I 117th CONGRESS 1st Session H. R. 3354 IN THE HOUSE OF REPRESENTATIVES May 19, 2021 Ms. Sánchez (for herself, Mr. LaHood , Ms. Matsui , Mr. Upton , Ms. Sherrill , Ms. Barragán , 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. Short title; table of contents; findings (a) Short title This Act may be cited as the Concentrating on High-value Alzheimer’s Needs to Get to an End Act of 2021 or the CHANGE Act of 2021 . (b) Table of contents The table of contents of 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. (c) Findings Congress finds as follows: (1) It is estimated that 6.2 million Americans age 65 and older are living with Alzheimer’s disease in 2021. More than one in nine people age 65 and older has Alzheimer’s. By 2050, the number of Americans age 65 and older with Alzheimer’s dementia is projected to reach 12.7 million. (2) Alzheimer’s disease disproportionately impacts women and people of color. (3) Almost two-thirds of Americans with Alzheimer’s disease are women. (4) According to the Centers for Disease Control and Prevention, among people ages 65 and older, African Americans have the highest prevalence of Alzheimer’s disease and related dementias (13.8 percent), followed by Hispanics (12.2 percent), and non-Hispanic Whites (10.3 percent), American Indian and Alaska Natives (9.1 percent), and Asian and Pacific Islanders (8.4 percent). This higher prevalence translates into a higher death rate: Alzheimer’s deaths increased 55 percent among all Americans between 1999 and 2014, while the number was 107 percent for Latinos and 99 percent for African Americans. (5) Currently available data shows that about half of individuals age 65 and older with mild cognitive impairment (MCI)—roughly 5 million Americans—have MCI due to Alzheimer’s disease. Approximately 15 percent of individuals with MCI develop dementia after two years and 32 percent develop Alzheimer’s dementia within five years’ follow-up. (6) Addressing modifiable risk factors such as physical activity, smoking, education, staying socially and mentally active, blood pressure, and diet might prevent or delay up to 40 percent of dementia cases. (7) An early, documented diagnosis, communicated to the patient and caregiver, enables early access to care planning services and available medical and nonmedical treatments, and optimizes patients’ ability to build a care team, participate in support services, and enroll in clinical trials. (8) Alzheimer’s exacts an emotional and physical toll on caregivers, resulting in higher incidence of heart disease, cancer, depression, and other health consequences. (9) More than 11 million Americans provide unpaid care for people with Alzheimer’s or other dementia and provided nearly $257 billion in unpaid care to people living with Alzheimer’s and other dementias in 2020. (10) In 2021, it is estimated that Alzheimer’s and related dementias will have cost Medicare and Medicaid programs $239 billion. By 2050, it is estimated that these direct costs will increase to as much as $1.1 trillion. 2. Cognitive impairment detection benefit in the Medicare annual wellness visit and initial preventive physical examination (a) Annual wellness visit (1) In general Section 1861(hhh)(2) of the Social Security Act ( 42 U.S.C. 1395x(hhh)(2) ) is amended— (A) by striking subparagraph (D) and inserting the following: (D) Detection of any cognitive impairment or progression of cognitive impairment that shall— (i) be performed using a cognitive impairment detection tool identified by the National Institute on Aging as meeting its criteria for selecting instruments to detect cognitive impairment in the primary care setting, and other validated cognitive detection tools as the Secretary determines; (ii) include documentation of the tool used for detecting cognitive impairment and results of the assessment in the patient’s medical record; and (iii) take into consideration the tool used, and results of, any previously performed cognitive impairment detection assessment. ; (B) by redesignating subparagraph (I) as subparagraph (J); and (C) by inserting after subparagraph (H) the following new subparagraph: (I) Referral of patients with detected cognitive impairment or potential cognitive decline to— (i) appropriate Alzheimer’s disease and dementia diagnostic services, including amyloid positron emission tomography, and other medically accepted diagnostic tests that the Secretary determines are safe and effective; (ii) specialists and other clinicians with expertise in diagnosing or treating Alzheimer’s disease and related dementias; (iii) available community-based services, including patient and caregiver counseling and social support services; and (iv) appropriate clinical trials. . (2) Effective date The amendments made by paragraph (1) shall apply to annual wellness visits furnished on or after January 1, 2022. (b) Initial preventive physical examination (1) In general Section 1861(ww)(1) of the Social Security Act ( 42 U.S.C. 1395x(ww)(1) ) is amended by striking agreement with the individual, and and inserting agreement with the individual, detection of any cognitive impairment or progression of cognitive impairment as described in subparagraph (D) of subsection (hhh)(2) and referrals as described in subparagraph (I) of such subsection, and . (2) Effective date The amendments made by paragraph (1) shall apply to initial preventive physical examinations furnished on or after January 1, 2022. 3. Medicare quality payment program Not later than January 1, 2022, the Secretary of Health and Human Services shall implement Medicare policies under title XVIII of the Social Security Act, including quality measures and Medicare Advantage plan rating and risk adjustment mechanisms, that reflect the public health imperative of— (1) promoting healthy brain lifestyle choices; (2) identifying and responding to patient risk factors for Alzheimer’s disease and related dementias; and (3) incentivizing providers for— (A) adequate and reliable cognitive impairment detection in the primary care setting, that is documented in the patient’s electronic health record and communicated to the patient; (B) timely Alzheimer’s disease diagnosis; and (C) appropriate care planning services, including identification of, and communication with patients and caregivers about, the potential for clinical trial participation. 4. Report to Congress on implementation of this Act Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit a report to Congress on the implementation of the provisions of, and amendments made by, this Act, including— (1) the increased use of validated tools for detection of cognitive impairment and Alzheimer’s disease; (2) utilization of Alzheimer’s disease diagnostic and care planning services; and (3) outreach efforts in the primary care and patient communities. 5. Study and report on regulatory and legislative changes or refinements that would accelerate Alzheimer’s disease research progress (a) In general The Comptroller General of the United States (in this section referred to as the Comptroller General ) shall conduct a study on regulatory and legislative changes or refinements that would accelerate Alzheimer’s disease research progress. In conducting such study, the Comptroller General shall consult with interested stakeholders, including industry leaders, researchers, clinical experts, patient advocacy groups, caregivers, patients, providers, and State leaders. Such study shall include an analysis of innovative public-private partnerships, innovative financing tools, incentives, and other mechanisms to enhance the quality of care for individuals diagnosed with Alzheimer’s disease, reduce the emotional, financial, and physical burden on familial care partners, and accelerate development of preventative, curative, and disease-modifying therapies. (b) Report Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.