Drug Shortage Prevention Act of 2023

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691, Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S. 2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 3285, Fairness for Patient Medications Act; S. 2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act; S. 5503, H.R. 10362, the Patients Before Monopolies (PBM) Act; P.L. No: 118-158 and draft FY2025 Continuing Resolution, issues related to PBMs.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Children's Hospital Graduate Medical Education (CHGME) - Continued to urge Congress to reauthorize CHGME program Drug shortages - Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Continued supporting passage of The Drug Shortage Prevention Act (H.R. 3008) and The Drug Origin Transparency Act (H.R. 3810) Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers, as well as key differences between traditional GPOs and PBMs. Monitored development of the Lower Costs, More Transparency Act (H.R. 5378) Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Mental and Behavioral Health - Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Pandemic and All Hazards Preparedness Act (PAHPA) - Encouraged the reauthorization of PAHPA Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Rural healthcare - Encouraged passage of the Save Rural Hospitals Act (S. 803) ; the Rural Hospital Closure Relief Act (S. 1571) and the Assistance for Rural Community Hospitals Act (H.R. 6430) Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Specifications, Standards and Ecolabels for Federal Purchasing - Responded to the Environmental Protection Agency (EPA) on EPAs Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing. Encouraged EPA to use a standard, ecolabel or certification that is recognized by the Environmental Sustainability Program. Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date. Telemedicine prescribing - Encouraged Congress to pass a two-year extension of Drug Enforcement Administration (DEA) prescribing flexibilities without requiring an in-person medical evaluation Workforce - Monitored development of the Bipartisan Primary Care and Health Workforce Act (S.2840) ; Encouraged passage of the Safety from Violence for Healthcare Employees (SAVE) Act (S. 2768/H.R. 2584) ; the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (S. 3679/H.R. 7153) ; the Healthcare Workforce Resilience Act (S.3211/H.R.6205) ; the Resident Physician Workforce Shortage Reduction Act of 2023 (S. 1302/H.R. 2389) ; and the Substance Use Disorder Workforce Act (H.R.7050)

Client expense: $260,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

340B Program; Issues related to affordable prescription drugs;H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages;

Client expense: $750,000 · Firm income: Not reported

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

340B Program; Issues related to affordable prescription drugs; Issues related to health care workforce and staffing; Issues related to health care privacy; Issues related to telehealth authorities; Issues related to hospital price transparency; Issues related to hospital reimbursement; Issues related to nonprofit hospital practices; Issues related to hospital outpatient department payments; Issues related to hospital outpatient department payments; Medicaid Disproportionate Share Hospital payment adjustment program; Issues related to Medicare payments; Issues related to Medicare Advantage payment and prior authorization; Childrens Hospital Graduate Medical Education Program (CHGME); issues related to childrens medical care; issues related to rural health; S. 4352/H.R. 8702, the Seniors Timely Access to Care Act H.R. 2584/S. 2768, the Safety From Violence for Healthcare Employees (SAVE) Act; Expanding Care in the Home Act; H.R. 1770, Equitable Access to Pharmacy Services Act; issues related to Program for All-Inclusive Care for the Elderly (PACE); H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages; H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act; H.R. 3263, the Support Faculty and Expand Access to Nursing Act; issues related to prior authorization, unwarranted claim denials, and payment delays; S. 2840, the Bipartisan Primary Care and Health Workforce Expansion Act; H.R. 3561, the PATIENT Act; H.R. 6363, Further Continuing Appropriations and Other Extension Act; H.R. 5378, the Lower Costs, More Transparency Act; Issues related to mental and behavioral health; the limit on Medicare payment days for inpatient psychiatric care; the Institutions for Mental Disease exclusion; issues related to extending programs under the SUPPORT for Patients Communities Act; issues related to cybersecurity; enhanced Advanced Premium Tax Credits

Client expense: $750,000 · Firm income: Not reported

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

PAHPA reauthorization, including S.2333 - the Pandemic and All-Hazards Preparedness and Response Act and H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act; Pharmaceutical supply chain issues; H.R.6992/S.2364 - MAPS Act; H.R.3008 - Drug Shortage Prevention and Mitigation Act; Issues related to drug shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Care Inflation Reduction Act (IRA). ACS CAN actively monitors implementation of the Inflation Reduction Acts Medicare Drug Price negotiation provisions to ensure cancer patients have access to costly prescription drugs. ACS CAN also supports the Medicare Prescription Payment Plan, which allows Part D enrollees to spread their out-of-pocket costs over the plan year. Enhanced Advanced Premium Tax Credits, H.R. 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

340b drug pricing program. Issues related to pharmacy benefit manager reform. Health care workforce. Health care supply chain. Health care drug shortages. Pandemic All-Hazard Preparedness Act Reauthorization. The Stop Drug Shortages Act (No Bill Number) discussion draft. H.R. 3008 - The Drug Shortage Prevention Act. H.R. 3810 - The Drug Origin Transparency Act.

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

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

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.

Client expense: $800,000 · Firm income: Not reported

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

S 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

Lobbying activities related to children's pain relieving medicines and supply chain. H.R. 3008 - Drug Shortage Prevention Act of 2023 Issues related to pharmaceutical tariffs

Client expense: Not reported · Firm income: $220,119

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

-H.R. 485 Protecting Health Care for All Patients Act of 2023 -H.R.3008 - Drug Shortage Prevention Act of 2023 -Rollout of 2024 Covid-19 vaccines -HR 2630, the Safe Step Act -H.R.8816 - American Medical Innovation and Investment Act of 2024 -Pharmacy benefit manager reform

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

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

340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Buffer inventory - Engagements with CMS on reimbursement for hospitals that stockpile buffer supplies of essential medicines. Children's Hospital Graduate Medical Education (CHGME) - Continued to urge Congress to reauthorize CHGME program through the Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Drug shortages -Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Continued supporting passage of The Drug Shortage Prevention Act (H.R. 3008) and The Drug Origin Transparency Act (H.R. 3810). Provided feedback on the Senate Finance Committee discussion draft on the Drug Shortage Prevention and Mitigation Act (No Bill Number) legislation. Healthcare Workforce - Monitored development of the Bipartisan Primary Care and Health Workforce Act (S.2840) and the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768). Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers, as well as key differences between traditional GPOs and PBMs. Interchangeability Status - Responded to the Food and Drug Administration (FDA) draft guidance on Considerations for Demonstrating Interchangeability with a Reference Product: Update. Urged FDA to promptly finalize the Draft Guidance. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Mental and Behavioral Health - Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date. Telemedicine prescribing - Encouraged Congress to pass a two-year extension of Drug Enforcement Administration (DEA) prescribing flexibilities without requiring an in-person medical evaluation. Workforce - Encouraged passage of The Health Workforce Innovation Act (S.4957).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2780, Medication Affordability and Patent Integrity Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $1,720,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program; Issues related to affordable prescription drugs; Issues related to health care workforce and staffing; Issues related to health care privacy; Issues related to telehealth authorities; Issues related to hospital price transparency; Issues related to hospital reimbursement; Issues related to nonprofit hospital practices; Issues related to hospital outpatient department payments; Issues related to hospital outpatient department payments; Medicaid Disproportionate Share Hospital payment adjustment program; Issues related to Medicare payments; Issues related to Medicare Advantage payment and prior authorization Childrens Hospital Graduate Medical Education Program (CHGME); issues related to childrens medical care; issues related to rural health; S. 4352/H.R. 8702, the Seniors Timely Access to Care Act Future Advancement of Academic Nursing (FAAN) Act; Veteran Nurses in Primary Care Program; H.R. 2584/S. 2768, the Safety From Violence for Healthcare Employees (SAVE) Act; Expanding Care in the Home Act; H.R. 1770, Equitable Access to Pharmacy Services Act; issues related to Program for All-Inclusive Care for the Elderly (PACE); H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages; H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act; H.R. 3263, the Support Faculty and Expand Access to Nursing Act; issues related to prior authorization, unwarranted claim denials, and payment delays; S. 2840, the Bipartisan Primary Care and Health Workforce Expansion Act; H.R. 3561, the PATIENT Act; H.R. 6363, Further Continuing Appropriations and Other Extension Act; H.R. 5378, the Lower Costs, More Transparency Act; Issues related to mental and behavioral health; the limit on Medicare payment days for inpatient psychiatric care; the Institutions for Mental Disease exclusion; issues related to extending programs under the SUPPORT for Patients Communities Act; issues related to cybersecurity.

Client expense: $800,000 · Firm income: Not reported

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

340B Program; Issues related to affordable prescription drugs;H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages;

Client expense: $800,000 · Firm income: Not reported

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

340b drug pricing program. Issues related to pharmacy benefit manager reform. Health care workforce. Health care supply chain. Health care drug shortages. Pandemic All-Hazard Preparedness Act Reauthorization. The Stop Drug Shortages Act (No Bill Number) discussion draft. H.R. 3008 - The Drug Shortage Prevention Act. H.R. 3810 - The Drug Origin Transparency Act.

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

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

PAHPA reauthorization, including S.2333 - the Pandemic and All-Hazards Preparedness and Response Act and H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act; Pharmaceutical supply chain issues; H.R.6992/S.2364 - MAPS Act; H.R.3008/S.2363 - Drug Shortage Prevention and Mitigation Act; S.5040 -Protecting Patients from Deceptive Drug Ads Online Act; Issues related to drug shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments to FDA on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061]; H.R.9096, the Pharmacists Fight Back Act; Comments to FDA on Docket No. FDA-2023-N-4806 - Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comment.

Client expense: $380,000 · 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), SENATE

Lobbying activities related to children's pain relieving medicines and supply chain. H.R. 3008 - Drug Shortage Prevention Act of 2023

Client expense: Not reported · Firm income: $118,712

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

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program Bayh-Done march in rights policy issues H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024: Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Vaccine provisions of the inflation reduction Act Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,510,000 · Firm income: Not reported

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets; S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act); H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act; S.150, the Affordable Prescription Drug for Patients Act; S. 148, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act); S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $2,200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity  Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network S. 3029/H.R. 6085 PREEMIE Reauthorization Act Issues regarding the Medicaid unwinding Issues regarding surprise billing, bad debt, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023 H.R. 4189, CONNECT for Health Act H.R. 1110, KEEP Telehealth Options Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issues regarding the Public Health Emergency Unwinding Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1884/H.R. 3713, Mental Health Services for Students Act H.R. 2389, The Resident Shortage Reduction Act S. 1774/H.R. 3761 the Assist Act H.R. 2665, Supporting Safety Net Hospitals Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act H.R. 3046, Medical Student Education Authorization Act S. 2556, Improving CARE for Youth Act S. 2647/H.R. 5012, SHINE for Autumn Act of 2023 S. 923/H.R. 4933, Mental Health Professionals Workforce Shortage Loan Repayment Act of 2023 S. 2362/H.R. 3008, Drug Shortage Prevention Act of 2023 S. 1409, Kids Online Safety Act S. 1769/H.R. 3805, the Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act. H.R. 5804, Mental Health Infrastructure Improvement Act H.R. 5976 /S. 3060 Youth Mental Health Research Act S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664, Innovation in Pediatric Drugs Act S. 4298: Esthers Law Issues regarding oversight and implementation of EPSDT

Client expense: $1,550,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061];

Client expense: $340,000 · 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), SENATE

340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Responded to the discussion draft of the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act) and supplemental request for information (RFI). Buffer inventory - Engagements with CMS on reimbursement for hospitals that stockpile buffer supplies of essential medicines Children's Hospital Graduate Medical Education (CHGME) - Continued to urge Congress to reauthorize CHGME program through the Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Drug shortages -Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Continued supporting passage of The Drug Shortage Prevention Act (H.R. 3008) and The Drug Origin Transparency Act (H.R. 3810) and engaged on the Stop Drug Shortages Act (McMorris Rodgers, No Bill Number) discussion draft. Healthcare Workforce - Monitored development of the Bipartisan Primary Care and Health Workforce Act (S.2840) and the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768). Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers, as well as key differences between traditional GPOs and PBMs. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Mental and Behavioral Health - Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Office of the National Coordinator (ONC) Standards Bulletin 2024-1 (SB24-1) - Offered recommendations to constructively improve Draft USCDI v5 to support efforts related to health equity. Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date.

Client expense: $290,000 · 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), SENATE

340B Program; Issues related to affordable prescription drugs; Issues related to health care workforce and staffing; Issues related to health care privacy; Issues related to telehealth authorities; Issues related to hospital price transparency; Issues related to hospital reimbursement; Issues related to nonprofit hospital practices; Issues related to hospital outpatient department payments; Issues related to hospital outpatient department payments; Medicaid Disproportionate Share Hospital payment adjustment program; Issues related to Medicare payments; Issues related to Medicare Advantage payment and prior authorization Childrens Hospital Graduate Medical Education Program (CHGME); issues related to childrens medical care; Future Advancement of Academic Nursing (FAAN) Act; Veteran Nurses in Primary Care Program; H.R. 2584/S. 2768, the Safety From Violence for Healthcare Employees (SAVE) Act; Expanding Care in the Home Act; H.R. 1770, Equitable Access to Pharmacy Services Act; issues related to Program for All-Inclusive Care for the Elderly (PACE); H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages; H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act; H.R. 3263, the Support Faculty and Expand Access to Nursing Act; issues related to prior authorization, unwarranted claim denials, and payment delays; S. 2840, the Bipartisan Primary Care and Health Workforce Expansion Act; H.R. 3561, the PATIENT Act; H.R. 6363, Further Continuing Appropriations and Other Extension Act; H.R. 5378, the Lower Costs, More Transparency Act; Issues related to mental and behavioral health; the limit on Medicare payment days for inpatient psychiatric care; the Institutions for Mental Disease exclusion; issues related to extending programs under the SUPPORT for Patients Communities Act; issues related to cybersecurity.

Client expense: $300,000 · Firm income: Not reported

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

340B Program; Issues related to affordable prescription drugs;H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages;

Client expense: $300,000 · Firm income: Not reported

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

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $6,960,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

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

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

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

-H.R. 485 Protecting Health Care for All Patients Act of 2023 -H.R.3008 - Drug Shortage Prevention Act of 2023 -On the creation of an executive branch Office of Caregiver Health -Rollout of 2024 Covid-19 vaccines -HR 2630, the Safe Step Act -H.R.8816 - American Medical Innovation and Investment Act of 2024 -Pharmacy benefit manager reform

Client expense: $117,694 · Firm income: Not reported

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

340b drug pricing program. Issues related to pharmacy benefit manager reform. Health care workforce. Health care supply chain. Health care drug shortages. Pandemic All-Hazard Preparedness Act Reauthorization. The Stop Drug Shortages Act (No Bill Number) discussion draft. H.R. 3008 - The Drug Shortage Prevention Act. H.R. 3810 - The Drug Origin Transparency Act.

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

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

Lobbying activities related to children's pain relieving medicines and supply chain. H.R. 3008 - Drug Shortage Prevention Act of 2023

Client expense: Not reported · Firm income: $163,498

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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: $200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern__ Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act

Client expense: $820,000 · Firm income: Not reported

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

340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Responded to the discussion draft of the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act) and supplemental request for information (RFI). Buffer inventory - Engagements with CMS on reimbursement for hospitals that stockpile buffer supplies of essential medicines. Children's Hospital Graduate Medical Education (CHGME) - Continued to urge Congress to reauthorize CHGME program through the Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Drug shortages -Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Engaged on recent FTC/HHS joint Request for Information related to generic drug shortages, as well as the January Senate Finance Committee White Paper Preventing and Mitigating Generic Drug Shortages: Policy Options Under Federal Health Programs. Continued supporting passage of The Drug Shortage Prevention Act (H.R. 3008) and The Drug Origin Transparency Act (H.R. 3810) and engaged on the Stop Drug Shortages Act (McMorris Rodgers, No Bill Number) discussion draft. Endorsed passage of legislation to address patent thickets (H.R. 6986/S.3583). Endorsed passage of the Affordable Prescriptions for Patients Act (S.150). Endorsed passage of the Mapping Americas Pharmaceutical Supply (MAPS) Act (H.R. 6992). Healthcare Workforce - Endorsed passage of the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768). Monitored development of the Bipartisan Primary Care and Health Workforce Act (S.2840). Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers, as well as key differences between traditional GPOs and PBMs. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Mental and Behavioral Health - Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Preparing for All Hazards and Pathogens Reauthorization Act (H.R. 4421) and Preparedness and Response Reauthorization Act (H.R. 4420) - Supported timely passage of legislation to reauthorize the Pandemic and All Hazards Preparedness Act. Advocated for including provisions to increase transparency in the healthcare supply chain and improve hospital and health system emergency preparedness. Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Supported an increase in the Physician Fee Schedule conversion factor in Consolidated Appropriations Act, 2024 (H.R. 4366) to offset recent administrative payment cuts. Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date.

Client expense: $270,000 · 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), SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $9,600,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, 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: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure; Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclosure Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets.

Client expense: $2,910,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding the implementation of the ACE Kids Act  H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity  Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments FY 2024 and FY 2025 Senate and House Labor-HHS appropriations provisions - Children's Hospitals Graduate Medical Education (CHGME) program funding   Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program reauthorization Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce and the Pediatric Specialty Loan Repayment Program S. 3029/H.R. 6085 PREEMIE Reauthorization Act Issues regarding the Medicaid unwinding Issues regarding surprise billing, bad debt, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023 H.R. 4189, CONNECT for Health Act H.R. 1110, KEEP Telehealth Options Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issues regarding the Public Health Emergency Unwinding Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1884/H.R. 3713, Mental Health Services for Students Act The Pursuing Equity in Mental Health America Act H.R. 2389, The Resident Shortage Reduction Act S. 1774/H.R. 3761 the Assist Act H.R. 3633, the Prevent HPV Cancers Act H.R. 2665, Supporting Safety Net Hospitals Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 923, Better Mental Health Care for Americans Act H.R. 3046, Medical Student Education Authorization Act S. 2556, Improving CARE for Youth Act S. 2647/H.R. 5012, SHINE for Autumn Act of 2023 S. 923/H.R. 4933, Mental Health Professionals Workforce Shortage Loan Repayment Act of 2023 S.2476/H.R. 4884, Mental Health for Latinos Act of 2023 S. 2362/H.R. 3008, Drug Shortage Prevention Act of 2023 H.R. 3759, Barriers to Suicide Act of 2023 S. 1409, Kids Online Safety Act S. 1769/H.R. 3805, the Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act. H.R. 5804, Mental Health Infrastructure Improvement Act H.R. 5976 /S. 3060 Youth Mental Health Research Act S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act S. 2560 Long COVID Support Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664, Innovation in Pediatric Drugs Act

Client expense: $1,400,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Oceanic & Atmospheric Administration (NOAA), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024;

Client expense: $320,000 · 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), 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

Educate policymakers on issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, ProtectingPatients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title Ill of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients' Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclo sure Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modemizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0). Educate policymakers on H.R.3285 - Faimess for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 6986/S.3583, to address patent thickets.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program; Issues related to affordable prescription drugs;H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages;

Client expense: $313,000 · Firm income: Not reported

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

340B Program; Issues related to affordable prescription drugs; Issues related to health care workforce and staffing; Issues related to health care privacy; Issues related to telehealth authorities; Issues related to hospital price transparency; Issues related to hospital reimbursement; Issues related to nonprofit hospital practices; Issues related to hospital outpatient department payments; Issues related to hospital outpatient department payments; Medicaid Disproportionate Share Hospital payment adjustment program; Issues related to Medicare payments; Issues related to Medicare Advantage payment and prior authorization Childrens Hospital Graduate Medical Education Program (CHGME); issues related to childrens medical care; Future Advancement of Academic Nursing (FAAN) Act; Veteran Nurses in Primary Care Program; H.R. 2584/S. 2768, the Safety From Violence for Healthcare Employees (SAVE) Act; Expanding Care in the Home Act; H.R. 1770, Equitable Access to Pharmacy Services Act; issues related to Program for All-Inclusive Care for the Elderly (PACE); H.R. 1770, Equitable Access to Pharmacy Services Act; H.R. 3008, the Drug Shortage Prevention Act; H.R. 3810, the Drug Origin Transparency Act; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act; issues related to preventing and mitigating drug shortages; H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act; H.R. 3263, the Support Faculty and Expand Access to Nursing Act; issues related to prior authorization, unwarranted claim denials, and payment delays; S. 2840, the Bipartisan Primary Care and Health Workforce Expansion Act; H.R. 3561, the PATIENT Act; H.R. 6363, Further Continuing Appropriations and Other Extension Act; H.R. 5378, the Lower Costs, More Transparency Act; Issues related to mental and behavioral health; the limit on Medicare payment days for inpatient psychiatric care; the Institutions for Mental Disease exclusion; issues related to extending programs under the SUPPORT for Patients Communities Act.

Client expense: $313,000 · Firm income: Not reported

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