Prescription Information Modernization Act of 2022

H.R. 3 - Lower Drug Costs Now Act; H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act; H.R. 5376 - the Inflation Reduction Act of 2022; S. 4348 - the Food and Drug Administration Safety and Landmark Advancements Act of 2022; Biosimilar interchangeability ; Part D Formulary Design and Generic Drug Tiering; H.R. 7667 - the Food and Drug Amendments of 2022; H.R. 8239 - Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2023, and for other purposes; S. 4338 - the Increasing Transparency in Generic Drug Applications Act S. 4351 - the Enhanced Access to Affordable Medicines Act H.R. 7559 - the Prescription Information Modernization Act of 2022; H.R. 2617 - Consolidated Appropriations Act of 2023

Client expense: $650,000 · Firm income: Not reported

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

Package Inserts/E-Labeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022); Issues related to the Vaccine Injury Compensation Program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.6973/S.4351, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032/S.4338, Increasing Transparency in Generic Drug Applications Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing legislation regarding health care costs. Opposing various legislative efforts to relocate supply and logistics chains. Opposing various legislative and executive efforts to impose an international price index. Supporting the DISARM Act (H.R. 4127). Supporting the PASTEUR Act (S. 2076 and H.R. 3932). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 7559). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting CMS proposed rule on Medicare Coverage of Innovative Technology (MCIT). Engaging various components of the Build Back Better Act. Opposing CMS reimbursement for combined diagnostics test. Opposing TRIPS waiver. Supporting PDUFA and MDUFA passage. Commenting on risk management to mitigate drug shortages. Supporting the extension of the SBIR program. Supporting H.R. 8188, the Saving Access to Laboratory Services Act (SALSA). Supporting H.R. 4346, the Creating Helpful Incentives to Produce Semiconductors (CHIPS) Act. Opposing the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act

Client expense: $55,145 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID services & COVID services for the uninsured S. 3799PREVENT Pandemics Act S. Amdt to H.R. 2471 Consolidated Appropriations Act of 2022 S. 1536Medical Nutrition Therapy Act of 2021 S. 4293Pharmacy Benefit Manager Transparency Act H.R. 7666 Restoring Hope for Mental Health and Wellbeing Act H.R. 2355 Opioid Prescription Verification Act H.R. 1384 Mainstreaming Addiction Treatment Act H.R. 7007 COVID Supplemental Appropriations Act of 2022 H.R. 3108 Medical Nutrition Therapy Act of 2021 H.R. 5585 Advanced Research Project Agency-Health H.R. 6279 Opioid Treatment Access Act H.R. 7559 Prescription Information Modernization Act H.R. 5376 Inflation Reduction Act H.R. 2617 Consolidated Appropriations Act of 2023

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

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

S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; Consolidated Appropriations Act, 2023 (PL 117-328), Division FF, Title III - Food and Drug Administration, Subtitle B - Drugs and Biologics and Subtitle F, Chapter 1 - Clinical Trial Diversity and Modernization; H.R. 7559 - the Prescription Information Modernization Act; Package Inserts/eLabeling Issues (H.R. 7559 - Prescription Information Modernization Act of 2022).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; Consolidated Appropriations Act, 2023 (PL 117-328), Division FF, Title III - Food and Drug Administration, Subtitle B - Drugs and Biologics and Subtitle F, Chapter 1 - Clinical Trial Diversity and Modernization; Package Inserts/eLabeling Issues (H.R. 7559 - Prescription Information Modernization Act of 2022).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services; Draft legislation, the PBM Transparency, Accountability, and Reform Act

Client expense: $320,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts Issues related to the 340B drug discount program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health care, including employee health care plans, HIPAA, health information technology, telehealth, including the Telehealth Modernization Act (H.R. 1332 / S. 368), the CONNECT Act (H.R. 2903 / S. 1512), the Telehealth Expansion Act (S. 1704 / H.R. 5981), and the Food and Drug Amendments Act of 2023 (H.R. 7667), the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (S. 4348), and the Prescription Information Modernization Act of 2022 (H.R. 7559). Issues related to pharmacy, vaccines, and COVID-19 testing.

