CREATES Act of 2019

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency

Client expense: $2,790,000 · Firm income: Not reported

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

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $2,790,000 · Firm income: Not reported

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

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

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

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

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

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

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

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

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

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

S.80, Jobs and Premium Protection Act (all provisions) S.172, Health Insurance Tax Relief Act (all provisions) S.340, CREATES Act (all provisions) S.684, Middle Class Health Benefits Tax Repeal Act (all provisions) S.1531, Stopping the Outrageous Practice of Surprise Medical Bills Act (all provisions) S.1895, Lower Health Care Costs Act S.1510, Employee Flexibility Act (all provisions) S.2366, Commonsense Reporting Act (all provisions) HR 748, Middle Class Health Benefits Tax Repeal Act (all provisions) HR 861, End Surprise Billing Act (all provisions) HR 965, CREATES Act (all provisions) HR 1384, Medicare for All Act (all provisions) HR 1398, Health Insurance Tax Relief Act (all provisions) HR 3630, No Surprises Act HR 2782, Employee Flexibility Act (all provisions) HR 4070, Commonsense Reporting Act (all provisions) HR 3502, Protecting People From Surprise Medical Bills Act (all provisions) S.2543 Prescription Drug Pricing Reduction Act (all provisions) H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (all provisions) H.R. 1994, the Setting Every Community Up for Retirement Enhancement (SECURE) Act (all provisions)

Client expense: $1,845,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Federal Maritime Commission, Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Postal Service (USPS), U.S. Trade Representative (USTR), White House Office

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

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.

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

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

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)

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

Proposed changes to Medicare hospital reimbursement policy Health care policy Proposals to strengthen the health care system and achieve Affordable Care Act (ACA) market stability H.R. 269, "Pandemic and All-Hazards Preparedness & Advancing Innovation Act" - provisions related to hospitals Funding for National Ebola Network 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 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 Surprise Billing S. 1895, Lower health Care Cost Act" H.R. 3630, "No Surprises Act" S. 1531, "STOP Surprise Medical Bills Act" H.R.5826, Consumer Protections Against Surprise Medical Bills Act of 2020 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 combating COVID, surprise medical bills and health programs Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $2,020,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Continued implementation of ACA Health care policy 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. 3, Elijah E. Cummings Lower Drug Costs Now Act S.2543, the Prescription Drug Pricing Reduction 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 Cost Act"- provisions related to surprise billing and payer/provider contracts S. 1531, "STOP Surprise Medical Bills Act" H.R. 3630, "No Surprises Act" H.R. 3502, "Protecting People from Surprise Medical Bills Act" H.R.5826, "Consumer Protections Against Surprise Medical Bills Act of 2020" 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 federal financial relief, including funding for healthcare providers, and health programs and related to surprise medical bills Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care payment and delivery system reform Health information technology and implementation of EHR meaningful use Policy related to health exchange risk corridors and cost-sharing reduction payments H.R. 269, "Pandemic and All-Hazards Preparedness& Advancing Innovation Act" - provisions related to hospitals 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 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 S. 1895, Lower Health Care Cost Act"- provisions related to surprise billing and payer/provider contracts 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" H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program 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 federal financial relief, including funding for healthcare providers, health programs and surprise medical billing Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Repeal of the Affordable Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program 340B dug pricing program CMS OPPS 340B rule moratorium-related legislation 42 CFR Part 2 CREATES Act-H.R.965 Cassidy Surprise Billing Draft Protecting Patients from Surprise Medical Bills Excellence in Metal Health Act (S.824/H.R.1767) Patient Centered Outcomes Research Institute Funding No Surprises Act Lower Health Care Costs Act Surprise Medical Bills H.R.4004 - Social Determinants Accelerator Act of 2019 S.2986 - Social Determinants Accelerator Act of 2019 H.R.2328 - Reauthorizing and Extending America's Community Health Act S.2723 - Mitigating Emergency Drug Shortages Act H.R.4995 - Maternal Health Quality Improvement Act of 2019 H.R.2889 - Closing Loopholes for Orphan Drugs Act 340B drug pricing program eligibility (Matsui-Stewart Dear Colleague letter) Relief for Rural Providers During Emergencies Act (S. 3631) Improving Social Determinants of Health Act (H.R. 6561) Liability reform Issues related to COVID-19 regulatory and financial relief COVID-19 Provider Relief Fund Resolution recognizing racism as public health issue - S. Res. 655 COVID-19 Bias and Anti-Racism Training Act - S. 4248 Protecting 340B eligibility during the pandemic - S. 4160 and HR 7838 Protect Telehealth Access Act of 2020 (HR 7391) Improving Social Determinants of Health Act - S. 4440 Maternal health 340B contract pharmacies (McKinley-DeGette-Gianforte-Matsui-Johnson-Welch Dear Colleague letter) 340B contract pharmacies (Baldwin-Capito-Cardin-Portman-Stabenow-Thune Dear Colleague letter) Delivering Immediate Relief to Americas Families, Schools and Small Businesses Act Health disparities COVID-19 payroll tax credits 340B rebate Dear Colleague letter (Spanberger-McKinley-Axne-Johnson-Matsui-Katko)

Client expense: $370,000 · Firm income: Not reported

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

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

Funding for hospitals and physicians related to COVID 19 Proposed changes to Medicare hospital reimbursement policy Health care policy Proposals to strengthen the health care system and achieve Affordable Care Act (ACA) market stability 42 CFR Part 2 alignment with HIPAA H.R. 269, "Pandemic and All-Hazards Preparedness& Advancing Innovation Act" - provisions related to hospitals Funding for National Ebola Network H.R. 2740, FY 2020 Labor, HHS, Education appropriations - provisions providing funding to support a National Ebola Education and Training Center 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 Additional legislative proposals to address rising drug costs H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program Surprise Billing S. 1895, Lower health Care Cost Act" H.R. 3630, "No Surprises Act" S. 1531, "STOP Surprise Medical Bills Act" Paycheck Protection Program Flexibility Act of 2020

Client expense: $398,118 · Firm income: Not reported

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

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 a Provisions related to prescription drug pricing and access H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers S. 1619/H.R. 2862: VACCINES Act CMSS. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity CMS rule on Value Based Payment purchasing, 85 FR 37286, CMS-2482-P, provisions related to the definition of line-extension drugs. S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing CBD DSHEA 2.0 S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatoruy recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening Na- tional Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26) Amendments to HHS Covid-19 Declaration

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)

S.80, Jobs and Premium Protection Act (all provisions) S.172, Health Insurance Tax Relief Act (all provisions) S.340, CREATES Act (all provisions) S.684, Middle Class Health Benefits Tax Repeal Act (all provisions) S.1531, Stopping the Outrageous Practice of Surprise Medical Bills Act (all provisions) S.1895, Lower Health Care Costs Act S.1510, Employee Flexibility Act (all provisions) S.2366, Commonsense Reporting Act (all provisions) HR 6800, Heroes Act HR 748, Middle Class Health Benefits Tax Repeal Act (all provisions) HR 861, End Surprise Billing Act (all provisions) HR 965, CREATES Act (all provisions) HR 1384, Medicare for All Act (all provisions) HR 1398, Health Insurance Tax Relief Act (all provisions) HR 3630, No Surprises Act HR 2782, Employee Flexibility Act (all provisions) HR 4070, Commonsense Reporting Act (all provisions) HR 3502, Protecting People From Surprise Medical Bills Act (all provisions) S.2543 Prescription Drug Pricing Reduction Act (all provisions) H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (all provisions) H.R. 1994, the Setting Every Community Up for Retirement Enhancement (SECURE) Act (all provisions) H.R. 1865, Consolidated Appropriations Act (surprise billing provisions) H.R. 133, Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (all provisions)

Client expense: $1,660,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Equal Employment Opportunity Commission (EEOC), Federal Maritime Commission, Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Postal Service (USPS), U.S. Trade Representative (USTR), White House Office

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

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, STAR Act; S. 474, SPIKE Act/Wyden; S. 1391, FAIR Drug Pricing Act; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, FAIR/More Efficient Tools to Realize Information for Consumers Act; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 3, Lower Drug Costs Now Act; H.R. 19, Lower Costs More Cures Act and related legislation; S. 2543, Prescription Drug Pricing Reduction Act

Client expense: $150,000 · Firm income: Not reported

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

Affordable Healthcare Act (ACA)Regulations; ACA Stabilization; American Health Care Act (AHCA); Health Care Reform; Reinsurance; Health Savings Accounts; Repeal and Replace; Grace Periods; SEPs; Medicare Cost plan; Marketplace Stability; Individual Marketplace Reform; Better Care Reconciliation Act (BCRA), mental health, transparency, HSA, Opioids, CREATES Act, Drug Pricing; Prescription Drug Costs Rebates, Telehealth,Surprise Billing, COVID19-Response Relief Packages; Healthcare Access/privacy,COVID-19 Response and Relief Packages, COVID-19 Testing, COVID-19 Vaccine Strategy and Treatment HR 1346 -Medicare Buy-In and Health Care Stabilization Act of 2019 HR1384 Medicare for All Act of 2019 HR 986 Protecting People from Preexisting Conditions Act HR 965 CREATES Act of 2019 HR 3502 Protecting people from Surprise Medical Bills HR 987 Strengthening Health Care and Lowering Prescription Drug Costs HR 1499 Patient Consumer Access to Generic Drugs Act HR 1425 State Health Care Premium Reduction Act S 1895 Lower Health Care Costs Act HR 3630 No Surprises Act Public Law 116-123 First Coronavirus Response Act HR6545 Health Insurance Marketplace Affordability Act of 2020

Client expense: $24,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; H.R.965, CREATES Act of 2019; H.R.3, Lower Drug Costs Now Act of 2019; S.2543, Prescription Drug Pricing Reduction Act of 2019. Advise client on and status of various COVID-19 legislative proposals.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 965 - the CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act 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 no specific bills, drug safety, prescription drug abuse, drug pricing

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

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 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

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

Issues pertaining to prescription drug pricing; Issues related to IPAB; Medicare Part D; Importation of drugs; Issues related to 340b; Issues related to Drug Price Competition and Patent Term Restoration Act (Public Law 98-417). Issues regarding H.R. 965/S. 340 - CREATES Act of 2019; Issues regarding H.R. 985 - FAST Generics Act of 2019; Issues related to H.R. 925 - The Heroes Act; Issues related to Section 340B of the Public Health Service Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act (P.L. 111-148, P.L. 111-152): Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62), which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries, and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, (H.R. 965/S. 340), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), to promote greater drug pricing transparency; Expressed appreciation to the House speaker for introduction of H.R. 3, the Lower Drug Costs Now Act, noting encouragement for its provisions to empower the Secretary of Health and Human Services (HHS) to negotiate with drug companies for lower prices and to cap out-of-pocket costs for seniors enrolled in the Medicare Part D program. Commented to the FDA on its prescription drug reimportation proposed rule noting that while the College is generally supportive of drug importation as laid out in the proposed rule as a means to control the cost of prescription drugs, the FDA must guarantee that the design and implementation of the rule includes numerous measures and safeguards to ensure patient safety. By limiting the origin of imported drugs to Canadian-certified and FDA-approved and registered drugs and entities, the College believes the proposed rule meets the required U.S. standards to assure high-quality drugs and patient safety. Any final drug importation system must also be one that is a closed system and has a tightly controlled and documented supply chain to assure authenticity and avoid degradation of the drug. Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2021 for federal programs/initiatives designed to support primary care including Title VII Health Professions grants and the National Health Service Corps (NHSC). Equally important is the need to fund essential health services and medical research by the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH) and public health programs supported by the Centers for Disease Control and Prevention (CDC). Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2019 (H.R. 1585), to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), to ban the sale of semi-automatic weapons and high capacity magazines. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border last summer; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Expressed concern to the U.S. Department of Homeland Security with the recent U.S. Citizenship and Immigration Service (USCIS) policy change to no longer accept or adjudicate non-military deferred action requests including those for individuals with serious medical conditions; Urged USCIS to reverse this decision immediately and resume consideration of deferred action requests for medical reasons; Opposed the proposed rule, U.S. Immigration and Customs Enforcement (ICE) Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media. This rule would change the process to extend the period of authorized stay in the United States for certain categories of nonimmigrants by eliminating the long-standing "duration of status and replacing it with a specific end date. The College urged the Department of Homeland Security to exclude physicians in the Department of States (DOS) Exchange Visitor Program in J-1 visa status from this rule change because it will otherwise disrupt the training of thousands of physicians - physicians who already have been thoroughly vetted, already are serving on our nations health care teams, and already are carefully monitored during their time in the U.S. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates; Supported H.R. 592, recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide; Urged the U.S. Department of Homeland Security (DHS) to reconsider its decision to not vaccinate families in the custody of U.S. Customs and Border Protection (CBP) against influenza (flu). Urged Congress to support payments for vaccines, as finalized by CMS, and set for implementation on Jan. 1, 2021. Surprise Medical Billing: Urged Congress to pass legislation that would protect patients from surprise out-of-network medical bills in both emergency and non-emergency settings that includes the following principles: hold patients harmless from surprise medical bills for out-of-network services, address narrow insurance networks, abandon efforts to establish an in-network median rate for services in these settings and instead opt for an independent dispute resolution process to determine payment. Appropriations: Urged Congress to fund Title VII, Section 747, Primary Care Training and Enhancement (PCTE) at $71 million for fiscal year 2021; Fund the Agency for Health Care Research and Quality (AHRQ) at $460 million for fiscal year 2021; Fund the National Health Service Corps (NHSC) at $830 million for fiscal year 2021; Fund the Title X Family Planning Program at $400 million for fiscal year 2021 and include language to remove barriers to care that interfere with the patient-physician relationship; Fund Research on Prevention of Firearms-related Injuries and Deaths at $50 million for Fiscal Year 2021; Fund the National Institutes of Health (NIH) at $44.7 billion for fiscal year 2021; Fund the Centers for Disease Control and Prevention (CDC) at $8.3 billion for fiscal year 2021; Urged the House and Senate Armed Services Committees to support provisions in any final FY2021 National Defense Authorization Act to prevent cuts to the Military Health Service and the military medical workforce without requiring appropriate congressional oversight and review. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for New Administration: Urged the incoming Biden Administration to identify and appoint physicians to health care leadership positions within your Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement.

Client expense: $241,204 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)

The Affordable Care Act (P.L. 111-148, P.L. 111-152): Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62), which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries, and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, (H.R. 965/S. 340), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), to promote greater drug pricing transparency; Expressed appreciation to the House speaker for introduction of H.R. 3, the Lower Drug Costs Now Act, noting encouragement for its provisions to empower the Secretary of Health and Human Services (HHS) to negotiate with drug companies for lower prices and to cap out-of-pocket costs for seniors enrolled in the Medicare Part D program. Commented to the FDA on its prescription drug reimportation proposed rule noting that while the College is generally supportive of drug importation as laid out in the proposed rule as a means to control the cost of prescription drugs, the FDA must guarantee that the design and implementation of the rule includes numerous measures and safeguards to ensure patient safety. By limiting the origin of imported drugs to Canadian-certified and FDA-approved and registered drugs and entities, the College believes the proposed rule meets the required U.S. standards to assure high-quality drugs and patient safety. Any final drug importation system must also be one that is a closed system and has a tightly controlled and documented supply chain to assure authenticity and avoid degradation of the drug. Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2021 for federal programs/initiatives designed to support primary care including Title VII Health Professions grants and the National Health Service Corps (NHSC). Equally important is the need to fund essential health services and medical research by the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH) and public health programs supported by the Centers for Disease Control and Prevention (CDC). Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2019 (H.R. 1585), to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), to ban the sale of semi-automatic weapons and high capacity magazines. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border last summer; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Expressed concern to the U.S. Department of Homeland Security with the recent U.S. Citizenship and Immigration Service (USCIS) policy change to no longer accept or adjudicate non-military deferred action requests including those for individuals with serious medical conditions; Urged USCIS to reverse this decision immediately and resume consideration of deferred action requests for medical reasons; Opposed the proposed rule, U.S. Immigration and Customs Enforcement (ICE) Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media. This rule would change the process to extend the period of authorized stay in the United States for certain categories of nonimmigrants by eliminating the long-standing "duration of status and replacing it with a specific end date. The College urged the Department of Homeland Security to exclude physicians in the Department of States (DOS) Exchange Visitor Program in J-1 visa status from this rule change because it will otherwise disrupt the training of thousands of physicians - physicians who already have been thoroughly vetted, already are serving on our nations health care teams, and already are carefully monitored during their time in the U.S. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates; Supported H.R. 592, recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide; Urged the U.S. Department of Homeland Security (DHS) to reconsider its decision to not vaccinate families in the custody of U.S. Customs and Border Protection (CBP) against influenza (flu). Urged Congress to support payments for vaccines, as finalized by CMS, and set for implementation on Jan. 1, 2021. Surprise Medical Billing: Urged Congress to pass legislation that would protect patients from surprise out-of-network medical bills in both emergency and non-emergency settings that includes the following principles: hold patients harmless from surprise medical bills for out-of-network services, address narrow insurance networks, abandon efforts to establish an in-network median rate for services in these settings and instead opt for an independent dispute resolution process to determine payment. Appropriations: Urged Congress to fund Title VII, Section 747, Primary Care Training and Enhancement (PCTE) at $71 million for fiscal year 2021; Fund the Agency for Health Care Research and Quality (AHRQ) at $460 million for fiscal year 2021; Fund the National Health Service Corps (NHSC) at $830 million for fiscal year 2021; Fund the Title X Family Planning Program at $400 million for fiscal year 2021 and include language to remove barriers to care that interfere with the patient-physician relationship; Fund Research on Prevention of Firearms-related Injuries and Deaths at $50 million for Fiscal Year 2021; Fund the National Institutes of Health (NIH) at $44.7 billion for fiscal year 2021; Fund the Centers for Disease Control and Prevention (CDC) at $8.3 billion for fiscal year 2021; Urged the House and Senate Armed Services Committees to support provisions in any final FY2021 National Defense Authorization Act to prevent cuts to the Military Health Service and the military medical workforce without requiring appropriate congressional oversight and review. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for New Administration: Urged the incoming Biden Administration to identify and appoint physicians to health care leadership positions within your Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement.

Client expense: $91,236 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS)

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

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

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

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 H.R. 4806 DEBAR Act of 2019 H.R. 3878 Block, Report, and Suspend Suspicious Shipments Act of 2019 H.R. 4812 Ensuring Compliance Against Drug Diversion Act H.R. 4814 Suspicious Order Identification Act of 2019 H.R. 8061 Community Immunity During COVID-19 Act S. 3548 The CARES Act H.R. 6800 The HEROES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). H.R. 2279/S.2546, the Safe Step Act. Policies to ensure an adequate supply of plasma generally and for the development of therapies for COVID-19. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health insurance and prescription drug pricing. H.R.965 - CREATES Act of 2019 H.R. 600 - Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act Health, Economic Assistance, Liability Protection and Schools (HEALS) Act Delivering Immediate Relief to America's Families, Schools and Small Business Act (Senate Amendment No. 2652 to the House Amendment S. 178) 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

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. Medicare Observation Status Regulations 10. Nursing Home Arbitration Regulations 11. Medicare 340(B) drug reimbursement policy 12. Home care workers and Medicare Reassignment Policy 13. Medicare equitable relief policy 14. S. 340, CREATES Act of 2019, entire bill 15. H.R. 965, CREATES Act of 2019, entire bill 16. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019, entire bill 17. CMS Proposals on Part D Drug Pricing 18. S. 691, Medicare Extra Rx HELP Act of 2019, entire bill 19. H.R. 1342, EMPOWER Care Act, entire bill 20. S. 548, EMPOWER Care Act, entire bill 21. H.R. 1343, Protecting Married Seniors from Impoverishment Act, entire bill 22. S. 97, Affordable and Safe Prescription Drug Importation Act, entire bill 23. S. 99, Medicare Drug Price Negotiation Act, entire bill 24. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 25. H.R. 1393, Medicare Dental, Vision and Hearing Benefit Act of 2019, entire bill 26. H.R. 1394, Medigap Consumer Protection Act of 2019, entire bill 27. H.R. 1682, Improving Access to Medicare Coverage Act of 2019, entire bill 28. H.R. 4386, Stop the Wait Act, entire bill 29. Proposals regarding the tiering generic drugs under Medicare Part D 30. Proposals regarding the use of Medicaid waivers during the COVID-19 pandemic 31. S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 32. H.R. 6305, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 33. Proposals to streamline Medicare enrollment during the COVID-19 pandemic 34. Proposals to expand oral health care under Medicare and Medicaid

Client expense: $70,000 · 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), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA)

H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Issues related to rural health access; health equity; Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole; Privacy; Universal Coverage. H.R. 861 - End Surprise Billing Act, H.R. 3630 - No Surprises Act, H.R. 3502 - Protecting People from Surprise Medical Bills Act, H.R. 5800 - Ban Surprise Billing Act, H.R. 5826 - Consumer Protections Against Surprise Medical Bills Act of 2020: Issues related to surprise billing, including benchmark payments, arbitration models, and out of network billing. S. 916 - MOMMAs Act, H.R. 2602, S. 1343 - MOMMIES Act: Issues related to options for states to extend coverage for pregnant women eligible for Medicaid via the pregnancy pathway to 365 days, Minority Maternity Care, Social Determinants of Health. S. 657 - Drug Price Transparency (DPT) Act, S. 2543 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug and price transparency. H.R. 3- Lower Drug Costs Now Act of 2019, S. 102 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug costs and prescription rebates. H.R. 19 - Lower Costs, More Cures Act of 2019: Issues related to prescription drug pricing S. 2546, H.R.2279 - Safe Step Act: Issues related to managed care, prior authorization. S. 3374 - Protecting Jessica Grubb's Legacy Act: Issues regarding HIPPA, confidentiality of substance abuse records H.R. 6139 - Health Care Protection Act: Issues related to COVID-19, funding for surveillance testing and treatment, financial assistance for individual health insurance, COBRA, financial assistance to maintain employer health plan coverage, and emergency funding for hospitals and providers. H.R. 6800 - HEROES ACT: Issues related to COVID-19, Federal Medical Assistance Percentages, Medicaid and COBRA. H.R. 1425 - Patient Protection and Affordable Care Enhancement ACT: Issues related to COVID-19, Medicaid expansion, and prescription drugs. Issues related to drug and price transparency, including the Administrations rule on interoperability and Executive order on transparency.

Client expense: $980,000 · 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. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Issues related to rural health access; health equity; Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole; Privacy; Universal Coverage. H.R. 861 - End Surprise Billing Act, H.R. 3630 - No Surprises Act, H.R. 3502 - Protecting People from Surprise Medical Bills Act, H.R. 5800 - Ban Surprise Billing Act, H.R. 5826 - Consumer Protections Against Surprise Medical Bills Act of 2020: Issues related to surprise billing, including benchmark payments, arbitration models, and out of network billing. S. 916 - MOMMAs Act, H.R. 2602, S. 1343 - MOMMIES Act, H.R. 4996 - Helping Medicaid Offer Maternity Services Act of 2019: Issues related to options for states to extend coverage for pregnant women eligible for Medicaid via the pregnancy pathway to 365 days, Minority Maternity Care, Social Determinants of Health. S. 657 - Drug Price Transparency (DPT) Act, S. 2543 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug and price transparency. H.R. 3- Lower Drug Costs Now Act of 2019, S. 102 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug costs and prescription rebates. H.R. 6201 Families First Coronavirus Response Act, S. 3548, H.R. 748 - CARES Act: Issues regarding taxes on high cost employer-sponsored health coverage. H.R. 19 - Lower Costs, More Cures Act of 2019: Issues related to prescription drug pricing S. 2546, H.R.2279 - Safe Step Act: Issues related to managed care, prior authorization. S. 3374 - Protecting Jessica Grubb's Legacy Act: Issues regarding HIPPA, confidentiality of substance abuse records Issues related to drug and price transparency, including the Administrations rule on interoperability and Executive order on transparency.

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

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

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

Continued implementation of ACA Health care policy 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. 3, Elijah E. Cummings Lower Drug Costs Now Act S.2543, the Prescription Drug Pricing Reduction 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 Cost Act"- provisions related to surprise billing and payer/provider contracts S. 1531, "STOP Surprise Medical Bills Act" H.R. 3630, "No Surprises Act" H.R. 3502, "Protecting People from Surprise Medical Bills Act" H.R.5826, "Consumer Protections Against Surprise Medical Bills Act of 2020" H.R. 748, "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) - provisions related to federal financial relief, including funding for healthcare providers, health programs and 42 CFR Part 2 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: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care payment and delivery system reform Health information technology and implementation of EHR meaningful use Policy related to health exchange risk corridors and cost-sharing reduction payments H.R. 269, "Pandemic and All-Hazards Preparedness& Advancing Innovation Act" - provisions related to hospitals 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 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 S. 1895, Lower Health Care Cost Act"- provisions related to surprise billing and payer/provider contracts 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" H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program H.R. 748, "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) - provisions related to federal financial relief, including funding for healthcare providers, health programs and 42 CFR Part 2 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: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposed changes to Medicare hospital reimbursement policy Health care policy Proposals to strengthen the health care system and achieve Affordable Care Act (ACA) market stability H.R. 269, "Pandemic and All-Hazards Preparedness & Advancing Innovation Act" - provisions related to hospitals Funding for National Ebola Network 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 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 Surprise Billing S. 1895, Lower health Care Cost Act" H.R. 3630, "No Surprises Act" S. 1531, "STOP Surprise Medical Bills Act" H.R.5826, Consumer Protections Against Surprise Medical Bills Act of 2020 H.R. 748, "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) - provisions related to federal financial relief, including funding for healthcare providers, and 42 CFR Part 2 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: $110,000

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. 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

S.80, Jobs and Premium Protection Act (all provisions) S.172, Health Insurance Tax Relief Act (all provisions) S.340, CREATES Act (all provisions) S.684, Middle Class Health Benefits Tax Repeal Act (all provisions) S.1531, Stopping the Outrageous Practice of Surprise Medical Bills Act (all provisions) S.1895, Lower Health Care Costs Act S.1510, Employee Flexibility Act (all provisions) S.2366, Commonsense Reporting Act (all provisions) HR 6800, Heroes Act HR 748, Middle Class Health Benefits Tax Repeal Act (all provisions) HR 861, End Surprise Billing Act (all provisions) HR 965, CREATES Act (all provisions) HR 1384, Medicare for All Act (all provisions) HR 1398, Health Insurance Tax Relief Act (all provisions) HR 3630, No Surprises Act HR 2782, Employee Flexibility Act (all provisions) HR 4070, Commonsense Reporting Act (all provisions) HR 3502, Protecting People From Surprise Medical Bills Act (all provisions) S.2543 Prescription Drug Pricing Reduction Act (all provisions) H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (all provisions) H.R. 1994, the Setting Every Community Up for Retirement Enhancement (SECURE) Act (all provisions)

Client expense: $1,400,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Federal Maritime Commission, Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Postal Service (USPS), U.S. Trade Representative (USTR), White House Office