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: $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)

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)

support for the safe step act H.R. 2163, unnumbered bill supporting children's vision and eye health, S. 2323 the Access to Genetic Counselor Services Act, Long-term Opportunities for Advancing New Studies (LOANS) for Biomedical Research Act H.R. 7539

Client expense: $24,640 · 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)

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)

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)

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

General issues related to drug research and innovation; H.R. 2163, Safe Step Act; general issues related to plasma-derived therapies.

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

Government targets: 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; 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

General issues related to drug research and innovation; H.R. 2163, Safe Step Act; general issues related to plasma-derived therapies.

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

Government targets: 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; 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

Lobbied in support of H.R. 464/H.R. 2163, the Safe Step Act, legislation to provide a fair and transparent appeals process for step therapy protocols.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

ARC Act of 2021 (H.R. 2631) Credit for Caring Act (S. 1670 / H.R. 3321) Easy Enrollment in Health Care Act (S. 3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S. 3904) Improving Social Determinants of Health Act (H.R. 379/S. 4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S. 779) Safe Step Act of 2021 (H.R. 2163) Immunization Infrastructure Modernization Act (H.R. 550) Implementation of the Advancing Care for Exceptional Kids Act (ACE Kids, Pub. L. 116-16) Prescription Drug User Fee Act (PDUFA), provisions related to improving clinical trial diversity and equitable opportunities for trial participation Palliative Care and Hospice Education and Training Act (H.R. 647) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301) Halt Obesity in America Act (H.R. 5625) Youth Sports Facilities Act (no bill number) Requirements related to No Surprises Act Final Rule

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

ARC Act of 2021 (H.R.2631) Credit for Caring Act (S.1670 / H.R. 3321) Easy Enrollment in Health Care Act (S.3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S.3904) Improving Social Determinants of Health Act (H.R. 379/S4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S.779) Requirements related to No Surprises Act Final Rule Safe Step Act of 2021 (H.R. 2163) Immunization Infrastructure Modernization Act (H.R. 550) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

ARC Act of 2021 (H.R.2631) Build Back Better Act (H.R.5376) Credit for Caring Act (S.1670 / H.R. 3321) Easy Enrollment in Health Care Act (S.3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S.3904) Improving Social Determinants of Health Act (H.R. 379/S4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S.779) Public Health Infrastructure Saves Lives Act (S. 674) Public Health Funding Prevents Pandemics Act (S. 571) Requirements related to No Surprises Act, Parts I & II interim final rules Safe Step Act of 2021 (H.R. 2163) To Fund Prevention and Public Health Fund (H.R. 1583) Immunization Infrastructure Modernization Act (H.R. 550) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

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

1.S. 1870/H.R. 7146, the Enhancing Emergency and Retirement Savings Act of 2021: The legislation would provide a penalty-free emergency distribution option from employer-sponsored retirement accounts and IRAs. 2.Portable Retirement and Investment Account Act (PRIA): Creates retirement accounts at birth to help establish lifelong savings/retirement accounts. 3.H.R. 2954, Securing a Strong Retirement Act (SECURE 2.0) / Retirement Security and Savings Act: Comprehensive retirement savings legislation. 4.S. 1272, The SIMPLE Plan Modernization Act: The bill would raise the contribution limit for SIMPLE plans from $13,500 to $16,500 with a corresponding increase in the catch-up limit from $3,000 to $4,750. 5.S. 1770, The Retirement Security & Savings Act: Comprehensive retirement savings legislation. 6.S. 1703, The Improving Access to Retirement Savings Act of 2021: The bill would expand Open Multiple Employer Plans to include 403(b) accounts, create a safe harbor for correcting employee deferrals and make clarifications for small businesses who wish to utilize a credit to offer a retirement plan to their employees. 7.S. 1443, The Retirement Parity for Student Loans Act: Allows employers to make matching contributions to a 401(k)-retirement plan while their employees make student loan repayments. 8. S. 975 / H.R. 2005, the Womens Retirement Security Act of 2021: Addresses the retirement gap and bolsters womens financial security through amending ERISA and increasing financial literacy. 9.S. 2452, the Encouraging Americans to Save Act: Reforms the savers credit, makes the credit refundable, establishes an R-bond program, and amends the deadline to fund an IRA with a tax refund, among other provisions. 10.H.R. 5891, The Retirement Improvement and Saving Enhancement (RISE) Act: Contains several retirement security provisions, also included within H.R. 2459 (SSRA). Also requires DOL, the Department of the Treasury, and the Pension Benefit Guaranty Corporation (PBGC) to review reporting and disclosure requirements for pension plans and make recommendations to Congress to consolidate, simplify, standardize, and improve such requirements. 11. Audit Consolidation Act and the Simplifying Retirement Act: Allows group plans to file a single Form 5500 for the entire retirement plan, ensures small employers are not burdened with administrative complexities. Allows pooled employer providers who manage PEPs to utilize Discretionary or Directed Trustees to manage assets and collect contributions would help to contain costs and make plan easier to manage for the small employers who choose to participate. 12.H.R. 6746, Lifetime Income for Employees (LIFE) Act of 2022: Amends the current rules for qualified default investment alternatives to facilitate the use of an annuity component will expand the availability of guaranteed returns and guaranteed lifetime income that help savers secure their retirement futures. 13.The Enhancing American Retirement Now (EARN) Act: Builds upon S. 1770 with additional retirement provisions. Considered the Senate version of SECURE 2.0. 14.The Rise and Shine Act: Senate HELP provisions covered by ERISA to be included with a Senate retirement package (SECURE 2.0). 15. S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. 16. S.4103, Helping Parents Save for College Act of 2022: Would make two important changes to the way 529 college savings accounts are designed to increase utilization. 17. S.4087, INFORM Act: would require plan sponsors to provide participants and beneficiaries with the critical information that would allow them to make an informed decision when presented with such a lump-sum offer. The INFORM Act also would require a notice to affected participants and beneficiaries 90 days before the period in which they must make a decision. The INFORM Act would further require disclosure to the Department of Labor, so information can be collected on these practices. 18. S.3993, the Savings Access for Escaping and Rebuilding Act (SAFER) Act: A bill to amend the Internal Revenue Code of 1986 to allow penalty-free withdrawals from retirement plans for domestic abuse victims. 19. S.1273, the Military Spouses Retirement Security Act: Would allow military spouses to vest earlier and provide incentives for employers. 20.American Worker Savings and Wealth Creation Plan Act: Would create a TSP type government-run retirement program. 21.Division T of the Consolidated Appropriations Act, 2023: Combines numerous retirement security bills, including the EARN act, Rise and Shine and SSRA into a comprehensive package. Would expand retirement savings for Americans. Income Security The Enhancing American Retirement Now (EARN) Act: Builds upon S. 1770 with additional retirement provisions. Considered the Senate version of SECURE 2.0. S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. H.R. 133, Both provisions are in the larger bill. H.R.1185 - FAMILY Act. Issue: paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member. H.R.1940 - New Parents Act of 2019. Issue: paid family and medical leave H.R.2163 - To amend the Internal Revenue Code of 1986 to allow for tax-advantaged distributions from health savings accounts during family or medical leave, and for other purposes. Issue: paid family and medical leave S.463 - FAMILY Act. Issue: paid family and medical leave- paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member S.920 - New Parents Act of 2019. Issue: paid family and medical leave Discussion draft - CRADLE Act. Issue: paid family and medical leave - allows for a deferment of retirement benefits for paid leave benefits. Proposed FY 2020 Budget proposal on paid family and medical leave. Issue: paid family and medical leave H.R. 2694 - Pregnant Workers Fairness Act. Issue: paid family and medical leave. Concurrent Resolution on the Budget, FY2022, S.Con.Res.14. The budget resolution calls for the $3.5 trillion in long-term investments to be fully offset by a combination of new tax revenues, health care savings, and long-term economic growth. In addition, the agreement would prohibit new taxes on families making less than $400,000 per year, and on small businesses and family farms. Issue: Medicare/Dental (Expanding Medicare to include dental, vision, hearing benefits and lowering the eligibility age). H.R. 5376- Build Back Better Act this bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child-care, health care, taxes, immigration, and the environment. Diversity and Inclusion H.R. 5084 - Improving Corporate Governance Through Diversity Act. Issue: diversity and inclusion. H.R. 5360 - Closing the Racial Wealth Gap Act. Issue: diversity and inclusion. H.R. 281 - Ensuring Diverse Leadership Act. Issue: diversity and inclusion. H.R. 7946 and S. 4464 - Federal Reserve Racial and Economic Equity Act. Issue: diversity and inclusion.

Client expense: $1,271,337 · Firm income: Not reported

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

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

S. 464/ H.R. 2163: Safe Step Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Safe Step Act (H.R.2163/S. 464); Telehealth Improvement for Kids' Essential Services Act "TIKES Act",(H.R. 1397/S. 1798); National Triple-Negative Breast Cancer Day (H.R.185); March 2021 as National Colorectal Cancer Awareness Month (H.R. 209); Improving Senior's Timely Access to Care Act (H.R. 3173);Lymphedema Treatment Act. (H.R. 3630/S. 1315) Waiting for reintroduction: Palliative Care Hospice Education & Treatment Act ("PCHETA"); Cancer Drug Parity Act;

Client expense: $88,296 · Firm income: Not reported

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