Affordable Insulin Now Act

Issues related to Direct-to-Consumer Prescription Drug Advertisements; Issues related to Cybersecurity; Health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act 2024; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption; S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S. 954, Affordable Insulin Now Act of 2023; H.R. 1488, Affordable Insulin Now Act; H.R. 1587, Making Insulin Affordable for All Children Act; H.R. 1485, Insulin for all Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; S. 464/H.R. 2630, the Safe Step Act; H.R. 1843/S. 1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; Issues related to mental health coverage, workforce, and mental health parity; Issues related to surprise billing law and regulation; Issues related to artificial intelligence and health care issues; Issues related to removing barriers to biosimilar medicine access; H.R. 4189/S. 2016, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; H.R. 3432/S.3651, Telemental Health Care Access Act of 2023; H.R. 1692, The Health Care Affordability Act; H.R. 8152, the American Privacy Rights Act (APRA) of 2024; P.L. No: 118-158 and draft FY2025 Continuing Resolution, issues related to telehealth.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value, access and quality; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care.

Client expense: $190,000 · Firm income: Not reported

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 2872 - Further Additional Continuing Appropriations and Other Extensions Act, 2024 - Rep. Graves, Garret - extends FY24 funding and program authorities through March 8, 2024 H.R. 2882 - Further Consolidated Appropriations Act, 2024 - Rep. Ciscomani, Juan - provides annual funding through September 30, 2024, for the Departments of Labor, Health and Human Services, and Education, and Related Agencies H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements H.R. 6956 - Opioid Settlement Accountability Act - Rep. Kaptur, Marcy - funding for opioid prevention and treatment services, training, equipment, and social support services H.R. 6960 - Emergency Medical Services for Children Reauthorization Act of 2024 - Rep. Carter, Earl L. Buddy - funding for emergency medical services for children program H.R. 7513 - Protecting Americas Seniors Access to Care Act - Rep. Fischbach, Michelle - regarding minimum staffing for nursing facilities H.R. 7623 - Telehealth Modernization Act of 2024- Rep. Carter, Buddy - including requirements for Part D plan contracts with PBMs including transparency and delinking provisions H.R. 7858 - Telehealth Enhancement for Mental Health Act of 2024 - Rep. James, John - Medicare, behavioral health, telehealth H.R. 7899 - To direct the Attorney General, in consultation with the Secretary of Health and Human Services, to promulgate the final regulations relating to special registration for telemedicine. - Rep. Ezell, Mike - telehealth H.R. 7907 - Welcome Back to the Health Care Workforce Act - Rep. Krishnamoorthi, Raja- grants/funding, health care workforce H.R. 7929 - Nursing Home Workforce Support and Expansion Act of 2024 - Rep. Horsford, Steven - grants/funding, health care workforce H.R. 7994 - Long-Term Care Workforce Support Act - Rep. Dingell, Debbie - health care workforce H.R. 8444 - Mental Health in Schools Act - Rep. Napolitano, Grace - grant to promote mental health S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality S. 3393 - SUPPORT for Patients and Communities Reauthorization Act. - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce S. 3612 - Access to Family Building Act- Sen. Duckworth, Tammy- right to access reproductive technology (ex. IVF) S. 3756 - At HOME Services Act of 2024- Sen. Rubio, Marco- pilot program for outpatient observation, acute care at home S. 3775 - BOLD Infrastructure for Alzheimers Reauthorization Act of 2024- Sen. Collins, Susan - healthcare infrastructure, Alzheimers S. 3805 - A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes. - Sen. Cassidy, Bill - SSA, healthcare, electronic funds, payments, remittance S. 3847 - Improving Social Determinants of Health Act of 2024- Sen. Smith, Tina- CDC authorization S. 4088 - Welcome Back to the Health Care Workforce Act - Sen. Kaine, Tim - grants/funding, health care workforce S. 4120 - Long-Term Care Workforce Support Act - Sen. Casey, Robert P., Jr. - health care workforce S. 4195 - Childhood Diabetes Reduction Act of 2024 - Sen. Sanders, Bernie - nutrition labeling S. 4357 - Comprehensive Dental Reform Act of 2024- Sen. Sanders, Bernie - promotes access to oral health care S. 4358 - Preventing and Treating Substance Use Disorders Among Older Adults Act- Sen. Casey, Robert - SAMHSA grant program for SUDs S. 4554 - Reproductive Freedom for Women Act- Sen. Murray, Patty - protecting abortion and reproductive rights Issues related to broadband and public health infrastructure; mental health and telehealth; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; artificial intelligence and privacy; insurance industry response to and support for providers regarding the Change Healthcare cyberattack and broader cyber security issues; ACA Marketplace; and Mental Health Parity Proposed Rule.

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

Issues: Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing, GLP-1s Bills: Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value, access and quality; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care.

Client expense: $1,795,000 · Firm income: Not reported

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

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 2872 - Further Additional Continuing Appropriations and Other Extensions Act, 2024 - Rep. Graves, Garret - extends FY24 funding and program authorities through March 8, 2024 H.R. 2882 - Further Consolidated Appropriations Act, 2024 - Rep. Ciscomani, Juan - provides annual funding through September 30, 2024, for the Departments of Labor, Health and Human Services, and Education, and Related Agencies H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements H.R. 6956 - Opioid Settlement Accountability Act - Rep. Kaptur, Marcy - funding for opioid prevention and treatment services, training, equipment, and social support services H.R. 6960 - Emergency Medical Services for Children Reauthorization Act of 2024 - Rep. Carter, Earl L. Buddy - funding for emergency medical services for children program H.R. 7513 - Protecting Americas Seniors Access to Care Act - Rep. Fischbach, Michelle - regarding minimum staffing for nursing facilities H.R. 7858 - Telehealth Enhancement for Mental Health Act of 2024 - Rep. James, John - Medicare, behavioral health, telehealth H.R. 7899 - To direct the Attorney General, in consultation with the Secretary of Health and Human Services, to promulgate the final regulations relating to special registration for telemedicine. - Rep. Ezell, Mike - telehealth H.R. 7907 - Welcome Back to the Health Care Workforce Act - Rep. Krishnamoorthi, Raja- grants/funding, health care workforce H.R. 7929 - Nursing Home Workforce Support and Expansion Act of 2024 - Rep. Horsford, Steven - grants/funding, health care workforce H.R. 7994 - Long-Term Care Workforce Support Act - Rep. Dingell, Debbie - health care workforce H.R. 8444 - Mental Health in Schools Act - Rep. Napolitano, Grace - grant to promote mental health S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality S. 3393 - SUPPORT for Patients and Communities Reauthorization Act. - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce S. 3612 - Access to Family Building Act- Sen. Duckworth, Tammy- right to access reproductive technology (ex. IVF) S. 3756 - At HOME Services Act of 2024- Sen. Rubio, Marco- pilot program for outpatient observation, acute care at home S. 3775 - BOLD Infrastructure for Alzheimers Reauthorization Act of 2024- Sen. Collins, Susan - healthcare infrastructure, Alzheimers S. 3805 - A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes. - Sen. Cassidy, Bill - SSA, healthcare, electronic funds, payments, remittance S. 3847 - Improving Social Determinants of Health Act of 2024- Sen. Smith, Tina- CDC authorization S. 4088 - Welcome Back to the Health Care Workforce Act - Sen. Kaine, Tim - grants/funding, health care workforce S. 4120 - Long-Term Care Workforce Support Act - Sen. Casey, Robert P., Jr. - health care workforce S. 4195 - Childhood Diabetes Reduction Act of 2024 - Sen. Sanders, Bernie - nutrition labeling S. 4357 - Comprehensive Dental Reform Act of 2024- Sen. Sanders, Bernie - promotes access to oral health care S. 4358 - Preventing and Treating Substance Use Disorders Among Older Adults Act- Sen. Casey, Robert - SAMHSA grant program for SUDs S. 4554 - Reproductive Freedom for Women Act- Sen. Murray, Patty - protecting abortion and reproductive rights Issues related to broadband and public health infrastructure; mental health and telehealth; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; artificial intelligence and privacy; insurance industry response to and support for providers regarding the Change Healthcare cyberattack; ACA Marketplace; and Mental Health Parity Proposed Rule.

Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care.

Client expense: $2,465,000 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.150 - Affordable Prescriptions for Patients Act S.652 - Safe Step Act S.655 - Chronic Disease Management Act S.727 - Insulin for All Act S.775 - Increasing Transparency in Generic Drug Applications Act S.954 - Affordable Insulin Now Act S.1038 - Drug Price Transparency in Medicaid Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1130 - Health Care PRICE Transparency Act S.1131 - Drug Price Transparency Act S.1217 - Ending the Prescription Drug Kickback Act S.1218 - Fair Prescription Drug Prices for Americans Act S.1269 - INSULIN Act S.1339 - Pharmacy Benefit Manager Reform Act S.1375 - HELP Copays Act S.1497 - Emergency Access to Insulin Act S.1491 - Pharmacy and Medically Underserved Areas Enhancement Act S.1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S.1543 - A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third party administration services S.1967 - Patients Before Middlemen (PBM) Act S.2052 - Protect Patient Access to Pharmacies Act S.2129 - Ensuring Access to Lower-Cost Medicines for Seniors Act S.2254 - Medicare PBM Accountability Act S.2405 - Strengthening Pharmacy Access for Seniors Act S.2406 - PBM Oversight Act S.2408 - IMPROVE Part D Regulations Act S.2436 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act S.2456 - Protecting Seniors from High Drug Costs Act S.2474 - Share the Savings with Seniors Act S.2477 - Equitable Community Access to Pharmacist Services Act S.2493 - PBM Reporting Transparency Act S.2666 - EPCS 2.0 Act S.2840 - Bipartisan Primary Care and Health Workforce Act (Bruan Amendment #3 - Price Transparency Requirements) S.2939 - Pharmacy Access Oversight and Reporting Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R.830 - HELP Copays Act H.R.1352 - Increasing Access to Biosimilars Act H.R.1488 - Affordable Insulin Now Act H.R.1587 - Making Insulin Affordable for All Children Act H.R.1613 - Drug Price Transparency in Medicaid Act H.R.1770 - Equitable Community Access to Pharmacists Act H.R.1790 - Biologics Competition Act H.R.2630 - Safe Step Act H.R.2666 - Medicaid VBPs for Patients (MVP) Act H.R.2670 - PBM Accountability Act H.R.2691 - Transparent PRICE Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.3030 - Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act H.R.3134 - Emergency Access to Insulin Act H.R.3262 - to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information H.R.3281 - Transparent PRICE Act H.R.3282 - Promoting Transparency and Health Competition in Medicare Act H.R.3285 - Fairness for Patient Medications H.R.3561- Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act H.R.3800 - Chronic Disease Flexible Coverage Act H.R.4011 - Timely Access to Clinical Treatment Act H.R.4507 - Transparency in Coverage Act H.R.4508 - Hidden Fee Disclosure Act H.R.4509 - Transparency in Billing Act H.R.4527 - Health Data Act H.R.4712 - Patient Right to Shop Act H.R.4822 - Health Care Price Transparency Act H.R.4846 - To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.4883 - Medicare Common Ownership Transparency Act H.R.5372 - Expanding Seniors Access to Lower Cost Medicines Act H.R.5376 - Share the Savings with Seniors Act H.R.5378 - Lower Costs More Transparency Act H.R.5384 - Advancing Enrollment and Reducing Drug Costs Act H.R.5385 - Medicare PBM Accountability Act H.R.5386 - Cutting Copays Act H.R.5393 -Transparency and Fairness for Pharmacies Act H.R.5400 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act H.R.5461 - Ensuring Access to Lower-Cost Medicines for Seniors Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - treating benefits for telehealth services offered under a group health plan or group health insurance coverage as excepted benefits H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 2872 - Further Additional Continuing Appropriations and Other Extensions Act, 2024 - Rep. Graves, Garret - extends FY24 funding and program authorities through March 8, 2024 H.R. 2882- Further Consolidated Appropriations Act, 2024 - Rep. Ciscomani, Juan - provides annual funding through September 30, 2024, for the Departments of Labor, Health and Human Services, and Education, and Related Agencies H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements H.R. 6956 - Opioid Settlement Accountability Act - Rep. Kaptur, Marcy - funding for opioid prevention and treatment services, training, equipment, and social support services H.R. 6960 - Emergency Medical Services for Children Reauthorization Act of 2024 - Rep. Carter, Earl L. - funding for emergency medical services for children program H.R. 7513 - Protecting Americas Seniors Access to Care Act - Rep. Fischbach, Michelle - regarding minimum staffing for nursing facilities S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality S. 3393 - SUPPORT for Patients and Communities Reauthorization Act - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce S. 3612- Access to Family Building Act- Sen. Duckworth, Tammy- right to access reproductive technology (ex. IVF) S. 3756- At HOME Services Act of 2024- Sen. Rubio, Marco- pilot program for outpatient observation, acute care at home S. 3775- BOLD Infrastructure for Alzheimer's Reauthorization Act of 2024- Sen. Collins, Susan - healthcare infrastructure, Alzheimers S. 3805- A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes. - Sen. Cassidy, Bill - SSA, healthcare, electronic funds, payments, remittance S. 3847- Improving Social Determinants of Health Act of 2024- Sen. Smith, Tina- CDC authorization Issues related to broadband and public health infrastructure; mental health and telehealth; COVID-19 testing; public option programs; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; and artificial intelligence and privacy. Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10 and ICD-11), 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.

