I 

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. SA ́NCHEZ (for herself, Mr. LAHOOD, Ms. MATSUI, Mr. UPTON, Ms. 

SHERRILL, Ms. BARRAGA ́N, 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. 

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 2021’’ or the ‘‘CHANGE Act of 2021’’. 

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 6.2 million Americans 

9 age 65 and older are living with Alzheimer’s disease 

10 in 2021. More than one in nine people age 65 and 

11 older has Alzheimer’s. By 2050, the number of 

12 Americans age 65 and older with Alzheimer’s de13 mentia is projected to reach 12.7 million. 

14 (2) Alzheimer’s disease disproportionately im15 pacts women and people of color. 

16 (3) Almost two-thirds of Americans with Alz17 heimer’s disease are women. 

18 (4) According to the Centers for Disease Con19 trol and Prevention, among people ages 65 and 

20 older, African Americans have the highest prevalence 

21 of Alzheimer’s disease and related dementias (13.8 

22 percent), followed by Hispanics (12.2 percent), and 


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1 non-Hispanic Whites (10.3 percent), American In2 dian and Alaska Natives (9.1 percent), and Asian 

3 and Pacific Islanders (8.4 percent). This higher 

4 prevalence translates into a higher death rate: Alz5 heimer’s deaths increased 55 percent among all 

6 Americans between 1999 and 2014, while the num7 ber was 107 percent for Latinos and 99 percent for 

8 African Americans. 

9 (5) Currently available data shows that about 

10 half of individuals age 65 and older with mild cog11 nitive impairment (MCI)—roughly 5 million Ameri12 cans—have MCI due to Alzheimer’s disease. Ap13 proximately 15 percent of individuals with MCI de14 velop dementia after two years and 32 percent de15 velop Alzheimer’s dementia within five years’ follow16 up. 

17 (6) Addressing modifiable risk factors such as 

18 physical activity, smoking, education, staying socially 

19 and mentally active, blood pressure, and diet might 

20 prevent or delay up to 40 percent of dementia cases. 

21 (7) An early, documented diagnosis, commu22 nicated to the patient and caregiver, enables early 

23 access to care planning services and available med24 ical and nonmedical treatments, and optimizes paVerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354

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1 tients’ ability to build a care team, participate in 

2 support services, and enroll in clinical trials. 

3 (8) 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 (9) More than 11 million Americans provide un8 paid care for people with Alzheimer’s or other de9 mentia and provided nearly $257 billion in unpaid 

10 care to people living with Alzheimer’s and other de11 mentias in 2020. 

12 (10) In 2021, it is estimated that Alzheimer’s 

13 and related dementias will have cost Medicare and 

14 Medicaid programs $239 billion. By 2050, it is esti15 mated that these direct costs will increase to as 

16 much as $1.1 trillion. 

17 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 

18 THE MEDICARE ANNUAL WELLNESS VISIT 

19 AND INITIAL PREVENTIVE PHYSICAL EXAM20 INATION. 

21 (a) ANNUAL WELLNESS VISIT.— 

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

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

24 amended— 


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1 (A) by striking subparagraph (D) and in2 serting the following: 

3 ‘‘(D) Detection of any cognitive impair4 ment or progression of cognitive impairment 

5 that shall— 

6 ‘‘(i) be performed using a cognitive 

7 impairment detection tool identified by the 

8 National Institute on Aging as meeting its 

9 criteria for selecting instruments to detect 

10 cognitive impairment in the primary care 

11 setting, and other validated cognitive de12 tection tools as the Secretary determines; 

13 ‘‘(ii) include documentation of the tool 

14 used for detecting cognitive impairment 

15 and results of the assessment in the pa16 tient’s medical record; and 

17 ‘‘(iii) take into consideration the tool 

18 used, and results of, any previously per19 formed cognitive impairment detection as20 sessment.’’; 

21 (B) by redesignating subparagraph (I) as 

22 subparagraph (J); and 

23 (C) by inserting after subparagraph (H) 

24 the following new subparagraph: 


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1 ‘‘(I) Referral of patients with detected cog2 nitive impairment or potential cognitive decline 

3 to— 

4 ‘‘(i) appropriate Alzheimer’s disease 

5 and dementia diagnostic services, including 

6 amyloid positron emission tomography, and 

7 other medically accepted diagnostic tests 

8 that the Secretary determines are safe and 

9 effective; 

10 ‘‘(ii) specialists and other clinicians 

11 with expertise in diagnosing or treating 

12 Alzheimer’s disease and related dementias; 

13 ‘‘(iii) available community-based serv14 ices, including patient and caregiver coun15 seling and social support services; and 

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

17 (2) EFFECTIVE DATE.—The amendments made 

18 by paragraph (1) shall apply to annual wellness vis19 its furnished on or after January 1, 2022. 

20 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA21 TION.— 

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

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

24 amended by striking ‘‘agreement with the individual, 

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


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1 detection of any cognitive impairment or progression 

2 of cognitive impairment as described in subpara3 graph (D) of subsection (hhh)(2) and referrals as 

4 described in subparagraph (I) of such subsection, 

5 and’’. 

6 (2) EFFECTIVE DATE.—The amendments made 

7 by paragraph (1) shall apply to initial preventive 

8 physical examinations furnished on or after January 

9 1, 2022. 

10 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 

11 Not later than January 1, 2022, the Secretary of 

12 Health and Human Services shall implement Medicare 

13 policies under title XVIII of the Social Security Act, in14 cluding quality measures and Medicare Advantage plan 

15 rating and risk adjustment mechanisms, that reflect the 

16 public health imperative of— 

17 (1) promoting healthy brain lifestyle choices; 

18 (2) identifying and responding to patient risk 

19 factors for Alzheimer’s disease and related demen20 tias; and 

21 (3) incentivizing providers for— 

22 (A) adequate and reliable cognitive impair23 ment detection in the primary care setting, that 

24 is documented in the patient’s electronic health 

25 record and communicated to the patient; 


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1 (B) timely Alzheimer’s disease diagnosis; 

2 and 

3 (C) appropriate care planning services, in4 cluding identification of, and communication 

5 with patients and caregivers about, the poten6 tial for clinical trial participation. 

7 SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION OF 

8 THIS ACT. 

9 Not later than 3 years after the date of the enact10 ment of this Act, the Secretary of Health and Human 

11 Services shall submit a report to Congress on the imple12 mentation of the provisions of, and amendments made by, 

13 this Act, including— 

14 (1) the increased use of validated tools for de15 tection of cognitive impairment and Alzheimer’s dis16 ease; 

17 (2) utilization of Alzheimer’s disease diagnostic 

18 and care planning services; and 

19 (3) outreach efforts in the primary care and pa20 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 

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

Æ 


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