Medicare Multi-Cancer Early Detection Screening Coverage Act

Issues related to multi-cancer early detection screening; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 10545, American Relief Act, 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act Discussions regarding Health ACCESS Act (Health Accelerating Consumers Care by Expediting Self-Scheduling)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407/S 2085 The Medicare Multi-Cancer Early Detection Screening Coverage Act; Appropriate payment and coverage criteria for certain advanced diagnostic tests; HR 10545 American Relief Act of 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2407 The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S. 2085 Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 2407 The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S. 2085 Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicaid; Issues relating to the Presidents FY25 budget; Issues related to regulatory reform; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 1075 Medicaid Work Requirements Act; S. 1063 A bill to amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; HR 1551 Jobs and Opportunities for Medicaid Act; H.R. 2583 Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023; H.R. 1114 Long COVID RECOVERY NOW Act; H.R. 833 Stop the Wait Act; S 2085 Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 2407 Nancy Garner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; HR 2811 Limit Save Grow Act; HR 442 Regulatory Accountability Act; S 1615 Regulatory Accountability Act;; HR 288 Separation of Powers Restoration Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; S. 2016 CONNECT for Health Act of 2023; HR 4189 CONNECT for Health Act of 2023;; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; HR 357 Ensuring Accountability in Agency Rulemaking; HR 6693 Lung Cancer Screening and Prevention Act;; S3821 Supplemental Oxygen Access Reform (SOAR) Act; HR7829 Supplemental Oxygen Access Reform (SOAR) Act; HR 485 Protecting Health Care for All Patients Act of 2023; HR 7867 Renewing Efficiency in Government by Budgeting Act; HR 115 Midnight Rules Relief Act; HR 1602, Health Care Affordability Act of 2023; S. 8 Improving Health Insurance Affordability Act of 2023; HR 9029 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2025; S. 4942 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025; HR 890 Guidance out of Regulatory Darkness Act; H.R. 9774, Health Care Affordability Act of 2024; S. 5194, Health Care Affordability Act of 2024; HR 10515, American Relief Act, 2025; HR 10545, American Relief Act, 2025

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

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

Bridge To Medicaid Act: extends enhanced premium tax credits to low-income Medicaid enrollees in the coverage gap. Medicaid Unwinding. ACS CAN is working to ensure that states comply with federal law by actively monitoring their data submissions and tracking the impact on Medicaid beneficiaries. We will continue to urge the Centers for Medicare & Medicaid Services (CMS) to take corrective action if states fail to comply with federal Medicaid redetermination requirements 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. 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. 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. 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 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 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. 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. Medical Nutrition Therapy 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

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

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

Medicare issues as they relate to oncology and multi-cancer early detection, including diagnostics and screening, H.R.2407/S.2085 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; and H.R.10445 - Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Issues related to chronic care and the Medicare Physician Fee Schedule. Issues related to patient access to prescription drugs. S. 2085/H.R. 2407, the Medicare Multi-Cancer Early Detection Screening Coverage Act. S. 2477/H.R. 1770, the Equitable Community Access to Pharmacists Act. Issues related to Pharmacy Benefit Managers. H.R. 4818/S. 2407, the Treat and Reduce Obesity Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Vitality, Grail testing, long term care insurance. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407). Federal long term care insurance program (FLTCIP) 2-year extension of moratorium on sales. The Medicare Multi-Cancer Early Detection Screening Coverage Act (S. 2085).

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

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

S. 260/H.R. 704 - Promoting Access to Diabetic Shoes Act H.R. 2583/S. 3481 - Increasing Access to Quality Cardiac Rehabilitation Care Act H.R. 2713/S. 2418 - Improving Care and Access to Nurses (ICAN) Act S. 3939/H.R. 7665 - ACO Assignment Improvement Act of 2024 H.R. 7623/S. 3967 - Telehealth Modernization Act H.R. 5163/ S. 3193 - Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act S. 923 - Better Mental Health Care for Americans Act H.R. 3305/S. 1606 - Black Maternal Health Momnibus Act H.R. 2663/S. 1176 - Workplace Violence Prevention for Health Care and Social Service Workers Act S. 2085 - A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests H.R. 2407 - the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act H.R. 4189/S. 2016 - CONNECT for Health Act S. 1869 - Site-based Invoicing and Transparency Enhancement Act (SITE) Act H.R. 3623/S. 1586 - Educating Future Nurses Act H.R. 2829 - Chronic Care Management Improvement Act of 2023 H.R. 2400/S. 1165 - Reentry Act of 2023 S.1378 - Connecting Our Medical Providers with Links to Expand Tailored and Effective Care (COMPLETE Care) Act H.R. 4822 - Health Care Price Transparency Act of 2023 H.R. 4779 - Breast Cancer Patient Equity Act Primary Care and Health Workforce Expansion Act S. 2840 - Bipartisan Primary Care and Health Workforce Act S. 1976/H.R. 4104 - Preserving Patient Access to Home Infusion Act Support implementation of Medicare code G2211 S. 3297/H.R. 6407 - Medical Nutrition Therapy Act of 2023 S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 4338 - Pay PCPs Act of 2024 H.R. 8261 - Preserving Telehealth, Hospital, and Ambulance Access Act Issues related to Medicare Part B reform Skilled nursing facility admitting examination and assessment requirements Health plan coverage and program requirements, including provider non-discrimination, network adequacy and prior authorization Nursing faculty and workforce shortage Include nurses, APRNs, and nursing students in all national public health plans Rural health care issues, including rural workforce, COVID-19 vaccination, and reimbursement Addressing health equity Medication-Assisted Treatment (MATs) Issues relating to the mental and substance use disorder workforce Opioid epidemic COVID-19 Pandemic, including funding, personal protective equipment, testing and vaccines Extension of CMS waivers beyond the COVID-19 Public Health Emergency Telehealth, remote patient monitoring and other forms of health technology Reducing regulatory burdens, including those relating to Medicare Conditions of Participation Medicare provider reimbursement Documentation of medical records Use of clinician home address on Medicare claims when providing telehealth services

Client expense: $470,000 · Firm income: Not reported

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

S. 260/H.R. 704 - Promoting Access to Diabetic Shoes Act H.R. 2583/S. 3481 - Increasing Access to Quality Cardiac Rehabilitation Care Act H.R. 2713/S. 2418 - Improving Care and Access to Nurses (ICAN) Act S. 3939/H.R. 7665 - ACO Assignment Improvement Act of 2024 H.R. 7266/S. 3770 - Future Advancement of Academic Nursing (FAAN) Act H.R. 7153/S. 3679 - Dr. Lorna Breen Health Care Provider Protection Reauthorization Act H.R. 7623/S. 3967 - Telehealth Modernization Act H.R. 7002/S. 2815 - Nurse Faculty Shortage Reduction Act H.R. 5163/ S. 3193 - Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act H.R. 4534/S. 2245 - the Women and Lung Cancer Research and Preventive Services Act H.R. 5829 - Health Care Practitioner Disaster Protection Act S. 923 - Better Mental Health Care for Americans Act H.R. 3768/S. 1851 - Midwives for MOMs Act H.R. 3305/S. 1606 - Black Maternal Health Momnibus Act H.R. 2411/S. 1150 - National Nursing Workforce Center Act of 2023 H.R. 2663/S. 1176 - Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 3523/S. 1710 - Perinatal Workforce Act S. 2085 - A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests H.R 2407 - the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2016 - CONNECT for Health Act S. 1869 - Site-based Invoicing and Transparency Enhancement Act (SITE) Act H.R. 3355 - Substance Use Disorder Treatment and Recovery Loan Repayment Program Reauthorization Act of 2023 S. 1627 - Providing Real-World Education and Clinical Experience by Precepting Tomorrows Nurses Act (PRECEPT) Nurses Act H.R. 3623/S. 1586 - Educating Future Nurses Act H.R. 3730/S. 198 - Rural Health Clinic Burden Reduction Act H.R. 2829 - Chronic Care Management Improvement Act of 2023 H.R. 2400/S. 1165 - Reentry Act of 2023 S. 1378 - Connecting Our Medical Providers with Links to Expand Tailored and Effective Care (COMPLETE Care) Act H.Con.Res.42 - Honoring Mary Eliza Mahoney, America's first professionally trained Black nurse. S.Res.201/H.Res.375 - A resolution supporting the goals and ideals of National Nurses Week, to be observed from May 6 through May 12, 2023. H.R. 4822 - Health Care Price Transparency Act of 2023 H.R. 4779 - Breast Cancer Patient Equity Act Primary Care and Health Workforce Expansion Act S. 2840 - Bipartisan Primary Care and Health Workforce Act S. 3297/H.R. 6407 - Medical Nutrition Therapy Act of 2023 Support funding for the National Health Service Corps S. 862 - Restoring Americas Health Care Workforce and Readiness Act S. 1976/H.R. 4104 - Preserving Patient Access to Home Infusion Act S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S.Res. 676/H.Res. 1208 - a resolution supporting the goals and ideals of National Nurses Week, to be observed from May 6 through May 12, 2024 S. 4338 - Pay PCPs Act of 2024 H.R. 9133/S. 4835 - Primary and Behavioral Health Care Access Act H.R. 6860/S. 5018 - the Restore Protections for Dialysis Patients Act H.R. 10280 - Strengthening Pathways to Health Professions Act Issues related to Medicare Part B reform Issues related to enhancing access to care at home in rural and underserved communities Support for the creation of the Office of Caregiver Health Support a final rule prohibiting menthol cigarettes and cigars Support implementation of Medicare code G2211 Extending COVID-19 waivers related to nurse practitioners and critical access hospitals Skilled nursing facility admitting examination and assessment requirements Health plan coverage and program requirements, including provider non-discrimination, network adequacy and prior authorization Nursing faculty and workforce shortage Nursing education Include nurses, APRNs, and nursing students in all national public health plans Public health and nursing workforce infrastructure Rural health care issues, including rural workforce, COVID-19 vaccination, and reimbursement Addressing health equity Medication-Assisted Treatment (MATs) Issues relating to the mental and substance use disorder workforce Opioid epidemic COVID-19 Pandemic, including funding, personal protective equipment, testing and vaccines Provide resources to support nurses, APRNs, and nursing students mental health needs, especially for those responding to the pandemic Extension of CMS waivers beyond the COVID-19 Public Health Emergency Use of telehealth to prescribe controlled substances under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 [Public Law No: 110-425] Site specific restrictions on providers under DEA controlled substances policy Implementation of the Medication Access and Training Expansion (MATE) Act Telehealth, remote patient monitoring and other forms of health technology Reducing regulatory burdens, including those relating to Medicare Conditions of Participation Medicare provider reimbursement Primary care payment reform Documentation of medical records Inclusion of NPs in the HPSA bonus program for clinicians practicing in primary care HPSAs Framework reform of the National Institutes of Health and the National Institute of Nursing Research Optimizing the Food and Drug Administration's Use of and Processes for Advisory Committees

Client expense: $470,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Anti-trust legislation, third party litigation reform, S.2085, Protecting Our Courts from Foreign Manipulation Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Anti-trust legislation, third party litigation reform, S.2085, Protecting Our Courts from Foreign Manipulation Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2039/H.R.6301, the Cancer Drug Parity Act; S. 1491, the Pharmacy and Medically Underserved Areas Enhancement Act, H.R. 1770, the Equitable Community Access to Pharmacist Services Act, S. 2085/H.R. 2407, the Medicare Multi-Cancer Early Detection Screening Coverage Act, Cancer Moonshoot

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

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

Support Medicare Multi-Cancer Early Detection Screening Coverage Act (HR 2407/ S 2085) Support Reducing Hereditary Cancer Act (HR 1526/S 765) Support Finn Sawyer Access to Cancer Testing Act (HR 1780/S 642) Support Equitable Community Access to Pharmacist Services Act (HR 1770) Support Find It Early Act (HR 3086) Support Access to Genetic Counselor Services Act HR 3876/S. 2323

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Support Medicare Multi-Cancer Early Detection Screening Coverage Act (HR 2407/ S 2085) Support Reducing Hereditary Cancer Act (HR 1526/S 765) Support Finn Sawyer Access to Cancer Testing Act (HR 1780/S 642) Support Equitable Community Access to Pharmacist Services Act (HR 1770) Support Find It Early Act (HR 3086) Support Access to Genetic Counselor Services Act HR 3876/S. 2323

Client expense: $420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related FDA regulation of laboratory tests H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act Finn Sawyer Access to Cancer Testing Act (H.R. 1780 / S. 642) Access to Genetic Counselor Services Act (H.R. 3876 / S. 2323)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Anti-trust legislation, third party litigation reform, S.2085, Protecting Our Courts from Foreign Manipulation Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1526/S. 765 -Reducing Hereditary Cancer Act of 2023; bill provides for Medicare coverage of germline mutation testing for individuals with a personal or family history of a hereditary cancer gene mutation or suspected history of hereditary cancer, as well as for associated coverage of risk-reducing surgeries and screenings H.R. 1780/S. 642 - Finn Sawyer Access to Cancer Testing Act; bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer. H.R. 2407/S. 2085 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; 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. H.R. 3086 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals at greater risk for breast cancer. H.R. 4189/S. 2016 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes. H.R. 3876/S .2323 - Access to Genetic Counselor Services Act of 2023; This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act - a bill to establish an electronic prior authorization standard to streamline approvals, reduce the amount of time a health plan is allowed to consider a prior authorization request, require MA plans to report on their use of prior authorization and the rate of approvals and denials, and encourage MA plans to adopt policies that adhere to evidence-based guidelines. H.R. 1770/S. 2477 - Equitable Community Access to Pharmacist Services Act ; would ensure Medicare beneficiaries receive prompt care and services from pharmacists to prevent, diagnose, and treat common infectious diseases. S. 3892 - Community Health Worker Access Act; a bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs. Women's Health and Cancer Rights Act (WHCRA) - a federal law that provides protections to patients who choose to have breast reconstruction in connection with a mastectomy. Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Medicaid unwinding and the process for redetermination of Medicaid eligibility Policies related to the imposition of work requirements within the Medicaid program Policies related to PBM reform Policies related to the implementation of the Inflation Reduction Act Comments in response to Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities (CMS-1809-P, RIN 0938-AV35)

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

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

Medicare issues as they relate to oncology and early multi-cancer detection, including diagnostics and screening; including H.R.2407 - The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S.2085 - A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare issues as they relate to oncology and early multi-cancer detection, including diagnostics and screening; including H.R.2407 - The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S.2085 - A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act Discussions regarding Health ACCESS Act (Health Accelerating Consumers Care by Expediting Self-Scheduling)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Multi-Cancer Early Detection Screening Coverage Act H.R.2407 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S.2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act Outreach re: expanding access to cancer detection technologies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to multi-cancer early detection screening; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; S. 2085, Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2407/S 2085 The Medicare Multi-Cancer Early Detection Screening Coverage Act; Appropriate payment and coverage criteria for certain advanced diagnostic tests

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare issues as they relate to oncology and multi-cancer early detection, including diagnostics and screening, H.R.2407 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; S.2085- A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

H.R. 2407 The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S. 2085 Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 2407 The Nancy Gardner Sewell Multi-Cancer Early Detection Screening Coverage Act; S. 2085 Medicare Multi-Cancer Early Detection Screening Coverage Act

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Bridge To Medicaid Act: extends enhanced premium tax credits to low-income Medicaid enrollees in the coverage gap. Medicaid Unwinding. ACS CAN is working to ensure that states comply with federal law by actively monitoring their data submissions and tracking the impact on Medicaid beneficiaries. We will continue to urge the Centers for Medicare & Medicaid Services (CMS) to take corrective action if states fail to comply with federal Medicaid redetermination requirements 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. 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. 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. 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 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 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. 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. Medical Nutrition Therapy 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

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

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

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

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

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