Drug Origin Transparency Act of 2023

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

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

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

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

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

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

Issues related to Medicare coverage of compounded medications, Drug shortages and Medicare reimbursement for compounded medications, pharmacy direct and indirect remuneration fees; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023; H.R. 8749, Safer Compounding in Hospitals Act

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

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

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

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

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

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

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. 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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

Issues related to Medicare coverage of compounded medications, Drug shortages and Medicare reimbursement for compounded medications, pharmacy direct and indirect remuneration fees; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023; H.R. 8749, Safer Compounding in Hospitals Act

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

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

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

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

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

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

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. 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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Client expense: $290,000 · Firm income: Not reported

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

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

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

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

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

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

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

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

Client expense: $170,000 · Firm income: Not reported

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

Issues related to Medicare coverage of compounded medications, Drug shortages and Medicare reimbursement for compounded medications, pharmacy direct and indirect remuneration fees; H.R. 3810 - Drug Origin Transparency Act of 2023

Client expense: $170,000 · Firm income: Not reported

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

Client expense: $270,000 · Firm income: Not reported

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

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

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. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues 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 related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Issues related to Medicare coverage of compounded medications, Drug shortages and Medicare reimbursement for compounded medications, pharmacy direct and indirect remuneration fees; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. Inflation Reduction Act - provisions related to vaccines and pharmaceuticals. H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: Increasing Transparency in Generic Drug Applications Act H.R. 4115: The Lower Drug Costs for Families Act H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Anticounterfeiting policy issues Artificial intelligence policy issues H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging Act - commercial delinking of PBM prices Labor HHS Appropriations Inflation Reduction Act of 2022, provisions related to Part D redesign and Medicare negotiation; 340B reform proposals

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

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

Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers. Endorsed passage of Connecting Our Medical Providers with Links to Expand Tailored and Effective (COMPLETE) Care Act (H.R. 5819/S.1378). Preparing for All Hazards and Pathogens Reauthorization Act (H.R. 4421) and Preparedness and Response Reauthorization Act (H.R. 4420) - Supported passage of legislation to reauthorize the Pandemic and All Hazards Preparedness Act. Advocated for including provisions to increase transparency in the healthcare supply chain and improve hospital and health system emergency preparedness. Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Drug shortages -Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Endorsed passage of the Drug Origin Transparency Act (H.R. 3810). Endorsed passage of the Biosimilar Red Tape Elimination Act (S. 2305). Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (S. 1355/H.R. 2940). Supported passage of the Biologics Competition Act (H.R. 1790). Endorsed passage of Biosimilar Red Tape Elimination Act (S.2305) 340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Endorsed passage of the Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act (H.R. 2534). Opposed legislation (H.R. 3290/S. 1133) that would place cumbersome reporting obligations on 340B covered entities. Buffer inventory - Engagements with CMS on reimbursement for hospitals that stockpile buffer supplies of essential medicines Mental and Behavioral Health - Highlighted during congressional briefing how hospitals are providing mental and behavioral health treatment and support for their communities. Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Healthcare Workforce - Supported passage of the Resident Physician Shortage Reduction Act (H.R. 2389 / S. 1302), the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768) and the Healthcare Workforce Resilience Act (H.R 6205/S. 3211); Monitored development and introduction of the Bipartisan Primary Care and Health Workforce Act (S.2840) Children's Hospital Graduate Medical Education (CHGME) - Urged Congress to reauthorize CHGME program through the Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Unique Device Identification (UDI) - Continued engagement to improve data standards and validation and support opportunities for the improved use of unique device identification and the Global UDI database (GUDID). Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date. Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Issues related to pharmacy benefit managers

Client expense: $780,000 · Firm income: Not reported

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

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

Client expense: $1,930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Issues related to Medicare coverage of compounded medications, Drug shortages and Medicare reimbursement for compounded medications, pharmacy direct and indirect remuneration fees; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), 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