Concentrating on High-value Alzheimer’s Needs to Get to an End (CHANGE) Act of 2019

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. 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 2019’’. 6 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 1126 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 5,800,000 million 4 Americans are living with Alzheimer’s disease in 5 2019. This includes an estimated 5,600,000 million 6 people age 65 and older and approximately 200,000 7 individuals under age 65 who have younger-onset 8 Alzheimer’s. By 2050, the number of people age 65 9 and older with Alzheimer’s dementia is projected to 10 increase to 13,800,000 Americans. 11 (2) As many as half of the estimated 5,100,000 12 American seniors with Alzheimer’s disease and other 13 dementias have never received a diagnosis. 14 (3) In 2019, it is expected that Alzheimer’s and 15 related dementias will cost Medicare and Medicaid 16 $195,000,000,000. By 2050, it is estimated that 17 overall Alzheimer’s costs will increase to more than 18 $1,100,000,000,000. 19 (4) Alzheimer’s exacts an emotional and phys- 20 ical toll on caregivers, resulting in higher incidence 21 of heart disease, cancer, depression, and other health 22 consequences. 23 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 1126 IS (5) Alzheimer’s disease disproportionately im- 1 pacts women and people of color. Women are twice 2 as likely to develop Alzheimer’s as they are breast 3 cancer. African Americans are about 2 times more 4 likely than White Americans to have Alzheimer’s dis- 5 ease and other dementias. Latinos are about 11⁄2 6 times more likely than White Americans to have Alz- 7 heimer’s disease and other dementias. According to 8 the Centers for Disease Control, among people ages 9 65 and older, African Americans have the highest 10 prevalence of Alzheimer’s disease and related demen- 11 tias (13.8 percent), followed by Hispanics (12.2 per- 12 cent), and non-Hispanic Whites (10.3 percent), 13 American Indian and Alaska Natives (9.1 percent), 14 and Asian and Pacific Islanders (8.4 percent). This 15 higher prevalence translates into a higher death 16 rate: Alzheimer’s deaths increased 55 percent among 17 all Americans between 1999 and 2014, while the 18 number was 107 percent for Latinos and 99 percent 19 for African Americans. 20 (6) The latest science reveals there are actions 21 that can be taken both now and across the lifespan 22 of an individual to help optimize brain health, reduce 23 the risk of cognitive decline, and help mitigate symp- 24 toms. There are also important behavioral and social 25 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 1126 IS dimensions that could delay cognitive decline and 1 build a resilient brain. For example, a 2016 study 2 supported by the National Institutes of Health 3 found that a diet high in natural plant-based foods 4 and limited in saturated fats was associated with re- 5 duced cognitive decline. A 2017 study published by 6 the Lancet Commission found that physical activity 7 had a significant protective effect against cognitive 8 decline. A study supported by the National Insti- 9 tutes of Health which was published in 2018 found 10 a connection between lower blood pressure and de- 11 creased cognitive impairment. An American Acad- 12 emy of Neurology study recently published found 13 that physical activity and cognitive activity were 14 both associated with reduced risk of total dementia. 15 (7) There are evidence-based, reliable, and Na- 16 tional Institutes of Health-identified cognitive im- 17 pairment detection tools that are available on the 18 Alzheimer’s and Dementia Resources website of the 19 National Institute on Aging that must replace detec- 20 tion by direct observation in the Medicare Annual 21 visits and Welcome to Medicare visits. The National 22 Institutes of Health-identified tools will allow for ap- 23 propriate follow-up instead of delaying diagnosis or 24 impeding opportunities for patients to access timely 25 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 1126 IS treatment options, including clinical trial participa- 1 tion. 2 (8) An early, documented diagnosis, commu- 3 nicated to the patient and caregiver, enables early 4 access to care planning services and available med- 5 ical and nonmedical treatments, and optimizes the 6 ability of patients to build a care team, participate 7 in support services, and enroll in clinical trials. 8 (9) African Americans represent 13 percent of 9 the United States population, but only 5 percent of 10 clinical trial participants, and Latinos represent 17 11 percent of the United States population, but less 12 than 1 percent of clinical trial participants. Further, 13 Latinos and African Americans account for only 3.5 14 percent and 1.2 percent, respectively, of principal in- 15 vestigators supported by the National Institutes of 16 Health funding, limiting this perspective in research. 17 Better recruitment and trial designs are critical to 18 addressing innovation in Alzheimer’s generally, in- 19 cluding the underrepresentation of African Ameri- 20 cans and Latinos. 21 (10) Inability to identify eligible patients at the 22 earliest stages of disease is a substantial impediment 23 to efficient research toward Alzheimer’s disease pre- 24 vention, treatment, and cure. 25 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 1126 IS (11) Advancing treatment options to prevent, 1 treat, or cure Alzheimer’s is an urgent national pri- 2 ority. 3 (12) A paradigm shift to drive synergies be- 4 tween high-value patient care, caregiver support, 5 brain health promotion, and research initiatives is 6 our best hope for preventing, treating, and curing 7 Alzheimer’s disease. 8 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 9 THE MEDICARE ANNUAL WELLNESS VISIT 10 AND INITIAL PREVENTIVE PHYSICAL EXAM- 11 INATION. 12 (a) ANNUAL WELLNESS VISIT.— 13 (1) IN GENERAL.—Section 1861(hhh)(2) of the 14 Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 15 amended— 16 (A) by striking subparagraph (D) and in- 17 serting the following: 18 ‘‘(D) Detection of any cognitive impairment or 19 progression of cognitive impairment that shall— 20 ‘‘(i) be performed using a cognitive impairment 21 detection tool identified by the National Institute on 22 Aging as meeting its criteria for selecting instru- 23 ments to detect cognitive impairment in the primary 24 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 7 •S 1126 IS care setting, and other validated cognitive detection 1 tools as the Secretary determines; 2 ‘‘(ii) include documentation of the tool used for 3 detecting cognitive impairment and results of the as- 4 sessment in the medical record of the patient; and 5 ‘‘(iii) take into consideration the tool used, and 6 results of, any previously performed cognitive im- 7 pairment detection assessment.’’; 8 (B) by moving subparagraphs (G) and (H) 9 two ems to the left; 10 (C) by redesignating subparagraph (I) as 11 subparagraph (J); and 12 (D) by inserting after subparagraph (H) 13 the following new subparagraph: 14 ‘‘(I) Referral of patients with detected cognitive 15 impairment or potential cognitive decline to— 16 ‘‘(i) appropriate Alzheimer’s disease and 17 dementia diagnostic services, including amyloid 18 positron emission tomography, and other medi- 19 cally accepted diagnostic tests that the Sec- 20 retary determines are safe and effective; 21 ‘‘(ii) specialists and other clinicians with 22 expertise in diagnosing or treating Alzheimer’s 23 disease and related dementias; 24 VerDate Sep 11 2014 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 8 •S 1126 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, 2020. 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, 2020. 21 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 22 Not later than January 1, 2020, 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 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 9 •S 1126 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 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS 10 •S 1126 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 21:06 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S1126.IS S1126 pamtmann on DSKBFK8HB2PROD with BILLS