SCREENS for Cancer Act of 2023

Health care priorities of ACCC: a) Oncology patient navigation; b) Oncology drug shortages; c) Financial toxicity for patients with cancer; and d) Inflation Reduction Act implementation (including Protecting Patient Access to Cancer and Complex Therapies Act (S. 2764/H.R. 5391). Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407, S. 2085); SCREENS for Cancer Act (H.R. 3916, S. 1840); Clinical Trial Modernization Act (H.R. 8412); Prior authorization, including Improving Seniors Timely Access to Care Act of 2024 (S. 4532, H.R. 8702); House resolution designating September 30, 2024 as Rare Cancer Day (H.Res. 1521); Extension of Medicare reimbursement for telehealth services; Medicare physician payment increases.

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Abortion access (general); Access to mifepristone (general); Contraception (general); Maternal mortality and morbidity (general); H.R. 1117, Advancing Safe Medications for Moms and Babies Act; Inclusion of pregnant and lactating individuals in research (general); Obstetric and gynecologic care in rural and underserved areas (general); impact of closures of ob-gyn units in rural hospitals on patient access to care and maternal morbidity and mortality; I H.R. 3305/S. 1606, Black Maternal Health Momnibus Act; H.R. 2569, Doctors of Community (DOC) Act; Teaching Health Center Graduate Medication Education (general); H.R. 3838/S. 2415, Preventing Maternal Deaths Reauthorization Act of 2023; H.R. 3226/S. 1573, PREEMIE Reauthorization Act of 2023; Telemedicine (general); H.R. 5012/S. 2647, SHINE for Autumn Act; S. 712/H.R. 8532, Connected MOM Act; S. 4079/H.R. 8383, Rural Obstetrics Readiness Act; Diversity, Equity, and Inclusion in medicine (general); S. 5236, Keeping Obstetrics Local Act; Implementation of P.L. 117-328, Pregnant Workers Fairness Act; National Health Service Corps (general); H.R. 8037/S. 4147, NIH IMPROVE Act; S. 2840, Bipartisan Primary Care and Health Workforce Act; S. 1840/H.R. 3916, SCREENS for Cancer Act; H.R. 10280, Strengthening Pathways to Health Professions Act; S. 5428/S. 10297, Jeanette Acosta Invest in Womens Health Act; S. 3247/H.R. 6298 Stop Shackling and Detaining Pregnant Women Act; H.R. 3503, NIH Clinical Trial Diversity Act; S. 3211/H.R. 6025, Healthcare Workforce Resilience Act; H.R. 3633, PREVENT HPV Cancers Act; S. 1409/H.R. 7891, Kids Online Safety Act; Patient-physician relationship (general); Alliance for Innovation on Maternal Health; Residency programs in obstetrics and gynecology (general); Abortion training in obstetrics and gynecology residency programs (general); Obstetrician-gynecologist workforce (general); Reproductive health data privacy (general); Substance use disorder during pregnancy (general); Maternal mental health (general); Coverage for infertility (general); Protections for in vitro fertilization (general); HPV vaccination (general); RSV vaccination (general); NIH restructuring (general); NICHD Strategic Plan (general); physician liability (general); Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) recommendations (general); NIH/NICHD womens health research (general);; human milk in NICUs; Executive Order 13952; EMTALA implementation (general); Medicare conditions of participation regarding opioids; Paid leave for patients who experience a stillbirth; menthol cigarettes and flavored cigars; nicotine limits in cigarettes; National Strategic Plans for HIV/AIDS, STIs, Vaccines and Viral Hepatitus; environmental health curriculum in medical school; heat-related deaths; hypertension in pregnancy and postpartum; adolescent reproductive health; immediate postpartum LARC; no-cost contraceptive coverage; access to fertility services and treatments; improving postpartum health care visit rates; worksite lactation support programs; newborn nutrition; Levels of Maternal Care; newborn screening; contraceptive and fertility counseling for patients with cancer; access to PrEP; maternal vaccinations; HPV vaccinations; syphilis screening during pregnancy; oral health care during pregnancy; opioid use disorder treatment for pregnant and postpartum individuals.

Client expense: $170,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3916/S.1840 - SCREENS for Cancer Act of 2023 IRA implementation, childhood cancer, access and coverage, prescription drug pricing and access, health disparities, cancer screenings, prostate cancer screenings, PCHETA, MCED

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 766/S 114, Dr. Michael C. Burgess Preventive Health Savings Act H.R. 1147/S. 1957, Whole Milk for Healthy Kids Act of 2023 H.R. 1843/S.1001, Telehealth Expansion Act of 2023 H.R. 2411/S. 1150, National Nursing Workforce Centers Act of 2023 H.R. 2663/S. 1176, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 2713/S. 2418, Improving Care and Access to Nurses (I CAN) Act H.R. 2901, Food Labeling Modernization Act of 2023 H.R. 3073/S. 1452, Community Mental Wellness and Resilience Act of 2023 H.R 3226/S. 1573, PREEMIE Reauthorization Act of 2023 H.R. 3305/S. 1606, Black Maternal Health Momnibus Act H.R. 3331/S. 754, Improving Mental Health and Wellness in Schools Act H.R.3433, Give Kids a Chance Act H.R. 3633, Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers (PREVENT HPV Cancers) Act of 2023 H.R. 4310/S. 2233, Youth Poisoning Protection Act H.R. 4581/S. 2231, Maternal and Child Health Stillbirth Prevention Act of 2023 H.R. 4758/S. 2372, Accelerating Kids Access to Care Act H.R. 4775, Helping Tobacco Users Quit Act H.R. 4892/S. 3921, Medicaid Bump Act H.R. 5012/S. 2647, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2023 H.R. 5378, Lower Costs, More Transparency Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act H.R. 6122/S. 2853, Train More Nurses Act H.R. 6149/S. 1291, Protecting Kids on Social Media Act H.R. 6766/S. 3512, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act H.R. 6960/S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 7002/S. 2815, Nurse Faculty Shortage Reduction Act of 2024 H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act H.R. 7224, To reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program. H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 8467, Farm, Food, and National Security Act of 2024 H.R. 8818, American Privacy Rights Act H.R. 9076, Protecting Americas Children by Strengthening Families Act H.R. 9425, Tobacco User Fee Modernization Act of 2024 H.R. 9774/S. 5194, Health Care Affordability Act of 2024 S. 397, Promoting Physical Activity for Americans Act S.644/H.R. 1359, Modernizing Opioid Treatment Access Act S. 1409/H.R. 7891, Kids Online Safety Act S. 1418/H.R. 7890, Children and Teens Online Privacy Protection Act S. 1840/H.R. 3916, Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act of 2023 S. 1884/H.R. 3713, Mental Health Services for Students Act of 2023 S. 2073, Kids Online Safety and Privacy Act S. 2840, Bipartisan Primary Care and Health Workforce Act S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 3193/H.R. 5163, Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act S. 3393/H.R. 4531, SUPPORT for Patients and Communities Reauthorization Act S. 3770/H.R. 7266, Future Advancement of Academic Nursing (FAAN) Act S. 4041, Creating Access and Resources in Education (CARE) for Student Mental Health Act S. 4532/H.R. 8702, Improving Seniors Timely Access to Care Act S. 4745, Federal Food Administration Act

Client expense: Not reported · Firm income: $24,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.8412 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Comments in relation to the establishment of a Brain and Spine Metastasis Month Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to ICD-10 codes for inflammatory breast cancer Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce Comments in response to Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V) (CFPB-2024- 0023) Comments in response to the House Energy & Commerce Committee Framework for Discussion on Reforming the National Institutes of Health Comments in response to a Request for Information on 21st Century Cures Comments in response to Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (FDA-2021D-0789)

Client expense: $100,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Consumer Financial Protection Bureau (CFPB), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the health care priorities of ACCC: a) Oncology patient navigation; b) Oncology drug shortages; c) Financial toxicity for patients with cancer; d) Protecting Patient Access to Cancer and Complex Therapies Act (S. 2764/ H.R. 5391); e) Inflation Reduction Act implementation; f) Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407/ S. 2085); SCREENS for Cancer Act (H.R. 3916/ S. 1840); Clinical Trial Modernization Act (H.R. 8412); Improving Seniors Timely Access to Care Act of 2024 (S. 4532/ H.R. 8702); House resolution designating September 30, 2024 as Rare Cancer Day (H.Res. 1521).

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Access to Care Inflation Reduction Act (IRA). ACS CAN actively monitors implementation of the Inflation Reduction Acts Medicare Drug Price negotiation provisions to ensure cancer patients have access to costly prescription drugs. ACS CAN also supports the Medicare Prescription Payment Plan, which allows Part D enrollees to spread their out-of-pocket costs over the plan year. Enhanced Advanced Premium Tax Credits, H.R. 9774, Improving Health Insurance Affordability Act of 2023, S.5194. House and Senate bills would permanently extend the enhanced advanced premium tax credits. Retaining Access and Restoring Exclusivity (RARE) Act H.R.7383. This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Help CoPays Act S.1375; Help Ensure Lower Patient Copays Act, H.R.830. This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. Safe Step Act, S.652, H.R. 2630. This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 H.R.4189, S.2016. This bill expands coverage of telehealth services under Medicare. Telehealth Modernization Act of 2924, H.R. 7623. Modifies requirements relating to coverage of telehealth services under Medicare. Permanently expands telehealth flexibilities first authorized during the public health emergency. The Preserving Telehealth, Hospital, and Ambulance Access Act, H.R. 8261. This bill allows employers to offer stand-alone telehealth benefits to all employees. This includes employees who are eligible for enrollment in their employer's group health plan. Equitable Community Access to Pharmacist Services Act, H.R.1770, S.2477. This bill expands Medicare coverage to permanently include services provided by a pharmacist, including incidental services and supplies, related to testing, vaccines, and treatment for COVID-19, influenza, and certain other illnesses. This bill also requires drug manufacturers to report on the suppliers of ingredients used in their products. Drug Shortage Prevention Act, H.R. 3008. This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage. Protecting Americans from Unsafe Drugs Act of 2023, H.R. 2500. This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs. Ensuring Access to Lifesaving Drugs Act of 2023, H.R. 3793. This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.) Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties. Medical Device Shortage Reduction Act of 2023, H.R. 3807. This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. Protecting PAHPA Action of 2023, H.R. 4697. ACS CAN is lobbying on all provisions related to drug shortages. This bill extends through FY2028 and modifies various programs and activities that support public health preparedness and response. The bill also addresses matters concerning shortages of drugs and medical devices and recalls of drugs. Essential Medicines Strategic Stockpile Act of 2023, H.R. 405. This bill requires the Department of Health and Human Services (HHS) to create a pilot program to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage. Alan Reinstein Ban Asbestos Now Act of 2023, H.R. 2402, S. 1069. This bill prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. RAPID Reserve Act, S. 2510. This bill improves supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies. Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, H.R.6802. A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies Senate Finance Committee Drug Shortage Proposal. This draft legislation would address the ongoing drug shortage crisis. Access to Breast Cancer Diagnosis Act of 2023, H.R.3851, S.2464. To amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations. Health Disparities Nancy Gardner Sewell Multi-Cancer Early Detection Act, H.R. 2407. This bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. Medicare Multi-Cancer Early Detection Screening Coverage (MCED) Act, S.2085. Legislation to improve access to new and innovative cancer screenings for Medicare beneficiaries by creating a pathway to allow Medicare to initiate coverage of multi-cancer tests following FDA approval if a clinical benefit is shown. Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act, S.1840, H.R.3916. Reauthorization of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for fiscal years 2024 through 2028 to provide the program greater flexibility in providing access to lifesaving screening, diagnostic, and treatment services and continue its innovative work aimed to reduce disparities and advance health equity in breast and cervical cancer. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, S.2821, H.R.1826. Legislation to remove cost sharing of PSA testing for those at the highest risk of being diagnosed with prostate cancer. Lung Cancer Screening and Prevention Act, H.R.6693. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Health Equity and Accountability Act (HEAA), H.R. 9161, S. 4773. Legislation to eliminate racial and ethnic health disparities. We actively advocate for provisions (HEAA), which focuses on health inequalities, societal injustices, and their intersection with immigration status, age, disability, sex, gender, sexual orientation, and socioeconomic status. Increased Funding for the National Institute for Minority Health and Health Disparities. Reducing disparities in the use of recommended preventive services targeting three leading causes of death in the United States - cancer, heart disease, and diabetes. Cancer Drug Parity Act of 2023, S.2039, H.R.6301. Level the playing field for cancer patients by ensuring that the cost-sharing for oral anticancer drugs is on par with intravenous chemotherapy, thereby removing a significant financial obstacle to effective treatment. Henrietta Lacks Enhancing Cancer Research Act of 2019 Report. Request for Congress to urge the Government Accountability Office (GAO) to revisit the Henrietta Lacks Enhancing Cancer Research Act of 2019 report, with respect to promoting diverse participation in cancer clinical trials and addressing fully the request for insight into either implementation challenges for current federal activities or recommendations for additional activities and policy changes related to clinical trial diversity. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act of 2022 (STAR) Act. Continued implementation and funding of the Childhood Cancer STAR Act to promote the development of new, safer therapies for children with cancer. Our appropriations request includes $30 million for the Childhood Cancer STAR Act and $50 million for the Childhood Cancer Data Initiative. Gabriella Miller Kids First Research Act 2.0, H.R. 623, S. 1523. This bill reauthorizes through FY2028 a pediatric disease research initiative within the National Institutes of Health (NIH) and requires the NIH to coordinate pediatric research activities to avoid duplicative efforts. Additionally, the Department of Health and Human Services must report to Congress about research funded through the initiative. Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act, H.R.3633. Legislation that would help prevent cancer and save lives by raising awareness about HPV and HPV-related cancers through a national campaign to educate providers, parents, and the public about the life-saving HPV vaccine. It would also boost resources for a federal initiative to provide access to timely cervical cancer screening and diagnostic services for uninsured and underserved individuals. Accelerating Kids Access to Care Act, S.2372, H.R.4758. Legislation that alleviates these burdens for families and providers by facilitating coordination across state lines and clarifying the process by which state Medicaid programs can cover specialized treatment regardless of where the child lives and where their care is received. Creating Hope Reauthorization Act of 2024, H.R. 7384. This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.) Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S.2243. Legislation to facilitate access to palliative care and coordinated care management. Palliative Care Research Funding. Funding to focus and expand national research programs in palliative care at the National Institutes of Health. Specifically, ACS CAN is working to ensure the U.S. Congress, for the first time, appropriates specific money for palliative care research, upon enactment of the FY2024 LHHS Appropriations bill. Patient Navigation for People with Cancer. Legislation and policies to increase access to patient navigation for people with cancer, prioritizing policies that create sustainable funding to ensure access to patient navigation services across the cancer continuum. Patient Navigation Assistance Act, H.R. 9446. This bill would require state Medicaid programs to provide patient navigation services for enrollees. Cancer Survivorship Comprehensive Cancer Survivorship Act (CCSA), S.2213, H.R.4363. ACS CAN supports legislation that sets new standards for survivorship from diagnosis to end of life, ensuring the best and most seamless experience for survivors, and their families and caregivers throughout the journey. CCSA will address gaps in survivorship care and develop needed standards to improve the overall patient-centered quality of care and navigation needs that cancer survivors and their families experience. Federal Health Care Programs Increased Funding Levels for Cancer Research and Prevention. Ensure continued progress in the fight against cancer at the National Institutes of Health (NIH), the National Cancer Institute (NCI), the Advanced Research Projects Agency for Health (ARPA-H), and the Centers for Disease Control and Preventions (CDC) cancer programs. CDC Cancer Programs, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Regulatory issues related to healthy food and dietary guidelines PC CARE Act, H.R.1315. This bill establishes a committee to develop, implement, and periodically revise a plan to coordinate federal activities and programs concerning prostate cancer, including those related to research, screening, diagnosis, and treatment. Women and Lung Cancer Research and Preventive Services Act of 2023, H.R.4534, S.2245. This bill requires the Department of Health and Human Services to conduct an interagency review of the status of women and lung cancer. Department of Defense Appropriations Act, 2024 H.R.4365, S.2587. DOD Congressionally Directed Medical Research Program. Cancer Alan Reinstein Ban Asbestos Act, H.R.2402, S.1069. This bill generally prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. The President may, on application, grant exemptions from the prohibition in situations where it is necessary to protect national security interests. Nutrition Medical Nutrition Act H.R.6407, S.3297. A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program Farm, Food, and National Security Act of 2024, H.R.8467. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Rural Prosperity and Food Security Act. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Clinical Trials Clinical Trial Modernization Act, H.R. 8412. Increase diversity in clinical trials and make it easier for all persons with cancer to participate by reducing barriers to enrollment. Barriers may include ancillary (non-medical) costs, such as transportation and lodging, and remote access to trials, particularly for people who are underrepresented, including certain racial and ethnic groups, older adults, rural residents, and those with limited incomes. NIH Clinical Trial Diversity Act, S.1701, H.R.3503. Legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. Harley Jacobsen Clinical Trial Participant Income Exemption Act, H.R.7090, H.R. 7418. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.

Client expense: $1,650,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; sustainable biofuels; and food loss and waste. Other Specific Activities: Farm, Food, and National Security Act of 2024 (H.R. 8467) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support Food Date Labeling Act (S. 1484/H.R. 3159) - support NO TIME TO Waste Act (S. 2889/H.R. 5657) - support

Client expense: $130,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

H.R.3916/S.1840 - SCREENS for Cancer Act of 2023 IRA implementation, childhood cancer, access and coverage, prescription drug pricing and access, health disparities, cancer screenings, prostate cancer screenings, PCHETA, MCED

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 766/S 114, Dr. Michael C. Burgess Preventive Health Savings Act H.R. 1147/S. 1957, Whole Milk for Healthy Kids Act of 2023 H.R. 1843/S.1001, Telehealth Expansion Act of 2023 H.R. 1692, Health Care Affordability Act of 2023 H.R. 2411/S. 1150, National Nursing Workforce Centers Act of 2023 H.R. 2663/S. 1176, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 2713/S. 2418, Improving Care and Access to Nurses (I CAN) Act H.R. 3073/S. 1452, Community Mental Wellness and Resilience Act of 2023 H.R 3226/S. 1573, PREEMIE Reauthorization Act of 2023 H.R. 3305/S. 1606, Black Maternal Health Momnibus Act H.R. 3331/S. 754, Improving Mental Health and Wellness in Schools Act H.R. 3633, Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers (PREVENT HPV Cancers) Act of 2023 H.R. 4310/S. 2233, Youth Poisoning Protection Act H.R. 4581/S. 2231, Maternal and Child Health Stillbirth Prevention Act of 2023 H.R. 4758/S. 2372, Accelerating Kids Access to Care Act H.R. 4775, Helping Tobacco Users Quit Act H.R. 4892/S. 3921, Medicaid Bump Act H.R. 5012/S. 2647, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2023 H.R. 5378, Lower Costs, More Transparency Act H.R. 6122/S. 2853, Train More Nurses Act H.R. 6149/S. 1291, Protecting Kids on Social Media Act H.R. 6766/S. 3512, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act H.R. 6960/S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 7002/S. 2815, Nurse Faculty Shortage Reduction Act of 2024 H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act H.R. 7224, To reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program. H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 8467, Farm, Food, and National Security Act of 2024 H.R. 8818, American Privacy Rights Act S. 8, Improving Health Insurance Affordability Act of 2023 S. 397, Promoting Physical Activity for Americans Act S.644/H.R. 1359, Modernizing Opioid Treatment Access Act S. 1409/H.R. 7891, Kids Online Safety Act S. 1418/H.R. 7890, Children and Teens Online Privacy Protection Act S. 1840/H.R. 3916, Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act of 2023 S. 1884/H.R. 3713, Mental Health Services for Students Act of 2023 S. 2840, Bipartisan Primary Care and Health Workforce Act S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 3393/H.R. 4531, SUPPORT for Patients and Communities Reauthorization Act S. 3770/H.R. 7266, Future Advancement of Academic Nursing (FAAN) Act S. 4041, Creating Access and Resources in Education (CARE) for Student Mental Health Act S. 4532/H.R. 8702, Improving Seniors Timely Access to Care Act

Client expense: Not reported · Firm income: $24,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.8412 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Comments in response to draft legislation titled the Drug Shortages Prevention and Mitigation Act Comments in relation to the establishment of a Brain and Spine Metastasis Month Comments in response to a request for information on appropriate use of artificial intelligence in healthcare Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to ICD-10 codes for inflammatory breast cancer Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce Comments in response to Draft Guidance for Industry: Cancer Clinical Trial Eligibility Criteria: Performance Status (FDA-2024-D-1377); Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications (FDA-2024-D1376); Cancer Clinical Trial Eligibility Criteria: Laboratory Values (FDA-2024-D-1402)

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; sustainable biofuels; and food loss and waste. Other Specific Activities: Farm, Food, and National Security Act of 2024 (H.R. 8467) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support Food Date Labeling Act (S. 1484/H.R. 3159) - support NO TIME TO Waste Act (S. 2889/H.R. 5657) - support

Client expense: $150,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Care Inflation Reduction Act (IRA). ACS CAN actively monitors implementation of the Inflation Reduction Acts Medicare Drug Price negotiation provisions to ensure cancer patients have access to costly prescription drugs. ACS CAN also supports the Medicare Prescription Payment Plan, which allows Part D enrollees to spread their out-of-pocket costs over the plan year. Enhanced Advanced Premium Tax Credits, H.R. 1692, Improving Health Insurance Affordability Act of 2023, S.8. House and Senate bills would permanently extend the enhanced advanced premium tax credits. Retaining Access and Restoring Exclusivity (RARE) Act H.R.7383. This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Help CoPays Act S.1375; Help Ensure Lower Patient Copays Act, H.R.830. This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. Safe Step Act, S.652. This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 H.R.4189, S.2016. This bill expands coverage of telehealth services under Medicare. Telehealth Modernization Act of 2924, H.R. 7623. Modifies requirements relating to coverage of telehealth services under Medicare. Permanently expands telehealth flexibilities first authorized during the public health emergency. The Preserving Telehealth, Hospital, and Ambulance Access Act, H.R. 8261. This bill allows employers to offer stand-alone telehealth benefits to all employees. This includes employees who are eligible for enrollment in their employer's group health plan. Equitable Community Access to Pharmacist Services Act, H.R.1770, S.2477. This bill expands Medicare coverage to permanently include services provided by a pharmacist, including incidental services and supplies, related to testing, vaccines, and treatment for COVID-19, influenza, and certain other illnesses. This bill also requires drug manufacturers to report on the suppliers of ingredients used in their products. Drug Shortage Prevention Act, H.R. 3008, Protecting PAHPA Act of 2023 H.R.4697. This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage. Protecting Americans from Unsafe Drugs Act of 2023, H.R. 2500, Protecting PAHPA Act of 2023, H.R.4697. This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs. Ensuring Access to Lifesaving Drugs Act of 2023, H.R. 3793, Protecting PAHPA Act of 2023, H.R.4697. This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.) Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties. Medical Device Shortage Reduction Act of 2023, H.R. 3807, Protecting PAHPA Act of 2023 H.R.4697. This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. Essential Medicines Strategic Stockpile Act of 2023, H.R. 405. This bill requires the Department of Health and Human Services (HHS) to create a pilot program to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage. Alan Reinstein Ban Asbestos Now Act of 2023, H.R. 2402, S. 1069. This bill prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. RAPID Reserve Act, S. 2510. This bill improves supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies. Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, H.R.6802. A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies Senate Finance Committee Drug Shortage Proposal Access to Breast Cancer Diagnosis Act of 2023, H.R.3851, S.2464. To amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations. Health Disparities Nancy Gardner Sewell Multi-Cancer Early Detection Act, H.R. 2407. This bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. Medicare Multi-Cancer Early Detection Screening Coverage (MCED) Act, S.2085. Legislation to improve access to new and innovative cancer screenings for Medicare beneficiaries by creating a pathway to allow Medicare to initiate coverage of multi-cancer tests following FDA approval if a clinical benefit is shown. Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act, S.1840, H.R.3916. Reauthorization of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for fiscal years 2024 through 2028 to provide the program greater flexibility in providing access to lifesaving screening, diagnostic, and treatment services and continue its innovative work aimed to reduce disparities and advance health equity in breast and cervical cancer. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, S.2821, H.R.1826. Legislation to remove cost sharing of PSA testing for those at the highest risk of being diagnosed with prostate cancer. Lung Cancer Screening and Prevention Act, H.R.6693. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Health Equity and Accountability Act (HEAA). Legislation to eliminate racial and ethnic health disparities. We actively advocate for provisions (HEAA), which focuses on health inequalities, societal injustices, and their intersection with immigration status, age, disability, sex, gender, sexual orientation, and socioeconomic status. Increased Funding for the National Institute for Minority Health and Health Disparities. Reducing disparities in the use of recommended preventive services targeting three leading causes of death in the United States - cancer, heart disease, and diabetes. Cancer Drug Parity Act of 2023, S.2039, H.R.6301. Level the playing field for cancer patients by ensuring that the cost-sharing for oral anticancer drugs is on par with intravenous chemotherapy, thereby removing a significant financial obstacle to effective treatment. Henrietta Lacks Enhancing Cancer Research Act of 2019 Report. Request for Congress to urge the Government Accountability Office (GAO) to revisit the Henrietta Lacks Enhancing Cancer Research Act of 2019 report, with respect to promoting diverse participation in cancer clinical trials and addressing fully the request for insight into either implementation challenges for current federal activities or recommendations for additional activities and policy changes related to clinical trial diversity. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act of 2022 (STAR) Act. Continued implementation and funding of the Childhood Cancer STAR Act to promote the development of new, safer therapies for children with cancer. Our appropriations request includes $30 million for the Childhood Cancer STAR Act and $50 million for the Childhood Cancer Data Initiative. Gabriella Miller Kids First Research Act 2.0, H.R. 623, S. 1523. This bill reauthorizes through FY2028 a pediatric disease research initiative within the National Institutes of Health (NIH) and requires the NIH to coordinate pediatric research activities to avoid duplicative efforts. Additionally, the Department of Health and Human Services must report to Congress about research funded through the initiative. Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act, H.R.3633. Legislation that would help prevent cancer and save lives by raising awareness about HPV and HPV-related cancers through a national campaign to educate providers, parents, and the public about the life-saving HPV vaccine. It would also boost resources for a federal initiative to provide access to timely cervical cancer screening and diagnostic services for uninsured and underserved individuals. Accelerating Kids Access to Care Act, S.2372, H.R.4758. Legislation that alleviates these burdens for families and providers by facilitating coordination across state lines and clarifying the process by which state Medicaid programs can cover specialized treatment regardless of where the child lives and where their care is received. Creating Hope Reauthorization Act of 2024, H.R. 7384. This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.) Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S.2243. Legislation to facilitate access to palliative care and coordinated care management. Palliative Care Research Funding. Funding to focus and expand national research programs in palliative care at the National Institutes of Health. Specifically, ACS CAN is working to ensure the U.S. Congress, for the first time, appropriates specific money for palliative care research, upon enactment of the FY2024 LHHS Appropriations bill. Patient Navigation for People with Cancer. Legislation and policies to increase access to patient navigation for people with cancer, prioritizing policies that create sustainable funding to ensure access to patient navigation services across the cancer continuum. Cancer Survivorship Comprehensive Cancer Survivorship Act (CCSA), S.2213,H.R.4363. ACS CAN supports legislation that sets new standards for survivorship from diagnosis to end of life, ensuring the best and most seamless experience for survivors, and their families and caregivers throughout the journey. CCSA will address gaps in survivorship care and develop needed standards to improve the overall patient-centered quality of care and navigation needs that cancer survivors and their families experience. Federal Health Care Programs Increased Funding Levels for Cancer Research and Prevention. Ensure continued progress in the fight against cancer at the National Institutes of Health (NIH), the National Cancer Institute (NCI), the Advanced Research Projects Agency for Health (ARPA-H), and the Centers for Disease Control and Preventions (CDC) cancer programs. CDC Cancer Programs, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Regulatory issues related to healthy food and dietary guidelines PC CARE Act, H.R.1315. This bill establishes a committee to develop, implement, and periodically revise a plan to coordinate federal activities and programs concerning prostate cancer, including those related to research, screening, diagnosis, and treatment. Women and Lung Cancer Research and Preventive Services Act of 2023, H.R.4534, S.2245. This bill requires the Department of Health and Human Services to conduct an interagency review of the status of women and lung cancer. Department of Defense Appropriations Act, 2024 H.R.4365, S.2587. DOD Congressionally Directed Medical Research Program. Cancer Alan Reinstein Ban Asbestos Act, H.R.2402, S.1069. This bill generally prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. The President may, on application, grant exemptions from the prohibition in situations where it is necessary to protect national security interests. Nutrition Medical Nutrition Act H.R.6407, S.3297. A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program Farm, Food, and National Security Act of 2024, H.R.8467. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Rural Prosperity and Food Security Act. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Clinical Trials Clinical Trial Modernization Act, H.R. 8412. Increase diversity in clinical trials and make it easier for all persons with cancer to participate by reducing barriers to enrollment. Barriers may include ancillary (non-medical) costs, such as transportation and lodging, and remote access to trials, particularly for people who are underrepresented, including certain racial and ethnic groups, older adults, rural residents, and those with limited incomes. NIH Clinical Trial Diversity Act, S.1701, H.R.3503. Legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. Harley Jacobsen Clinical Trial Participant Income Exemption Act, H.R.7090, H.R. 7418. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.

