NIH Clinical Trial Diversity Act of 2023

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. LDT Regulation- A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. 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. 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. 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.

Client expense: $2,570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), 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 Affordable Care Act tax credits. 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. 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 Drug Shortage Prevention and Mitigation Act, S.2586. This 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 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, S.5335. 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: $2,570,000 · 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

Hemophilia research, prevention, surveillance and service programs and issues H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act (H.R. 3884/S. 1852)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 8311 / S 4289, Medical Debt Cancellation Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; HR 8261, Preserving Telehealth, Hospital, and Ambulance Access Act; HR 8412, the Clinical Trial Modernization Act; HR 8574, the 340B ACCESS Act; HR 9129, Patient Debt Relief Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 9774 / S 5194, the Health Care Affordability Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Efforts to extend and make permanent the current enhanced Advance Premium Tax Credits; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

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

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

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

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

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. LDT Regulation- A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. 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. 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. 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.

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

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

Hemophilia research, prevention, surveillance and service programs and issues H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Letter in response to Congressional Framework on Reforming the National Institutes of Health Letter in response to FDA Draft Guidance on Diversity Action Plans

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act - Reducing Drug Prices for Seniors Act - Improving Seniors Timely Access to Care Act - Health Care Affordability Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $1,060,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to fertility treatment and coverage for federal employees (no bill); issues related to veteran health care coverage (no bill); H.R. 544, Veterans Infertility Treatment Act (entire bill); S. 2801/H.R. 5492, Veteran Families Health Services Act (entire bill); S. 2386/H.R. 4731, Access to Infertility Treatment and Care Act (entire bill); S. 2213/H.R. 4363, Comprehensive Cancer Survivorship Act (entire bill); S. 1262/H.R. 2828, Family Building FEHB Fairness Act (entire bill); S.2226/H.R. 2670, National Defense Authorization Act (issues related to health care access); H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023 (entire bill); H.R. 3305, Black Maternal Health Momnibus Act (entire bill); H.R. 3503, NIH Clinical Trial Diversity Act of 2023 (entire bill).

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY2025 Labor-HHS bill to include report language on education for the Medicare Prescription Payment Plan Expand access to adult dental care under Medicare, Medicaid and ACA plans Prohibiting copay accumulators in ACA Exchange plans: (H.R. 830 / S. 1375)- Help Ensure Lower Patient (HELP) Copays Act Prohibit use of Alternative Funding Programs in private insurance Streamline utilization management protocols including prior authorization and step therapy; Safe Step Act (H.R. 2630 / S. 652) and Improving Senior's Timely Access to Care Act (H.R. 8702/S. 4518) Make Medicare telehealth flexibilities permanent H.R. 8725 Increasing Medication Access for Seniors Act H.R. 8412 Clinical Trial Modernization Act H.R. 3503/S. 1701 NIH Clinical Trial Diversity Act Extend federal flexibilities for teleprescribing of controlled substances

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

Government targets: HOUSE OF REPRESENTATIVES, 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

H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Outreach to the Dr. Bertagnolli, NIH Director, and the Office of the Director Outreach to the White House RE: Initiative on Women's Health Research

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

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

Hemophilia research, prevention, surveillance and service programs and issues H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

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. LDT Regulation- A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. 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. 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. 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.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), 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. 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

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act - Reducing Drug Prices for Seniors Act - Improving Seniors Timely Access to Care Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Issues related to fertility treatment and coverage for federal employees (no bill); issues related to veteran health care coverage (no bill); H.R. 544, Veterans Infertility Treatment Act (entire bill); S. 2801/H.R. 5492, Veteran Families Health Services Act (entire bill); S. 2386/H.R. 4731, Access to Infertility Treatment and Care Act (entire bill); S. 2213/H.R. 4363, Comprehensive Cancer Survivorship Act (entire bill); S. 1262/H.R. 2828, Family Building FEHB Fairness Act (entire bill); S.2226/H.R. 2670, National Defense Authorization Act (issues related to health care access); H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023 (entire bill); H.R. 3305, Black Maternal Health Momnibus Act (entire bill); H.R. 3503, NIH Clinical Trial Diversity Act of 2023 (entire bill).

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare coverage and reimbursement and Medicaid coverage and reimbursement H.R. 3503 NIH Clinical Trial Diversity Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES

HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 2868, the Association Health Plans; HR 2813, Self-Insurance Protection Act; HR 3799, CHOICE Arrangement Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 2630 / S 652, the Safe Step Act; HR 7383 / S 1214, the RARE Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 1692 / S 8, the Health Care Affordability Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5688 the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 5609, the Advancing Health Savings Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 7384, the Creating Hope Reauthorization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 3433 / S 2897, the Give Kids a Chance Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 113, the Prescription Pricing for the People Act; HR 2880, the Protecting Patients Against PBM Abuses Act; S 1967 the Patients Before Middlemen Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; Implementation of the FY23 omnibus, specifically provisions related to increasing access to clinical trials; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; Legislation to increase federal investment in Consumer Assistance Programs; FDA draft guidance related to dose optimization studies in clinical trials

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

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

H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Outreach to the Dr. Bertagnolli, NIH Director, and the Office of the Director Outreach to the White House RE: Initiative on Women's Health Research

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

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

Hemophilia research, prevention, surveillance and service programs and issues H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Modernization of Clinical Trials Act Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act NIH Clinical Trial Diversity Act 2023 H.R. 3503 and S.1701 Multi Cancer Early Detection Screening Coverage Act The Alan Reinstein Ban Asbestos Act S1609/HR 2402 The Firefighter Cancer Registry Reauthorization Act of 2023 H.R.3821 Harley Jacobsen Clinical Trial Participant Income Exemption Act (H.R. 7090)

Client expense: $2,670,000 · Firm income: Not reported

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

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act - Reducing Drug Prices for Seniors Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare coverage and reimbursement and Medicaid coverage and reimbursement H.R. 3503 NIH Clinical Trial Diversity Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to fertility treatment and coverage for federal employees (no bill); issues related to veteran health care coverage (no bill); H.R. 544, Veterans Infertility Treatment Act (entire bill); S. 2801/H.R. 5492, Veteran Families Health Services Act (entire bill); S. 2386/H.R. 4731, Access to Infertility Treatment and Care Act (entire bill); S. 2213/H.R. 4363, Comprehensive Cancer Survivorship Act (entire bill); S. 1262/H.R. 2828, Family Building FEHB Fairness Act (entire bill); S.2226/H.R. 2670, National Defense Authorization Act (issues related to health care access); H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023 (entire bill); H.R. 3305, Black Maternal Health Momnibus Act (entire bill); H.R. 3503, NIH Clinical Trial Diversity Act of 2023 (entire bill).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

HR 711, the Throw Away Junk Plans Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; S. 2039, The Cancer Drug Parity Act; HR 824, the Telehealth Benefit Expansion Act; HR 2868, the Association Health Plans; HR 2813, Self-Insurance Protection Act; HR 3799, CHOICE Arrangement Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; S 652, the Safe Step Act; S 1214, the RARE Act; S 2243, the Palliative Care and Hospice Education and Training Act; draft legislation regarding Health Care Sharing Ministry transparency; Implementation of the FY23 omnibus, specifically provisions related to increasing access to clinical trials; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; Legislation to increase federal investment in Consumer Assistance Programs; FDA draft guidance related to dose optimization studies in clinical trials

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

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

H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Letter regarding Request for Information on Modernizing the National Institutes of Health (NIH) Letter supporting the nomination of Dr. Bertagnolli to NIH Director

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hemophilia research, prevention, surveillance and service programs and issues H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act Comments on: Modernizing Recalls of FDA-Regulated Commodities

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

DIVERSE Trials Act Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act NIH Clinical Trial Diversity Act 2023 H.R. 3503 and S.1701 Multi Cancer Early Detection Screening Coverage Act The Alan Reinstein Ban Asbestos Act S1609/HR 2402 The Firefighter Cancer Registry Reauthorization Act of 2023 H.R.3821

Client expense: $3,030,000 · Firm income: Not reported

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

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Issues related to health coverage. Issues related to prescription drug costs and affordability. Issues related to the No Surprises Act and patient protections. Issues related to agency funding for medical and cancer research. Issues related to H.R.4758/S.2372, The Accelerating Kids' Access to Care Act. Issues related to clinical trial diversity, including H.R. 3503/S.1701, the NIH Clinical Trial Diversity Act. Issues related to the pharmaceutical supply chain and drug shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to fertility treatment and coverage for federal employees (no bill); issues related to veteran health care coverage (no bill); H.R. 544, Veterans Infertility Treatment Act (entire bill); S. 2801/H.R. 5492, Veteran Families Health Services Act (entire bill); S. 2386/H.R. 4731, Access to Infertility Treatment and Care Act (entire bill); S. 2213/H.R. 4363, Comprehensive Cancer Survivorship Act (entire bill); S. 1262/H.R. 2828, Family Building FEHB Fairness Act (entire bill); S.2333/H.R. 4420, Pandemic and All Hazards Preparedness Act (issues related to infectious disease); S.2226/H.R. 2670, National Defense Authorization Act (issues related to health care access); H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023 (entire bill); H.R.3305, Black Maternal Health Momnibus Act (entire bill); H.R.3503, NIH Clinical Trial Diversity Act of 2023 (entire bill).

Client expense: $200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Personnel Management (OPM), SENATE

HR 35, the Close the Medigap Act; HR 711, the Throw Away Junk Plans Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; S. 2039, The Cancer Drug Parity Act; HR 824, the Telehealth Benefit Expansion Act; HR 2868, the Association Health Plans; HR 2813, Self-Insurance Protection Act; HR 3799, CHOICE Arrangement Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; S 652, the Safe Step Act; S 1214, the RARE Act; S 2243, the Palliative Care and Hospice Education and Training Act; draft legislation regarding Health Care Sharing Ministry transparency; Implementation of the FY23 omnibus, specifically provisions related to increasing access to clinical trials; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; Legislation to increase federal investment in Consumer Assistance Programs; FDA draft guidance related to dose optimization studies in clinical trials

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of, White House Office

Advocate for medical research and prevention funding for the National Institutes of Health and Centers for Disease Control and Prevention via the FY2024 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R.5894/S.2624. Advocate for Defense Health Research Programs (CDMRP) in the FY24 Defense Appropriations Act, specifically the Melanoma Research Program (MRP) (H.R.4635/S.2587). Support H.R.3503,NIH Clinical Trial Diversity Act.

Client expense: $1,120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE