Safe Step Act

Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; H.R. 5539 - ORPHAN Cures Act; P.L. 115-97 - Tax Cuts and Jobs Act of 2017, Orphan Drug Tax Credit; Awareness of need for transparency and patient access within the 340B program; H.R. 9029 Labor, Health and Human Services, Education Appropriations, 2025; H.R. 9026 Commerce, Justice, Science, and Related Agencies Appropriations, 2025; H.R. 8580 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2025; H.R. 9747 Continuing Appropriations and Extensions Act, 2025 PDUFA implementation and efficiency improvements at the FDA;

Client expense: $490,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Issues related to Direct-to-Consumer Prescription Drug Advertisements; Issues related to Cybersecurity; Health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act 2024; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption; S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S 954, Affordable Insulin Now Act of 2023; HR 1488, Affordable Insulin Now Act; HR 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for all Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; S. 464/ H.R. 2630, the Safe Step Act; H.R. 5688, the Bipartisan HSA Improvement Act of 2023; H.R. 5687, the HSA Modernization Act of 2023; H.R. 1843/S. 1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; Issues related to mental health coverage, workforce, and mental health parity; Issues related to surprise billing law and regulation; Issues related to artificial intelligence and health care issues; Issues related to removing barriers to biosimilar medicine access; H.R. 4189/S. 2016, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; H.R. 3432/S.3651, Telemental Health Care Access Act of 2023; H.R. 1692, The Health Care Affordability Act; H.R. 8152, the American Privacy Rights Act (APRA) of 2024.

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

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

Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; H.R. 5539 - ORPHAN Cures Act; P.L. 115-97 - Tax Cuts and Jobs Act of 2017, Orphan Drug Tax Credit; Awareness of need for transparency and patient access within the 340B program; H.R. 9029 Labor, Health and Human Services, Education Appropriations, 2025; H.R. 9026 Commerce, Justice, Science, and Related Agencies Appropriations, 2025; H.R. 8580 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2025; H.R. 9747 Continuing Appropriations and Extensions Act, 2025 PDUFA Implementation and efficiency improvements at the FDA;

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Issues related to Direct-to-Consumer Prescription Drug Advertisements; Issues related to Cybersecurity; Health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act 2024; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption; S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S 954, Affordable Insulin Now Act of 2023; HR 1488, Affordable Insulin Now Act; H.R. 1587, Making Insulin Affordable for All Children Act; H.R. 1485, Insulin for all Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; S. 464/ H.R. 2630, the Safe Step Act; H.R. 5688, the Bipartisan HSA Improvement Act of 2023; H.R. 5687, the HSA Modernization Act of 2023; H.R. 1843/S. 1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; Issues related to mental health coverage, workforce, and mental health parity; Issues related to surprise billing law and regulation; Issues related to artificial intelligence and health care issues; Issues related to removing barriers to biosimilar medicine access; H.R. 4189/S. 2016, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; H.R. 3432/S.3651, Telemental Health Care Access Act of 2023; H.R. 1692, The Health Care Affordability Act; H.R. 8152, the American Privacy Rights Act (APRA) of 2024.

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

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

Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; Awareness of need for transparency and patient access within the 340B program; H.R. 2882 Further Consolidated Appropriations Act, 2024; Labor, Health and Human Services, Education Appropriations, 2025; Commerce, Justice, Science, and Related Agencies Appropriations, 2025; H.R.8580 - Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2025; PDUFA Implementation and efficiency improvements at the FDA;

Client expense: $450,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Issues related to Direct-to-Consumer Prescription Drug Advertisements; Issues related to Cybersecurity; Health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act 2024; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption; S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S 954, Affordable Insulin Now Act of 2023; HR 1488, Affordable Insulin Now Act; HR 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for all Act of 2023; S. 5093, Behavioral Health Network and Directory Improvement 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; S. 464/ H.R. 2630, the Safe Step Act; H.R. 5688, the Bipartisan HSA Improvement Act of 2023; H.R. 5687, the HSA Modernization Act of 2023; H.R. 1843/S. 1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; S. 3393 Support for Patients and Communities Reauthorization Act; Issues related to mental health coverage, workforce, and mental health parity; Issues related to surprise billing law and regulation; Issues related to artificial intelligence and health care issues; Issues related to removing barriers to biosimilar medicine access; Issues related to the proposed rule on Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Childrens Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program; H.R. 4189/S. 2016, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; H.R. 3432/S.3651, Telemental Health Care Access Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; Awareness of need for transparency and patient access within the 340B program; H.R. 2882 Further Consolidated Appropriations Act, 2024; Labor, Health and Human Services, Education Appropriations, 2025; Commerce, Justice, Science, and Related Agencies Appropriations, 2025; Military Construction, Veterans Affairs, and Related Agencies Appropriations Bill, 2025; Support FDA efficiency reforms

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Issues related to surprise billing law and regulation; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023, including telehealth and redeterminations; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to removing barriers to biosimilar medicine access; Issues related to the proposed rule on Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Childrens Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program; Issues related to insulin pricing, including S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S 954, Affordable Insulin Now Act of 2023; HR 1488, Affordable Insulin Now Act; HR 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for all Act of 2023; Issues related to mental health coverage, workforce, and mental health parity. S. 5093, Behavioral Health Network and Directory Improvement Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; Issues relating to S. 464/ H.R. 2630, the Safe Step Act; related amendment to S. 1339, the Pharmacy Benefit Manager Reform Act; H.R. 5688, the Bipartisan HSA Improvement Act of 2023; H.R. 5687, the HSA Modernization Act of 2023; S. 2840, Bipartisan Primary Care and Health Workforce Act and issues related commercial insurance, telehealth, and pharmacy benefits; H.R. 1843/S. 1001, the Telehealth Expansion Act of 2023 and related issues; S. 3393 Support for Patients and Communities Reauthorization Act; Issues related to artificial intelligence and health care issues; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions H.R. 2630/S.464, Safe Step Act - regarding all bio-pharmaceutical related provisions Discussions regarding health equity End of year health package/PBM reform H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023 Discussions in support of H.R.5376, Share the Savings with Seniors Act Discussions in support of H.R.5539, ORPHAN Cures Act H.R.3561, The PATIENT Act H.R.4895, Lowering Drug Costs for American Families Act Discussions in support of H.R.2880, Protecting Patients Against PBM Abuses Act H.R.2408, Access to Innovative Treatments Act of 2023

Client expense: $2,060,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Awareness of the need for treatment system reform and access to all FDA-approved medications; Support patient-centered care and treatment that ensures comprehensive care and access to all FDA approved treatments; Awareness of outcomes data and the need for training on all medication assisted treatment; Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act Policies impacting pharmaceutical development, reimbursement, and patient access and cost Awareness of need for transparency and patient access within the 340B program H.R. 5894/S. 2624 - Labor, Health and Human Services, Education Appropriations, 2024 H.R. 5893/S. 2321 - Commerce, Justice, Science, and Related Agencies Appropriations, 2024 H.R. 4366/S. 2127 - Military Construction, Veterans Affairs, and Related Agencies Appropriations Bill, 2024 Support FDA efficiency reforms

Client expense: $640,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Educate policymakers on pharmacy issues related to TRICARE and H.R. 2670, S.2226 Fiscal Year 2024 National Defense Authorization Act; issues related to removing barriers to biosimilar medicine access; issues relating to S. 464 / H.R. 2630, the Safe Step Act; related amendment to S. 1339, the Pharmacy Benefit Manager Reform Act; S. 2840,Bipartisan Primary Care and Health Workforce Act and issues related commercial insurance, telehealth, and pharmacy benefits; S. 3393 Support for Patients and Communities Reauthorization Act; and issues related to artificial intelligence and health care issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/H.R. 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Discussions regarding health equity PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023 Discussions in support of H.R.5376, Share the Savings with Seniors Act Discussions in support of H.R.5539, ORPHAN Cures Act H.R.3561, The PATIENT Act H.R.4895, Lowering Drug Costs for American Families Act Discussions in support of H.R.2880, Protecting Patients Against PBM Abuses Act H.R.2408, Access to Innovative Treatments Act of 2023

Client expense: $2,180,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Awareness of the need for treatment system reform and access to all FDA-approved medications; Support patient-centered care and treatment that ensures comprehensive care and access to all FDA approved treatments; Awareness of outcomes data and the need for training on all medication assisted treatment; Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act Policies impacting pharmaceutical development, reimbursement, and patient access and cost Awareness of need for transparency and patient access within the 340B program H.R. 5894/S. 2624 - Labor, Health and Human Services, Education Appropriations, 2024 H.R. 5893/S. 2321 - Commerce, Justice, Science, and Related Agencies Appropriations, 2024 H.R. 4366/S. 2127 - Military Construction, Veterans Affairs, and Related Agencies Appropriations Bill, 2024 Support FDA health data privacy reforms

Client expense: $580,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Patient Access Issues Healthcare Appropriations The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1770: Equitable Community Access to Pharmacist Services Act; Clinical trial diversity, health equity; Emergency preparedness and response; Healthcare innovation, ARPA-H, oncology research; H.R. 1835: Saving Access to Laboratory Services Act; Pandemic Response; Biden Cancer Moonshot Initiative; H.R.3258 Timely Access to Cancer Treatment Act; H.R.2163, S.464 The Safe Step Act; H.R. 8800 Supporting Medicare Providers Act of 2022; PAHPA reauthorization; Community health center fund reauthorization.

Client expense: $1,230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Awareness of the need for treatment system reform and access to all FDA-approved medications; Support patient-centered care and treatment that ensures comprehensive care and access to all FDA approved treatments; Awareness of outcomes data and the need for training on all medication assisted treatment; Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; Awareness of need for transparency and patient access within the 340B program; FY2024 - Labor, Health and Human Services, Education Appropriations; FY2024 - Commerce, Justice, Science, and Related Agencies Appropriations; H.R. 4366 /S. 2127- Military Construction, Veterans Affairs, and Related Agencies Appropriations Bill, 2024

Client expense: $630,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

HR 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/HR 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Discussions regarding health equity PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023

Client expense: $2,230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830 - HELP Copays Act H.R. 2163 - Safe Step Act S. 464 - Safe Step Act Inflation Reduction Act Orphan Drug Tax Credit

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/HR 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Proposed reconciliation bill encompassing all pharmaceutical provisions Discussions regarding health equity HR 5376, the Build Back Better Act regarding all bio-pharmaceutical provisions PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023

Client expense: $2,410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.464/H.R.2163, the Safe Step Act; H.R.1319/P.L. 117-2, American Rescue Plan Act of 2021-issues related to economic and regulatory relief for health care providers; issues related to coverage of products under drug formulary; policies reforming prior authorization of physician services; implementation of the No Surprises Act, P.L. 116-260; H.R.2617, the Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1770: Equitable Community Access to Pharmacist Services Act; Clinical trial diversity, health equity; Emergency preparedness and response; Healthcare innovation, ARPA-H, oncology research; H.R. 1835: Saving Access to Laboratory Services Act; Pandemic Response; Biden Cancer Moonshot Initiative; H.R.3258 Timely Access to Cancer Treatment Act; H.R.2163, S.464 The Safe Step Act; H.R. 8800 Supporting Medicare Providers Act of 2022; PAHPA reauthorization; Community health center fund reauthorization.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Awareness of the need for treatment system reform and access to all FDA-approved medications; Support patient-centered care and treatment that ensures comprehensive care and access to all FDA approved treatments; Awareness of outcomes data and the need for training on all medication assisted treatment; Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; Awareness of need for transparency and patient access within the 340B program; FY2024 - Labor, Health and Human Services, Education Appropriations; FY2024 - Commerce, Justice, Science, and Related Agencies Appropriations; FY2024 - Military Construction, Veterans Affairs, and Related Agencies Appropriations;

Client expense: $1,800,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Pharmacist equitable access, health equity. H.R. 7213 Clinical trial diversity, health equity. H.R. 5030/S. 2706 Emergency preparedness and response. S. 3799 Healthcare innovation, ARPA-H, oncology research. H.R. 6000 Laboratory diagnostic services, schedule reimbursement S. 4449 Omnibus federal appropriations Pandemic Response Biden Cancer Moonshot Initiative H.R.3258 Timely Access to Cancer Treatment Act. H.R.2163, S.464 The Safe Step Act. H.R. 8800 Supporting Medicare Providers Act of 2022

Client expense: $810,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 3137, Improving Seniors Timely Access to Care Act of 2021 Issue: Support streamlining prior authorization procedures to be more seamless, automated, and transparent for physicians. H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021 Issue: Support extending telehealth payment parity and ending geographic origination site restriction. H.R. 2163/S. 464, Safe Step Act Issue: Support requiring insurers to implement a clear and fair appeals that allows step therapy to be bypassed in medically necessary circumstances.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination

Client expense: $4,550,000 · 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), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), President of the U.S., SENATE, Vice President of the U.S., White House Office

Issues surrounding the enactment or repeal of the Affordable Care Act. Medicare reimbursement reform for providers including the Medicare Access and CHIP Reauthorization Act (MACRA). Medicare Part B Drug Reimbursement. FDA issues. The Palliative Care and Hospice Education and Training Act. Draft legislation to reform the FDA's regulation of cosmetics. Legislation to address physician workforce shortage (HR 2256/S.834). Ensuring Lasting Smiles Act (HR 1916/S. 754). Improving Seniors Access to Timely Care Act, HR 3173, Safe Step Act, HR 2163/S.464. Financial relief and policy and regulatory changes for the provider community in COVID-19 legislation including the CARES Act. Regulation of Organ Procurement Networks (OPOs). The Food and Drug Amendments of 2022 (FDA22).Inflation Reduction Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support the Safe Step Act (S. 464 / H.R. 2163) which creates a clear, timely and transparent process for a patient or physician to request an exception to step therapy protocols in certain situations. Step therapy is a tactic used by insurance companies that requires a patient to try and fail on their preferred medications before covering the therapy prescribed by their health care provider.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4612/S. 2412 - Protecting Access to Lifesaving Screenings Act of 2021; a bill to make a series of changes relating to health insurance coverage of screening mammography H.R. 5769/S. 1067 - Access to Breast Cancer Diagnosis Act; bill to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging H.R. 2163/S. 464 - Safe Step Act; bill to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes H.R. 4385/S.3080 - Cancer Drug Parity Act; bill to require health plans that cover anticancer medications administered by a health care provider to provide no less favorable cost sharing for patient-administered anticancer medications. H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act; a bill 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. 7045/S. 3796 - Closing Health Coverage Gaps for Public Servants Act; a bill to eliminate the opt-out for nonfederal governmental health plans, including the opt-out for coverage for full mastectomy and reconstruction care Administrative actions necessary to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging Issues related to regulation of short-term limited duration plans Implementation of the No Surprises Act Implementation of the Inflation Reduction Act Implementation of the Affordable Care Act Policies regarding White House Cancer Moonshot implementation Public and private insurance adjustments and other policy changes due to the COVID-19 emergency, including those impacting the immunocompromised populations S. 942 - No Junk Plans Act; bill to overturn previous administration rule expanding non-comprehensive health insurance plans that dont have to provide healthcare coverage for people with pre-existing conditions S. 1002 - Junk Plan Accountability and Disclosure Act; a bill which establishes requirements for certain noncomprehensive health insurance coverage and provides for additional outreach activities to increase enrollment in qualified health plans Policies related to co-pay assistance programs Comments in response to the RFI on Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals (CMS9900-NC) Comments regarding Section 1557 Nondiscrimination in Health Programs and Activities (RIN 0945-AA17)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus

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

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill S. 464: Safe Step Act; all provisions of the bill S.3018 - Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic

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

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill S. 464: Safe Step Act: all provisions of the bill S. 3108: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General issues related to pharmaceutical pricing General issues related to drug development lifecycle

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

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

Pharmacist equitable access, health equity. H.R. 7213 Clinical trial diversity, health equity. H.R. 5030/S. 2706 Emergency preparedness and response. S. 3799 Healthcare innovation, ARPA-H, oncology research. H.R. 6000 Laboratory diagnostic services, schedule reimbursement S. 4449 Omnibus federal appropriations Pandemic Response Biden Cancer Moonshot Initiative H.R.3258 Timely Access to Cancer Treatment Act. H.R.2163, S.464 The Safe Step Act. H.R. 8800 Supporting Medicare Providers Act of 2022

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Transparency. Copay Accumulators/Maximizers. Benefit Design. Quality-Adjusted Life Years. Home Health Services. National Coverage Determination H.R.5376 - Inflation Reduction Act of 2022. H.R.2163/S464 - Safe Step Act. H.R.3173/S.3018 - Improving Seniors Timely Access to Care Act. H.R.5801 - HELP Copays Act. H.R.7667 - Food and Drug Amendments of 2022. H.R.4472/S.373 - BENEFIT Act of 2021. H.R.7634 - Protecting Health Care for All Patients Act. H.R.8581/S.4605 - Preserving Access to Home Health Act. S.4348 - FDASLA Act of 2022. H.R.5067/S.2652 - Preserving Access to Home Infusion Act. H.R.8800 - Medicare Providers Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Mainstreaming Addiction Treatment Act (S. 445/H.R. 1384), all provisions related to removing the waiver requirement for health care providers to prescribe buprenorphine for opioid use disorder. Improving Access to Remote Behavioral Health Treatment Act of 2019, all provisions related to amending regulations for the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and allowing community mental health centers to register to practice telemedicine. Medication Access and Training Expansion Act (H.R. 2067), all provisions related to requiring physicians and other prescribers of controlled substances to complete training on treating and managing patients with substance use disorders. CONNECT for Health Act of 2021 (H.R. 2903/S. 1512), all provisions related to expanding access to telehealth services. Telemental Health Care Access Act of 2021 (S. 2061), all provisions related to ensuring coverage of mental health services furnished through telehealth. HELP Act of 2021 (S. 1570), all provisions related to the accessibility and coordination of 211 services and 988 services. Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/S. 168), all provisions related to temporary authorization of in-person and telehealth services. Behavioral Health Crisis Services Expansion Act (S. 1902), all provisions related to empowering communities to establish a continuum of care for individuals experiencing a behavioral health crisis. Preventing Overdoses and Saving Lives Act of 2021 (H.R. 5442), all provisions related to authorizing grants to develop strategic response plans with respect to the opioid crisis, and to require practitioners prescribing an opioid for certain patients to also prescribe an opioid overdose reversal drug. Coronavirus Mental Health and Addiction Assistance Act of 2021 (H.R. 593/S. 135), all provisions related to providing grants to entities that provide mental health and substance use disorder programs during the COVID-19 pandemic. Mental Health Services for Students Act of 2021 (H.R. 721/S. 1841), all provisions related to school-based mental health services. Stopping the Mental Health Pandemic Act (H.R. 7080/S. 4059), all provisions related to grants to support behavioral health treatment and services during the COVID-19 pandemic. Emergency Support for Substance Use Disorders Act (S. 4058), all provisions related to grants for harm reduction activities during the COVID-19 pandemic. Elementary and Secondary School Counseling Act (H.R. 6214/S. 3356), all provisions related to awarding grants to increase access to school-based, mental health services. Campus Prevention and Recovery Services for Students Act of 2019 (H.R. 3591), all provisions related to expanding the illicit drug and alcohol abuse prevention program to include campus efforts to prevent substance misuse. Opioid Treatment Access Act of 2022 (H.R. 6279), all provisions related to authorizing a study on certain exemptions for treatment of opioid use disorder through opioid treatment programs. 9-8-8 Implementation Act of 2022 (H.R. 7116), all provisions related to providing for improvements in the implementation of the National Suicide Prevention Lifeline, and for other purposes. 9-8-8 and Parity Assistance Act of 2022 (H.R.7232), all provisions related to providing for improvements in the implementation of the National Suicide Prevention Lifeline, and for other purposes. Into the Light for MMH and SUD Act of 2022 (H.R. 7073), all provisions related to reauthorizing a grant program for screening, assessment, and treatment services for maternal mental health and substance use disorders, and for other purposes. Anna Westin Legacy Act (H.R. 7249/S. 3686), all provisions related to providing education and training on eating disorders for health care providers and communities, and for other purposes. Behavioral Health Information Technology Act, (H.R.7427), all provisions related to CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes Safe Step Act (H.R. 2163/S. 464), all provisions related to creating an exception for medication step-therapy. Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act (S. 586), all provisions related to establishing separate payments for certain non-opioid treatments under the Medicare prospective payment system for hospital outpatient department services and the payment system for ambulatory surgical center services Food and Drug Administration Safety and Landmark Advancements Act of 2022 (S.4348), all provisions related to addressing substance use disorders and the safe disposal of opioids. Telemental Health Access to Care Act (S.2061/H.R. 4058), all provisions related to intended to increase access to tele-mental health care and telehealth. Stop Pills That Kill Act (S.4151), all provisions related to penalizing the manufacture and/or facilitation of manufacturing counterfeit pills that contain fentanyl, an analogue of fentanyl, or a counterfeit substance. Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666), all provisions related to reauthorizations, expansions, and modifications of programs, grants, and activities that focus on mental and behavioral health. CONNECT Act of 2022 (H.R.8391), all provisions related to awarding grants for crisis centers to provide follow-up services to individuals receiving suicide prevention and crisis intervention services. BENEFIT Act of 2021 (H.R.4472), all provisions related to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs. Advancing Telehealth Beyond COVID-19 Act of 2021 (H.R.4040), all provisions related to extending telehealth flexibilities under the Medicare program Expanding Access to Mental Health Training Act (S. 4461), all provisions related to reauthorizing grants for training teachers and other school personnel to recognize the symptoms of childhood and adolescent mental health disorders. Behavioral Health Network and Directory Improvement Act (S. 5093), all provisions related to protect patients and improve the accuracy of provider directory information by eliminating ghost networks. Any legislation published by the Senate Finance Committee relating to behavioral healthcare, including workforce, mental health integration, and parity policy.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Communications Commission (FCC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of legislative or regulatory changes to Medicare and Medicaid, including: Advancing Telehealth Beyond COVID-19 Act of 2021, HR 4040 Patient Navigation Assistance Act (Soon to be introduced), Rep. DeSaulnier Cancer survivorship legislation, soon to be introduced, Rep. Wasserman Schultz The Inflation Reduction Act, HR 5376 - Medicaid Coverage Gap fix (not included in the legislation), cap on out-of-pocket expenses for Medicare Part D HR 1946/S 1873, Multi Cancer Early Detection Screening Coverage Act S 464/HR 2163 Safe Step Act HR 2594, To amend title XVIII of the Social Security Act to eliminate the coinsurance requirement for certain colorectal cancer screening tests furnished under the Medicare program. Issues related to governance of state Medicaid programs, including work requirements and block grant proposals. Policy issues related to coverage for low-income populations in states that have not yet expanded their Medicaid programs (coverage gap) CONNECT Act (telehealth), S. 1512 Lymphedema Treatment Act, HR 3630, S. 1315 Bipartisan Seniors Prescription Drug Relief Act - Cassidy/Menendez Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Rosen Accelerating Kids Access to Care Act, S. 1544/H.R. 3089 Regulations related to the Public Charge Rule & Medicaid - DHS Docket No. USCIS-2021-0013, the notice of proposed rulemaking, Public Charge Ground of Inadmissibility Public Health Emergency Extension Advocacy around cost sharing for follow on colonoscopy after a positive at home test with CMS, related to Medicare coverage

Client expense: $1,990,000 · Firm income: Not reported

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

Federal Step Therapy Reform: Safe Step Act (HR 2163/S 464). The bill reforms step therapy insurance protocols to ensure patients and providers have access to a clear exemption process. It establishes a patient and provider friendly step therapy guidelines in ERISA regulated health insurance plans. Federal copay accumulator reform: HELP Copays Act (HR 5801). The bill ensures that all copays count by requiring insurers to count all third-party copay assistance towards a patients deductible or out-of-pocket maximum.

Client expense: $14,517 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.464/H.R.2163, the Safe Step Act; H.R.1319/P.L. 117-2, American Rescue Plan Act of 2021-issues related to economic and regulatory relief for health care providers; issues related to coverage of products under drug formulary; policies reforming prior authorization of physician services; implementation of the No Surprises Act, P.L. 116-260; H.R.2617, the Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Medicare Physician Payment Reform Issues Medicare sequestration cuts Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprise Act HR 3173/S 3018, the Improving Seniors' Timely Access to Care Act HR 2163/S 464, Safe Step Act HR 1916/S 754, Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices HR 4187, the Medicare Vision Act HR 869/S 289, Research Investment to Spark the Economy (RISE) Act HR 366, Protecting Access to Post-COVID 19 Telehealth Act HR3662, Patient Access to Urgent-Use Pharmacy Compounding Act of 2021 HR 3353, the Contact Lens Prescription Verification Modernization Act HR4122, Resident Education Deferred Interest (REDI) Act HR 5376, the Build Back Better Act HR 6000, Cures 2.0 Act S. 4333, the CLEAR Act S. 4348, Food and Drug Administration Safety & Landmark Advancements (FDASLA) Act

Client expense: $406,636 · Firm income: Not reported

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

Telehealth coverage S 464 Safe Step Act - Step therapy utilization management reform S 2327 - A bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D. (Support for out-of-pocket cap and smoothing mechanism) Education on health impact of obesity Generic Drug User Fee Amendments

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Draft, Hospital Competition Act of 2021 (no bill number) - procedural changes around The Mental Health Parity and Addiction Equity Act (MHPEA) litigation H.R. 19 - Lower Costs, More Cures Act of 2021- Rep. McMorris, Rodgers - prescription drug prices for Medicare and Medicaid H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 432 - Mental Health Access Improvement Act of 2021- Rep. Thompson, Mike - mental health services under Medicare H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 959 - Black Maternal Health Momnibus Act of 2021 - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option H.R. 2163 - Safe Step Act - Rep. Ruiz, Raul - commercial plans and medication step-therapy requirements H.R. 2617 - Consolidated Appropriations Act, 2023 - Rep. Connolly, Gerald - continued Medicaid and Medicare provisions and funding for FY2023 H.R. 3173 - Improving Seniors Timely Access to Care Act of 2021 - Rep. DelBene, Suzan - prior authorization in Medicare Advantage H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony - mental health parity H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act of 2021- Rep. Cheney, Liz - telehealth H.R. 4595 - Medicaid Saves Lives Act - Rep. Bourdeaux, Carolyn - Medicaid expansion H.R. 6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - Rep. Craig, Angie - continued funding for Medicare and Medicaid H.R. 7236 - Strengthen Kids Mental Health Now Act of 2022 - Rep. Eshoo, Anna - mental health and Medicaid H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. - Rep. Matsui, Doris - behavioral health and electronic health records H.R. 7512 - Protecting Patients from Deceptive Health Plans Act - Rep. Hayes, Jahana - excepted benefits coverage H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 - Rep. Pallone, Frank - reauthorization of several behavioral health programs H.R. 7667 - Food and Drug Amendments of 2022 - Rep. Eshoo, Anna - reauthorization of user fee programs H.R. 7780 - Mental Health Matters Act - Rep. DeSaulnier, Mark - changes to the procedure around MHPEA litigation H.R. 8152 - American Data Privacy and Protection Act - Rep. Pallone, Frank, Jr. - data privacy H.R. 8594 - Restore Protections for Dialysis Patients Act - Rep. Clarke, Yvette - reform of the Medicare Secondary Payer act H.R. 8876 - The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 - Rep. Davis, Danny - funding for maternal and early childhood health programs H.R. 8878 - To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. - Rep. Chu, Judy - mental health and Medicare H.R. 8879 - Inpatient Psychiatric Facility Improvement Act - Rep. Evans, Dwight - mental health and Medicare H.R. 8881 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes. - Rep. Horsford, Steven - commercial plans H.R. 8884 - To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program. - Rep. Kelly Mike - mental health and Medicare H.R. 8885 - Better Health Care Directories Act - Rep. Kildee, Daniel - commercial plans H.R. 8886 - Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act - Rep. Moore, Gwen - commercial plans H.R. 8889 - RICE Act - Rep. Plaskett, Stacey - commercial plans H.R. 8890 - Physician Wellness Program Act of 2022 - Rep. Ruiz, Raul - mental health and Medicare H.R. 8891 - No Surprises for Survivors Act of 2022 - Rep. Sanchez, Linda - requirements for group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for forensic medical exams with no cost sharing H.R. 8892 - To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes. - Rep. Sewell, Terri - commercial plans H.R. 8908 - Fighting Stimulant and other Substance Use Disorders Act - Rep. Estes, Ron - mental health and Medicare H.R. 8910 - Behavioral Health Integration Awareness Act of 2022 - Rep. Smith, Jason - mental health and Medicare S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 464 - Safe Step Act - Sen. Murkowski, Lisa - commercial plans and medication step-therapy requirements S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 1512 - CONNECT for Health Act of 2021 - Sen. Schatz, Brian - expansion of telehealth for Medicare S. 1873 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 - Sen. Crapo, Mike - Cancer screening in Medicare S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher - mental health parity S. 2164 - Lower Costs, More Cures Act of 2021 - Sen. Crapo, Mike - prescription drug prices for Medicare and Medicaid S. 2315 - Medicaid Saves Lives Act - Sen. Warnock, Raphael - Medicaid expansion S. 2499 - SAFE DATA Act - Sen. Wicker, Roger - consumer data privacy and data transparency and security S. 3018 - Improving Seniors Timely Access to Care Act of 2021 - Sen. Marshall, Roger - prior authorization in Medicare Advantage S. 3195 - Consumer Online Privacy Rights Act - Sen. Cantwell, Maria - data privacy S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness S. 3983 - PATCH Act - Sen. Cassidy, Bill - data privacy S. 4264 - Advancing Integration in Medicare and Medicaid (AIM) Act - Sen. Scott, Tim - coordinating full-benefits for dual eligible individuals S. 4293 - Pharmacy Benefit Manager Transparency Act of 2022 - Sen. Cantwell, Maria and Sen. Grassley, Chuck - scope of PBM practices S. 4306 - Improving Access to Behavioral Health Integration Act - Sen. Smith, Tina - behavioral health S. 4750 - Restore Protections for Dialysis Patients Act - Sen. Menendez, Robert - reform of MSP Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage and reproductive health; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; ACA risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Client expense: $2,470,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $2,578,869 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $2,578,869 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE