CHANGE Act of 2021
Bill: H.R.3354 | Sponsor: Rep. Sánchez, Linda T. (D-CA)
Policy area: Health

Summary:
Concentrating on High-value Alzheimer's Needs to Get to an End Act of 2021 or the CHANGE Act of 2021  This bill modifies the requirements under Medicare for diagnosing and treating Alzheimer's disease and other cognitive impairments in older adults. Specifically, the bill expands the cognitive impairment detection benefit during annual wellness visits to require the use of validated detection tools and documentation of the results in the patient's medical record. Further, when a cognitive impairment is detected, the patient must be referred to an appropriate diagnostic service provider and other specified supports.  Additionally, the Centers for Medicare & Medicaid Services must implement Medicare policies that increase the identification and response to patients' Alzheimer's disease risk factors and incentivize providers to utilize high-quality cognitive impairment diagnosis practices.  The Government Accountability Office also must conduct a study of policies that may accelerate progress in Alzheimer's disease research and enhance the quality of care for individuals diagnosed with Alzheimer's disease.

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 Representatives of the 
United States of America in Congress assembled,

SECTION 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.
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