[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2387 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  2d Session
                                S. 2387

     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

                            February 7, 2018

 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 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 (CHANGE) Act of 2018''.
    (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. Test of care delivery models offering a continuum of 
                            comprehensive care, and caregiver support 
                            services, for patients with Alzheimer's 
                            disease and other dementias.
Sec. 4. State innovation models for family caregivers of patients with 
                            Alzheimer's and related dementias.
Sec. 5. Medicare quality payment program.
Sec. 6. Report to Congress on implementation of this Act.
Sec. 7. 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) The number of individuals in the United States with 
        Alzheimer's disease and related dementias has more than doubled 
        since 1980 and, based on the trajectory of Alzheimer's, as many 
        as 14 to 16 million individuals in the United States will have 
        Alzheimer's by 2050.
            (2) Alzheimer's is the only disease among the top 10 causes 
        of death in the United States without an effective means of 
        prevention, treatment, or cure.
            (3) In 2017, Alzheimer's care will cost Medicare and 
        Medicaid an estimated $175,000,000,000 and by 2050, Alzheimer's 
        disease will cost Medicare and Medicaid as much as 
        $758,000,000,000.
            (4) Alzheimer's exacts an emotional and physical toll on 
        caregivers, resulting in higher incidence of heart disease, 
        cancer, depression, and other health consequences.
            (5) Alzheimer's disease disproportionately impacts women 
        and people of color. Women are twice as likely to develop 
        Alzheimer's as they are breast cancer. African Americans are 
        about two times more likely than White Americans to have 
        Alzheimer's disease and other dementias. Latinos are about one 
        and one-half times more likely than White Americans to have 
        Alzheimer's disease and other dementias. 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.
            (6) As many as half of the estimated 5,100,000 American 
        seniors with Alzheimer's disease and other dementias have never 
        received a diagnosis.
            (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) The lack of uniform, reliable cognitive impairment 
        detection methodologies in the Medicare annual wellness visit, 
        and appropriate follow-up, delays diagnosis, resulting in 
        decreased opportunities for patients to access timely treatment 
        options, including clinical trial participation.
            (9) African Americans represent 13 percent of the U.S. 
        population but only 5 percent of clinical trial participants 
        and Latinos represent 17 percent of the U.S. population but 
        less than one percent of clinical trial participants. Further, 
        Latinos and African Americans account for only 3.5 percent and 
        1.2 percent, respectively, of principal investigators supported 
        by the National Institutes of Health funding, limiting this 
        perspective in research. Better recruitment and trial designs 
        are critical to addressing innovation in Alzheimer's generally, 
        including the underrepresentation of African Americans and 
        Latinos.
            (10) Inability to identify eligible patients at the 
        earliest stages of disease is a substantial impediment to 
        efficient research toward Alzheimer's disease prevention, 
        treatment, and cure.
            (11) Advancing treatment options to prevent, treat, or cure 
        Alzheimer's is an urgent national priority.
            (12) Continued Federal investment in Alzheimer's research 
        and the implementation of innovative programs, such as the 
        breakthrough EUREKA prize competition authorized in the 21st 
        Century Cures Act, are critical to advance the search to 
        identify, treat, cure, and prevent Alzheimer's disease.
            (13) Existing health care systems--
                    (A) are costly;
                    (B) do not adequately meet the needs of Alzheimer's 
                patients;
                    (C) overburden familial caregivers; and
                    (D) perpetuate hurdles to efficient Alzheimer's 
                research.
            (14) A paradigm shift to drive synergies between high-value 
        patient care, caregiver support, and research initiatives is 
        our best hope for preventing, treating, and curing Alzheimer's 
        disease.
            (15) Section 1115A of the Social Security Act, as amended 
        by the PACE Innovation Act of 2015, enables identification of 
        Alzheimer's disease care models that focus on improving 
        patient-centered outcomes, reduce the burden on informal and 
        familial caregivers, and facilitate clinical trial 
        participation.

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 (G) as 
                subparagraph (H); and
                    (C) by inserting after subparagraph (F) the 
                following new subparagraph:
                    ``(G) 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, 2019.
    (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 ``paragraph 
        (2) and'' and inserting ``paragraph (2), 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 (G) 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, 2019.

SEC. 3. TEST OF CARE DELIVERY MODELS OFFERING A CONTINUUM OF 
              COMPREHENSIVE CARE, AND CAREGIVER SUPPORT SERVICES, FOR 
              PATIENTS WITH ALZHEIMER'S DISEASE AND OTHER DEMENTIAS.

    Section 1115A of the Social Security Act (42 U.S.C. 1315a) is 
amended--
            (1) in subsection (b)(2)(A), by adding at the end the 
        following new sentence: ``The models selected under this 
        subparagraph shall include the model described in subsection 
        (h), which shall be implemented by not later than 6 months 
        after the date of the enactment of the Concentrating on High-
        value Alzheimer's Needs to Get to an End (CHANGE) Act of 
        2018.'';
            (2) by adding at the end the following new subsection:
    ``(h) Delivery Models Offering a Continuum of Comprehensive Care, 
and Caregiver Support Services, for Patients With Alzheimer's Disease 
and Other Dementias.--
            ``(1) In general.--The models described in this subsection 
        are Medicare, Medicaid, or multi-payer models that incorporate 
        a comprehensive continuum of care framework, such as that 
        contained in the Program of All-Inclusive Care for the Elderly 
        (PACE), to individuals diagnosed with Alzheimer's disease or 
        related dementia, at any stage.
            ``(2) Requirements for models.--The models described in 
        this subsection shall include the following:
                    ``(A) The enrollment of patients diagnosed with 
                Alzheimer's disease, at any stage, without regard to 
                medical need for skilled nursing facility care or 
                Medicaid eligibility.
                    ``(B) Through case management and care coordination 
                services, the offering of a flexible menu of services, 
                based upon identified patient needs over time, for 
                high-quality, appropriate care from diagnosis through 
                disease progression, including identification of 
                appropriate clinical trials.
                    ``(C) The employment of a comprehensive approach to 
                caring for patients with Alzheimer's disease or related 
                dementia that integrates treatment of such patients 
                with training and support services for their families 
                and caregivers, and facilitates participation in 
                clinical trials. Such services may include--
                            ``(i) day healthcare, including health care 
                        services and dementia-specific social, 
                        rehabilitative, recreational, memory, exercise, 
                        nutritional counseling, occupational therapy, 
                        and personal care services;
                            ``(ii) physician care, including referred 
                        specialists;
                            ``(iii) respite care and, for clinical 
                        trial participants, care partner surrogate 
                        services as needed;
                            ``(iv) medications and medication 
                        management, including for clinical trial 
                        compliance;
                            ``(v) nursing care, and occupational, 
                        physical, and speech therapy as prescribed;
                            ``(vi) identification and management of 
                        comorbidities;
                            ``(vii) social worker services;
                            ``(viii) meals at day health care and, if 
                        needed, at home;
                            ``(ix) transportation to and from day 
                        health care and clinical trial study visits; 
                        and
                            ``(x) personal care, skilled nursing 
                        services, and other services the Secretary 
                        determines appropriate that--
                                    ``(I) incorporate caregiver 
                                training, support, and counseling 
                                services successfully evaluated and 
                                implemented in previous or existing 
                                models tested under such section 1115A 
                                and that are specific to Alzheimer's 
                                disease patients and their caregivers;
                                    ``(II) maintain documentation and 
                                data likely to further scientific 
                                understanding of Alzheimer's disease 
                                natural history, taking into account 
                                gender, race, ethnicity, age of onset, 
                                and other factors; and
                                    ``(III) provide outreach activities 
                                to inform the public of the services of 
                                the program, and provide information on 
                                Alzheimer's disease and related 
                                dementias to the primary care community 
                                and general public.
            ``(3) Model selection and evaluation.--
                    ``(A) Requests for proposals.--In implementing the 
                models described in this subsection, the Secretary 
                shall seek requests for proposals from States, PACE 
                programs (as defined in section 1894(a)(2)), 
                Alzheimer's disease and dementia care centers, and 
                specialized MA plans for special needs individuals (as 
                defined in section 1859(b)(6)) that have the 
                demonstrated ability to deliver the comprehensive 
                continuum of dementia care described in paragraph (2).
                    ``(B) Phase i models.--In selecting models under 
                this subsection to be tested under subsection (b), and 
                in evaluating models, the Secretary shall primarily 
                focus on patient and caregiver outcomes, such as--
                            ``(i) improved quality of life;
                            ``(ii) maintaining functional or cognitive 
                        performance;
                            ``(iii) management of comorbidities and 
                        behavioral and safety concerns; and
                            ``(iv) continued ability to remain in the 
                        community.
                    ``(C) Phase ii.--Subject to the requirements under 
                subsection (c), in determining which models under this 
                subsection to expand under subsection (c), the 
                Secretary shall take into account--
                            ``(i) any recommendations or strategies 
                        identified in the report under section 8 of the 
                        Concentrating on High-value Alzheimer's Needs 
                        to Get to an End (CHANGE) Act of 2018; and
                            ``(ii) whether the model incorporates care 
                        delivery, payment, and evaluation strategies 
                        that are likely to demonstrate improved patient 
                        outcomes, including the outcomes described in 
                        subparagraph (B) and reduced hospitalizations, 
                        emergency room visits, and skilled nursing 
                        facility stays, without increasing spending 
                        under the applicable title.''.

SEC. 4. STATE INNOVATION MODELS FOR FAMILY CAREGIVERS OF PATIENTS WITH 
              ALZHEIMER'S AND RELATED DEMENTIAS.

    Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C. 
1315(b)(2)(B)) is amended by adding the following new clause:
                            ``(xxv) Allowing States to develop and test 
                        programs that increase an Alzheimer's disease 
                        patient's ability to remain in the community by 
                        reducing the financial burden to family 
                        caregivers, and that include--
                                    ``(I) familial caregiver support 
                                services, including training necessary 
                                to enable such caregivers to provide 
                                services at the level of a home health 
                                aide;
                                    ``(II) certification of familial 
                                caregiver training and satisfactory 
                                completion of testing or other 
                                requirements demonstrating caregiver 
                                competence;
                                    ``(III) appropriate familial 
                                caregiver oversight, including home 
                                visits or other activities; and
                                    ``(IV) for familial caregivers of 
                                Alzheimer's disease and other dementia 
                                patients for whom a care plan includes 
                                home health aide services, payment to 
                                the caregiver for the hours of one-on-
                                one services provided in the care plan, 
                                and performed by the familial 
                                caregivers, in an amount that is not 
                                below the then-applicable minimum wage 
                                in that State and does not exceed the 
                                prevailing hourly rate paid to a home 
                                health aide.''.

SEC. 5. MEDICARE QUALITY PAYMENT PROGRAM.

    Not later than January 1, 2019, 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. 6. 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) models undergoing testing and evaluation under the 
        provisions of, and amendments made by, sections 3 and 4;
            (3) utilization of Alzheimer's disease diagnostic and care 
        planning services; and
            (4) outreach efforts in the primary care and patient 
        communities.

SEC. 7. 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--
            (1) 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; and
            (2) the results of any models under the provisions of, and 
        amendments made by, sections 3 and 4 and the feasibility of 
        incorporating into such models innovative arrangements with 
        research sponsors, through a user fee or otherwise, to 
        facilitate budget neutrality or incentivize providers through a 
        shared-savings approach.
    (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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