Client expense: $4,950,000 · Firm income: Not reported

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

Package Inserts/E-Labeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts Issues related to the 340B drug discount program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6072, Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act of 2021, provisions relating to social determinants of health, mental health, and social services S. 509, LINC to Address Social Needs Act of 2021, provisions relating to social determinants of health, 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 H.R. 1218, Data Mapping to Save Moms Lives Act, all provisions S. 198, Data Mapping to Save Moms' Lives Act, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, MAT Act of 2021, 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. 5602, Bolstering Infectious Outbreaks (BIO) Preparedness Workforce Act of 2021, all provisions S. 3244, BIO Preparedness Workforce 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. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, MATE Act of 2021, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions H.R. 8296, Womens Health Protection Act of 2022, all provisions H.R. 8373, Right to Contraception Act, all provisions H.R. 8318, To restrict limitations on the possession, sale, purchase, transportation or use of any contraceptive that relates to interstate commerce, all provisions H.R. 8454, Medical Marijuana and Cannabidiol Research Expansion Act S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions S. 2866, Treatment Restoration for Emergency Antibody Therapeutics (TREAT) 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 S. 1675, Maternal Health Quality Improvement 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, VALID Act of 2021, all provisions H.R. 8152, American Data Privacy and Protection Act, 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, Protecting Our Kids 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. 8297, Ensuring Womens Right to Reproductive Freedom Act, all provisions H.R. 1235, Charlotte Woodward Organ Transplant Discrimination Prevention Act, all provisions S. 3301, Charlotte Woodward Organ Transplant Discrimination Prevention Act, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, TREAT Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity 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. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, NOVID Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions H.R. 8890, Physician Wellness Program Act of 2022, all provisions H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act, all provisions H.R. 8891, No Surprises for Survivors Act of 2022, all provisions H.R. 8885, Better Health Care Directories Act, all provisions H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act, all provisions 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, all provisions 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, all provisions H.R. 8889, Readable Insurance Coverage Explanations (RICE) Act, all provisions H.R. 7780, Mental Health Matters Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, 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. 925, Data to Save Moms 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 2022, 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 Emergency Room Hero and Patient Safety Act No Surprises Act/implementation Global health security/pandemics Digital Health/AI/Digital Therapeutics Privacy/non-HIPAA covered health apps Abortion/Dobbs decision Drug overdose epidemic Telehealth Scope of practice/patient safety Prior authorization Physician burnout/mental health stigma Health equity/COVID-19 COVID-19 Provider Relief Fund COVID-91/testing/misinformation/vaccine issues/therapeutics Section 1557/nondiscrimination/limited English proficiency Maternal Mortality Modifier 25, Impossible Day Hunger, Nutrition and Health WIC/SNAP/Nutrition Strengthening primary health care Data privacy Physician-led aerospace medicine teams Men who have sex with men/blood donations Federally qualified health centers and clinical trials

Client expense: $4,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office

H.R. 3 - Lower Drug Costs Now Act; Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act; Generic drug quality and FDA oversight H.R. 5376 - the Inflation Reduction Act of 2022; S. 4348 - the Food and Drug Administration Safety and Landmark Advancements Act of 2022 Biosimilar interchangeability Part D Formulary Design and Generic Drug Tiering; Electronic labeling of prescription drugs H.R. 7667 - the Food and Drug Amendments of 2022; H.R. 8239 - Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2023, and for other purposes; FDA facility inspections S. 4338 - the Increasing Transparency in Generic Drug Applications Act S. 4351 - the Enhanced Access to Affordable Medicines Act H.R. 7559 - the Prescription Information Modernization Act of 2022; Complex Generic Drug Approvals

Client expense: $830,000 · Firm income: Not reported

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

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.6973/S.4351, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032/S.4338, Increasing Transparency in Generic Drug Applications Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021.

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

Government targets: HOUSE OF REPRESENTATIVES

Issues related to drug pricing, reimbursement for prescription drugs, and the pharmaceutical supply chain; H.R. 6833/S. 3700 - Affordable Insulin Now Act; S. 2199 - Insulin Price Reduction Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; The Continuing resolution and Ukraine Supplemental Appropriations Act 2023 (PL 117-180), Division F - FDA User Fee Reauthorization Act of 2022; H.R. 7559 - the Prescription Information Modernization Act; Package Inserts/eLabeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; H.R. 6833 - The Continuing Resolution and Ukraine Supplemental Appropriations Act 2023, Division F - FDA User Fee Reauthorization Act of 2022; H.R. 7559 - the Prescription Information Modernization Act; Package Inserts/eLabeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

COVID services & COVID services for the uninsured S. 3799PREVENT Pandemics Act S. Amdt to H.R. 2471 Consolidated Appropriations Act of 2022 S. 1536Medical Nutrition Therapy Act of 2021 S. 4293Pharmacy Benefit Manager Transparency Act H.R. 7666 Restoring Hope for Mental Health and Wellbeing Act H.R. 2355 Opioid Prescription Verification Act H.R. 1384 Mainstreaming Addiction Treatment Act H.R. 7007 COVID Supplemental Appropriations Act of 2022 H.R. 3108 Medical Nutrition Therapy Act of 2021 H.R. 5585 Advanced Research Project Agency-Health H.R. 6279 Opioid Treatment Access Act H.R. 7559 Prescription Information Modernization Act H.R. 5376 Inflation Reduction Act

Client expense: $220,000 · Firm income: Not reported

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

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing legislation regarding health care costs. Opposing various legislative efforts to relocate supply and logistics chains. Opposing various legislative and executive efforts to impose an international price index. Supporting the DISARM Act (H.R. 4127). Supporting the PASTEUR Act (S. 2076 and H.R. 3932). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 7559). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting CMS proposed rule on Medicare Coverage of Innovative Technology (MCIT). Engaging various components of the Build Back Better Act. Opposing CMS reimbursement for combined diagnostics test. Opposing TRIPS waiver. Supporting PDUFA and MDUFA passage. Commenting on risk management to mitigate drug shortages. Supporting the extension of the SBIR program. Supporting H.R. 8188, the Saving Access to Laboratory Services Act (SALSA). Supporting H.R. 4346, the Creating Helpful Incentives to Produce Semiconductors (CHIPS) Act. Opposing the Inflation Reduction Act.

Client expense: $51,552 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing legislation regarding health care costs. Opposing various legislative efforts to relocate supply and logistics chains. Opposing various legislative and executive efforts to impose an international price index. Supporting the DISARM Act (H.R. 4127). Supporting the PASTEUR Act (S. 2076 and H.R. 3932). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 7559). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting CMS proposed rule on Medicare Coverage of Innovative Technology (MCIT). Engaging various components of the Build Back Better Act. Opposing CMS reimbursement for combined diagnostics test. Opposing TRIPS waiver. Supporting PDUFA and MDUFA passage.

Client expense: $43,386 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts

Client expense: $1,270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Package Inserts/E-Labeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).

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

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

COVID services & COVID services for the uninsured S. 3799PREVENT Pandemics Act S. Amdt to H.R. 2471 Consolidated Appropriations Act of 2022 S. 1536Medical Nutrition Therapy Act of 2021 S. 4293Pharmacy Benefit Manager Transparency Act H.R. 7666 Restoring Hope for Mental Health and Wellbeing Act H.R. 2355 Opioid Prescription Verification Act H.R. 1384 Mainstreaming Addiction Treatment Act H.R. 7007 COVID Supplemental Appropriations Act of 2022 H.R. 3108 Medical Nutrition Therapy Act of 2021 H.R. 5585 Advanced Research Project Agency-Health H.R. 6279 Opioid Treatment Access Act H.R. 7559 Prescription Information Modernization Act

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

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

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

S. 1388 -- Prescription Pricing for the People Act of 2021, a bill to require the Federal Trade Commission (FTC) to report about anticompetitive practices and other trends within the pharmaceutical supply chain that may impact the cost of prescriptions drugs. The FTC also must provide recommendations to increase transparency in the supply chain and prevent anticompetitive practices. S. 298/H.R. 1829 -- Pharmacy Benefit Manager Accountability Study Act of 2021, a bill to require the Government Accountability Office to report on the role of pharmacy benefit managers in the pharmaceutical supply chain and recommend legislative actions to lower the cost of prescription drugs. The report must address the use of rebates and fees, the average prior authorization approval time, and the use of step therapy within the 10 largest pharmacy benefit managers. S. 3399 To amend the Federal Food, Drug, and Cosmetic Act to provide a process to lock and suspend domain names used to facilitate the online sale of drugs illegally, and for other purposes. H.R. 7559 -- Required prescribing information for drugs subject to section 503(b)(1) may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law, that the manufacturer affords prescribers and dispensers the opportunity to elect to also continue to receive all such information in paper form, or to request paper labeling on an as-needed basis, and after such request, and that the manufacturer promptly provides the requested information without additional cost. S. 4293 -- To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE