RAPID Reserve Act

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

HR 405 Essential Medicines Strategic Stockpile Act of 2023 HR 3837 Improving Public Health Preparedness Act HR 3557: Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act H.R.4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act HR 6992/S. 2364 - MAPS Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

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

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

HR 405 - Essential Medicines Strategic Stockpile Act of 2023 HR 3837 - Improving Public Health Preparedness Act HR 3557 - Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act S.2333/HR 4421 - Pandemic and All-Hazards Preparedness and Response Act HR 4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act HR 6992/S. 2364 - MAPS Act H.R. 10445, Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

Client expense: $511,136 · Firm income: Not reported

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

Work on medical supply chain issues impacting drug shortages for inpatient facilities. Advocate for SNS product rotation, buffer stock, private sector collaboration and updated FDA drug shortage warnings. This includes work on S. 2510, the RAPID Reserve Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526/S.3458) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054) Drug Supply Chain Security Act (DSCSA)

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE

Education about efforts to provide greater resiliency in the drug supply chain. S. 2510: RAPID Reserve Act.

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 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

RAPID Reserve Act (S. 2510); Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (H.R. 6802); Administrations activities related to pharmaceutical supply chain and domestic capacity; DOD activities related to pharmaceutical and medical countermeasure supply chain for the warfighter

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

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

RAPID Reserve Act (S. 2510); Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (H.R. 6802); Administrations activities related to pharmaceutical supply chain and domestic capacity; DOD activities related to pharmaceutical and medical countermeasure supply chain for the warfighter

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

Government targets: Defense, Dept of (DOD), 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.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 405 Essential Medicines Strategic Stockpile Act of 2023 HR 3837 Improving Public Health Preparedness Act HR 3557: Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act H.R.4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act HR 6992/S. 2364 - MAPS Act H.R.9540 - Fight Illicit Pill Presses Act of 2024 H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act H.R. 7623, Telehealth Modernization Act of 2024 General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

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

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

Work on medical supply chain issues impacting drug shortages for inpatient facilities. Advocate for SNS product rotation, buffer stock, private sector collaboration and updated FDA drug shortage warnings. This includes work on S. 2510, the RAPID Reserve Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 405 - Essential Medicines Strategic Stockpile Act of 2023 HR 3837 - Improving Public Health Preparedness Act HR 3557 - Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act S.2333/HR 4421 - Pandemic and All-Hazards Preparedness and Response Act HR 4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act HR 6992/S. 2364 - MAPS Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

Client expense: $497,548 · Firm income: Not reported

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

S. 3565, Affordable Connectivity Program Extension Act of 2024, all provisions; Draft Bill, Sustain 340B Program Discussion Draft, Issues pertaining to 340B Program access; S. 1302/H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions; S. 3679/H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; S.2415, Preventing Maternal Deaths Reauthorization Act, all provisions; H.R. 7931, Preserving Emergency Access in Key Sites Act (PEAKS) , all provisions; H.R. 8245, Rural Hospital Stabilization Act , all provisions; H.R. 8246, Second Chances for Rural Hospitals Act, all provisions; S.940/ H.R. 1711, Rural America Health Corps Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S. 3765 / H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024, all provisions; H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, Issues pertaining to 340B Program access; S. 2364, Mapping Americas Pharmaceutical Supply Act, all provisions; S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, all provisions; S. 2510, RAPID Reserve Act, all provisions; S. 2362, Drug Shortage Prevention Act, all provisions; Draft Bill, the Drug Shortage Prevention and Mitigation Act, Issues pertaining to proposed solutions to address generic drug shortages; S. 862, Restoring America's Health Care Workforce and Readiness Act, all provisions; HR 2584/ S.2768, Safety From Violence for Healthcare Employees (SAVE) Act, all provisions; S.4079/H.R. 8383, Rural Obstetrics Readiness Act , all provisions; H.R. 8186, Healthy Affordable Housing Act, all provisions; S. 4289, Medical Debt Cancellation Act, all provisions; S. 4054, Health Care Cybersecurity Improvement Act of 2024, all provisions; S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions; H.R. 977/S. 470, Patient Access to Higher Quality Care Act, all provisions; Draft Bill, Family Health Affordability Act, all provisions; Draft Bill, HEALTH for MOM Act, all provisions; U.S. Department of Labor, Health Plan Accountability, health plan accountability; Office of the U.S. Trade Representative, Section 301 Tariffs, Issues related to tariffs on health care products manufactured in China; Federal Emergency Management Agency (FEMA), Public Assistance for COVID expenses, Issues related to distribution of public assistance funds to hospitals; Administration for Strategic Preparation & Response (ASPR / HHS), Pediatric Emergencies, Issues related to Pediatric Disaster Care Centers of Excellence; U.S. Department of State Immigration, Issues related to visas for foreign-trained health care workers; Immediate Office of the Secretary (IOS - HHS), Medical Debt, Issues related to how hospitals address medical debt; Cyber Security, Issues pertaining to Change Health Care cyber attack, breach notifications and ongoing cyber risks to the health care field; Lab Developed Tests (LDTs), Issues related to proposed regulatory oversight of Lab Developed Tests (LDTs); Employment Retirement Income Security Act (ERISA), ERISA improvements; Artificial Intelligence (AI), AI use in health care; Rural Health Care Access, Issues to protect access to rural health care; Prescription drug shortages, Issues pertaining to Drug shortages, supply chains; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, community benefit, physician practice acquisition; Workforce nurse staffing mandate, workforce development programs; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages; Behavioral Health, Related to expanding access to care and reducing regulatory barriers; Price Transparency, Issues related to hospital price transparency; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay and cost-based reimbursement for critical access hospitals under Medicare Advantage; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Physician Owned Hospitals, Physician-owned hospitals; Tax-exempt status, not-for-profit hospitals' tax exempt status; Health Professions Diversity, Increasing health professionals of color, National health service corps; centers of excellence; health careers opportunity programs.

Client expense: $6,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Education about efforts to provide greater resiliency in the drug supply chain. S. 2510: RAPID Reserve Act.

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

Government targets: 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. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458 Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3565, Affordable Connectivity Program Extension Act of 2024, all provisions; Draft Bill, Sustain 340B Program Discussion Draft, Issues pertaining to 340B Program access; S. 1302/H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions; S. 3679/H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; S.2415, Preventing Maternal Deaths Reauthorization Act, all provisions; H.R. 7931, Preserving Emergency Access in Key Sites Act (PEAKS) , all provisions; H.R. 8245, Rural Hospital Stabilization Act , all provisions; H.R. 8246, Second Chances for Rural Hospitals Act, all provisions; S.940/ H.R. 1711, Rural America Health Corps Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S. 3765 / H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024, all provisions; H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, Issues pertaining to 340B Program access; S. 2364, Mapping Americas Pharmaceutical Supply Act, all provisions; S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, all provisions; S. 2510, RAPID Reserve Act, all provisions; S. 2362, Drug Shortage Prevention Act, all provisions; Draft Bill, the Drug Shortage Prevention and Mitigation Act, Issues pertaining to proposed solutions to address generic drug shortages; S. 862, Restoring America's Health Care Workforce and Readiness Act, all provisions; HR 2584/ S.2768, Safety From Violence for Healthcare Employees (SAVE) Act, all provisions; S.4079/H.R. 8383, Rural Obstetrics Readiness Act , all provisions; H.R. 8186, Healthy Affordable Housing Act, all provisions; S. 4289, Medical Debt Cancellation Act, all provisions; S. 4054, Health Care Cybersecurity Improvement Act of 2024, all provisions; S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions; H.R. 977/S. 470, Patient Access to Higher Quality Care Act, all provisions; Draft Bill, Family Health Affordability Act, all provisions; Draft Bill, HEALTH for MOM Act, all provisions; U.S. Department of Labor, Health Plan Accountability, health plan accountability; Office of the U.S. Trade Representative, Section 301 Tariffs, Issues related to tariffs on health care products manufactured in China; Federal Emergency Management Agency (FEMA), Public Assistance for COVID expenses, Issues related to distribution of public assistance funds to hospitals; Administration for Strategic Preparation & Response (ASPR / HHS), Pediatric Emergencies, Issues related to Pediatric Disaster Care Centers of Excellence; U.S. Department of State Immigration, Issues related to visas for foreign-trained health care workers; Immediate Office of the Secretary (IOS - HHS), Medical Debt, Issues related to how hospitals address medical debt; Cyber Security, Issues pertaining to Change Health Care cyber attack, breach notifications and ongoing cyber risks to the health care field; Lab Developed Tests (LDTs), Issues related to proposed regulatory oversight of Lab Developed Tests (LDTs); Employment Retirement Income Security Act (ERISA), ERISA improvements; Artificial Intelligence (AI), AI use in health care; Rural Health Care Access, Issues to protect access to rural health care; Prescription drug shortages, Issues pertaining to Drug shortages, supply chains; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, community benefit, physician practice acquisition; Workforce nurse staffing mandate, workforce development programs; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages; Behavioral Health, Related to expanding access to care and reducing regulatory barriers; Price Transparency, Issues related to hospital price transparency; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay and cost-based reimbursement for critical access hospitals under Medicare Advantage; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Physician Owned Hospitals, Physician-owned hospitals; Tax-exempt status, not-for-profit hospitals' tax exempt status; Health Professions Diversity, Increasing health professionals of color, National health service corps; centers of excellence; health careers opportunity programs.

