Comprehensive Cancer Survivorship Act

Issues related to lung disease treatment, prevention and research; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to the Tobacco Control Act; Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to menthol cigarettes; Issues related to tobacco prevention; Issues related to youth cessation research; Issues related to nicotine; Issues related to health equity; Issues related to COVID-19 Response; Issues related to tobacco litter; Issues related to synthetic nicotine; Issues related to regulatory reform;; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 277 REINS Act; S 184 REINS Act; S. 107 Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2023; HR 901 To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; S. 464 No Tax Subsidies for E-Cigarette and Tobacco Ads; 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 4020 Children Don't Belong on Tobacco Farms Act;; S 1411, Prove It Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; HR 2398 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes.; S 1040 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; ; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; HR 4775 Helping Tobacco Users Quit Act; S 3108 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 6038 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 357 Ensuring Accountability in Agency Rulemaking; SJ Res 99 Exclude premium cigars from FDA oversight; issues related to enforcement of illegal vaping; HR 7867 Renewing Efficiency in Government by Budgeting Act; HR 115 Midnight Rules Relief Act; HR 9027 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2025; HR 9029 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2025; HR 9367 Preventing Vape Use Act; S. 4942 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025; S 4690 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2025; HR 890 Guidance out of Regulatory Darkness Act; HR 10515, American Relief Act, 2025; HR 10545, American Relief Act, 2025

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Provide input regarding Comprehensive Cancer Survivorship Act (HR 4364/S 2213) sponsored by Representative Wasserman Schultz in House of Representatives and Senator Klobuchar in Senate. Analyze 21st Century Cures report from DeGette and Bucshon.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

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

Comprehensive Cancer Survivorship Act, HR 4364/S 2213 21st Century Cures Act report from Representatives DeGette and Bucshon

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services. HR 3633: Prevent HPV Cancers ACt of 2023 - To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. S 5368/HR 10239: End Drug Shortages Act - To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for the Comprehensive Cancer Survivorship Act (HR 4363/S 2213); appropriations for survivorship and pediatric cancer drug development; legislation to promote increased childhood cancer therapies - Innovation in Pediatric Drugs Act (HR 6664/S. 4905)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), 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

Lobbied in favor of legislation to ensure that uncompensated care pool days can be included in the medicaid fraction of the medicare DSH %. In the FY 2024 IPPS CMS changed a rule that would prevent these days from being included. Discussed this solution with members/staff of the following offices: Buchanan (FL), Luna, Bilirakis, Lee (FL), Castor, Rubio, Scott, Soto, Franklin. Advocated on behalf of the At-HOME Services Act (S. 3756, H.R.7742). To expand hospital-at-home waiver to include observation patients for medicare payment. Ongoing conversations with Senator Rubio's office, Congresswoman Castor's office, and Congressman Buchanan's office in advancing At-HOME Services Act. Commented on the following proposed rules out of CMS: -CY 2025 Home Health Prospective Payment System Proposed Rule Fact Sheet (CMS-1803-P) -CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS 1809-P) -CY 2025 Medicare Physician Fee Schedule Proposed Rule (CMS-1807-P)-Medicare Shared Savings Program Proposals. Sent a letter to the following offices in support of the bills listed below. -Reps. Bilirakis, Buchanan, Castor, Donalds, Dunn, Franklin, Frost, Lee, Luna, Soto, Steube -Sens. Rubio and Scott -Legislation: HR 4286, HR 6693, HR 4363, S 2213, HR 4531, HR 2412, HR 7742, S 3756

Client expense: $211,558 · 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), Health Resources & Services Administration (HRSA), SENATE

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Comprehensive Cancer Survivorship Act, HR 4364/S2213

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

Provide input regarding Comprehensive Cancer Survivorship Act (HR 4364/S 2213) sponsored by Representative Wasserman Schultz in House of Representatives and Senator Klobuchar in Senate. Lobbying activity in House of Representatives.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

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 lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to Medicaid; Issues related to ERISA; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to Cancer Moonshot; Issues related to short-term limited duration plans; Issues related to Healthy Future Taskforce; Issues related to regulatory reform; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 277 REINS Act; S 184 REINS Act; 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. 1692 Health Care Affordability Act of 2023; HR 3073 Community Mental Wellness and Resilience Act; S 1452 Community Mental Wellness and Resilience 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; S 1411, Prove It Act of 2023; S 1995 Public Health Infrastructure Saves Lives Act; HR 824 Telehealth Benefit Expansion for Workers Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 2813 The Self-Insurance Protec􀆟on Act; HR 3799 CHOICE Arrangement Act; HR 2868 Association Health Plans Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; S. 2016 CONNECT for Health Act of 2023; HR 4189 CONNECT for Health Act of 2023;; HR 5749 Family Asthma Act; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; S 2245 Women and Lung Cancer Research and Preventive Services Act; HR 4534 Women and Lung Cancer Research and Preventive Services Act; S 2333 Pandemic and All Hazards Preparedness and Response Act; HR 4420 Pandemic and All-Hazards Preparedness and Response Act; S 1489 National Task Force on the COVID-19 Pandemic Act;; HR 6302 Health Share Transparency Act; HR 357 Ensuring Accountability in Agency Rulemaking;; 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; H.R. 8774 Department of Defense Appropriations Act 2025; S. 4942 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025; S 4921 Department of Defense Appropriations Act 2025; HR 890 Guidance out of Regulatory Darkness Act; HR 9747 Continuing Appropriations and Extensions Act, 2025; HR 9494 Continuing Appropriations and Other Matters Act 2025; H.R. 9774, Health Care Affordability Act of 2024; S. 5194 Health Care Affordability Act of 2024; S. 652 Safe Step Act; HR 2630 Safe Step Act

Client expense: $180,000 · Firm income: Not reported

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

Issues related to lung disease treatment, prevention and research; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to the Tobacco Control Act; Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to menthol cigarettes; Issues related to tobacco prevention; Issues related to youth cessation research; Issues related to nicotine; Issues related to health equity; Issues related to COVID-19 Response; Issues related to tobacco litter; Issues related to synthetic nicotine; Issues related to regulatory reform;; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 277 REINS Act; S 184 REINS Act; S. 107 Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2023; HR 901 To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; S. 464 No Tax Subsidies for E-Cigarette and Tobacco Ads; 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 4020 Children Don't Belong on Tobacco Farms Act;; S 1411, Prove It Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; HR 2398 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes.; S 1040 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; ; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; HR 4775 Helping Tobacco Users Quit Act; S 3108 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 6038 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 357 Ensuring Accountability in Agency Rulemaking; SJ Res 99 Exclude premium cigars from FDA oversight; issues related to enforcement of illegal vaping; HR 7867 Renewing Efficiency in Government by Budgeting Act; HR 115 Midnight Rules Relief Act; HR 9027 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2025; HR 9029 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2025; HR 9367 Preventing Vape Use Act; S. 4942 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025; S 4690 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2025; HR 890 Guidance out of Regulatory Darkness Act; HR 9747 Continuing Appropriations and Extensions Act, 2025; HR 9494 Continuing Appropriations and Other Matters Act 2025

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Support for the Comprehensive Cancer Survivorship Act (HR 4363/S 2213); appropriations for survivorship and pediatric cancer drug development; legislation to promote increased childhood cancer therapies - Innovation in Pediatric Drugs Act (HR 6664/S. 4905)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4121, S 1999, S 4381 - Right to Contraception Act All provisions This bill would safeguard Americans right to access all forms of birth control and protect against federal and state efforts to restrict it HR 4731, S 2386 - Access to Infertility Treatment and Care Act All provisions This bill will require health insurance coverage for the treatment of infertility. HR 880 - Heart Health Enhancement through Access to Research and Training Act All provisions This bill authorizes grants for continuing medical education programs for physicians on preventing, identifying, and treating cardiovascular disease in women. H.Res. 345 - A resolution recognizing that infertility is a widespread problem that affects populations of diverse ages, races, ethnicities, and genders. All provisions This resolution recognizes the need for education, research, and medical interventions to address infertility and disparities associated with that disease. HR 7056, S 3612 - Access to Family Building Act All provisions This bill provides a statutory right to access assisted reproductive technology (e.g., In vitro fertilization). HR 4363, S 2213 - Comprehensive Cancer Survivorship Act All provisions This bill addresses the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment. S 4445 - Right to IVF Act All provisions This bill protects and expands nationwide access to fertility treatment, including in vitro fertilization. HR 8223, S 4246 - Advancing Menopause Care and Mid-Life Womens Health Act All provisions This bill aims to improve menopause care and mid-life women's health through expanded research, public health promotion, education, training, and the establishment of Centers of Excellence, with significant funding allocated for these initiatives from 2025 to 2029. HR 8796, S4619 Stop Comstock Act All provisions This bill would repeal language in the Comstock Laws that could be used to ban the mailing of mifepristone and other drugs used in medication abortions, instruments and equipment used in abortions, and educational material related to sexual health. HR 8821 - HOPE with Fertility Services Act All provisions This bill requires group health plans to cover infertility treatments, sets compliance and penalty guidelines, and mandates annual reporting for five years, effective from 2026. HR 9269 - IVF Access and Affordability Act All provisions This bill introduces a tax credit for fertility treatments, capping at $20,000 annually, with provisions for joint filers, income-based reductions, and a five-year carryforward for unused credits, effective for taxable years post-enactment. H.Res. 1448, S.Res. 828 - Expressing the sense of the House of Representatives that every person has the basic right to emergency health care, including abortion care. All provisions This resolution asserts that everyone has a basic right to emergency health care, including abortion, and highlights the negative impacts of restrictive state laws on marginalized communities and healthcare providers.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), 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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458 Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.

Client expense: $540,000 · 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 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

Issues related to lung disease treatment, prevention and research; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to the Tobacco Control Act; Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to menthol cigarettes; Issues related to tobacco prevention; Issues related to youth cessation research; Issues related to nicotine; Issues related to health equity; Issues related to COVID-19 Response; Issues related to tobacco litter; Issues related to synthetic nicotine; Issues related to regulatory reform;; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 277 REINS Act; S 184 REINS Act; S. 107 Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2023; HR 901 To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; S. 464 No Tax Subsidies for E-Cigarette and Tobacco Ads; 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 4020 Children Don't Belong on Tobacco Farms Act;; S 1411, Prove It Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; HR 2398 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes.; S 1040 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; ; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; HR 4775 Helping Tobacco Users Quit Act; S 3108 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 6038 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 357 Ensuring Accountability in Agency Rulemaking; SJ Res 99 Exclude premium cigars from FDA oversight; issues related to enforcement of illegal vaping; HR 7867 Renewing Efficiency in Government by Budgeting Act; HR 115 Midnight Rules Relief Act; Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2025; Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2025;

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to Medicaid; Issues related to ERISA; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to Cancer Moonshot; Issues related to short-term limited duration plans; Issues related to Healthy Future Taskforce; Issues related to regulatory reform; Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; HR 277 REINS Act; S 184 REINS Act; 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. 1692 Health Care Affordability Act of 2023; HR 3073 Community Mental Wellness and Resilience Act; S 1452 Community Mental Wellness and Resilience 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; S 1411, Prove It Act of 2023; S 1995 Public Health Infrastructure Saves Lives Act; HR 824 Telehealth Benefit Expansion for Workers Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 2813 The Self-Insurance Protec􀆟on Act; HR 3799 CHOICE Arrangement Act; HR 2868 Association Health Plans Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; S. 2016 CONNECT for Health Act of 2023; HR 4189 CONNECT for Health Act of 2023;; HR 5749 Family Asthma Act; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; S 2245 Women and Lung Cancer Research and Preventive Services Act; HR 4534 Women and Lung Cancer Research and Preventive Services Act; S 2333 Pandemic and All Hazards Preparedness and Response Act; HR 4420 Pandemic and All-Hazards Preparedness and Response Act; S 1489 National Task Force on the COVID-19 Pandemic Act;; HR 6302 Health Share Transparency Act; HR 357 Ensuring Accountability in Agency Rulemaking;; 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; Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2025; H.R. 8774 Department of Defense Appropriations Act 2025

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

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

Comprehensive Cancer Survivorship Act (HR 4364/S 2213)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

Comprehensive Cancer Survivorship Act (HR 4364/S 2213)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

Provide input regarding Comprehensive Cancer Survivorship Act (HR 4364/S 2213) sponsored by Representative Wasserman Schultz in House of Representatives and Senator Klobuchar in Senate. Discussion with House staffer regarding breast reconstruction coverage and payment. Lobbying activity in House of Representatives.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

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

Support for the Comprehensive Cancer Survivorship Act (HR 4363/S 2213); appropriations for survivorship and pediatric cancer drug development; legislation to promote increased childhood cancer therapies - Innovation in Pediatric Drugs Act (HR 6664)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4121, S 1999, S 4381 - Right to Contraception Act All provisions This bill would safeguard Americans right to access all forms of birth control and protect against federal and state efforts to restrict it HR 4731, S 2386 - Access to Infertility Treatment and Care Act All provisions This bill will require health insurance coverage for the treatment of infertility. HR 880 - Heart Health Enhancement through Access to Research and Training Act All provisions This bill authorizes grants for continuing medical education programs for physicians on preventing, identifying, and treating cardiovascular disease in women. H.Res. 345 - A resolution recognizing that infertility is a widespread problem that affects populations of diverse ages, races, ethnicities, and genders. All provisions This resolution recognizes the need for education, research, and medical interventions to address infertility and disparities associated with that disease. S 2415 - Preventing Maternal Deaths Reauthorization Act of 2023 All provisions This bill reauthorizes through FY2028 and otherwise modifies federal support for state-based efforts to improve maternal mortality review committees; enhance surveillance of pregnancy-associated and -related deaths; and otherwise improve, and reduce disparities in, maternal health outcomes. HR 7056, S 3612 - Access to Family Building Act All provisions This bill provides a statutory right to access assisted reproductive technology (e.g., In vitro fertilization). HR 7153, S 3679 - Dr. Lorna Breen Health Care Provider Protection Reauthorization Act All provisions This bill reauthorizes the Dr. Lorna Breen Health Care Provider Protection Act. HR 2907, S 1297 - Let Doctors Provide Reproductive Health Care Act All provisions This bill sets out protections for and establishes programs to support health care providers (and those who assist such providers) who offer reproductive health care services that are lawful in the state where the services are provided. HR 782 - Ensuring Womens Right to Reproductive Freedom Act All provisions This bill prohibits anyone acting under state law from interfering with a person's ability to access out-of-state abortion services. S 631 - UPHOLD Privacy Act of 2023 All provisions This bill would protect the privacy of personally identifiable health and location data HR 4363, S 2213 - Comprehensive Cancer Survivorship Act All provisions This bill addresses the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment. HR 4581, S 2231 - Maternal and Child Health Stillbirth Prevention Act of 2024 All provisions This bill expands the scope of the Maternal and Child Health Services Block Grant to include research and activities to prevent stillbirths. H.Res. 1240 - Providing for consideration of the bill (HR 4121) to protect an individuals ability to access contraceptives and to engage in contraception and to protect a health care providers ability to provide contraceptives, contraception, and information related to contraception. All provisions This bill states that immediately upon adoption of this resolution, the House shall proceed to the consideration in the House of H.R. 4121. S 2544 - Reproductive Health Care Accessibility Act All provisions This bill establishes various grants and related programs that address sexual and reproductive health care for individuals with disabilities. S 4445 - Right to IVF Act All provisions This bill protects and expands nationwide access to fertility treatment, including in vitro fertilization. HR 12, S 701 - Womens Health Protection Act of 2023 All provisions This bill prohibits governmental restrictions on the provision of, and access to, abortion services. Stop Comstock Act All provisions This bill would repeal language in the Comstock Laws that could be used to ban the mailing of mifepristone and other drugs used in medication abortions, instruments and equipment used in abortions, and educational material related to sexual health. HR 8821 - Helping to Optimize Patients Experience (HOPE) with Fertility Services Act All provisions The bill ensures that infertility treatments and diagnostic care, including in vitro fertilization (IVF), be covered by private insurance plans.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provide input regarding Comprehensive Cancer Survivorship Act (HR 4364/S 2213) sponsored by Representative Wasserman Schultz in House of Representatives and Senator Klobuchar in Senate. Discussion with House staffer regarding breast reconstruction coverage and payment. Lobbying activity in House of Representatives.

Client expense: Not reported · Firm income: Not reported

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

Issues related to lung disease treatment, prevention and research; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to the Tobacco Control Act; Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to menthol cigarettes; Issues related to tobacco prevention; Issues related to youth cessation research; Issues related to nicotine; Issues related to health equity; Issues related to COVID-19 Response; Issues related to tobacco litter; Issues related to synthetic nicotine; Issues related to regulatory reform; Issues relating to the Presidents FY24 budget; Issues relating to FY25 appropriations; HR 277 REINS Act; S 184 REINS Act; S. 107 Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2023; HR 901 To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; S. 464 No Tax Subsidies for E-Cigarette and Tobacco Ads; 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 4368 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024; S.2131 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024; HR 4020 Children Don't Belong on Tobacco Farms Act; Issues related to Labor, Health and Human Services, Education and Related Agencies Appropriations Act, 2024; S 1411, Prove It Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; HR 2398 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes.; S 1040 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S 2624 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024; ; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; HR 4775 Helping Tobacco Users Quit Act; HR 5894 Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes; S 3108 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 6038 Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction Act; HR 357 Ensuring Accountability in Agency Rulemaking; SJ Res 99 Exclude premium cigars from FDA oversight; ; HR 7463 Extension of Continuing Appropriations and Other Matters Act, 2024; HR 2872 Further Additional Continuing Appropriations and Other Extensions Act, 2024; HR4366 Consolidated Appropriations Act, 2024; HR 2882 Further Consolidated Appropriations Act, 2024; issues related to enforcement of illegal vaping;

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to Medicaid; Issues related to ERISA; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to Cancer Moonshot; Issues related to short-term limited duration plans; Issues related to Healthy Future Taskforce; Issues related to regulatory reform; Issues relating to the Presidents FY25 budget; Issues relating to FY25 appropriations; HR 277 REINS Act; S 184 REINS Act; 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. 1692 Health Care Affordability Act of 2023; HR 3073 Community Mental Wellness and Resilience Act; S 1452 Community Mental Wellness and Resilience 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; Issues related to Labor, Health and Human Services, Education and Related Agencies Appropriations Act, 2024; S 1411, Prove It Act of 2023; S 1995 Public Health Infrastructure Saves Lives Act; HR 824 Telehealth Benefit Expansion for Workers Act of 2023; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 2813 The Self-Insurance Protec􀆟on Act; HR 3799 CHOICE Arrangement Act; HR 2868 Association Health Plans Act; S 2213 Comprehensive Cancer Survivorship Act; HR 4363 Comprehensive Cancer Survivorship Act; S. 2016 CONNECT for Health Act of 2023; HR 4189 CONNECT for Health Act of 2023; S 2624 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024;; HR 5749 Family Asthma Act; HR 4286 Increasing Access to Lung Cancer Screening Act; HR 890 The Guidance Out of Darkness Act; S 791 The Guidance Out of Darkness Act; S 2245 Women and Lung Cancer Research and Preventive Services Act; HR 4534 Women and Lung Cancer Research and Preventive Services Act; S 2333 Pandemic and All Hazards Preparedness and Response Act; HR 4420 Pandemic and All-Hazards Preparedness and Response Act; S 1489 National Task Force on the COVID-19 Pandemic Act; HR 5894 Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes; HR 6302 Health Share Transparency Act; HR 357 Ensuring Accountability in Agency Rulemaking; ; HR 7463 Extension of Continuing Appropriations and Other Matters Act, 2024; HR 2872 Further Additional Continuing Appropriations and Other Extensions Act, 2024; HR4366 Consolidated Appropriations Act, 2024; HR 2882 Further Consolidated Appropriations Act, 2024; 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

Client expense: $220,000 · Firm income: Not reported

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act - extension of expanded tax credits for ACA marketplaces; The Prevent HPV Cancers Act Women and Lung Cancer Research and Preventive Services Act of 2021 Gabriella Miller Kids First Research Act 2.0 (H.R. 623/S. 1523) The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act Modernization of Clinical Trials Act DEPICT Act NIH Clinical Trials Diversity Act Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Retaining Access and Restoring Exclusivity (RARE) Act Health Equity and Accountability Act Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines Help CoPays Act Compact Fairness Act Nancy Gardner Sewell Multi-Cancer Early Detection Act PSA for HIM Act PC CARE Act Alan Reinstein Ban Asbestos Act Firefighter Cancer Registry Act DOD Directed Medical Research Program Childhood Cancer STAR Act H.R. 3810, the Drug Origin Transparency Act of 2023, H.R. 3008, the Drug Shortage Prevention Act, H.R. 2500, the Protecting Americans from Unsafe Drugs Act of 2023 H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3807, the Medical Device Shortage Reduction Act of 2023, H.R. 405, Essential Medicines Strategic Stockpile Act of 2023 Comprehensive Cancer Survivorship Act (S.2213 H bill number TBD): Safe Step Act Cancer Drug Parity Act (S.2039 - Cancer Drug Parity Act of 2023; H.R. 6301 Cancer Drug Parity Act of 2023) Equitable Community Access to Pharmacist Services Act PBM Reform 340B Reform Medical Nutrition Act Drug Shortages The Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act - H.R. 3916 - SCREENS for Cancer Act of 2023 Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act - H.R. 3633 PREVENT HPV Cancers Act of 2023; Promotion Resources to Expand Vaccination, Education and New Treatment for HPV Cancers Act of 2023 Access to Breast Cancer Diagnosis Act of 2023 Find It Early Act - H.R. 3086 Henrietta Lacks Congressional Gold Medal Act Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 Accelerating Kids Access to Care Act- S.2372; H.R. 4758 RAPID Reserve Act (S. 2510) Energy & Commerce Majority Drug Shortage RFI Energy & Commerce Majority/Finance Minority Drug Shortage RFI House Budget Committee RFI on how to reduce healthcare spending Telehealth Benefit Expansion for Workers Act (H.R. 824) Multi-Cancer Early Detection Act Women and Lunch Cancer Research and Preventative Services Act Lung Cancer Screening and Prevention Act Veterans Counting Cancer Act Harley Jacobsen Clinical Trial Participant Income Exemption Act (H.R. 7090) Creating Hope Reauthorization Act of 2024 (H.R. 7384) The Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963) The Counting Veterans Cancer Act of 2023 (S. 1994) Lung Cancer Screening and Prevention Act (H.R. 6693) Health Equity Accountability Act

Client expense: $2,670,000 · 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Comprehensive Cancer Survivorship Act, HR 4364/S2213 Breast reconstruction surgery third-party coverage and payment issues

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

Comprehensive Cancer Survivorship Act, HR 4364/S2213

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

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

Support for the Comprehensive Cancer Survivorship Act (HR 4363/S 2213); appropriations for survivorship and pediatric cancer drug development; legislation to promote increased childhood cancer therapies - Innovation in Pediatric Drugs Act (HR 6664)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE