CHANGE Act of 2021

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 sub- sequently 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3354 IH SECTION 1. SHORT TITLE; TABLE OF CONTENTS; FINDINGS. 1 (a) SHORT TITLE.—This Act may be cited as the 2 ‘‘Concentrating on High-value Alzheimer’s Needs to Get 3 to an End Act of 2021’’ or the ‘‘CHANGE Act of 2021’’. 4 (b) TABLE OF CONTENTS.—The table of contents of 5 this Act is as follows: 6 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. (c) FINDINGS.—Congress finds as follows: 7 (1) It is estimated that 6.2 million Americans 8 age 65 and older are living with Alzheimer’s disease 9 in 2021. More than one in nine people age 65 and 10 older has Alzheimer’s. By 2050, the number of 11 Americans age 65 and older with Alzheimer’s de- 12 mentia is projected to reach 12.7 million. 13 (2) Alzheimer’s disease disproportionately im- 14 pacts women and people of color. 15 (3) Almost two-thirds of Americans with Alz- 16 heimer’s disease are women. 17 (4) According to the Centers for Disease Con- 18 trol and Prevention, among people ages 65 and 19 older, African Americans have the highest prevalence 20 of Alzheimer’s disease and related dementias (13.8 21 percent), followed by Hispanics (12.2 percent), and 22 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3354 IH non-Hispanic Whites (10.3 percent), American In- 1 dian and Alaska Natives (9.1 percent), and Asian 2 and Pacific Islanders (8.4 percent). This higher 3 prevalence translates into a higher death rate: Alz- 4 heimer’s deaths increased 55 percent among all 5 Americans between 1999 and 2014, while the num- 6 ber was 107 percent for Latinos and 99 percent for 7 African Americans. 8 (5) Currently available data shows that about 9 half of individuals age 65 and older with mild cog- 10 nitive impairment (MCI)—roughly 5 million Ameri- 11 cans—have MCI due to Alzheimer’s disease. Ap- 12 proximately 15 percent of individuals with MCI de- 13 velop dementia after two years and 32 percent de- 14 velop Alzheimer’s dementia within five years’ follow- 15 up. 16 (6) Addressing modifiable risk factors such as 17 physical activity, smoking, education, staying socially 18 and mentally active, blood pressure, and diet might 19 prevent or delay up to 40 percent of dementia cases. 20 (7) An early, documented diagnosis, commu- 21 nicated to the patient and caregiver, enables early 22 access to care planning services and available med- 23 ical and nonmedical treatments, and optimizes pa- 24 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3354 IH tients’ ability to build a care team, participate in 1 support services, and enroll in clinical trials. 2 (8) Alzheimer’s exacts an emotional and phys- 3 ical toll on caregivers, resulting in higher incidence 4 of heart disease, cancer, depression, and other health 5 consequences. 6 (9) More than 11 million Americans provide un- 7 paid care for people with Alzheimer’s or other de- 8 mentia and provided nearly $257 billion in unpaid 9 care to people living with Alzheimer’s and other de- 10 mentias in 2020. 11 (10) In 2021, it is estimated that Alzheimer’s 12 and related dementias will have cost Medicare and 13 Medicaid programs $239 billion. By 2050, it is esti- 14 mated that these direct costs will increase to as 15 much as $1.1 trillion. 16 SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN 17 THE MEDICARE ANNUAL WELLNESS VISIT 18 AND INITIAL PREVENTIVE PHYSICAL EXAM- 19 INATION. 20 (a) ANNUAL WELLNESS VISIT.— 21 (1) IN GENERAL.—Section 1861(hhh)(2) of the 22 Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 23 amended— 24 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3354 IH (A) by striking subparagraph (D) and in- 1 serting the following: 2 ‘‘(D) Detection of any cognitive impair- 3 ment or progression of cognitive impairment 4 that shall— 5 ‘‘(i) be performed using a cognitive 6 impairment detection tool identified by the 7 National Institute on Aging as meeting its 8 criteria for selecting instruments to detect 9 cognitive impairment in the primary care 10 setting, and other validated cognitive de- 11 tection tools as the Secretary determines; 12 ‘‘(ii) include documentation of the tool 13 used for detecting cognitive impairment 14 and results of the assessment in the pa- 15 tient’s medical record; and 16 ‘‘(iii) take into consideration the tool 17 used, and results of, any previously per- 18 formed cognitive impairment detection as- 19 sessment.’’; 20 (B) by redesignating subparagraph (I) as 21 subparagraph (J); and 22 (C) by inserting after subparagraph (H) 23 the following new subparagraph: 24 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3354 IH ‘‘(I) Referral of patients with detected cog- 1 nitive impairment or potential cognitive decline 2 to— 3 ‘‘(i) appropriate Alzheimer’s disease 4 and dementia diagnostic services, including 5 amyloid positron emission tomography, and 6 other medically accepted diagnostic tests 7 that the Secretary determines are safe and 8 effective; 9 ‘‘(ii) specialists and other clinicians 10 with expertise in diagnosing or treating 11 Alzheimer’s disease and related dementias; 12 ‘‘(iii) available community-based serv- 13 ices, including patient and caregiver coun- 14 seling and social support services; and 15 ‘‘(iv) appropriate clinical trials.’’. 16 (2) EFFECTIVE DATE.—The amendments made 17 by paragraph (1) shall apply to annual wellness vis- 18 its furnished on or after January 1, 2022. 19 (b) INITIAL PREVENTIVE PHYSICAL EXAMINA- 20 TION.— 21 (1) IN GENERAL.—Section 1861(ww)(1) of the 22 Social Security Act (42 U.S.C. 1395x(ww)(1)) is 23 amended by striking ‘‘agreement with the individual, 24 and’’ and inserting ‘‘agreement with the individual, 25 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 3354 IH detection of any cognitive impairment or progression 1 of cognitive impairment as described in subpara- 2 graph (D) of subsection (hhh)(2) and referrals as 3 described in subparagraph (I) of such subsection, 4 and’’. 5 (2) EFFECTIVE DATE.—The amendments made 6 by paragraph (1) shall apply to initial preventive 7 physical examinations furnished on or after January 8 1, 2022. 9 SEC. 3. MEDICARE QUALITY PAYMENT PROGRAM. 10 Not later than January 1, 2022, the Secretary of 11 Health and Human Services shall implement Medicare 12 policies under title XVIII of the Social Security Act, in- 13 cluding quality measures and Medicare Advantage plan 14 rating and risk adjustment mechanisms, that reflect the 15 public health imperative of— 16 (1) promoting healthy brain lifestyle choices; 17 (2) identifying and responding to patient risk 18 factors for Alzheimer’s disease and related demen- 19 tias; and 20 (3) incentivizing providers for— 21 (A) adequate and reliable cognitive impair- 22 ment detection in the primary care setting, that 23 is documented in the patient’s electronic health 24 record and communicated to the patient; 25 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 3354 IH (B) timely Alzheimer’s disease diagnosis; 1 and 2 (C) appropriate care planning services, in- 3 cluding identification of, and communication 4 with patients and caregivers about, the poten- 5 tial for clinical trial participation. 6 SEC. 4. REPORT TO CONGRESS ON IMPLEMENTATION OF 7 THIS ACT. 8 Not later than 3 years after the date of the enact- 9 ment of this Act, the Secretary of Health and Human 10 Services shall submit a report to Congress on the imple- 11 mentation of the provisions of, and amendments made by, 12 this Act, including— 13 (1) the increased use of validated tools for de- 14 tection of cognitive impairment and Alzheimer’s dis- 15 ease; 16 (2) utilization of Alzheimer’s disease diagnostic 17 and care planning services; and 18 (3) outreach efforts in the primary care and pa- 19 tient communities. 20 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 3354 IH SEC. 5. STUDY AND REPORT ON REGULATORY AND LEGIS- 1 LATIVE CHANGES OR REFINEMENTS THAT 2 WOULD ACCELERATE ALZHEIMER’S DISEASE 3 RESEARCH PROGRESS. 4 (a) IN GENERAL.—The Comptroller General of the 5 United States (in this section referred to as the ‘‘Comp- 6 troller General’’) shall conduct a study on regulatory and 7 legislative changes or refinements that would accelerate 8 Alzheimer’s disease research progress. In conducting such 9 study, the Comptroller General shall consult with inter- 10 ested stakeholders, including industry leaders, researchers, 11 clinical experts, patient advocacy groups, caregivers, pa- 12 tients, providers, and State leaders. Such study shall in- 13 clude an analysis of innovative public-private partnerships, 14 innovative financing tools, incentives, and other mecha- 15 nisms to enhance the quality of care for individuals diag- 16 nosed with Alzheimer’s disease, reduce the emotional, fi- 17 nancial, and physical burden on familial care partners, 18 and accelerate development of preventative, curative, and 19 disease-modifying therapies. 20 (b) REPORT.—Not later than 1 year after the date 21 of the enactment of this Act, the Comptroller General shall 22 submit to Congress a report containing the results of the 23 study conducted under subsection (a), together with rec- 24 VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 3354 IH ommendations for such legislation and administrative ac- 1 tion as the Comptroller General determines appropriate. 2 Æ VerDate Sep 11 2014 00:43 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H3354.IH H3354 kjohnson on DSK79L0C42PROD with BILLS