Client expense: $9,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054)

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

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

RAPID Reserve Act (S. 2510); Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (H.R. 6802); Administrations activities related to pharmaceutical supply chain and domestic capacity; DOD activities related to pharmaceutical and medical countermeasure supply chain for the warfighter

Client expense: $330,000 · Firm income: Not reported

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

RAPID Reserve Act (S. 2510); Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (H.R. 6802); Administrations activities related to pharmaceutical supply chain and domestic capacity; DOD activities related to pharmaceutical and medical countermeasure supply chain for the warfighter

Client expense: $330,000 · Firm income: Not reported

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

HR977/S470, Patient Access to Higher Quality Health Care Act of 2023; HR5378, Lower Costs, More Transparency Act; S2840, Bipartisan Primary Care and Health Workforce Act; S2510, RAPID Reserve Act; HR3561, PATIENT Act of 2023; S3394, Rural Emergency Hospital Adjustment Act;

Client expense: $950,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR977/S470, Patient Access to Higher Quality Health Care Act of 2023; HR5378, Lower Costs, More Transparency Act; S2840, Bipartisan Primary Care and Health Workforce Act; S2510, RAPID Reserve Act; HR3561, PATIENT Act of 2023; S3394, Rural Emergency Hospital Adjustment Act;

Client expense: $950,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities; Federal policy relating to requiring the military to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically; Draft Senate Finance Committee drug shortage legislation, provisions relating to Medicare reimbursement policies for generic drugs; and Federal policy relating to rebating impacts on access to biosimilars

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

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

HR 405 - Essential Medicines Strategic Stockpile Act of 2023 HR 3837 - Improving Public Health Preparedness Act HR 3557 - Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act S.2333/HR 4421 - Pandemic and All-Hazards Preparedness and Response Act HR 4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act HR 6992/S. 2364 - MAPS Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

Client expense: $518,503 · Firm income: Not reported

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

Work on medical supply chain issues impacting drug shortages for inpatient facilities. Advocate for SNS product rotation, buffer stock, private sector collaboration and updated FDA drug shortage warnings. This includes work on S. 2510, the RAPID Reserve Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 405 Essential Medicines Strategic Stockpile Act of 2023 HR 3837 Improving Public Health Preparedness Act HR 3557: Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act H.R.4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

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

Government targets: Drug Enforcement Administration (DEA), 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

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

Discussion with OMB/OIRA regarding OSHA Occupational Exposure to COVID-19 in Healthcare Settings Final Rule; Discussion with FDA Drug Shortage expert regarding Inflation Reduction Act Provisions that could impact duration of shortages; Discussion with ASPR Hospital Preparedness Program Staff about speaking at a meeting regarding HPP issues; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Inpatient Prospective Payment System/Long Term Care Hospital Proposed Rule; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Medicare Advantage Final Rule; Hill outreach about reducing hospital workplace violence; Hill outreach about the benefits of hospital mergers and acquisitions; Statement to the U.S. Senate Committee on Health, Education, Labor, and Pensions, Examining Health Care Workforce Shortages: Where Do We Go from Here?; Letter to the U.S. Senate Committee on Health, Education, Labor, and Pensions in response to an RFI on the drivers of health care workforce shortages; Support S.1110, Rural Hospitals Support Act, a bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Support H.R. 1110, Telehealth Option Act, a bill to direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and Childrens Health Insurance programs during the COVID-19 emergency; Feedback on the Connect for Health Act; AHA provided feedback on the creating opportunities new for necessary and effective care technologies (CONNECT) Act; False Claims Act Case AHA Provides Statement for House Hearing on Price Transparency, Competition; Oppose H.R.977/S.470 Patient Access Higher Quality Health Care Act, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Support S.940, The Rural America Health Corps Act A bill to establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program; Support the Conrad State 30 and Physician Access Reauthorization Act that would allow international doctors trained in the United States to remain in the country if they practice in areas experiencing medical shortages; Letter to CMS regarding intent to issue staffing mandates for nursing homes and urged CMS and policy makers to focus on efforts that will bolster our workforce; Support HR 2389/ S 1302, Resident Physician Shortage Reduction Act of 2023, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Support HR 2411/ S 1150, National Nursing Workforce Center Act of 2023, a bill to amend the Public Health Service Act to support and stabilize the existing nursing workforce, establish programs to increase the number of nurses; Support HR 2534, Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023 or the PROTECT 340B Act of 2023, a bill to amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program; Support HR 2559, Strengthening Community Care Act of 2023, a bill to extend funding for community health centers and the National Health Service Corp; Statement to the House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing titled, Competition and Transparency: The Pathway Forward for a Stronger Health Care Market highlighting that mergers and acquisitions can be a helpful tool for many hospitals and pushing back against site-neutral payment policies; Letter urging Congress to continue to protect this critical program and oppose efforts to cut its benefits, which would result in reduced access to quality care for the patients and communities served by 340B hospitals; Statement to Subcommittee on Health of the Committee on Energy and Commerce on its hearing Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care; Support S 1447, Bipartisan Solution to Cyclical Violence Act of 2023, a bill to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes; Support HR 3046/ S 1403, Medical Student Education Authorization Act of 2023, a bill to amend the Public Health Service Act to establish a grant program to award grants to accredited public institutions of higher education, and for other purposes; Concerns with HR 2691, Transparent Prices Required to Inform Consumer and Employers Act or the Transparent PRICE Act, a bill to promote hospital and insurer price transparency; Letter strongly opposing the draft bills, which would create additional site-neutral payment cuts and threaten access to care, especially in rural and other vulnerable communities; Comment letter to the Office of Civil Rights on its HIPAA Privacy Rule to Support Reproductive Health Care Privacy and concerns the guidance is too broad and will result in significant adverse consequences for hospitals, patients and the public at large; Statement to SFC for the hearing on Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs; Comment letters to CMS on their Inpatient and Long-term Care Facility Prospective Payment System FY 2024 proposed rule; Letter to reauthorize key programs within the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018, supporting policies that will reduce barriers to receiving and administering behavioral health care by improving payment policies, reducing unnecessary regulatory and administrative burden, and strengthening the behavioral health workforce; Comment letter on the Environmental Protection Agencys (EPA) proposed standards for the use of ethylene oxide (EtO) to sterilize medical devices urge caution and thoughtfulness in EPAs approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain; Comment on Energy and Commerce Committee Chair Rodgers drug shortages discussion draft; Support S. 2364 Mapping Americas Pharmaceutical Supply Act A bill to map the United States pharmaceutical supply chain and use data analytics to identify supply chain vulnerabilities and other national security threats; Support S. 2510 RAPID Reserve Act 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; Support S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, A bill to require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes; support the Drug Shortage Prevention Act that will help pave the way for additional improvements to the U.S. drug supply chain, which will, in turn, improve patient access and care; Support S.1636/H.R. 3440 Protecting Rural Telehealth Access Act A bill to amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program. Drug Shortages RFI Letter to the U.S. Senate Committee on Finance in response to a Request For Information on drug shortages; Support H.R. 4713 Rural Hospital Technical Assistance Program Act A letter to support HR 4713, the Rural Hospital Technical Assistant Program Act. A bill to make permanent a program that provides technical assistance for rural hospitals to help prevent closures; Verbal Support Train More Nurse Act, It instructs HHS and DOL to conduct a joint review of all grant programs supporting the nursing workforce and coming up with recommendations to Congress within a year on how to change the programs to increase nurse faculty, provide pathways for those who want to become nurse faculty, and increase the nursing pipeline for both RNs and LPNs; Support H.R.2412 Helping Kids Cope Act To amend the Public Health Service Act to authorize grants to increase national capacity to provide pediatric behavioral health services at childrens hospitals and through community-based providers to improve childrens access to care; and to authorize grants to begin to address large numbers of children boarding in emergency departments, to support the pediatric behavioral health workforce, and for other purposes; Meeting with OMB to discuss Proposed Minimum Staffing Requirements for Long-term Care Facilities; Meeting with OMB to discuss FY 2024 IPPS and LTCH Final Rule; Meeting with Senate Finance Committee regarding the FY 2024 LTCH Final Rule; A letter to comment on ways to improve access to care in rural and underserved areas ensuring that Americans in these rural and underserved areas have high-quality, affordable health care; Support S. 2016/ H.R. 4189, CONNECT for Health Act of 2023, a bill to support to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; A letter to the Department of Veterans Affairs (VA) expressing significant concerns about Cotivitis audit and appeals process, including its inadequate appeals procedures, the scope of audits being performed and the untenable timelines that are being executed; Support S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, a bill to support Healthcare Workforce Resilience Act to enhance our Nations nurse and physician workforce by recapturing unused immigrant visas; Support for Reauthorization of PAPHA, The Pandemic and All-Hazards Preparedness Act (PAHPA), To amend the Public Health Service Act to reauthorize certain programs with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response and certain programs with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Prevention, and for other purposes; Support H.R. 6430, Rural Community Hospitals (ARCH) Act, a bill to support the Assistance for Rural Community Hospitals (ARCH) Act; To support small rural hospitals for which Medicare patients make up a significant percentage of inpatient days or discharges, Congress established the Medicare- dependent Hospital (MDH) program in 1987, allowing eligible hospitals to receive the sum of their prospective payment system (PPS) payment rate, plus three- quarters of the amount by which their cost per discharge exceeds the PPS rate; Support H.R. 4531/ S.3393, Patients and Communities Reauthorization Act, a bill to reauthorize certain programs that provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; A letter to the FDA on its laboratory developed tests (LDTs) proposed rule urging the agency to not apply its device regulations to hospital and health system LDTs because they are not devices; rather, they are diagnostic tools developed and used in the context of patient care. Instead, we urged the FDA to continue to apply its enforcement discretion to hospital and health system LDTs; Submit Statement to the Committee on Energy and Commerce Subcommittee on Health hearing, Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care to share the hospital fields comments on proposed regulations for minimum staffing standards for LTC facilities and their potential impact on access to care; Concern H.R. 5378 Lower Costs, More Transparency Act, A bill to promotes price transparency in the health care sector, and for other purposes; Hill Briefing on SAVE Act, Support S. 2768 / H.R. 2584, The Safety from Violence for Healthcare Employees (SAVE) Act, A bill to protect hospital personnel from violence, and for other purposes; Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers; Statement to the House Committee on Energy and Commerce Subcommittee on Health regarding the topic of national health expenditures, The Independent Dispute Resolution Process (IDR), To comment on the proposed rule related to the operations of the Independent Dispute Resolution Process (IDR) established by the No Surprises Act (NSA); Examining Chronic Drug Shortages in the United States, Statement to the House Committee on Ways and Means regarding the important topic of drug shortages in the United States; Support H.R. 6205 / S. 3211, Healthcare Workforce Resilience Act, A bill to reauthorize title II of the Higher Education Act of 1965, and for other purposes; H.R. 7513; Protecting Americas Seniors Access to Care, Statement to the House Committee on Ways and Means regarding Protecting Americas Seniors Access to Care to prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the skilled nursing facility workforce; Enhancing Access to Care at Home in Rural and Underserved Communities, Statement to the House Committee on Ways and Means on how telehealth flexibilities, the hospital-at-home (H@H) program and home health agencies have expanded access to care for patients in their homes and the need for these programs to continue; The recent cyberattack on Change Healthcare, Letter to House and Senate leadership requesting assistance for hospitals impacted by the cyberattack; The recent cyberattack on Change Healthcare, Letter to Senate Finance Committee leadership to share concerns regarding the Administrations proposal to penalize hospitals that do not meet certain cybersecurity requirements; Support S. 3779 / H.R. 7265, Child Suicide Prevention and Lethal Means Safety Act, A bill authorizing the Secretary of Health and Human Services to award grants to establish or expand programs to implement evidence-aligned practices in health care settings for the purpose of reducing the suicide rates of covered individuals, and for other purposes; Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDAs Proposed Rule.", Statement to the House Committee on Energy and Commerce Subcommittee on Health on the impact of the Food and Drug Administrations (FDA) proposed regulation of diagnostic tests; Senate RFI on the SUSTAIN 340B Act Draft, A letter to provide feedback on the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of (SUSTAIN) 340B Act bipartisan discussion draft and accompanying request for information on the 340B Drug Pricing Program; Access to Health Care in America: Ensuring Resilient Emergency Medical Care, Statement to the House Committee on Ways and Means on access to emergency medical services in rural areas; Support H.R. 7623, Telehealth Modernization Act, A bill to amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program; House RFI on strengthening ERISA, A letter to provide feedback on an RFI from the House Education and Workforce Committee on ways to strengthen and improve ERISA, Addressing drug shortagesAHAs statement for record to Ways and Means committee hearing on Examining Chronic Drug Shortages in the United States, Statement commenting on the impact of the FDAs proposed regulation of laboratory developed tests (LDTs), AHAs statement for the record to Energy and Commerce Subcommittee on Health on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDAs Proposed Rule.", Response to RFI on oversight and regulation of LDTs, Response to Sen. Cassidy, Ranking Member of HELP Committee on his RFI seeking feedback on the FDAs proposed regulation of hospital LDTs, OMB meeting, including FDA officials, on the FDAs rulemaking on the regulation of hospital LDTs as medical devicesOMB/FDA; Support S 3679 / H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, A bill to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes, Support S. 1110, the Rural Hospital Support Act, A bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Support HR 1565, Critical Access Hospital Relief Act of 2023, A bill to amend title XVIII of the Social Security Act to remove the 96-hour physician certification requirement for inpatient critical access hospital services.

Client expense: $6,010,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages. Block, Report and Suspend Suspicious Shipments Act (H.R.501). Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2024 National Defense Authorization Act. FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution.

Client expense: $1,190,000 · Firm income: Not reported

Government targets: 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

HR977, Patient Access to Higher Quality Health Care Act of 2023; HR5378, Lower Costs, More Transparency Act; S2510, RAPID Reserve Act; S2840, Bipartisan Primary Care and Health Workforce Act;

Client expense: $930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR977, Patient Access to Higher Quality Health Care Act of 2023; HR5378, Lower Costs, More Transparency Act; S2840, Bipartisan Primary Care and Health Workforce Act; S2510, RAPID Reserve Act;

Client expense: $930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 405 Essential Medicines Strategic Stockpile Act of 2023 HR 3837 Improving Public Health Preparedness Act HR 3557: Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act S.2333/H.R.4421 - Pandemic and All-Hazards Preparedness and Response Act H.R.4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

Client expense: $540,662 · Firm income: Not reported

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

Work on medical supply chain issues impacting drug shortages for inpatient facilities. Advocate for SNS product rotation, buffer stock, private sector collaboration and updated FDA drug shortage warnings. This includes work on S. 2510, the RAPID Reserve Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 405 Essential Medicines Strategic Stockpile Act of 2023 HR 3837 Improving Public Health Preparedness Act HR 3557: Medical and Health Stockpile Accountability Act HR 3631/S 2080: State Strategic Stockpile Act HR 4421: Reauthorization of the Pandemic All-Hazards Preparedness Act H.R.4531/S. 2433 - Support for Patients and Communities Reauthorization Act S.2510 - RAPID Reserve Act General Issues Related to Drug Shortages including Senate Finance Proposal and Drug Shortages Appropriations Requests General Issues Related to the Strategic National Stockpile

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

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

HR977, Patient Access to Higher Quality Health Care Act of 2023; HR5378, Lower Costs, More Transparency Act; S3018, A bill to amend the Fair Labor Standards Act of 1938 and the National Labor Relations Act to clarify the standard for determining whether an individual is an employee, and for other purposes; S2510, RAPID Reserve Act; S2840, Bipartisan Primary Care and Health Workforce Act; HR6363, Further Continuing Appropriations and Other Extensions Act, 2024 (portions related to hospitals and healthcare)

Client expense: $1,090,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussion with OMB/OIRA regarding OSHA Occupational Exposure to COVID-19 in Healthcare Settings Final Rule; Discussion with FDA Drug Shortage expert regarding Inflation Reduction Act Provisions that could impact duration of shortages; Discussion with ASPR Hospital Preparedness Program Staff about speaking at a meeting regarding HPP issues; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Inpatient Prospective Payment System/Long Term Care Hospital Proposed Rule; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Medicare Advantage Final Rule; Hill outreach about reducing hospital workplace violence; Hill outreach about the benefits of hospital mergers and acquisitions; Hill outreach about the anticompetitive behaviors of travel nurse staffing agencies; Statement to the U.S. Senate Committee on Health, Education, Labor, and Pensions, Examining Health Care Workforce Shortages: Where Do We Go from Here?; Letter to the U.S. Senate Committee on Health, Education, Labor, and Pensions in response to an Request For Information on the reauthorization of the Pandemic and All-Hazards Preparedness Act; Letter to the U.S. Senate Committee on Health, Education, Labor, and Pensions in response to an RFI on the drivers of health care workforce shortages; Support S.1110, Rural Hospitals Support Act, a bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Support H.R. 1110Telehealth Option Act, a bill to direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and Childrens Health Insurance programs during the COVID-19 emergency; Feedback on the Connect for Health Act; AHA provided feedback on the creating opportunities new for necessary and effective care technologies (CONNECT) Act; False Claims Act Case AHA Provides Statement for House Hearing on Price Transparency, Competition; Oppose H.R.977/S.470 Patient Access Higher Quality Health Care Act, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Support S.940, The Rural America Health Corps Act A bill to establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program; Support the Conrad State 30 and Physician Access Reauthorization Act that would allow international doctors trained in the United States to remain in the country if they practice in areas experiencing medical shortages; Letter to CMS regarding intent to issue staffing mandates for nursing homes and urged CMS and policy makers to focus on efforts that will bolster our workforce; Support HR 2389/ S 1302, Resident Physician Shortage Reduction Act of 2023, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Support HR 2411/ S 1150, National Nursing Workforce Center Act of 2023, a bill to amend the Public Health Service Act to support and stabilize the existing nursing workforce, establish programs to increase the number of nurses; Support HR 2534, Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023 or the PROTECT 340B Act of 2023, a bill to amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program; Support HR 2559, Strengthening Community Care Act of 2023, a bill to extend funding for community health centers and the National Health Service Corp; Support HR 2584/S.2768, Safety From Violence for Healthcare Employees Act or the SAVE Act, a bill to protect hospital personnel from violence, and for other purpose; Statement to the House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing titled, Competition and Transparency: The Pathway Forward for a Stronger Health Care Market highlighting that mergers and acquisitions can be a helpful tool for many hospitals and pushing back against site-neutral payment policies; Letter urging Congress to continue to protect this critical program and oppose efforts to cut its benefits, which would result in reduced access to quality care for the patients and communities served by 340B hospitals; Statement to Subcommittee on Health of the Committee on Energy and Commerce on its hearing Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care; Support S 1447, Bipartisan Solution to Cyclical Violence Act of 2023, a bill to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes; Support HR 3046/ S 1403, Medical Student Education Authorization Act of 2023, a bill to amend the Public Health Service Act to establish a grant program to award grants to accredited public institutions of higher education, and for other purposes; Concerns with HR 2691, Transparent Prices Required to Inform Consumer and Employers Act or the Transparent PRICE Act, a bill to promote hospital and insurer price transparency; Letter strongly opposing the draft bills, which would create additional site-neutral payment cuts and threaten access to care, especially in rural and other vulnerable communities; Comment letter to the Office of Civil Rights on its HIPAA Privacy Rule to Support Reproductive Health Care Privacy and concerns the guidance is too broad and will result in significant adverse consequences for hospitals, patients and the public at large; Statement to SFC for the hearing on Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs; Comment letters to CMS on their Inpatient and Long-term Care Facility Prospective Payment System FY 2024 proposed rule; Letter to reauthorize key programs within the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018, we encourage you to consider policies that will reduce barriers to receiving and administering behavioral health care by improving payment policies, reducing unnecessary regulatory and administrative burden, and strengthening the behavioral health workforce; Comment letter on the Environmental Protection Agencys (EPA) proposed standards for the use of ethylene oxide (EtO) to sterilize medical devices urge caution and thoughtfulness in EPAs approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain; Hill briefing, Site-neutral Payment Proposals Would Jeopardize Access to Care for Patients and Communities; Comment on Energy and Commerce Committee Chair Rodgers drug shortages discussion draft; Support S. 2364 Mapping Americas Pharmaceutical Supply Act A bill to map the United States pharmaceutical supply chain and use data analytics to identify supply chain vulnerabilities and other national security threats; Support S. 2510 RAPID Reserve Act 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; Support S. 1961Pharmaceutical Supply Chain Risk Assessment Act of 2023A bill to require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes; Drug Shortage Prevention Act Letter to express support for the Drug Shortage Prevention Act that will help pave the way for additional improvements to the U.S. drug supply chain, which will, in turn, improve patient access and care; Bipartisan request for information on the critically important 340B Drug Pricing Program Letter on the savings 340B hospitals achieve through purchasing certain outpatient drugs at a discount allow them to provide a range of programs and services that directly benefit their patients; Support S.1636/H.R. 3440 Protecting Rural Telehealth Access Act A bill to amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program. Drug Shortages RFI Letter to the U.S. Senate Committee on Energy and Commerce and Finance in response to a Request For Information on drug shortages; Support H.R. 4713 Rural Hospital Technical Assistance Program Act A letter to support HR 4713, the Rural Hospital Technical Assistant Program Act. A bill to make permanent a program that provides technical assistance for rural hospitals to help prevent closures; Verbal Support Train More Nurse Act It instructs HHS and DOL to conduct a joint review of all grant programs supporting the nursing workforce and coming up with recommendations to Congress within a year on how to change the programs to increase nurse faculty, provide pathways for those who want to become nurse faculty, and increase the nursing pipeline for both RNs and LPNs; Support H.R.2412 Helping Kids Cope Act To amend the Public Health Service Act to authorize grants to increase national capacity to provide pediatric behavioral health services at childrens hospitals and through community-based providers to improve childrens access to care; and to authorize grants to begin to address large numbers of children boarding in emergency departments, to support the pediatric behavioral health workforce, and for other purposes; Meeting with OMB to discuss Proposed Minimum Staffing Requirements for Long-term Care Facilities; Meeting with OMB to discuss FY 2024 IPPS and LTCH Final Rule; Meeting with Senate Finance Committee regarding the FY 2024 LTCH Final Rule; A letter to comment on ways to improve access to care in rural and underserved areas ensuring that Americans in these rural and underserved areas have high-quality, affordable health care; Support S. 2016/ H.R. 4189, CONNECT for Health Act of 2023, a bill to support to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; A letter to the Department of Veterans Affairs (VA) expressing significant concerns about Cotivitis audit and appeals process, including its inadequate appeals procedures, the scope of audits being performed and the untenable timelines that are being executed; Support S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, a bill to support Healthcare Workforce Resilience Act to enhance our Nations nurse and physician workforce by recapturing unused immigrant visas; Support for Reauthorization of PAPHA, The Pandemic and All-Hazards Preparedness Act (PAHPA), To amend the Public Health Service Act to reauthorize certain programs with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response and certain programs with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Prevention, and for other purposes; Support H.R. 6430, Rural Community Hospitals (ARCH) Act, a bill to support the Assistance for Rural Community Hospitals (ARCH) Act; To support small rural hospitals for which Medicare patients make up a significant percentage of inpatient days or discharges, Congress established the Medicare- dependent Hospital (MDH) program in 1987, allowing eligible hospitals to receive the sum of their prospective payment system (PPS) payment rate, plus three- quarters of the amount by which their cost per discharge exceeds the PPS rate; Support H.R. 4531/ S.3393, Patients and Communities Reauthorization Act, a bill to reauthorize certain programs that provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; A letter to the FDA on its laboratory developed tests (LDTs) proposed rule urging the agency to not apply its device regulations to hospital and health system LDTs because they are not devices; rather, they are diagnostic tools developed and used in the context of patient care. Instead, we urged the FDA to continue to apply its enforcement discretion to hospital and health system LDTs; Submit Statement to the Committee on Energy and Commerce Subcommittee on Health hearing, Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care to share the hospital fields comments on proposed regulations for minimum staffing standards for LTC facilities and their potential impact on access to care.

Client expense: $8,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages. Block, Report and Suspend Suspicious Shipments Act (H.R.501). Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S. 2510). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY 2024 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution.

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

Government targets: 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 DIVERSE 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

Client expense: $3,030,000 · 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

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

Client expense: $530,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

Client expense: $530,000 · Firm income: Not reported

Government targets: 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 PN 649: Monica M. Bertagnolli, Department of Health and Human Services - Nomination of Monica Bertagnolli for the Director of the National Institutes of Health

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE