Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1692 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 MAY 19, 2021 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS; FINDINGS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Concentrating on High-Value Alzheimer’s Needs to Get 5 to an End (CHANGE) Act of 2021’’. 6 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1692 IS (b) TABLE OF CONTENTS.—The table of contents for 1 this Act is as follows: 2 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. (c) FINDINGS.—Congress finds the following: 3 (1) It is estimated that 6,200,000 Americans 4 age 65 and older are living with Alzheimer’s disease 5 in 2021. More than 1 in 9 people age 65 and older 6 has Alzheimer’s. By 2050, the number of Americans 7 age 65 and older with Alzheimer’s dementia is pro- 8 jected to reach 12,700,000. 9 (2) Alzheimer’s disease disproportionately im- 10 pacts women and people of color. 11 (3) Almost two-thirds of Americans with Alz- 12 heimer’s disease are women. 13 (4) According to the Centers for Disease Con- 14 trol and Prevention, among people ages 65 and 15 older, African Americans have the highest prevalence 16 of Alzheimer’s disease and related dementias (13.8 17 percent), followed by Hispanics (12.2 percent), and 18 non-Hispanic Whites (10.3 percent), American In- 19 dian and Alaska Natives (9.1 percent), and Asian 20 and Pacific Islanders (8.4 percent). This higher 21 prevalence translates into a higher death rate—Alz- 22 heimer’s deaths increased 55 percent among all 23 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1692 IS Americans between 1999 and 2014, while the num- 1 ber was 107 percent for Latinos and 99 percent for 2 African Americans. 3 (5) Currently available data shows that about 4 half of individuals age 65 and older with mild cog- 5 nitive impairment (MCI)—roughly 5,000,000 Ameri- 6 cans—have MCI due to Alzheimer’s disease. Ap- 7 proximately 15 percent of individuals with MCI de- 8 velop dementia after 2 years and 32 percent develop 9 Alzheimer’s dementia within 5 years’ follow-up. 10 (6) Addressing modifiable risk factors such as 11 physical activity, smoking, education, staying socially 12 and mentally active, blood pressure, and diet might 13 prevent or delay up to 40 percent of dementia cases. 14 (7) An early, documented diagnosis, commu- 15 nicated to the patient and caregiver, enables early 16 access to care planning services and available med- 17 ical and nonmedical treatments, and optimizes pa- 18 tients’ ability to build a care team, participate in 19 support services, and enroll in clinical trials. 20 (8) Alzheimer’s exacts an emotional and phys- 21 ical toll on caregivers, resulting in higher incidence 22 of heart disease, cancer, depression, and other health 23 consequences. 24 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1692 IS (9) More than 11,000,000 Americans provide 1 unpaid care for people with Alzheimer’s or other de- 2 mentia and provided nearly $257,000,000,000 in un- 3 paid care to people living with Alzheimer’s and other 4 dementias in 2020. 5 (10) In 2021, it is estimated that Alzheimer’s 6 and related dementias will have cost Medicare and 7 Medicaid programs $239,000,000,000. By 2050, it 8 is estimated that these direct costs will increase to 9 as much as $1,100,000,000,000. 10 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 11 THE MEDICARE ANNUAL WELLNESS VISIT 12 AND INITIAL PREVENTIVE PHYSICAL EXAM- 13 INATION. 14 (a) ANNUAL WELLNESS VISIT.— 15 (1) IN GENERAL.—Section 1861(hhh)(2) of the 16 Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 17 amended— 18 (A) by striking subparagraph (D) and in- 19 serting the following: 20 ‘‘(D) Detection of any cognitive impairment or 21 progression of cognitive impairment that shall— 22 ‘‘(i) be performed using a cognitive impairment 23 detection tool identified by the National Institute on 24 Aging as meeting its criteria for selecting instru- 25 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1692 IS ments to detect cognitive impairment in the primary 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 as- 5 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 im- 8 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 medi- 20 cally accepted diagnostic tests that the Sec- 21 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; 25 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1692 IS ‘‘(iii) available community-based services, 1 including patient and caregiver counseling and 2 social support services; and 3 ‘‘(iv) appropriate clinical trials.’’. 4 (2) EFFECTIVE DATE.—The amendments made 5 by paragraph (1) shall apply to annual wellness vis- 6 its furnished on or after January 1, 2022. 7 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA- 8 TION.— 9 (1) IN GENERAL.—Section 1861(ww)(1) of the 10 Social Security Act (42 U.S.C. 1395x(ww)(1)) is 11 amended by inserting ‘‘detection of any cognitive im- 12 pairment or progression of cognitive impairment as 13 described in subparagraph (D) of subsection 14 (hhh)(2) and referrals as described in subparagraph 15 (I) of such subsection,’’ after ‘‘upon the agreement 16 with the individual,’’. 17 (2) EFFECTIVE DATE.—The amendments made 18 by paragraph (1) shall apply to initial preventive 19 physical examinations furnished on or after January 20 1, 2022. 21 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 22 Not later than January 1, 2022, the Secretary of 23 Health and Human Services shall implement Medicare 24 policies under title XVIII of the Social Security Act (42 25 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1692 IS U.S.C. 1395 et seq.), including quality measures and 1 Medicare Advantage plan rating and risk adjustment 2 mechanisms, that reflect the public health imperative of— 3 (1) promoting healthy brain lifestyle choices; 4 (2) identifying and responding to patient risk 5 factors for Alzheimer’s disease and related demen- 6 tias; and 7 (3) incentivizing providers for— 8 (A) adequate and reliable cognitive impair- 9 ment detection in the primary care setting, that 10 is documented in the electronic health record of 11 the patient and communicated to the patient; 12 (B) timely Alzheimer’s disease diagnosis; 13 and 14 (C) appropriate care planning services, in- 15 cluding identification of, and communication 16 with patients and caregivers regarding, the po- 17 tential for clinical trial participation. 18 SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION. 19 Not later than 3 years after the date of the enact- 20 ment of this Act, the Secretary of Health and Human 21 Services shall submit to Congress a report on the imple- 22 mentation of the provisions of, and amendments made by, 23 this Act, including— 24 VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1692 IS (1) the increased use of validated tools for de- 1 tection of cognitive impairment and Alzheimer’s dis- 2 ease; 3 (2) utilization of Alzheimer’s disease diagnostic 4 and care planning services; and 5 (3) outreach efforts in the primary care and pa- 6 tient communities. 7 Æ VerDate Sep 11 2014 02:24 May 28, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\S1692.IS S1692 kjohnson on DSK79L0C42PROD with BILLS