BLOCKING Act of 2019

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, 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)

Patent Settlments BLOCKING Act (H.R. 938). Pharmaceutical Supply Chain Medicaid & Medicare

Client expense: $131,690 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

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

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

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

Client expense: $580,000 · 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), SENATE, White House Office

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

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

Client expense: $550,000 · 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), SENATE, White House Office

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

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets"; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements; Support S 4349, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support S. 3595Ensuring Understanding of COVID-19 to Protect Public Health Act, a bill that directs the NIH to conduct a longitudinal study on mild, moderate, and severe cases of COVID-19 on a diverse patient population.

Client expense: $4,460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

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

HR 938, BLOCKING Act, issues related to pharmaceutical manufacturing supply chain

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

Government targets: HOUSE OF REPRESENTATIVES, 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

H.R. 938- BLOCKING Act of 2019

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

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

Supply Chain, Biosimilars, Generic Drug Issues, H.R. 938- BLOCKING Act of 2019

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

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

H.R. 938- BLOCKING Act of 2019

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposed changes to Medicare hospital reimbursement policy Health care policy H.R. 986/S. 466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the ACA shall have no force or effect H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act" - provisions related to studying rising hospital drug prices and reporting of drug costs H.R. 965/S. 340, "CREATES Act" H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 - provisions related to eligibility for approval of a subsequent generic drug and to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval H.R. 1499 Protecting Consumer Access to Generic Drugs Act of 2019 - provisions related to prohibiting brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products S. 2543, the Prescription Drug Pricing Reduction Act H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act" Additional legislative proposals to address rising drug costs H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program S.1895, Lower Health Care Costs Act- provisions related to surprise billing and provider/payer agreements S. 1531, "STOP Surprise Medical Bills Act" H.R. 3630, "No Surprises Act" H.R.5826, "Consumer Protections Against Surprise Medical Bills Act of 2020" Other proposals to address surprise billing Proposals to strengthen the health care system and achieve ACA market stability Legislation aimed at combating COVID-19 - provisions related to healthcare and hospitals H.R. 925, "Health and Economic Recovery Omnibus Emergency Solutions Act (HEROS Act 2.0) H.R. 133, "Consolidated Appropriations Act, 2021" - provisions related to COVID-response and hospitals Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

The Blocking Act (H.R. 938); Strengthening Health Care and Lowering Prescription Drug Costs (H.R. 987); Lower Health Care Costs Act (Sec.205) (S. 1895).

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

Government targets: HOUSE OF REPRESENTATIVES, 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: $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. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act Patent eligibility reform, no specific bill

Client expense: $2,560,000 · Firm income: Not reported

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

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. 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. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Client expense: $1,260,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; H.R.938, BLOCKING Act of 2019; H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019; H.R.5444, Lower Insulin Costs Now Act; Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.6482/S.3537/S.3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020; H.R.6431, Made in America Emergency Preparedness Act; H.R.133, Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes (P.L.116-260).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

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

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

HR 938, the Bringing Low-cost Options and Competition while Keeping Incentives for new Generics (BLOCKING) Act of 2019, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework

Client expense: $520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 938 - the BLOCKING Act of 2019 H.R. 1520 - the Purple Book Continuity Act of 2019 H.R. 1503 - the Orange Book Transparency Act of 2019 H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act S. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S. 3129 - Lower Costs, More Cures Act of 2019 H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act H.R. 133 - Consolidated Appropriations Act, 2021 no specific bills, prescription drug importation, import safety, supply chain integrity, innovation no specific bills, 304B, Innovation, Transparency, Importation, Non-Interference

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

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

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 938 - the BLOCKING Act of 2019 H.R. 1520 - the Purple Book Continuity Act of 2019 H.R. 1503 - the Orange Book Transparency Act of 2019 H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R. 965 - the CREATES Act of 2019 S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act S. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S. 3129 - Lower Costs, More Cures Act of 2019 H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act H.R. 133 - Consolidated Appropriations Act, 2021 no specific bills, health care reform, Biosimilars, FDA policies, Innovation, 340B, comparative effectiveness research, non-interference, opioids

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 938 - the BLOCKING Act of 2019 H.R. 1520 - the Purple Book Continuity Act of 2019 H.R. 1503 - the Orange Book Transparency Act of 2019 H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R. 965 - the CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions For Patients Act of 2019 H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act S. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S. 3129 - Lower Costs, More Cures Act of 2019 ***, no specific bills, Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, patent settlements, break through therapies, Innovation, transparency ***, no specific bills, Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee reauthorization, Innovation

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Medicaid and Medicare drug pricing. Prescription drug pricing. S.1895 - Lower Health Care Costs Act. H.R. 938 - BLOCKING Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 133 - Consolidated Appropriations Act, 2021.

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

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

H. R. 133 (Consolidated Appropriations Act): Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes. H.R. 925 (HEROES): Coronavirus Recovery Supplemental Appropriations H.R.6800 (HEROES): Making emergency supplemental appropriations for the fiscal year ending September 30, 2020, and for other purposes. HR 2477 (BENES): To amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3: A bill to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. HR 3276: A bill to amend title XIX of the Social Security Act to exclude authorized generic drugs from calculation of the average manufacturer price for purposes of the Medicaid drug rebate program, and for other purposes. HR 2113: A bill to a mend titles XI and XVIII of the Social Security Act to provide for drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain health care providers, and for other purposes. S. 1895: A bill to lower health care costs by preventing surprise medical bills, reducing prescription drug prices, improving transparency in health care, investing in public health and improving health information exchange. H.R. 1384: This bill establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). S. 1129: This bill establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). S. 981: A bill to establish a public health plan. HR 938: A bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes HR 1520: A bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1503: A bill to amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR 1499: A bill prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 965: promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. H.R. 3: An act to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S. 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

Medicaid TPL (H.R. 938, Medicaid TPL Act) Medicare RAC auditing activities TRICARE HFPP

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

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

H.R. 691 H.R. 691: Telehealth Modernization Act of 2015Support H.R. 938: BLOCKING ActSupport S.3599 - Healthcare Workforce Resilience ActSupport

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, 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. 133-Consolidated Appropriations Act of 2021 relating to H.R. 938-The Blocking Act and S. 1895-Lower Health Care Costs Act (Section 205).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General information about the company and the industry. Issues related to affordability and pricing of pharmaceuticals. Issues related to the implementation of H.R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including drug supply chain dynamics. H.R. 6800, the HEROES Act. S. Amdt 2652, the Targeted COVID Relief Package. Issues related to the federal response to the COVID-19 pandemic. Supply chain and essential medicine manufacturing. Issues related to H.R. 133, Consolidated Appropriations Act for Fiscal Year 2021, including provisions affecting the generic drug industry. Issues related to H.R. 938, BLOCKING Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 133-Consolidated Appropriations Act of 2021 relating to H.R. 938-The Blocking Act and S. 1895-Lower Health Care Costs Act (Section 205).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CREATES Act (S. 794). BLOCKING Act (H.R. 938). CARES Act HEROES Act CARES Act 2.0

Client expense: $116,690 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

CREATES Act (S. 794). BLOCKING Act (H.R. 938). CARES Act HEROES Act CARES Act 2.0

Client expense: $91,158 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Proposed changes to Medicare hospital reimbursement policy Health care policy H.R. 986/S. 466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the ACA shall have no force or effect H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act" - provisions related to studying rising hospital drug prices and reporting of drug costs H.R. 965/S. 340, "CREATES Act" H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 - provisions related to eligibility for approval of a subsequent generic drug and to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval H.R. 1499 Protecting Consumer Access to Generic Drugs Act of 2019 - provisions related to prohibiting brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products S. 2543, the Prescription Drug Pricing Reduction Act H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act" Additional legislative proposals to address rising drug costs H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program S.1895, Lower Health Care Costs Act- provisions related to surprise billing and provider/payer agreements S. 1531, "STOP Surprise Medical Bills Act" H.R. 3630, "No Surprises Act" H.R.5826, "Consumer Protections Against Surprise Medical Bills Act of 2020" Other proposals to address surprise billing Proposals to strengthen the health care system and achieve ACA market stability Legislation aimed at combating COVID-19 - provisions related to healthcare and hospitals H.R. 6201, "Families First Coronavirus Response Act" - provisions related to healthcare, Medicaid and Medicare H.R. 748, "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) - provisions related to federal financial relief, including funding for healthcare providers Senate Health, Economic Assistance, Liability Protections and Schools (HEALS) Act H.R. 925, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROS Act 2.0) Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134, Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs

Client expense: $590,000 · Firm income: Not reported

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

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements.

Client expense: $4,860,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act

Client expense: $2,920,000 · Firm income: Not reported

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