Client expense: $1,250,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 766/S 114, Dr. Michael C. Burgess Preventive Health Savings Act H.R. 1147/S. 1957, Whole Milk for Healthy Kids Act of 2023 H.R. 1843/S.1001, Telehealth Expansion Act of 2023 H.R. 2411/S. 1150, National Nursing Workforce Centers Act of 2023 H.R. 2663/S. 1176, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 2713/S. 2418, Improving Care and Access to Nurses (I CAN) Act H.R. 3073/S. 1452, Community Mental Wellness and Resilience Act of 2023 H.R 3226/S. 1573, PREEMIE Reauthorization Act of 2023 H.R. 3305/S. 1606, Black Maternal Health Momnibus Act H.R. 3331/S. 754, Improving Mental Health and Wellness in Schools Act H.R. 3633, Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers (PREVENT HPV Cancers) Act of 2023 H.R. 4892/S. 3921, Medicaid Bump Act H.R. 4531/S. 3393, SUPPORT for Patients and Communities Reauthorization Act of 2023 H.R. 4581/S. 2231, Maternal and Child Health Stillbirth Prevention Act of 2023 H.R. 4758/S. 2372, Accelerating Kids Access to Care Act H.R. 4775, Helping Tobacco Users Quit Act H.R. 5012/S. 2647, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2023 H.R. 5378, Lower Costs, More Transparency Act H.R. 6122/S. 2853, Train More Nurses Act H.R. 6766/S. 3512, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act H.R. 6960/S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 7002/S. 2815, Nurse Faculty Shortage Reduction Act of 2024 H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act H.R. 7224, To reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program. S.644/H.R. 1359, Modernizing Opioid Treatment Access Act S. 1409, Kids Online Safety Act S. 1418, Children and Teens Online Privacy Protection Act S. 1840/H.R. 3916, Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act of 2023 S. 1884/H.R. 3713, Mental Health Services for Students Act of 2023 S. 2840, Bipartisan Primary Care and Health Workforce Act S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 3393/H.R. 4531, SUPPORT for Patients and Communities Reauthorization Act S. 3770/H.R. 7266, Future Advancement of Academic Nursing (FAAN) Act

Client expense: Not reported · Firm income: $24,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Comments related to healthcare affordability Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Efforts to preserve protections in the Affordable Care Act (ACA) for LGBTQ+ patients Policies related to ICD-10 codes for inflammatory breast cancer Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; sustainable biofuels; and food loss and waste. Other Specific Activities: 2023 Farm bill (not yet introduced) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support COVER Act (no bill number yet) - support Food Date Labeling Act (S. 1484/H.R. 3159) - support NO TIME TO Waste Act (S. 2889/H.R. 5657) - support Whole Farm Revenue Improvement Act (S. 2598) - support

Client expense: $210,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 1147/S. 1957, Whole Milk for Healthy Kids Act of 2023 H.R. 1843/S.1001, Telehealth Expansion Act of 2023 H.R. 2411/S. 1150, National Nursing Workforce Centers Act of 2023 H.R. 2663/S. 1176, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 2713/S. 2418, Improving Care and Access to Nurses (I CAN) Act H.R. 3073/S. 1452, Community Mental Wellness and Resilience Act of 2023 H.R 3226/S. 1573, PREEMIE Reauthorization Act of 2023 H.R. 3305/S. 1606, Black Maternal Health Momnibus Act H.R. 3331/S. 754, Improving Mental Health and Wellness in Schools Act H.R. 4531/S. 3393, SUPPORT for Patients and Communities Reauthorization Act of 2023 H.R.4775 - Helping Tobacco Users Quit Act H.R. 5378, Lower Costs, More Transparency Act H.R. 6122/S. 2853, Train More Nurses Act S.644/H.R. 1359, Modernizing Opioid Treatment Access Act S. 1409, Kids Online Safety Act S. 1418, Children and Teens Online Privacy Protection Act S. 1840/H.R. 3916, Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act of 2023 S. 2840, Bipartisan Primary Care and Health Workforce Act S. 3085, Preventing Adverse Childhood Experiences (PACE) Act

Client expense: Not reported · Firm income: $24,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; and food loss and waste. Other Specific Activities: Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; sustainable biofuels; and food loss and waste. Other Specific Activities: 2023 Farm bill (not yet introduced) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support COVER Act (no bill number yet) - support Food Date Labeling Act (S. 1484/H.R. 3159) - support NO TIME TO Waste Act (S. 2889/H.R. 5657) - support Whole Farm Revenue Improvement Act (S. 2598) - support

Client expense: $120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 H.R. 1202 / S. 704 - Resident Education Deferred Interest (REDI) Act H.R. 2389 - Resident Physician Shortage Reduction Act of 2023 H.R. 2400 / S. 1165 - Reentry Act of 2023 H.R. 2474 - Strengthening Medicare for Patients and Providers Act H.R. 4189 / S. 2016 - CONNECT for Health Act of 2023 H.R. 4892 - Medicaid Bump Act H.R. 4933 / S. 462 - Mental Health Professionals Workforce Shortage Loan Repayment Act H.R. 4942 / S. 665 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5116 / S. 2688 - Behavioral Health Information Technology (BHIT) Coordination Act H.R. 5819 - COMPLETE Care Act H.R. 6683 - Preserving Seniors Access to Physicians Act of 2023 H.R. 3305 / S. 1606 - Black Maternal Health Momnibus Act H.R. 3226 - Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023 H.R. 3312 / S. 1602 - Moms Matter Act H.R. 3838 - Preventing Maternal Deaths Reauthorization Act of 2023 S. 1409 - Kids Online Safety Act S. 1418 - Children and Teens Online Privacy Protection Act S. 3106 - SUPPORT for Patients and Communities Reauthorization Act H.R. 6663 / S. 3364 - Kid PROOF Act of 2023 S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Health Extenders Act S. 3157 - More Behavioral Health Providers Act of 2023 S. 3158 - Expand the Behavioral Health Workforce Now Act H.R. 773 / S. 3165 - Homelessness and Behavioral Health Care Coordination Act of 2023 H.R. 2577 / S. 1137 - DHS Suicide Prevention and Resiliency for Law Enforcement Act H.R. 4331 - Strengthening Medicaid for Serious Mental Illness Act H.R. 4830 / S. 2444 - ATTAIN Mental Health Act H.R. 4974 / S. 3444 - Local 9-8-8 Response Act of 2023 HR 5510 - HOPE and Mental Wellbeing Act of 2023 H.R. 5975 - Keeping Drugs Out of Schools Act of 2023 H.R. 6033 - Supporting Patient Education And Knowledge (SPEAK) Act of 2023 H.R. 6149 / S. 1291 - Protecting Kids on Social Media Act H.R. 6364 - Medicare Telehealth Privacy Act of 2023 H.R. 6407 - Medical Nutrition Therapy Act of 2023 H.R. 6545 - Physician Fee Schedule Update and Improvements Act S. 644 - Modernizing Opioid Treatment Access Act S. 1840 - SCREENS for Cancer Act of 2023 S. 3392 - Advancing Research in Education Act S. 2511 - ADAPT Act S. 2966 - Targeting Emotional and Mentally Stability (TEAMS) Act of 2023 S. 3070 - Youth Prevention and Recovery Reauthorization Act of 2023

Client expense: $330,289 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. Efforts to reauthorize the Pandemic and All-Hazards Preparedness Act Efforts regarding the nomination and confirmation of new National Institutes of Health Director Comments in response to Medical Devices; Laboratory Developed Tests Proposed Rule Comments in response to modernizing the National Institutes of Health and Centers for Disease Control and Prevention Comments related to healthcare affordability Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce

Client expense: $60,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation and sustainable grazing; regenerative agriculture; and food loss and waste. Other Specific Activities: 2023 Farm bill (not yet introduced) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support COVER Act (no bill number yet) - support Food Date Labeling Act (S. 1484/H.R. 3159) - support NO TIME TO Waste Act (S. 2889/H.R. 5657) - support Whole Farm Revenue Improvement Act (S. 2598) - support

Client expense: $110,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Health disparities Access to clinical trials for underrepresented populations Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 (H.R.3916/S.1840) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 and the 2023 Final Rule Amending Part 900 of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021, requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs (S.373/ H.R.4472) Palliative Care and Hospice Education Training Act (PCHETA) (S. 2243) Comments in response to the discussion draft of the Stop Drug Shortages Act Letter to Congressional leadership related to drug shortages

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues related to coverage of diagnostic testing for cancer; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. Efforts to reauthorize the Pandemic and All-Hazards Preparedness Act Efforts regarding the nomination and confirmation of new National Institutes of Health Director Comments regarding FDA Draft Guidance Decentralized Clinical Trials for Drugs, Biological Products, and Devices Comments in response to the discussion draft of the Stop Drug Shortages Act Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce

Client expense: $60,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 1339 - Pharmacy Benefit Manager Reform Act; bill establishes various requirements for pharmacy benefit managers (PBMs) with respect to services provided to health insurance plans Efforts to reintroduce legislation which requires the Department of Health and Human Services (HHS) to take a series of actions relating to palliative-care training known as the Palliative Care and Hospice Education and Training Act Comments regarding the nomination and confirmation of new National Institutes of Health Director Comments in response to a Congressional Request for Information regarding the role and mission of the Centers for Disease Control and Prevention Comments in response to draft recommendations on breast cancer screening release by the United States Preventative Services Taskforce Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 and the 2023 Final Rule Amending Part 900 of the Mammography Quality Standards Act Policies related to the implementation of the National Cancer Institutes National Cancer Plan Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce

Client expense: $110,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation; and food loss and waste. Other Specific Activities: 2023 Farm bill (not yet introduced) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support COVER Act (no bill number yet) - support Food Date Labeling Act (not yet reintroduced) - support

Client expense: $110,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Abortion access (general); Access to Mifepristone (general); Contraception (general); Maternal Mortality and Morbidity (general); S. ___, Expanded Genetic Screening Act; H.R. 734, Protection of Women and Girls in Sports Act; H.R. ___, Indian Health Service Health Professions Tax Fairness Act of 2023; H.R. 1117, Advancing Safe Medications for Moms and Babies Act; H.Res. 309, Resolution expressing the sense of Congress that the Food and Drug Administration (FDA) has the authority to approve drugs for abortion care; obstetric and gynecologic care in rural areas (general); S.___, MOMMIES Act; H.R. ___/S.___, MOMMAs Act; H.R. 3589/S. 1698, Affordability is Access Act of 2023; H.R. 3305/S. 1606, Black Maternal Health Momnibus Act; H.R. 952, Kids Access to Primary Care Act of 2023; H.R. 1202/S. 704, Resident Education Deferred Interest (REDI) Act; S. 462, Mental Health Professionals Workforce Shortage Loan Repayment Act of 2023; H.R. 2389/S. 1302, Resident Physician Shortage Reduction Act of 2023; H.R. 2569, Doctors of Community (DOC) Act; Teaching Health Center Graduate Medication Education (general); H.Res.351, Recognizing the impact the stigmatization of menstruation has on the lives of women, girls, and people who menstruate, and expressing support for the designation of the month of May as "National Menstrual Health Awareness Month"; H.R. 3633, PREVENT HPV Cancers Act of 2023; physician workforce and training (general); H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023; H.R. 3226/S. 1573, PREEMIE Reauthorization Act of 2023; inclusion of pregnant and lactating individuals in research (general); Implementation of P.L. 115-320, Improving Access to Maternity Care Act; telemedicine (general); H.R. ___, SHINE for Autumn Act; Rural Residency Planning and Development (RRPD) Program; H.R. 2819, Good Samaritan Health Professionals Act of 2023; H.R. 3916/S. 1840, SCREENS for Cancer Act of 2023; H.R. 4189/S. 2016, CONNECT for Health Act of 2023; S. 2231, Maternal and Child Health Stillbirth Prevention Act; S. 1378, Connecting Our Medical Providers with Links to Expand Tailored and Effective Care; H.R. 3503, NIH Clinical Trial Diversity Act of 2023; H.R. 4121/S. 1999, Right to Contraception Act; H.R. 4147/S. 2024, Reproductive Health Care Training Act of 2023; Pandemic All-Hazards Preparedness Act reauthorization; Implementation of P.L. 117-328, Consolidated Appropriations Act, including the Pregnant Workers Fairness Act; Health Insurance Portability and Accountability Act (general); patient-physician relationship (general).

Client expense: $280,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, White House Office

Health disparities Access to clinical trials for underrepresented populations Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 (H.R.3916/S.1840) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 and the 2023 Final Rule Amending Part 900 of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021, requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs (S.373/ H.R.4472) Palliative Care and Hospice Education Training Act (PCHETA)

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Monitor and evaluate federal initiatives, both authorizing and appropriations related, and regulatory matters regarding sustainable agriculture and food systems; grassland conservation; and food loss and waste. Other Specific Activities: 2023 Farm bill (not yet introduced) - support strong provisions related to conservation and sustainable food systems Zero Food Waste Act (S.2389/H.R.4444) - support Agriculture Innovation Act (S. 98) - support Agriculture Resilience Act (H.R.1016/S.1840) - support COVER Act (no bill number yet) - support

Client expense: $160,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE