Preserve Access to Affordable Generics and Biosimilars Act

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; S. 64, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 938, BLOCKING Act of 2019 and HR 1506, FAIR Generics Act; Hatch-Waxman Integrity Act of 2019, H.R. 990 and S. 344; S. 1416, Affordable Prescriptions for Patients Act of 2019; issues related to the pharmaceutical supply chain; and issues related to FDA Abbreviated New Drug Application reviews of complex generics.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act

Client expense: $2,000,785 · Firm income: Not reported

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

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Client expense: $5,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, medical malpractice reform, the impact on small business, section 1557 on nondiscrimination, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; Medicare hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; distribution of COVID-19 vaccines; comments on notice of proposed rulemaking: securing updated and necessary statutory evaluations timely (SUNSET); reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization; COVID-19 liability issues; Phase IV COVID-19 relief legislation and civil liability issues affecting the business community

Client expense: $22,290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

Client expense: $660,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S. 3952, the Protecting American Intellectual Property Act of 2020 H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

Client expense: $10,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Library of Congress (LOC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Monitor sovereign immunity issues relating to patent ownership. Monitor patent settlement issues. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. Monitor issues relating to the treatment of pharmaceutical patents in inter partes reviews. Monitor issues relating to product hopping.

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Medicare Coverage of Dental Care: H.R. 576 and S. 22, Negotiation of Prescription Drug Prices: S. 99 and H.R. 448 and S. 62 and H.R. 275, Prescription Drug Importation: H.R. 447 and S. 97 and S. 61, Improving Access to Affordable Generics: S. 64. SS Immunization Act: H.R. 5076

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R.8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R.8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R.8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act

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

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

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (H.R. 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Second Look at Drug Patents Act of 2019 (S. 1617); Recall Unsafe Drugs Act of 2020 (H.R. 5578); Executive Order 13944; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393); Drug recalls, registration and listing, inspections, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (H.R. 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Potential Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board; Executive Order 13948; Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts.

Client expense: Not reported · Firm income: $350,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Client expense: $2,676,362 · Firm income: Not reported

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

Issues related to drug pricing; S. 64, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 938, BLOCKING Act of 2019 and HR 1506, FAIR Generics Act; Hatch-Waxman Integrity Act of 2019, H.R. 990 and S. 344; S. 1416, Affordable Prescriptions for Patients Act of 2019; issues related to the pharmaceutical supply chain; and issues related to FDA Abbreviated New Drug Application reviews of complex generics.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

Client expense: Not reported · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Library of Congress (LOC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act.

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

Client expense: $1,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Monitor sovereign immunity issues relating to patent ownership. Monitor patent settlement issues. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. Monitor issues relating to the treatment of pharmaceutical patents in inter partes reviews. Monitor issues relating to product hopping.

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

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

Medicare Coverage of Dental Care: H.R. 576 and S. 22, Negotiation of Prescription Drug Prices: S. 99 and H.R. 448 and S. 62 and H.R. 275, Prescription Drug Importation: H.R. 447 and S. 97 and S. 61, Improving Access to Affordable Generics: S. 64. SS Immunization Act: H.R. 5076

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 64, Preserve Access to Affordable Generics and Biosimilars Act HR 938, BLOCKING Act HR 1499, Protecting Consumer Access to Generic Drugs Act of 2019 HR 1506, FAIR Generics Act

Client expense: $135,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3991); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Client expense: $1,173,453 · Firm income: Not reported

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

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Federal Register 16,834, April 23, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55,766-55,847, October 17, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; medical hospital outpatient prospective payment system for CY 2020; drug pricing; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments on HHS notice of benefit and payment parameters for 2021; transparency in coverage; Medicaid fiscal accountability regulations; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use

Client expense: $12,300,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Labor Statistics (BLS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act.

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

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