Prescription Drug STAR Act

Issues related to reporting of average sales price to Medicare, including relevant provisions in Lower Drug Costs Now Act (H.R. 3), Prescription Drug Pricing Reduction Act (S. 2543), Prescription Drug STAR Act (H.R. 2113), Strengthening Average Sales Price Reporting Act (S. 2051), and Consolidated Appropriations Act, 2021 (H.R. 133) Issues related to advancing Access to Infertility Treatment and Care Act (H.R. 2803, S. 1461) Issues related to advancing Access to Infertility Treatment for Military Veterans (no bill)

Client expense: $17,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act S. 3300, Data Protection Act of 2021 H.R.3801, Data Localization Compendium Legislation - 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 - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and acces - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $1,670,000 · 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)

Issues related to reporting of average sales price to Medicare, including relevant provisions in Lower Drug Costs Now Act (H.R. 3), Prescription Drug Pricing Reduction Act (S. 2543), Prescription Drug STAR Act (H.R. 2113), Strengthening Average Sales Price Reporting Act (S. 2051), and Consolidated Appropriations Act, 2021 (H.R. 133) Issues related to advancing Access to Infertility Treatment and Care Act (H.R. 2803, S. 1461) Issues related to advancing Access to Infertility Treatment for Military Veterans (no bill)

Client expense: $17,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - 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 - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $3,130,000 · 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

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) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, 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), from the 116th Congress, to promote greater drug pricing transparency. 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), from the 116th Congress, 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), from the 116th Congress, 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 2021, which passed the House in 2021, 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), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as 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 under the last administration; 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. 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 following legislation from the 116th Congress: 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), from the 116th Congress, 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. 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 a variety of COVID-related bills from the 116th Congress as follows: 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 the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his 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. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.

Client expense: $170,367 · 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) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, 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), from the 116th Congress, to promote greater drug pricing transparency. 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), from the 116th Congress, 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), from the 116th Congress, 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 2021, which passed the House in 2021, 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), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as 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 under the last administration; 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. 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 following legislation from the 116th Congress: 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), from the 116th Congress, 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. 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 a variety of COVID-related bills from the 116th Congress as follows: 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 the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his 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. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.

Client expense: $92,741 · 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)

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · 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), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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.4100 - DISARM Act of 2019 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.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Ac - 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 - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $2,030,000 · 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

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.4100 - DISARM Act of 2019 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.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 - 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: $2,750,000 · 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

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.4100 - DISARM Act of 2019 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 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - 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 Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

Client expense: $1,930,000 · 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

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. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

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. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

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. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

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)

Issues related to reporting of average sales prices to Medicare, including relevant provisions in the Lower Drug Costs Now Act (H.R. 3), Prescription Drug Pricing Reduction Act (S. 2543), Prescription Drug STAR Act (H.R. 2113), Strengthening Average Sales Price Reporting Act (S. 2051), and Consolidated Appropriations Act, 2021 (H.R. 133) Reproductive Health legislation including Access to Infertility Treatment and Care Act (S. 1461, H.R. 2803)

Client expense: $23,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

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

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129: Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.3: Lower Drug Costs Now Act H.R. 6557 MAIL Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.223/S.532: PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes

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

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

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

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

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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Prescription drug pricing transparency H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532: PBM Study Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D H.R.19/S.3129: Lower Costs More Cures Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act

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

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

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

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.4100 - DISARM Act of 2019 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.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Ac - 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 - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

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

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

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation

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

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

Issues related to reporting of average sales price to Medicare, including relevant provisions in Lower Drug Costs Now Act (H.R. 3), Prescription Drug Pricing Reduction Act (S. 2543), Prescription Drug STAR Act (H.R. 2113), Strengthening Average Sales Price Reporting Act (S. 2051), and Consolidated Appropriations Act, 2021 (H.R. 133).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

no specific bill, Raising Awareness of Cystic Fibrosis no specific bill, appropriation for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies, drug pricing, transparency H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act S. 1895 - Lower Health Care Costs Act H.R. 2113 - Prescription Drug STAR Act H.R. 3276 - Fair AMP Act 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

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

Issues related to drug innovation; value of prescription drugs; issues related to march in rights under the Bayh-Dole Act 96-517; issues related to Medicare Part D redesign and reform; H.R. 2296; H.R. 2113; H.R. 3; S. 2543; S. 1895.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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. 2477 (Benes Act of 2020): 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. S. 4318: A bill to create $1,200 stimulus check, for individuals with incomes up to $75,000 the same as in the CARES Act. The bill also contains the supplemental employment benefits, with $600 per week through July 31, $200 per week through October 5th, and then becomes a payment of 70% of lost wages though December 31 S. 4317: A bill to establish a COVID-19 liability shield for employers. S. 4321: A bill which extends he Paycheck Protection Program, providing money for additional loans, while reserving loans only for companies with under 300 employees and at least a 50% reduction in gross receipts S. 4320: An appropriations bill, contains a total of $306 billion in discretionary spending S. 2733: A bill to set up committees to produce a report regarding the financial health of the various federal trust funds S. 4322: A bill to defer student loan payments for borrowers with no income, funds scholarships for students returning to and starting at private schools, includes provisions related to medical stockpiles, diagnostic testing, and disease surveillance S. 4324: A bill to decrease the United States' dependence on foreign countries for personal protective equipment manufacturing, tighten oversight of federally funded research, and others. S. 4319: A bill to allow businesses to deduct 100% of the cost of business meals in 2020, compared to the current 50% tax deduction S. 1531: A bill to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing. HR 5800: A bill to end surprise medical billing and increase transparency in health coverage. 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 6201 (FFCRA): A bill making emergency supplemental appropriations for the fiscal year ending September 30, 2020, and for other purposes. HR 748 (CARES): This bill responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. S. 3548 (CARES): A bill to provide emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic. 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 4070: A bill to streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. S. 2366: A bill to streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. HR 3796: A bill to amend the Internal Revenue Code of 1986 to provide that coverage under Medicare is permissible for purposes of contributions to health savings accounts. HR 861: A bill to amend title XVIII of the Social Security Act to prevent surprise billing practices, 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 amend 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. H.R. 2782: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. The bill increases the hours of service threshold from an average of at least 30 hours of service a week to an average of at least 40 hours of service a week. S. 1510: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. H.R.2564: This bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA)-a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. H.R. 1682: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. S. 753: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. 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. H.R. 1346: To amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes. S. 470: To amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare. 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. 3630: To amend title XXVII of the Public Health Service Act to protect health care consumers from surprise billing practices, 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

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. 2477 (Benes Act of 2020): 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. S. 4318: A bill to create $1,200 stimulus check, for individuals with incomes up to $75,000 the same as in the CARES Act. The bill also contains the supplemental employment benefits, with $600 per week through July 31, $200 per week through October 5th, and then becomes a payment of 70% of lost wages though December 31 S. 4317: A bill to establish a COVID-19 liability shield for employers. S. 4321: A bill which extends he Paycheck Protection Program, providing money for additional loans, while reserving loans only for companies with under 300 employees and at least a 50% reduction in gross receipts S. 4320: An appropriations bill, contains a total of $306 billion in discretionary spending S. 2733: A bill to set up committees to produce a report regarding the financial health of the various federal trust funds S. 4322: A bill to defer student loan payments for borrowers with no income, funds scholarships for students returning to and starting at private schools, includes provisions related to medical stockpiles, diagnostic testing, and disease surveillance S. 4324: A bill to decrease the United States' dependence on foreign countries for personal protective equipment manufacturing, tighten oversight of federally funded research, and others. S. 4319: A bill to allow businesses to deduct 100% of the cost of business meals in 2020, compared to the current 50% tax deduction S. 1531: A bill to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing. HR 5800: A bill to end surprise medical billing and increase transparency in health coverage. 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 6201 (FFCRA): A bill making emergency supplemental appropriations for the fiscal year ending September 30, 2020, and for other purposes. HR 748 (CARES): This bill responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. S. 3548 (CARES): A bill to provide emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic. 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 4070: A bill to streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. S. 2366: A bill to streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. HR 3796: A bill to amend the Internal Revenue Code of 1986 to provide that coverage under Medicare is permissible for purposes of contributions to health savings accounts. HR 861: A bill to amend title XVIII of the Social Security Act to prevent surprise billing practices, 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 amend 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. H.R. 2782: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. The bill increases the hours of service threshold from an average of at least 30 hours of service a week to an average of at least 40 hours of service a week. S. 1510: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. H.R.2564: This bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA)-a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. H.R. 1682: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. S. 753: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. 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. H.R. 1346: To amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes. S. 470: To amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare. 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. 3630: To amend title XXVII of the Public Health Service Act to protect health care consumers from surprise billing practices, 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

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. 2477 (Benes Act of 2020): 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. S. 2733: A bill to set up committees to produce a report regarding the financial health of the various federal trust funds S. 1531: A bill to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing. HR 5800: A bill to end surprise medical billing and increase transparency in health coverage. H.R. 925 (HEROES): Coronavirus Recovery Supplemental Appropriations 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 861: A bill to amend title XVIII of the Social Security Act to prevent surprise billing practices, 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 amend 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. H.R.2564: This bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA)-a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. H.R. 1682: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. S. 753: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. H.R. 1346: To amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes. S. 470: To amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare.

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

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. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

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)

Issues impacting drug prices; H.R. 1503 - Orange Book Transparency Act; H.R. 1520 - Purple Book Continuity Act of 2019; H.R. 2113 - Prescription Drug STAR Act; H.R 3 - Lower Drug Costs Now Act; S. 2543 - The Prescription Drug Pricing Reduction Act.

Client expense: Not reported · Firm income: $25,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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