Issues related to Direct-to-Consumer Prescription Drug Advertisements; Issues related to Cybersecurity; Health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act 2024; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023; Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; Issues related to P.L. 93-406, Employee Retirement Income Security Act of 1974 (ERISA), preemption; S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S 954, Affordable Insulin Now Act of 2023; HR 1488, Affordable Insulin Now Act; HR 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for all Act of 2023; S. 5093, Behavioral Health Network and Directory Improvement Act; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; S. 464/ H.R. 2630, the Safe Step Act; H.R. 5688, the Bipartisan HSA Improvement Act of 2023; H.R. 5687, the HSA Modernization Act of 2023; H.R. 1843/S. 1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; S. 3393 Support for Patients and Communities Reauthorization Act; Issues related to mental health coverage, workforce, and mental health parity; Issues related to surprise billing law and regulation; Issues related to artificial intelligence and health care issues; Issues related to removing barriers to biosimilar medicine access; Issues related to the proposed rule on Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Childrens Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program; H.R. 4189/S. 2016, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023; H.R. 3432/S.3651, Telemental Health Care Access Act of 2023.

Educate policymakers on health care issues related to P.L. 118-42, the Consolidated Appropriations Act 2024, and P.L. 118-47, the Further Consolidated Appropriations Act; Issues related to P.L. , the Inflation reduction Act of 2022, including enhanced advance premium tax creidts (APTCs) and Medicare Part D redisign; S. 727, Inslulin for All Act of 2023; S.1269, Improving Needed Safeguards for Uses of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146 Cap Insulin Prices Act; S. 954 Affordable Insulin Now Act of 2023; H.R. 1488, Affordable Insulin Now Act; H.R. 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for All Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 1843 / S.1001, Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expnsion for Workers Act of 2023; Issues related to artificial intelligence and health care issues; Issues related to the proposed rule on Advancing Interoperability and Improving Prior Authorization Processes for Mediare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligibile Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program

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

Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care.

Client expense: $1,730,000 · Firm income: Not reported

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl -spread-pricing by PBMs for Medicaid H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - preventing anti-competitive tactics for prescription drugs S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - pharmacy benefit manager transparency S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - cost-sharing for insulin products S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - prohibits spread-pricing by PBMs in Medicaid S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality S. 3393 - SUPPORT for Patients and Communities Reauthorization Act. - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce Issues related to broadband and public health infrastructure; mental health and telehealth; COVID-19 testing; public option programs; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; and artificial intelligence and privacy. Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10 and ICD-11), 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.

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

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.150 - Affordable Prescriptions for Patients Act S.652 - Safe Step Act S.655 - Chronic Disease Management Act S.727 - Insulin for All Act S.775 - Increasing Transparency in Generic Drug Applications Act S.954 - Affordable Insulin Now Act S.1038 - Drug Price Transparency in Medicaid Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1130 - Health Care PRICE Transparency Act S.1131 - Drug Price Transparency Act S.1217 - Ending the Prescription Drug Kickback Act S.1218 - Fair Prescription Drug Prices for Americans Act S.1269 - INSULIN Act S.1339 - Pharmacy Benefit Manager Reform Act S.1375 - HELP Copays Act S.1497 - Emergency Access to Insulin Act S.1491 - Pharmacy and Medically Underserved Areas Enhancement Act S.1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S.1543 - A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third party administration services S.1967 - Patients Before Middlemen (PBM) Act S.2052 - Protect Patient Access to Pharmacies Act S.2129 - Ensuring Access to Lower-Cost Medicines for Seniors Act S.2254 - Medicare PBM Accountability Act S.2405 - Strengthening Pharmacy Access for Seniors Act S.2406 - PBM Oversight Act S.2408 - IMPROVE Part D Regulations Act S.2436 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act S.2456 - Protecting Seniors from High Drug Costs Act S.2474 - Share the Savings with Seniors Act S.2477 - Equitable Community Access to Pharmacist Services Act S.2493 - PBM Reporting Transparency Act S.2666 - EPCS 2.0 Act S.2840 - Bipartisan Primary Care and Health Workforce Act (Bruan Amendment #3 - Price Transparency Requirements) S.2939 - Pharmacy Access Oversight and Reporting Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R.830 - HELP Copays Act H.R.1352 - Increasing Access to Biosimilars Act H.R.1488 - Affordable Insulin Now Act H.R.1587 - Making Insulin Affordable for All Children Act H.R.1613 - Drug Price Transparency in Medicaid Act H.R.1770 - Equitable Community Access to Pharmacists Act H.R.1790 - Biologics Competition Act H.R.2630 - Safe Step Act H.R.2666 - Medicaid VBPs for Patients (MVP) Act H.R.2670 - PBM Accountability Act H.R.2691 - Transparent PRICE Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.3030 - Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act H.R.3134 - Emergency Access to Insulin Act H.R.3262 - to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information H.R.3281 - Transparent PRICE Act H.R.3282 - Promoting Transparency and Health Competition in Medicare Act H.R.3285 - Fairness for Patient Medications H.R.3561- Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act H.R.3800 - Chronic Disease Flexible Coverage Act H.R.4011 - Timely Access to Clinical Treatment Act H.R.4507 - Transparency in Coverage Act H.R.4508 - Hidden Fee Disclosure Act H.R.4509 - Transparency in Billing Act H.R.4527 - Health Data Act H.R.4712 - Patient Right to Shop Act H.R.4822 - Health Care Price Transparency Act H.R.4846 - To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.4883 - Medicare Common Ownership Transparency Act H.R.5372 - Expanding Seniors Access to Lower Cost Medicines Act H.R.5376 - Share the Savings with Seniors Act H.R.5378 - Lower Costs More Transparency Act H.R.5384 - Advancing Enrollment and Reducing Drug Costs Act H.R.5385 - Medicare PBM Accountability Act H.R.5386 - Cutting Copays Act H.R.5393 -Transparency and Fairness for Pharmacies Act H.R.5400 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act H.R.5461 - Ensuring Access to Lower-Cost Medicines for Seniors Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act

Client expense: $2,530,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. Rodgers, Cathy McMorris - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Buddy - prohibits spread-pricing by PBMs in Medicaid H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. Rodgers, Cathy McMorris - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. Rodgers, Cathy McMorris - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3797 - Paperwork Burden Reduction Act - Rep. Smith, Jason - employers mailing 1095 physical tax forms H.R. 3798 - Small Business Flexibility Act - Rep. Tenney, Claudia - small business coverage notifications H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - preventing anti-competitive tactics for prescription drugs S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - pharmacy benefit manager transparency S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - cost-sharing for insulin products S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - prohibits spread-pricing by PBMs in Medicaid S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality Accessible, Affordable Internet for All Act (no bill number) - broadband Advancing Integration in Medicare and Medicaid (AIM) Act (no bill number) - coordinating full-benefits for dual eligible individuals Advancing Telehealth Beyond COVID-19 Act (no bill number) - telehealth American Data Privacy and Protection Act (no bill number) - data privacy American Rescue Plan Act (no bill number) - COVID-19 relief Behavioral Health Integration Awareness Act (no bill number) - mental health and Medicare Better Health Care Directories Act (no bill number) - commercial plans Building COVID-19 Vaccine Confidence Act (no bill number) - COVID-19 CHOICE Act (no bill number) - public option CONNECT for Health Act (no bill number) - expansion of telehealth for Medicare Consolidated Appropriations Act (no bill number) - continued Medicaid and Medicare provisions and funding for FY2023 Consumer Online Privacy Rights Act (no bill number) - data privacy Continuing Appropriations and Ukraine Supplemental Appropriations Act (no bill number) - continued funding for Medicare and Medicaid Improving Seniors Timely Access to Care Act (no bill number) - prior authorization in Medicare Advantage Medicaid Saves Lives Act (no bill number) - Medicaid expansion Medicare for All Act (no bill number) - public option Medicare Multi-Cancer Early Detection Screening Coverage Act (no bill number) - Cancer screening in Medicare Mental Health Matters Act (no bill number) - changes to the procedure around MHPEA litigation MOMMAs Act (no bill number) - maternal health Moms Matter Act (no bill number) - maternal mental health conditions and SUD MORE Health Education Act (no bill number) - Federal Exchange outreach and educational activities NO PAIN Act (no bill number) - non-opioid treatment No Surprises for Survivors Act (no bill number) - 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 Nursing Home Reform Modernization Act (no bill number) - nursing home quality and transparency Parity Enforcement Act (no bill number) - mental health and SUD Parity Implementation Assistance Act (no bill number) - mental health parity PATCH Act (no bill number) - privacy and cybersecurity Patients Before Middlemen Act (no bill number) - pharmacy benefit managers Physician Wellness Program Act (no bill number) - mental health and Medicare Prevent Pandemics Act (no bill number) - pandemic preparedness Preventing Mental Health and Substance Use Crises During Emergencies Act (no bill number) - mental health and SUD national strategy Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act (no bill number) - commercial plans Protecting Americans with Pre-Existing Conditions Act (no bill number) - state innovation waivers Protecting Patients from Deceptive Health Plans Act (no bill number) - excepted benefits coverage Protecting Personal Health Data Act (no bill number) - privacy Public Health Infrastructure Saves Lives Act (no bill number) - public health infrastructure Public Option Deficit Reduction Act (no bill number) - public option Restore Protections for Dialysis Patients Act (no bill number) - reform of MSP Secondary Payer Act Restoring Hope for Mental Health and Well-Being Act (no bill number) - reauthorization of several behavioral health programs RICE Act (no bill number) - commercial plans SAFE DATA Act (no bill number) - consumer data privacy and data transparency and security Safe Step Act (no bill number) -commercial plans and medication step-therapy requirements Secure Data and Privacy for Contact Tracing Act (no bill number) - digital contact tracing for COVID-19 Social Determinants for Moms Act (no bill number) - SDOH and maternal health Strengthen Kids Mental Health Now Act (no bill number) - mental health and Medicaid Supporting Best Practices for Healthy Moms Act (no bill number) - maternal health Tech to Save Moms Act (no bill number) - maternal health The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act (no bill number) - funding for maternal and early childhood health programs 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 (no bill number) - Broadband 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. (no bill number) - commercial plans 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. (no bill number) - behavioral health and electronic health records To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. (no bill number) - mental health and Medicare 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. (no bill number) - commercial plans 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. (no bill number) - mental health and Medicare TREATS Act (no bill number) - increase use of telehealth for SUD treatment Turn the Tide Act (no bill number) - Substance Use Disorder Virtual Community Support Act (no bill number) - mental health and SUD grants for community peer support Issues related to benefits, design, or structure of HIPAA-excepted benefits and supplemental benefits; mental health parity; surprise billing; broadband and public health infrastructure; mental health and telehealth; COVID-19 testing; public option programs; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; and provider directories. Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10 and ICD-11), 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.

H.R. 4420 - Preparedness and Response Reauthorization Act H.R. 3561 - PATIENT Act of 2023 H.R. 5378 - Lower Costs, More Transparency Act S. 1855 - Special Diabetes Program Reauthorization Act of 2023 S. 1269 - INSULIN Act of 2023 S. 954/H.R. 1488 - Affordable Insulin Now Act H.R. 4758/S. 2372 - Accelerating Kids Access to Care Act S.2205/H.R. 4304 - The ISLET Act Issues related to Medicare and Medicaid

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements.

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.150 - Affordable Prescriptions for Patients Act S.652 - Safe Step Act S.655 - Chronic Disease Management Act S.727 - Insulin for All Act S.775 - Increasing Transparency in Generic Drug Applications Act S.954 - Affordable Insulin Now Act S.1038 - Drug Price Transparency in Medicaid Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1130 - Health Care PRICE Transparency Act S.1131 - Drug Price Transparency Act S.1217 - Ending the Prescription Drug Kickback Act S.1218 - Fair Prescription Drug Prices for Americans Act S.1269 - INSULIN Act S.1339 - Pharmacy Benefit Manager Reform Act S.1375 - HELP Copays Act S.1497 - Emergency Access to Insulin Act S.1491 - Pharmacy and Medically Underserved Areas Enhancement Act S.1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S.1543 - A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third party administration services S.1967 - Patients Before Middlemen (PBM) Act S.2052 - Protect Patient Access to Pharmacies Act S.2129 - Ensuring Access to Lower-Cost Medicines for Seniors Act S.2254 - Medicare PBM Accountability Act S.2405 - Strengthening Pharmacy Access for Seniors Act S.2406 - PBM Oversight Act S.2408 - IMPROVE Part D Regulations Act S.2436 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act S.2456 - Protecting Seniors from High Drug Costs Act S.2474 - Share the Savings with Seniors Act S.2477 - Equitable Community Access to Pharmacist Services Act S.2493 - PBM Reporting Transparency Act S.2666 - EPCS 2.0 Act S.2840 - Bipartisan Primary Care and Health Workforce Act (Bruan Amendment #3 - Price Transparency Requirements) S.2939 - Pharmacy Access Oversight and Reporting Act S.2973 - Modernizing and Ensuring PBM Accountability Act H.R.830 - HELP Copays Act H.R.1352 - Increasing Access to Biosimilars Act H.R.1488 - Affordable Insulin Now Act H.R.1587 - Making Insulin Affordable for All Children Act H.R.1613 - Drug Price Transparency in Medicaid Act H.R.1770 - Equitable Community Access to Pharmacists Act H.R.1790 - Biologics Competition Act H.R.2630 - Safe Step Act H.R.2666 - Medicaid VBPs for Patients (MVP) Act H.R.2670 - PBM Accountability Act H.R.2691 - Transparent PRICE Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.3030 - Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act H.R.3134 - Emergency Access to Insulin Act H.R.3262 - to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information H.R.3281 - Transparent PRICE Act H.R.3282 - Promoting Transparency and Health Competition in Medicare Act H.R.3285 - Fairness for Patient Medications H.R.3561- Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act H.R.3800 - Chronic Disease Flexible Coverage Act H.R.4011 - Timely Access to Clinical Treatment Act H.R.4507 - Transparency in Coverage Act H.R.4508 - Hidden Fee Disclosure Act H.R.4509 - Transparency in Billing Act H.R.4527 - Health Data Act H.R.4712 - Patient Right to Shop Act H.R.4822 - Health Care Price Transparency Act H.R.4846 - To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.4883 - Medicare Common Ownership Transparency Act H.R.5372 - Expanding Seniors Access to Lower Cost Medicines Act H.R.5376 - Share the Savings with Seniors Act H.R.5378 - Lower Costs More Transparency Act H.R.5384 - Advancing Enrollment and Reducing Drug Costs Act H.R.5385 - Medicare PBM Accountability Act H.R.5386 - Cutting Copays Act H.R.5393 -Transparency and Fairness for Pharmacies Act H.R.5400 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act H.R.5461 - Ensuring Access to Lower-Cost Medicines for Seniors Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Legislative and administrative monitoring and outreach on healthcare policy. Legislative and administrative monitoring and outreach on prescription drug pricing/PBMs. Legislative and administrative monitoring and outreach on policy issues affecting Medicaid programs. H.R. 134, To amend title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services. H.R. 197, Rural Telehealth Expansion Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 207, Advanced Safe Testing at Residence Telehealth Act of 2023 H.R. 497, Freedom for Health Care Workers Act H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023 H.R. 1066, CARING for Social Determinants Act of 2023 H.R. 1215, Healthcare Worker Retention Act H.R. 1488, Affordable Insulin Now Act H.R. 1587, Making Insulin Affordable for All Children Act H.R. 1613, Drug Price Transparency in Medicaid Act of 2023 H.R. 1843, Telehealth Expansion Act of 2023 H.R. 2534, To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes. S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 146, Cap Insulin Prices Act S. 710, Striking and Locked Out Workers Healthcare Protection Act S. 729, Audio-Only Telehealth for Emergencies Act S. 731, TELEHEALTH HSA Act of 2023 S. 880, Coordinating Dual Eligible Recommendations Act S. 1001, A bill to amend the Internal Revenue Code of 1986 to permanently extend the exemption for telehealth services from certain high deductible health plan rules. S.113, Prescription pricing for the People Act S.1339, Pharmacy Benefit Manager Reform Act H.R. 3284, Providers and Payers Compete Act H.R. 3561, Patient Act S. 880, Coordinating Dual Eligible Recommendations Act H.R. 4697, Protecting PAHPA Act S.2624, Labor-HHS-Education Appropriations Act H.R. 5378, Lower Costs, More Transparency ActPrice Transparency H.R. 4368, Agriculture Appropriations Act S. 2131, Agriculture Appropriations Act H.R. 5860, Continuing Appropriations Act

Educate policymakers on pharmacy issues related to TRICARE and H.R.2670, S.2226 Fiscal Year 2024 National Defense Authorization Act; issues related to P.L 117-328, the Consolidated Appropriations Act 2023, including telehealth and redeterminations; issues related to P.L 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign; issues related to removing barriers to biosimilar medicine access; issues related to insulin pricing, including S. 727, Insulin for All Act of 2023; S. 1269, INSULIN Act of 2023; S. 146, Cap Insulin Prices Now Act of 2023; HR 1488, Affordable Insulin Now Act; HR 1587, Making Insulin Affordable for All Children Act; HR 1485, Insulin for All Act of 2023; issues related to mental health coverage, workforce, and mental health parity and the Behavioral Health Network and Directory Improvement Act and S. 2840, Bipartisan Primary Care and Health Workforce Act; and issues related commercial insurance, telehealth, and pharmacy benefits.

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

Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).

Client expense: $72,000 · Firm income: Not reported

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

Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act

Client expense: $2,301,360 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig Angie - cost-sharing for insulin products H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl -spread-pricing by PBMs for Medicaid H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3797 - Paperwork Burden Reduction Act - Rep. Smith, Jason - employers mailing 1095 physical tax forms H.R. 3798 - Small Business Flexibility Act - Rep. Tenney, Claudia - small business coverage notifications H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - preventing anti-competitive tactics for prescription drugs S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - pharmacy benefit manager transparency S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - cost-sharing for insulin products S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - prohibits spread-pricing by PBMs in Medicaid S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernard - pharmacy benefit managers S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality Accessible, Affordable Internet for All Act (no bill number) - broadband Advancing Integration in Medicare and Medicaid (AIM) Act (no bill number) - coordinating full-benefits for dual eligible individuals Advancing Telehealth Beyond COVID-19 Act (no bill number) - telehealth American Data Privacy and Protection Act (no bill number) - data privacy American Rescue Plan Act (no bill number) - COVID-19 relief Behavioral Health Integration Awareness Act (no bill number) - mental health and Medicare Better Health Care Directories Act (no bill number) - commercial plans Building COVID-19 Vaccine Confidence Act (no bill number) - COVID-19 CHOICE Act (no bill number) - public option CONNECT for Health Act (no bill number) - expansion of telehealth for Medicare Consolidated Appropriations Act (no bill number) - continued Medicaid and Medicare provisions and funding for FY2023 Consumer Online Privacy Rights Act (no bill number) - data privacy Continuing Appropriations and Ukraine Supplemental Appropriations Act (no bill number) - continued funding for Medicare and Medicaid COVID Community Care Act (no bill number) - COVID-19 response COVID-19 Emergency Telehealth Impact Reporting Act (no bill number) - telehealth and COVID-19 COVID-19 Health Disparities Action Act (no bill number) -COVID-19 and health disparities Data Mapping to Save Moms Lives Act (no bill number) - maternal health data Equitable Data Collection and Disclosure on COVID-19 Act (no bill number) - COVID-19 Data Collection Fighting Stimulant and other Substance Use Disorders Act (no bill number) - mental health and Medicare Food and Drug Amendments (no bill number) - reauthorization of user fee programs Health Care Improvement Act (no bill number) - care costs and coverage Hospital Competition Act (no bill number) - procedural changes around The Mental Health Parity and Addiction Equity Act (MHPEA) litigation IMPACT to Save Moms Act (no bill number) - maternal health Improving Access to Behavioral Health Integration Act (no bill number) - behavioral health Improving Access to Health Care in Rural and Underserved Areas Act (no bill number)- rural health Improving Seniors Timely Access to Care Act (no bill number) - prior authorization in Medicare Advantage Improving Social Determinants of Health Act (no bill number) - health disparities Inpatient Psychiatric Facility Improvement Act (no bill number) - mental health and Medicare Kira Johnson Act (no bill number) - maternal health LIFT America Act (no bill number) - broadband and public health infrastructure Lower Costs, More Cures Act (no bill number) - prescription drug prices for Medicare and Medicaid Maternal Vaccinations Act (no bill number) - maternal health Medicaid Saves Lives Act (no bill number) - Medicaid expansion Medicare for All Act (no bill number) - public option Medicare Multi-Cancer Early Detection Screening Coverage Act (no bill number) - Cancer screening in Medicare Mental Health Matters Act (no bill number) - changes to the procedure around MHPEA litigation MOMMAs Act (no bill number) - maternal health Moms Matter Act (no bill number) - maternal mental health conditions and SUD MORE Health Education Act (no bill number) - Federal Exchange outreach and educational activities NO PAIN Act (no bill number) - non-opioid treatment No Surprises for Survivors Act (no bill number) - 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 Nursing Home Reform Modernization Act (no bill number) - nursing home quality and transparency Parity Enforcement Act (no bill number) - mental health and SUD Parity Implementation Assistance Act (no bill number) - mental health parity PATCH Act (no bill number) - privacy and cybersecurity Patients Before Middlemen Act (no bill number) - pharmacy benefit managers Physician Wellness Program Act (no bill number) - mental health and Medicare Prevent Pandemics Act (no bill number) - pandemic preparedness Preventing Mental Health and Substance Use Crises During Emergencies Act (no bill number) - mental health and SUD national strategy Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act (no bill number) - commercial plans Protecting Americans with Pre-Existing Conditions Act (no bill number) - state innovation waivers Protecting Patients from Deceptive Health Plans Act (no bill number) - excepted benefits coverage Protecting Personal Health Data Act (no bill number) - privacy Public Health Infrastructure Saves Lives Act (no bill number) - public health infrastructure Public Option Deficit Reduction Act (no bill number) - public option Restore Protections for Dialysis Patients Act (no bill number) - reform of MSP Secondary Payer Act Restoring Hope for Mental Health and Well-Being Act (no bill number) - reauthorization of several behavioral health programs RICE Act (no bill number) - commercial plans SAFE DATA Act (no bill number) - consumer data privacy and data transparency and security Safe Step Act (no bill number) -commercial plans and medication step-therapy requirements Secure Data and Privacy for Contact Tracing Act (no bill number) - digital contact tracing for COVID-19 Social Determinants for Moms Act (no bill number) - SDOH and maternal health Strengthen Kids Mental Health Now Act (no bill number) - mental health and Medicaid Supporting Best Practices for Healthy Moms Act (no bill number) - maternal health Tech to Save Moms Act (no bill number) - maternal health The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act (no bill number) - funding for maternal and early childhood health programs 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 (no bill number) - Broadband 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. (no bill number) - commercial plans 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. (no bill number) - behavioral health and electronic health records To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. (no bill number) - mental health and Medicare 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. (no bill number) - commercial plans 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. (no bill number) - mental health and Medicare TREATS Act (no bill number) - increase use of telehealth for SUD treatment Turn the Tide Act (no bill number) - Substance Use Disorder Virtual Community Support Act (no bill number) - mental health and SUD grants for community peer support Issues related to broadband and public health infrastructure; mental health and telehealth; COVID-19 testing; public option programs; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; and provider directories. Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10 and ICD-11), 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.

H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig Angie - cost-sharing for insulin products H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl -spread-pricing by PBMs for Medicaid H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - preventing anti-competitive tactics for prescription drugs S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - pharmacy benefit manager transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - prohibits spread-pricing by PBMs in Medicaid S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernard - pharmacy benefit managers Biosimilar Red Tape Elimination Act (no bill number) - pharmacy and biosimilar prescription drugs Empowering Medicare Seniors to Negotiate Drug Prices Act (no bill number) -Medicare drug prices Fairness in Orphan Drug Exclusivity Act (no bill number) - orphan drugs Increasing Transparency in Generic Drug Applications Act (no bill number) - cuts red tape for generics to come to market Medicare Drug Price Negotiation Act (no bill number) - Drug Prices Patent Eligibility Restoration Act (no bill number) - patent changes Protecting Consumer Access to Generic Drugs Act (no bill number) - patent infringement settlements Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; issues related to comparative effectiveness research and quality-adjusted life years; issues related to health plan step-therapy; and other issues relating to health care reform implementation.

Issues related to surprise billing law and regulation. Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023, including telehealth and redeterminations. Issues related to P.L. 117-169, the Inflation Reduction Act of 2022, including enhanced advance premium tax credits (APTCs) and Medicare Part D redesign. Issues related to removing barriers to biosimilar medicine access. Issues related to Quality-Adjusted Life Year (QALY) or similar metrics in health coverage legislation. Issues related to the proposed rule on Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Childrens Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program. Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S. 1542, the Delinking Revenue from Unfair Gouging Act (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, the PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act. H.R. 2813, Self-Insurance Protection Act. Issues related to insulin pricing, including S. 727, Insulin for All Act of 2023; S. 1269, Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023; S. 146, Cap Insulin Prices Act; S. 954, Affordable Insulin Now Act of 2023; H.R. 1488, Affordable Insulin Now Act; H.R. 1587, Making Insulin Affordable for All Children Act; H.R. 1485, Insulin for all Act of 2023. Issues related to mental health coverage, workforce, and mental health parity. Behavioral Health Network and Directory Improvement Act. S. 1001, Issues related to the Telehealth Expansion Act; H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; H.R. 1843, the Telehealth Expansion Act of 2023. H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. Issues relating to H.R. 3799, Custom Health Option and Individual Care Expense Arrangement Act (the CHOICE Arrangement Act). Issues relating to S. 464 / H.R. 2630, the Safe Step Act; related amendment to S. 1339.

H.R. 2547 - Special Diabetes Program for Indians Reauthorization Act of 2023 H.R. 2550 - Special Diabetes Program Reauthorization Act of 2023 S. 1855 - Special Diabetes Program Reauthorization Act of 2023 S. 1269 - INSULIN Act of 2023 H.R. 1488 - Affordable Insulin Now Act S. 954 - Affordable Insulin Now Act H.R. 3561 - PATIENT Act of 2023 Issues related to insulin affordability Issues related to collection of race and ethnicity data Issues related to Medicare and Medicaid Issues related to preventative care

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).

Client expense: $72,000 · Firm income: Not reported

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

Insulin, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements.

Legislative and administrative monitoring and outreach on healthcare policy. Legislative and administrative monitoring and outreach on prescription drug pricing/PBMs. Legislative and administrative monitoring and outreach on policy issues affecting Medicaid programs. H.R. 134, To amend title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services. H.R. 197, Rural Telehealth Expansion Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 207, Advanced Safe Testing at Residence Telehealth Act of 2023 H.R. 497, Freedom for Health Care Workers Act H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023 H.R. 1066, CARING for Social Determinants Act of 2023 H.R. 1215, Healthcare Worker Retention Act H.R. 1488, Affordable Insulin Now Act H.R. 1587, Making Insulin Affordable for All Children Act H.R. 1613, Drug Price Transparency in Medicaid Act of 2023 H.R. 1843, Telehealth Expansion Act of 2023 H.R. 2534, To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes. S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 146, Cap Insulin Prices Act S. 710, Striking and Locked Out Workers Healthcare Protection Act S. 729, Audio-Only Telehealth for Emergencies Act S. 731, TELEHEALTH HSA Act of 2023 S. 880, Coordinating Dual Eligible Recommendations Act S. 1001, A bill to amend the Internal Revenue Code of 1986 to permanently extend the exemption for telehealth services from certain high deductible health plan rules. S.113, Prescription pricing for the People Act S.1339, Pharmacy Benefit Manager Reform Act H.R. 3284, Providers and Payers Compete Act H.R. 3561, Patient Act H.R. 3746, Fiscal Responsibility Act S. 880, Coordinating Dual Eligible Recommendations Act

Issues related to prescription drug pricing, particularly as it relates to insulin S. 146 - Cap Insulin Prices Act HR 1488/S. 954 - Affordable Insulin Now Act H.R. 1485 - Insulin for All Act of 2023 H.R.1587 - Making Insulin Affordable for All Children Act Issues related to the Special Diabetes Program renewal

Client expense: $330,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1488 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing Biosimilar Red Tape Elimination Act (no bill number) - pharmacy and biosimilar prescription drugs Empowering Medicare Seniors to Negotiate Drug Prices Act (no bill number) -Medicare drug prices Fairness in Orphan Drug Exclusivity Act (no bill number) - orphan drugs Increasing Transparency in Generic Drug Applications Act (no bill number) - cuts red tape for generics to come to market Medicare Drug Price Negotiation Act (no bill number) - Drug Prices Protecting Consumer Access to Generic Drugs Act (no bill number) - patent infringement settlements Issues related to pharmacy benefit managers Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; issues related to comparative effectiveness research and quality-adjusted life years; issues related to health plan step-therapy; and other issues relating to health care reform implementation.

Insulin, Drug Pricing, Drug Patent Reform, Pharmacy Benefit Manager (PBM) Reform H.R. 1488/S. 954 - The Affordable Insulin Now Act A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act A bill 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. S. 142 -- The Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative and administrative monitoring and outreach on healthcare policy. Legislative and administrative monitoring and outreach on prescription drug pricing/PBMs. Legislative and administrative monitoring and outreach on policy issues affecting Medicaid programs. H.R. 134, To amend title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services. H.R. 197, Rural Telehealth Expansion Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 207, Advanced Safe Testing at Residence Telehealth Act of 2023 H.R. 497, Freedom for Health Care Workers Act H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023 H.R. 1066, CARING for Social Determinants Act of 2023 H.R. 1215, Healthcare Worker Retention Act H.R. 1488, Affordable Insulin Now Act H.R. 1587, Making Insulin Affordable for All Children Act H.R. 1613, Drug Price Transparency in Medicaid Act of 2023 H.R. 1843, Telehealth Expansion Act of 2023 H.R. 2534, To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes. S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 146, Cap Insulin Prices Act S. 710, Striking and Locked Out Workers Healthcare Protection Act S. 729, Audio-Only Telehealth for Emergencies Act S. 731, TELEHEALTH HSA Act of 2023 S. 880, Coordinating Dual Eligible Recommendations Act S. 1001, A bill to amend the Internal Revenue Code of 1986 to permanently extend the exemption for telehealth services from certain high deductible health plan rules.

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