ‘‘detection of any cognitive im13 pairment or progression of cognitive impairment as 

14 described in subparagraph (D) of subsection 

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

16 (I) of such subsection,’’ after ‘‘upon the agreement 

17 with the individual,’’. 

18 (2) EFFECTIVE DATE.—The amendments made 

19 by paragraph (1) shall apply to initial preventive 

20 physical examinations furnished on or after January 

21 1, 2020. 

22 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 

23 Not later than January 1, 2020, the Secretary of 

24 Health and Human Services shall implement Medicare 

25 policies under title XVIII of the Social Security Act (42 


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1 U.S.C. 1395 et seq.), including quality measures and 

2 Medicare Advantage plan rating and risk adjustment 

3 mechanisms, that reflect the public health imperative of— 

4 (1) promoting healthy brain lifestyle choices; 

5 (2) identifying and responding to patient risk 

6 factors for Alzheimer’s disease and related demen7 tias; and 

8 (3) incentivizing providers for— 

9 (A) adequate and reliable cognitive impair10 ment detection in the primary care setting, that 

11 is documented in the electronic health record of 

12 the patient and communicated to the patient; 

13 (B) timely Alzheimer’s disease diagnosis; 

14 and 

15 (C) appropriate care planning services, in16 cluding identification of, and communication 

17 with patients and caregivers regarding, the po18 tential for clinical trial participation. 

19 SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION. 

20 Not later than 3 years after the date of the enact21 ment of this Act, the Secretary of Health and Human 

22 Services shall submit to Congress a report on the imple23 mentation of the provisions of, and amendments made by, 

24 this Act, including— 


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1 (1) the increased use of validated tools for de2 tection of cognitive impairment and Alzheimer’s dis3 ease; 

4 (2) utilization of Alzheimer’s disease diagnostic 

5 and care planning services; and 

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

Æ 


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