HEALTHY BRAINS Act of 2024

Discussions around improving access, coverage, and prior authorization for treatments and drugs under Medicare, Medicare Advantage, and private insurance. Seniors Timely Access to Care (S.4532 / H.R. 8702) - CONNECT for Health Act of 2023 (H.R.4189/S.2016) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Telehealth Modernization Act (H.R. 7623 / S. 3967) - All Provisions. Protecting Health Care for All Patients Act of 2023 (H.R. 485) - provisions to ban the usage of quality adjusted life years in public insurance programs. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions. Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) - All provisions HEALTHY BRAINS Act (H.R. 9233) - All Provisions relating to creating a research grant program to study environmental toxin exposure, its impact on the development of neurodegenerative diseases like ALS, and developing strategies to prevent, treat, and slow the progression of neurodegenerative diseases. Seniors Timely Access to Care (S.4532 / H.R. 8702) - All provisions

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocating for a ban on Trichloroethylene (TCE) and paraquat. H.R.9233 - The Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act of 2024 - a bill to create a Centers of Excellence grant program within the National Institute of Health to focus on the intersection between environmental risk factors and neurodegenerative disease. Efforts to ban paraquat.

Client expense: $50,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

General Education on Parkinson's Risk Factors: Focused on raising awareness about triggers and risks of Parkinson's disease, including exposure to TCE, paraquat, air pollution, and other environmental chemicals. H.R.9233/S. - The HEALTHY BRAINS Act: Draft legislation to create a Centers of Excellence grant program within the National Institutes of Health to focus on the intersection between environmental risk factors and neurodegenerative diseases. Supporting FDA Neurology Drug Program Funding: Advocacy for funding through the FY 2025 Agriculture Appropriations bills (H.R. 9027, S. 4690) and the Labor, Health and Human Services FY 2025 Appropriations bill (not yet filed). S.269 - Protect America's Children from Toxic Pesticides Act (PACTPA): Legislation focused on protecting children from harmful pesticides, including those linked to Parkinson's. S.806 - The Healthy H2O Act: A bill that addresses concerns about water quality and its effects on health, relevant to Parkinsons disease prevention. Neurodegenerative Disease Center of Excellence: Ongoing development of a legislative proposal to create a center at the National Institute of Environmental Health Sciences (NIEHS) to focus on neurodegenerative diseases like Parkinsons. Efforts to ban paraquat.

Client expense: $50,000 · Firm income: Not reported

H.R.2365/S.1064 - National Plan to End Parkinson's Act: A bill to create an advisory council comprising members of federal agencies that support research, care, and services for Parkinson's disease, as well as patients, care partners, researchers, clinicians, and other non-federal experts, to ensure efficient and effective coordination among all federal entities responsible for managing, treating, and curing Parkinson's disease. General Parkinson's Disease Information: Covers symptoms, triggers, health coverage, health costs, social determinants of health, data collection, research, environmental risks, and health access for underserved communities, particularly through the CDC's National Neurological Conditions Surveillance System (NNCSS). H.R.2630/S.652/S.1339 - Safe Step Act: Requires group health plans to provide an exception process for any medication step therapy protocol to ensure that individuals living with Parkinson's disease can access treatments safely and efficiently. Establishing Parkinson's Disease ICD-10-CM Codes: Aims to assist in the coordination of care for Parkinson's patients who experience OFF episodes and to allow researchers to gather data to study disease progression. S.1544/H.R.1199 - Facilitating Innovative Nuclear Diagnostics Act of 2023: A bill to establish separate payment requirements for diagnostic radiopharmaceuticals, including DaTscans, which aid in confirming a Parkinson's diagnosis under the Medicare prospective payment system for hospital outpatient services. H.R.3432 - Telemental Health Care Access Act of 2023: Permanently removes Medicare's originating site requirements for mental health services furnished via telehealth. Parkinson's non-motor symptoms include mental health conditions, and many people with Parkinson's are Medicare beneficiaries who may face barriers due to in-person requirements. H.R.830/S.1375 - Help Ensure Lower Patient Copays Act: A bill requiring health insurance plans to apply certain payments, including third-party payments, financial assistance, and product vouchers, toward a plan's cost-sharing requirements. This helps Parkinson's patients afford medications for managing symptoms. The Medicare Part D Six Protected Classes Policy: Requires Part D plans to cover all drugs in six protected classes, including antidepressants and antipsychotics. For individuals with Parkinson's disease, these medications are crucial for managing non-motor symptoms such as depression and psychosis. H.R.4752/S.2379 - CHANGE Act of 2023: A bill to improve early screening, detection, and diagnosis of Alzheimer's and related dementias, including Parkinson's disease dementia, during Medicare wellness visits. H.R.4942/S.655 - Conrad State 30 and Physician Access Reauthorization Act: Reauthorizes the Conrad State 30 program and improves policies to address health care provider shortages, supporting neurological care for Parkinson's patients. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act: Establishes requirements regarding the use of prior authorization under Medicare Advantage plans. H.R.9233/S.- The HEALTHY Brains Act: Draft legislation to create a Centers of Excellence grant program within the National Institutes of Health to focus on the intersection between environmental risk factors and neurodegenerative diseases. H.R.8331/S. 4280 - Essential Caregivers Act of 2024: To amend titles XVIII and XIX of the Social Security Act to require skilled nursing facilities, nursing facilities, intermediate care facilities for the intellectually disabled, and inpatient rehabilitation facilities to permit essential caregivers access during any period in which regular visitation is restricted. General Outreach for Establishing an ""Office of Caregiver Health"": Supports the creation of an Office of Caregiver Health within the Department of Health and Human Services to address the needs of caregivers, particularly in relation to Parkinson's disease care.

FY 2025 Appropriations bills including funding requests for Parkinson's research within: H.R.8774/ S.4921: The Department of Defense within the FY 2025 Defense Appropriation bill. Funding for the Parkinson's Research Program (PRP) under the Department of Defense's Congressionally Directed Medical Research Programs (CDMRP). H.R.9029/S.4942: The National Institute of Health and Centers for Disease Control and Prevention within the FY 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriation bill. Possible funding to implement the National Plan to End Parkinson's Act (HR 2365/ PL 118-66) within LHHS appropriations. H.R.9027/ S.4690: The Food and Drug Administration within the FY 2025 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation bill. H.R.8580/ S.4677: The Department of Veterans Affairs within the FY 2025 Military Construction, Veterans Affairs, and Related Agencies Appropriation bill. Support funding for Neurology Centers of Excellence and medical care and research through Veterans Health Administration, including the Parkinson's Disease Research, Education and Clinical Centers. H.R.9029/S.4942: General advocacy in support of robust non-defense discretionary investments in Labor, Health and Human Services, Education and Related Agencies appropriations bill for FY 2025. Funding for discretionary, non-defense priorities including overall investment in the National Institute of Health, ARPA-H, and Centers for Disease Control and Prevention within the FY 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriation bills. Funding for the Parkinson's Research Program (PRP) under the Department of Defense's Congressionally Directed Medical Research Programs (CDMRP). Increased funding for NIEHS (no bill introduced). H.R.9233: The HEALTHY BRAINS Act - developing support for implementation funding for centers of excellence within NIH.

H.R. 9233, HEALTHY BRAINS Act of 2024, All provisions.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Linking Seniors to Needed Legal Services Act (H.R. 8588) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619/P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134/H.R. 620/P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (S. 3775/ H.R. 7218) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (csf)

General Education on Parkinson's Risk Factors: Focused on raising awareness about triggers and risks of Parkinson's disease, including exposure to TCE, paraquat, air pollution, and other environmental chemicals. H.R.9233/S. - The HEALTHY BRAINS Act: Draft legislation to create a Centers of Excellence grant program within the National Institutes of Health to focus on the intersection between environmental risk factors and neurodegenerative diseases. Supporting FDA Neurology Drug Program Funding: Advocacy for funding through the FY 2025 Agriculture Appropriations bills (H.R. 9027, S. 4690) and the Labor, Health and Human Services FY 2025 Appropriations bill (not yet filed). S.269 - Protect America's Children from Toxic Pesticides Act (PACTPA): Legislation focused on protecting children from harmful pesticides, including those linked to Parkinson's. S.806 - The Healthy H2O Act: A bill that addresses concerns about water quality and its effects on health, relevant to Parkinsons disease prevention. Neurodegenerative Disease Center of Excellence: Ongoing development of a legislative proposal to create a center at the National Institute of Environmental Health Sciences (NIEHS) to focus on neurodegenerative diseases like Parkinsons.

Client expense: $70,000 · Firm income: Not reported

H.R.2365/S.1064 - National Plan to End Parkinson's Act: A bill to create an advisory council comprising members of federal agencies that support research, care, and services for Parkinson's disease, as well as patients, care partners, researchers, clinicians, and other non-federal experts, to ensure efficient and effective coordination among all federal entities responsible for managing, treating, and curing Parkinson's disease. General Parkinson's Disease Information: Covers symptoms, triggers, health coverage, health costs, social determinants of health, data collection, research, environmental risks, and health access for underserved communities, particularly through the CDC's National Neurological Conditions Surveillance System (NNCSS). H.R.2630/S.652/S.1339 - Safe Step Act: Requires group health plans to provide an exception process for any medication step therapy protocol to ensure that individuals living with Parkinson's disease can access treatments safely and efficiently. Establishing Parkinson's Disease ICD-10-CM Codes: Aims to assist in the coordination of care for Parkinson's patients who experience OFF episodes and to allow researchers to gather data to study disease progression. S.1544/H.R.1199 - Facilitating Innovative Nuclear Diagnostics Act of 2023: A bill to establish separate payment requirements for diagnostic radiopharmaceuticals, including DaTscans, which aid in confirming a Parkinson's diagnosis under the Medicare prospective payment system for hospital outpatient services. H.R.3432 - Telemental Health Care Access Act of 2023: Permanently removes Medicare's originating site requirements for mental health services furnished via telehealth. Parkinson's non-motor symptoms include mental health conditions, and many people with Parkinson's are Medicare beneficiaries who may face barriers due to in-person requirements. H.R.830/S.1375 - Help Ensure Lower Patient Copays Act: A bill requiring health insurance plans to apply certain payments, including third-party payments, financial assistance, and product vouchers, toward a plan's cost-sharing requirements. This helps Parkinson's patients afford medications for managing symptoms. The Medicare Part D Six Protected Classes Policy: Requires Part D plans to cover all drugs in six protected classes, including antidepressants and antipsychotics. For individuals with Parkinson's disease, these medications are crucial for managing non-motor symptoms such as depression and psychosis. H.R.4752/S.2379 - CHANGE Act of 2023: A bill to improve early screening, detection, and diagnosis of Alzheimer's and related dementias, including Parkinson's disease dementia, during Medicare wellness visits. H.R.4942/S.655 - Conrad State 30 and Physician Access Reauthorization Act: Reauthorizes the Conrad State 30 program and improves policies to address health care provider shortages, supporting neurological care for Parkinson's patients. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act: Establishes requirements regarding the use of prior authorization under Medicare Advantage plans. H.R.9233/S.- The HEALTHY Brains Act: Draft legislation to create a Centers of Excellence grant program within the National Institutes of Health to focus on the intersection between environmental risk factors and neurodegenerative diseases. General Outreach for Establishing an ""Office of Caregiver Health"": Supports the creation of an Office of Caregiver Health within the Department of Health and Human Services to address the needs of caregivers, particularly in relation to Parkinson's disease care.

Advocating for a ban on Trichloroethylene (TCE) and paraquat. H.R.9233 - The Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act of 2024 - a bill to create a Centers of Excellence grant program within the National Institute of Health to focus on the intersection between environmental risk factors and neurodegenerative disease.

Client expense: $70,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Discussions around improving access, coverage, and prior authorization for treatments and drugs under Medicare, Medicare Advantage, and private insurance. Seniors Timely Access to Care (S.4532 / H.R. 8702) - CONNECT for Health Act of 2023 (H.R.4189/S.2016) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Telehealth Modernization Act (H.R. 7623 / S. 3967) - All Provisions. Protecting Health Care for All Patients Act of 2023 (H.R. 485) - provisions to ban the usage of quality adjusted life years in public insurance programs. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions. Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) - All provisions HEALTHY BRAINS Act (H.R. 9233) - All Provisions relating to creating a research grant program to study environmental toxin exposure, its impact on the development of neurodegenerative diseases like ALS, and developing strategies to prevent, treat, and slow the progression of neurodegenerative diseases.

Client expense: $30,000 · Firm income: Not reported

HR 619, NAPA Reauthorization Act - to extend the National Alzheimer's Project S 133, NAPA Reauthorization Act - to extend the National Alzheimer's Project S 4775, Reauthorize the Older Americans Act HR 9233, HEALTHY BRAINS Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 9233, HEALTHY BRAINS Act of 2024, All provisions.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE