,,ii #aaeth ,,congress #b;d ,session ,s4 #bchg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #g1 #bjah,mrs4 ,capito 7for herself1 ,ms4 ,stabenow1 ,mr4 ,wicker1 and ,mr4 ,menendez7 introduced the following bill2 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 strategies1 disease modifying treatments1 and1 ultimately1 a cure4 #a4 ,short title2 table of contents2 findings 7a7 ,short title ,this ,act may be cited as the ,concentrating on ,high-value ,alzheimer's ,needs to ,get to an ,end 7,,change7 ,act of #bjah4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents2 findings4 ,sec4 #b4 ,cognitive impairment detection benefit in the ,medicare annual wellness visit and initial preventive physical examination4 ,sec4 #c4 ,test of care delivery models offering a continuum of comprehensive care1 and caregiver support services1 for patients with ,alzheimer's disease and other dementias4 ,sec4 #d4 ,state innovation models for family caregivers of patients with ,alzheimer's and related dementias4 ,sec4 #e4 ,medicare quality payment program4 ,sec4 #f4 ,report to ,congress on implementation of this ,act4 ,sec4 #g4 ,study and report on regulatory and legislative changes or refinements that would accelerate ,alzheimer's disease research progress4 7c7 ,findings ,congress finds as follows3 7#a7 ,the number of individuals in the ,united ,states with ,alzheimer's disease and related dementias has more than doubled since #aihj and1 based on the trajectory of ,alzheimer's1 as many as #ad to #af million individuals in the ,united ,states will have ,alzheimer's by #bjej4 7#b7 ,alzheimer's is the only disease among the top #aj causes of death in the ,united ,states without an effective means of prevention1 treatment1 or cure4 7#c7 ,in #bjag1 ,alzheimer's care will cost ,medicare and ,medicaid an estimated #age1jjj1jjj1jjj and by #bjej1 ,alzheimer's disease will cost ,medicare and ,medicaid as much as #geh1jjj1jjj1jjj4 7#d7 ,alzheimer's exacts an emotional and physical toll on caregivers1 resulting in higher incidence of heart disease1 cancer1 depression1 and other health consequences4 7#e7 ,alzheimer's disease disproportionately impacts women and people of color4 ,women are twice as likely to develop ,alzheimer's as they are breast cancer4 ,african ,americans are about two times more likely than ,white ,americans to have ,alzheimer's disease and other dementias4 ,latinos are about one and one-half times more likely than ,white ,americans to have ,alzheimer's disease and other dementias4 ,this higher prevalence translates into a higher death rate3 ,alzheimer's deaths increased #ee percent among all ,americans between #aiii and #bjad1 while the number was #ajg percent for ,latinos and #ii percent for ,african ,americans4 7#f7 ,as many as half of the estimated #e1ajj1jjj ,american seniors with ,alzheimer's disease and other dementias have never received a diagnosis4 7#g7 ,an early1 documented diagnosis1 communicated to the patient and caregiver1 enables early access to care planning services and available medical and nonmedical treatments1 and optimizes patients' ability to build a care team1 participate in support services1 and enroll in clinical trials4 7#h7 ,the lack of uniform1 reliable cognitive impairment detection methodologies in the ,medicare annual wellness visit1 and appropriate follow-up1 delays diagnosis1 resulting in decreased opportunities for patients to access timely treatment options1 including clinical trial participation4 7#i7 ,african ,americans represent #ac percent of the ,u4,s4 population but only #e percent of clinical trial participants and ,latinos represent #ag percent of the ,u4,s4 population but less than one percent of clinical trial participants4 ,further1 ,latinos and ,african ,americans account for only #c4e percent and #a4b percent1 respectively1 of principal investigators supported by the ,national ,institutes of ,health funding1 limiting this perspective in research4 ,better recruitment and trial designs are critical to addressing innovation in ,alzheimer's generally1 including the underrepresentation of ,african ,americans and ,latinos4 7#aj7 ,inability to identify eligible patients at the earliest stages of disease is a substantial impediment to efficient research toward ,alzheimer's disease prevention1 treatment1 and cure4 7#aa7 ,advancing treatment options to prevent1 treat1 or cure ,alzheimer's is an urgent national priority4 7#ab7 ,continued ,federal investment in ,alzheimer's research and the implementation of innovative programs1 such as the breakthrough ,,eureka prize competition authorized in the #bast ,century ,cures ,act1 are critical to advance the search to identify1 treat1 cure1 and prevent ,alzheimer's disease4 7#ac7 ,existing health care systems-- 7,a7 are costly2 7,b7 do not adequately meet the needs of ,alzheimer's patients2 7,c7 overburden familial caregivers2 and 7,d7 perpetuate hurdles to efficient ,alzheimer's research4 7#ad7 ,a paradigm shift to drive synergies between high-value patient care1 caregiver support1 and research initiatives is our best hope for preventing1 treating1 and curing ,alzheimer's disease4 7#ae7 ,section #aaae;,a of the ,social ,security ,act1 as amended by the ,,pace ,innovation ,act of #bjae1 enables identification of ,alzheimer's disease care models that focus on improving patient-centered outcomes1 reduce the burden on informal and familial caregivers1 and facilitate clinical trial participation4 #b4 ,cognitive impairment detection benefit in the ,medicare annual wellness visit and initial preventive physical examination 7a7 ,annual wellness visit 7#a7 ,in general ,section #ahfa7;hhh77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7hhh77#b77 is amended-- 7,a7 by striking subparagraph 7,d7 and inserting the following3 7,d7 ,detection of any cognitive impairment or progression of cognitive impairment that shall-- 7i7 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 setting1 and other validated cognitive detection tools as the ,secretary determines2 7ii7 include documentation of the tool used for detecting cognitive impairment and results of the assessment in the patient's medical record2 and 7iii7 take into consideration the tool used1 and results of1 any previously performed cognitive impairment detection assessment4 2 7,b7 by redesignating subparagraph 7,g7 as subparagraph 7,h72 and 7,c7 by inserting after subparagraph 7,f7 the following new subparagraph3 7,g7 ,referral of patients with detected cognitive impairment or potential cognitive decline to-- 7i7 appropriate ,alzheimer's disease and dementia diagnostic services1 including amyloid positron emission tomography1 and other medically accepted diagnostic tests that the ,secretary determines are safe and effective2 7ii7 specialists and other clinicians with expertise in diagnosing or treating ,alzheimer's disease and related dementias2 7iii7 available community-based services1 including patient and caregiver counseling and social support services2 and 7iv7 appropriate clinical trials4 4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to annual wellness visits furnished on or after ,january #a1 #bjai4 7b7 ,initial preventive physical examination 7#a7 ,in general ,section #ahfa7ww77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77#a77 is amended by striking paragraph 7#b7 and and inserting paragraph 7#b71 detection of any cognitive impairment or progression of cognitive impairment as described in subparagraph 7,d7 of subsection 7hhh77#b7 and referrals as described in subparagraph 7,g7 of such subsection1 and4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to initial preventive physical examinations furnished on or after ,january #a1 #bjai4 #c4 ,test of care delivery models offering a continuum of comprehensive care1 and caregiver support services1 for patients with ,alzheimer's disease and other dementias ,section #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7 is amended-- 7#a7 in subsection 7b77#b77;,a71 by adding at the end the following new sentence3 ,the models selected under this subparagraph shall include the model described in subsection 7h71 which shall be implemented by not later than #f months after the date of the enactment of the ,concentrating on ,high-value ,alzheimer's ,needs to ,get to an ,end 7,,change7 ,act of #bjah42 7#b7 by adding at the end the following new subsection3 7h7 ,delivery models offering a continuum of comprehensive care1 and caregiver support services1 for patients with ,alzheimer's disease and other dementias 7#a7 ,in general ,the models described in this subsection are ,medicare1 ,medicaid1 or multi-payer models that incorporate a comprehensive continuum of care framework1 such as that contained in the ,program of ,all-,inclusive ,care for the ,elderly 7,,pace71 to individuals diagnosed with ,alzheimer's disease or related dementia1 at any stage4 7#b7 ,requirements for models ,the models described in this subsection shall include the following3 7,a7 ,the enrollment of patients diagnosed with ,alzheimer's disease1 at any stage1 without regard to medical need for skilled nursing facility care or ,medicaid eligibility4 7,b7 ,through case management and care coordination services1 the offering of a flexible menu of services1 based upon identified patient needs over time1 for high-quality1 appropriate care from diagnosis through disease progression1 including identification of appropriate clinical trials4 7,c7 ,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 caregivers1 and facilitates participation in clinical trials4 ,such services may include-- 7i7 day healthcare1 including health care services and dementia-specific social1 rehabilitative1 recreational1 memory1 exercise1 nutritional counseling1 occupational therapy1 and personal care services2 7ii7 physician care1 including referred specialists2 7iii7 respite care and1 for clinical trial participants1 care partner surrogate services as needed2 7iv7 medications and medication management1 including for clinical trial compliance2 7v7 nursing care1 and occupational1 physical1 and speech therapy as prescribed2 7vi7 identification and management of comorbidities2 7vii7 social worker services2 7viii7 meals at day health care and1 if needed1 at home2 7ix7 transportation to and from day health care and clinical trial study visits2 and 7x7 personal care1 skilled nursing services1 and other services the ,secretary determines appropriate that-- 7,i7 incorporate caregiver training1 support1 and counseling services successfully evaluated and implemented in previous or existing models tested under such section #aaae;,a and that are specific to ,alzheimer's disease patients and their caregivers2 7,,ii7 maintain documentation and data likely to further scientific understanding of ,alzheimer's disease natural history1 taking into account gender1 race1 ethnicity1 age of onset1 and other factors2 and 7,,iii7 provide outreach activities to inform the public of the services of the program1 and provide information on ,alzheimer's disease and related dementias to the primary care community and general public4 7#c7 ,model selection and evaluation 7,a7 ,requests for proposals ,in implementing the models described in this subsection1 the ,secretary shall seek requests for proposals from ,states1 ,,pace programs 7as defined in section #ahid7;a77#b771 ,alzheimer's disease and dementia care centers1 and specialized ,,ma plans for special needs individuals 7as defined in section #ahei7;b77#f77 that have the demonstrated ability to deliver the comprehensive continuum of dementia care described in paragraph 7#b74 7,b7 ,phase ,i models ,in selecting models under this subsection to be tested under subsection 7b71 and in evaluating models1 the ,secretary shall primarily focus on patient and caregiver outcomes1 such as-- 7i7 improved quality of life2 7ii7 maintaining functional or cognitive performance2 7iii7 management of comorbidities and behavioral and safety concerns2 and 7iv7 continued ability to remain in the community4 7,c7 ,phase ,,ii ,subject to the requirements under subsection 7c71 in determining which models under this subsection to expand under subsection 7c71 the ,secretary shall take into account-- 7i7 any recommendations or strategies identified in the report under section #h of the ,concentrating on ,high-value ,alzheimer's ,needs to ,get to an ,end 7,,change7 ,act of #bjah2 and 7ii7 whether the model incorporates care delivery1 payment1 and evaluation strategies that are likely to demonstrate improved patient outcomes1 including the outcomes described in subparagraph 7,b7 and reduced hospitalizations1 emergency room visits1 and skilled nursing facility stays1 without increasing spending under the applicable title4 4 #d4 ,state innovation models for family caregivers of patients with ,alzheimer's and related dementias ,section #aaae;,a7b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7;b77#b77;,b77 is amended by adding the following new clause3 7xxv7 ,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 caregivers1 and that include-- 7,i7 familial caregiver support services1 including training necessary to enable such caregivers to provide services at the level of a home health aide2 7,,ii7 certification of familial caregiver training and satisfactory completion of testing or other requirements demonstrating caregiver competence2 7,,iii7 appropriate familial caregiver oversight1 including home visits or other activities2 and 7,,iv7 for familial caregivers of ,alzheimer's disease and other dementia patients for whom a care plan includes home health aide services1 payment to the caregiver for the hours of one-on-one services provided in the care plan1 and performed by the familial caregivers1 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 aide4 4 #e4 ,medicare quality payment program ,not later than ,january #a1 #bjai1 the ,secretary of ,health and ,human ,services shall implement ,medicare policies under title ,,xviii of the ,social ,security ,act1 including quality measures and ,medicare ,advantage plan rating and risk adjustment mechanisms1 that reflect the public health imperative of-- 7#a7 promoting healthy brain lifestyle choices2 7#b7 identifying and responding to patient risk factors for ,alzheimer's disease and related dementias2 and 7#c7 incentivizing providers for-- 7,a7 adequate and reliable cognitive impairment detection in the primary care setting1 that is documented in the patient's electronic health record and communicated to the patient2 7,b7 timely ,alzheimer's disease diagnosis2 and 7,c7 appropriate care planning services1 including identification of1 and communication with patients and caregivers about1 the potential for clinical trial participation4 #f4 ,report to ,congress on implementation of this ,act ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit a report to ,congress on the implementation of the provisions of1 and amendments made by1 this ,act1 including-- 7#a7 the increased use of validated tools for detection of cognitive impairment and ,alzheimer's disease2 7#b7 models undergoing testing and evaluation under the provisions of1 and amendments made by1 sections #c and #d2 7#c7 utilization of ,alzheimer's disease diagnostic and care planning services2 and 7#d7 outreach efforts in the primary care and patient communities4 #g4 ,study and report on regulatory and legislative changes or refinements that would accelerate ,alzheimer's disease research progress 7a7 ,in general ,the ,comptroller ,general of the ,united ,states 7in this section referred to as the ,comptroller ,general7 shall conduct a study on regulatory and legislative changes or refinements that would accelerate ,alzheimer's disease research progress4 ,in conducting such study1 the ,comptroller ,general shall consult with interested stakeholders1 including industry leaders1 researchers1 clinical experts1 patient advocacy groups1 caregivers1 patients1 providers1 and ,state leaders4 ,such study shall include an analysis of-- 7#a7 innovative public-private partnerships1 innovative financing tools1 incentives and other mechanisms to enhance the quality of care for individuals diagnosed with ,alzheimer's disease1 reduce the emotional1 financial1 and physical burden on familial care partners1 and accelerate development of preventative1 curative1 and disease-modifying therapies2 and 7#b7 the results of any models under the provisions of1 and amendments made by1 sections #c and #d and the feasibility of incorporating into such models innovative arrangements with research sponsors1 through a user fee or otherwise1 to facilitate budget neutrality or incentivize providers through a shared-savings approach4 7b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under subsection 7a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4