Essential Medicines Strategic Stockpile Act of 2023

Medicare Part B Issues; Drug pricing and access, including Inflation Reduction Act; Drug shortage issues; Medicare physician reimbursement issues; HR 405-EMSSA; HR 5378-Lower Costs, More Transparency Act; S.2973-Modernizing and Ensuring PBM Accountability Act; HR 5526-Seniors' Access to Critical Medications Act of 2023; S.2764 and HR 5391, the Protecting Patient Access to Cancer and Complex Therapies Act, Seniors Access to Critical Medications Act (H.R. 5526).

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), 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

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

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

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

Issues pertaining to pharmacists' services including HR 1770 and S 2477, Equitable Community Access to Pharmacists Services and S.1491 Pharmacy and Medically Underserved Areas Enhancement Act Issues relating to the pharmaceutical supply chain, including HR 405, Essential Medicines Strategic Stockpile Act Drug pricing legislation, including S 113

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Issues; Drug pricing and access, including Inflation Reduction Act; Drug shortage issues; Medicare physician reimbursement issues; HR 405-EMSSA; HR 5378-Lower Costs, More Transparency Act; S.2973-Modernizing and Ensuring PBM Accountability Act; HR 5526-Seniors' Access to Critical Medications Act of 2023; S.2764 and HR 5391, the Protecting Patient Access to Cancer and Complex Therapies Act, Seniors Access to Critical Medications Act (H.R. 5526).

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2023 S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

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

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. 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

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

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

Medicare Part B Issues; Drug pricing and access, including Inflation Reduction Act; Drug shortage issues; Medicare physician reimbursement issues; HR 405-EMSSA; HR 5378-Lower Costs, More Transparency Act; S.2973-Modernizing and Ensuring PBM Accountability Act; HR 5526-Seniors' Access to Critical Medications Act of 2023; S.2764 and HR 5391, the Protecting Patient Access to Cancer and Complex Therapies Act, Seniors Access to Critical Medications Act (H.R. 5526).

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

Issues pertaining to pharmacists' services including HR 1770 and S 2477, Equitable Community Access to Pharmacists Services and S.1491 Pharmacy and Medically Underserved Areas Enhancement Act Issues relating to the pharmaceutical supply chain, including HR 405, Essential Medicines Strategic Stockpile Act Drug pricing legislation, including S 113 Issues pertaining to Health sector cybersecurity

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

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

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

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

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), 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

Issues pertaining to pharmacists' services including HR 1770 and S 2477, Equitable Community Access to Pharmacists Services and S.1491 Pharmacy and Medically Underserved Areas Enhancement Act Issues relating to the pharmaceutical supply chain, including HR 405, Essential Medicines Strategic Stockpile Act Drug pricing legislation, including S 113 Issues pertaining to Health sector cybersecurity

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

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/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

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

Medicare Part B Issues; Drug pricing and access, including Inflation Reduction Act; Drug shortage issues; Medicare physician reimbursement issues; HR 405-EMSSA; HR 5378-Lower Costs, More Transparency Act; S.2973-Modernizing and Ensuring PBM Accountability Act; HR 5526-Seniors' Access to Critical Medications Act of 2023; S.2764 and HR 5391, the Protecting Patient Access to Cancer and Complex Therapies Act, Seniors Access to Critical Medications Act (H.R. 5526).

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R. 133: MERIT Act H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 447: MMEDS Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues WTO Trade Related Aspects of Intellectual Property - vaccine patents"

Client expense: $1,500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 447: MMEDS Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Client expense: $6,430,000 · Firm income: Not reported

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. 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

Generic Drug Tiering, Supply Chain, Drug Shortages, S.2129 - Ensuring Access to Lower-Cost Medicines for Seniors Act, H.R.6369 - To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models, S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023, H.R.405 - Essential Medicines Strategic Stockpile Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act - extension of expanded tax credits for ACA marketplaces; The Prevent HPV Cancers Act Women and Lung Cancer Research and Preventive Services Act of 2021 Gabriella Miller Kids First Research Act 2.0 (H.R. 623/S. 1523) The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act 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

HR 405 Essential Medicines Strategic Stockpile Act of 2023 S 113: Prescription Pricing for the People 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 General Issues Related to Drug Shortages including House Energy and Commerce Committee discussion draft General Issues Related to the Strategic National Stockpile 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

Client expense: $604,567 · Firm income: Not reported

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

HR 405 Essential Medicines Strategic Stockpile Act of 2023 S 113: Prescription Pricing for the People 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 General Issues Related to Drug Shortages, including House Energy and Commerce Committee discussion draft General Issues Related to the Strategic National Stockpile 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

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

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Labeling of Generic Drugs and Biosimilars. H.R.4134/S.2886: Updated Drug Labeling for Patient Safety Act. Hickenlooper Safe Harbor for Skinny Labeling. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. S.2510: RAPID Reserve Act. Drug Shortages. Stop Drug Shortages Act of 2023. H.R.405: Essential Medicines Strategic Stockpile Act of 2023. S.2305: Biosimilar Red Tape Eliminations Act. FDA Inspections. Process issues regarding third-party contract to assess drug quality. Inflation Reduction Act (IRA) Implementation. H.R.3561: PATIENT Act of 2023. H.R.3793: Ensuring Access to Lifesaving Drugs Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE

Issues pertaining to pharmacists' services including HR 1770 and S 2477, Equitable Community Access to Pharmacists Services and S.1491 Pharmacy and Medically Underserved Areas Enhancement Act Issues relating to the pharmaceutical supply chain, including HR 405, Essential Medicines Strategic Stockpile Act Drug pricing legislation, including S 113

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S.2477, The Equitable Community Access to Pharmacist Services Act. Issues related to drug distribution and access. Issues related to the reauthorization of the Pandemic and All Hazards Preparedness Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Issues related to drug pricing transparency. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S. 2477, The Equitable Community Access to Pharmacist Services Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Issues; Drug pricing and access, including Inflation Reduction Act; Drug shortage issues; Medicare physician reimbursement issues; HR 405-EMSSA; HR 5378-Lower Costs, More Transparency Act; S.2973-Modernizing and Ensuring PBM Accountability Act; HR 5526-Seniors' Access to Critical Medications Act of 2023; S.2764 and HR 5391, the Protecting Patient Access to Cancer and Complex Therapies Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S.2477, The Equitable Community Access to Pharmacist Services Act. Issues related to drug distribution and access. Issues related to the reauthorization of the Pandemic and All Hazards Preparedness Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Issues related to drug pricing transparency. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S. 2477, The Equitable Community Access to Pharmacist Services Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act - extension of expanded tax credits for ACA marketplaces; The Prevent HPV Cancers Act Women and Lung Cancer Research and Preventive Services Act of 2021 Gabriella Miller Kids First Research Act 2.0 (H.R. 623/S. 1523) The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins 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 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 Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act Access to Breast Cancer Diagnosis Act of 2023 Find It Early Act 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 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

Client expense: $2,060,000 · 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

HR 405 Essential Medicines Strategic Stockpile Act of 2023 S 113: Prescription Pricing for the People 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 General Issues Related to Drug Shortages including House Energy and Commerce Committee discussion draft General Issues Related to the Strategic National Stockpile 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

Client expense: $572,964 · Firm income: Not reported

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

HR 405 Essential Medicines Strategic Stockpile Act of 2023 S 113: Prescription Pricing for the People Act of 2023 HR 382: Pandemic is Over Act 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 General Issues Related to Drug Shortages, including House Energy and Commerce Committee discussion draft General Issues Related to the Strategic National Stockpile 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

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

Government targets: 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 S 113: Prescription Pricing for the People 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 General Issues Related to Drug Shortages including House Energy and Commerce Committee discussion draft General Issues Related to the Strategic National Stockpile 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

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

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

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Issues related to drug pricing transparency. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S. 2477, The Equitable Community Access to Pharmacist Services Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the pharmaceutical supply chain, drug shortages, and national stockpiles, including H.R. 405, the Essential Medicines Strategic Stockpile Act of 2023. Legislation that would permanently provide Medicare coverage of services provided by a pharmacist, including incidental services and supplies relating to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses, including H.R. 1770/S.2477, The Equitable Community Access to Pharmacist Services Act. Issues related to drug distribution and access. Issues related to the reauthorization of the Pandemic and All Hazards Preparedness Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to pharmacists' services including HR 1770 and S 2477, Equitable Community Access to Pharmacists Services and S.1491 Pharmacy and Medically Underserved Areas Enhancement Act Issues relating to the pharmaceutical supply chain, including HR 405, Essential Medicines Strategic Stockpile Act Drug pricing legislation, including S 113

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act - extension of expanded tax credits for ACA marketplaces; The Prevent HPV Cancers Act Women and Lung Cancer Research and Preventive Services Act of 2021 Gabriella Miller Kids First Research Act 2.0 (H.R. 623/S. 1523) The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins 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 Equitable Community Access to Pharmacist Services Act PBM Reform 340B Reform Medical Nutrition Act Drug Shortages

Client expense: $1,660,000 · 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