I 

116TH CONGRESS 

1ST SESSION H. R. 2283 

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 

APRIL 10, 2019 

Ms. SA ́NCHEZ (for herself, Mr. LAHOOD, Ms. MATSUI, and Mrs. RODGERS of 

Washington) 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS; FINDINGS. 

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

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

4 to an End Act of 2019’’ or the ‘‘CHANGE Act of 2019’’. 

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

6 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. 

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

8 (1) It is estimated that 5.8 million Americans 

9 are living with Alzheimer’s disease in 2019. This in10 cludes an estimated 5.6 million people age 65 and 

11 older and approximately 200,000 individuals under 

12 age 65 who have younger-onset Alzheimer’s. By 

13 2050, the number of people age 65 and older with 

14 Alzheimer’s dementia is projected to increase to 13.8 

15 million Americans. 

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

17 American seniors with Alzheimer’s disease and other 

18 dementias have never received a diagnosis. 

19 (3) In 2019, it is estimated that Alzheimer’s 

20 and related dementias will have cost the Medicare 

21 and Medicaid programs $195 billion. By 2050, it is 


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1 estimated that these direct costs will increase to as 

2 much as $1.1 trillion. 

3 (4) Alzheimer’s exacts an emotional and phys4 ical toll on caregivers, resulting in higher incidence 

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

6 consequences. 

7 (5) Alzheimer’s disease disproportionately im8 pacts women and people of color. Women are twice 

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

10 cancer. African Americans are about two times more 

11 likely than White Americans to have Alzheimer’s dis12 ease and other dementias. Latinos are about one 

13 and one-half times more likely than White Ameri14 cans to have Alzheimer’s disease and other demen15 tias. According to the Centers for Disease Control 

16 and Prevention, among people ages 65 and older, 

17 African Americans have the highest prevalence of 

18 Alzheimer’s disease and related dementias (13.8 per19 cent), followed by Hispanics (12.2 percent), and 

20 non-Hispanic Whites (10.3 percent), American In21 dian and Alaska Natives (9.1 percent), and Asian 

22 and Pacific Islanders (8.4 percent). This higher 

23 prevalence translates into a higher death rate: Alz24 heimer’s deaths increased 55 percent among all 

25 Americans between 1999 and 2014, while the numVerDate Sep 11 2014 19:43 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2283.IH H2283

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1 ber was 107 percent for Latinos and 99 percent for 

2 African Americans. 

3 (6) There are evidence-based, reliable, and 

4 NIH-identified cognitive impairment detection tools 

5 available at the National Institute on Aging’s Alz6 heimer’s and Dementia Resources for Professionals 

7 website that must replace detection by direct obser8 vation in the Medicare Annual visits and Welcome to 

9 Medicare visits. The NIH-identified tools will allow 

10 for appropriate follow-up instead of delaying diag11 nosis or impeding opportunities for patients to ac12 cess timely treatment options, including clinical trial 

13 participation. 

14 (7) An early, documented diagnosis, commu15 nicated to the patient and caregiver, enables early 

16 access to care planning services and available med17 ical and nonmedical treatments, and optimizes pa18 tients’ ability to build a care team, participate in 

19 support services, and enroll in clinical trials. 

20 (8) African Americans represent 13 percent of 

21 the population of the United States but only 5 per22 cent of clinical trial participants, and Latinos rep23 resent 17 percent of the population of the United 

24 States but less than one percent of clinical trial par25 ticipants. Further, Latinos and African Americans 


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1 account for only 3.5 percent and 1.2 percent, respec2 tively, of principal investigators supported by the 

3 National Institutes of Health funding, limiting this 

4 perspective in research. Better recruitment and trial 

5 designs are critical to addressing innovation in Alz6 heimer’s generally, including the underrepresentation 

7 of African Americans and Latinos. 

8 (9) Inability to identify eligible patients at the 

9 earliest stages of disease is a substantial impediment 

10 to efficient research toward Alzheimer’s disease pre11 vention, treatment, and cure. 

12 (10) Advancing treatment options to prevent, 

13 treat, or cure Alzheimer’s is an urgent national pri14 ority. 

15 (11) A paradigm shift to drive synergies be16 tween high-value patient care, caregiver support, 

17 brain health promotion, and research initiatives is 

18 our best hope for preventing, treating, and curing 

19 Alzheimer’s disease. 

20 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 

21 THE MEDICARE ANNUAL WELLNESS VISIT 

22 AND INITIAL PREVENTIVE PHYSICAL EXAM23 INATION. 

24 (a) ANNUAL WELLNESS VISIT.— 


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

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

3 amended— 

4 (A) by striking subparagraph (D) and in5 serting the following: 

6 ‘‘(D) Detection of any cognitive impair7 ment or progression of cognitive impairment 

8 that shall— 

9 ‘‘(i) be performed using a cognitive 

10 impairment detection tool identified by the 

11 National Institute on Aging as meeting its 

12 criteria for selecting instruments to detect 

13 cognitive impairment in the primary care 

14 setting, and other validated cognitive de15 tection tools as the Secretary determines; 

16 ‘‘(ii) include documentation of the tool 

17 used for detecting cognitive impairment 

18 and results of the assessment in the pa19 tient’s medical record; and 

20 ‘‘(iii) take into consideration the tool 

21 used, and results of, any previously per22 formed cognitive impairment detection as23 sessment.’’; 

24 (B) by redesignating subparagraph (I) as 

25 subparagraph (J); and 


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1 (C) by inserting after subparagraph (H) 

2 the following new subparagraph: 

3 ‘‘(I) Referral of patients with detected cog4 nitive impairment or potential cognitive decline 

5 to— 

6 ‘‘(i) appropriate Alzheimer’s disease 

7 and dementia diagnostic services, including 

8 amyloid positron emission tomography, and 

9 other medically accepted diagnostic tests 

10 that the Secretary determines are safe and 

11 effective; 

12 ‘‘(ii) specialists and other clinicians 

13 with expertise in diagnosing or treating 

14 Alzheimer’s disease and related dementias; 

15 ‘‘(iii) available community-based serv16 ices, including patient and caregiver coun17 seling and social support services; and 

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

19 (2) EFFECTIVE DATE.—The amendments made 

20 by paragraph (1) shall apply to annual wellness vis21 its furnished on or after January 1, 2020. 

22 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA23 TION.— 

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

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


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1 amended by striking ‘‘agreement with the individual, 

2 and’’ and inserting ‘‘agreement with the individual, 

3 detection of any cognitive impairment or progression 

4 of cognitive impairment as described in subpara5 graph (D) of subsection (hhh)(2) and referrals as 

6 described in subparagraph (I) of such subsection, 

7 and’’. 

8 (2) EFFECTIVE DATE.—The amendments made 

9 by paragraph (1) shall apply to initial preventive 

10 physical examinations furnished on or after January 

11 1, 2020. 

12 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 

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

14 Health and Human Services shall implement Medicare 

15 policies under title XVIII of the Social Security Act, in16 cluding quality measures and Medicare Advantage plan 

17 rating and risk adjustment mechanisms, that reflect the 

18 public health imperative of— 

19 (1) promoting healthy brain lifestyle choices; 

20 (2) identifying and responding to patient risk 

21 factors for Alzheimer’s disease and related demen22 tias; and 

23 (3) incentivizing providers for— 

24 (A) adequate and reliable cognitive impair25 ment detection in the primary care setting, that 


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1 is documented in the patient’s electronic health 

2 record and communicated to the patient; 

3 (B) timely Alzheimer’s disease diagnosis; 

4 and 

5 (C) appropriate care planning services, in6 cluding identification of, and communication 

7 with patients and caregivers about, the poten8 tial for clinical trial participation. 

9 SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION OF 

10 THIS ACT. 

11 Not later than 3 years after the date of the enact12 ment of this Act, the Secretary of Health and Human 

13 Services shall submit a report to Congress on the imple14 mentation of the provisions of, and amendments made by, 

15 this Act, including— 

16 (1) the increased use of validated tools for de17 tection of cognitive impairment and Alzheimer’s dis18 ease; 

19 (2) utilization of Alzheimer’s disease diagnostic 

20 and care planning services; and 

21 (3) outreach efforts in the primary care and pa22 tient communities. 


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1 SEC. 5. STUDY AND REPORT ON REGULATORY AND LEGIS2 LATIVE CHANGES OR REFINEMENTS THAT 

3 WOULD ACCELERATE ALZHEIMER’S DISEASE 

4 RESEARCH PROGRESS. 

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

6 United States (in this section referred to as the ‘‘Comp7 troller General’’) shall conduct a study on regulatory and 

8 legislative changes or refinements that would accelerate 

9 Alzheimer’s disease research progress. In conducting such 

10 study, the Comptroller General shall consult with inter11 ested stakeholders, including industry leaders, researchers, 

12 clinical experts, patient advocacy groups, caregivers, pa13 tients, providers, and State leaders. Such study shall in14 clude an analysis of innovative public-private partnerships, 

15 innovative financing tools, incentives, and other mecha16 nisms to enhance the quality of care for individuals diag17 nosed with Alzheimer’s disease, reduce the emotional, fi18 nancial, and physical burden on familial care partners, 

19 and accelerate development of preventative, curative, and 

20 disease-modifying therapies. 

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

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

23 submit to Congress a report containing the results of the 

24 study conducted under subsection (a), together with recVerDate Sep 11 2014 19:43 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2283.IH H2283

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1 ommendations for such legislation and administrative ac2 tion as the Comptroller General determines appropriate. 

Æ 


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