REMEDY Act

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)

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

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

Client expense: $810,000 · 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, SENATE

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

Client expense: $1,600,000 · 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. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

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

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

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

Issues related to drug pricing; issues related to the MFN and drug rebate rules H.R. 3 - The Lower Drug Costs Now Act S. 1895 - Lower Health Care Costs Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

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

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Adult vaccines and immunizations; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; COVID-19 vaccines; Vaccines catch up; Proposed rule on Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products (79 Fed. Reg. 75,506-75,527, December 18, 2014); Coronavirus Aid Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $980,000 · Firm income: Not reported

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

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

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $1,600,000 · 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)

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. Pilot test 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, to take effect in 2020, 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. 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; Advocated with regard to a complaint filed with the Department of Homeland Security Office of the Inspector General (OIG) on September 14, 2020 concerning Lack of Medical Care, Unsafe Work Practices, and Absence of Adequate Protection Against COVID-19 for Detained Immigrants and Employees Alike at the Irwin County Detention Center. The concerns raised in the complaint, if substantiated, would represent an alarming violation of patient autonomy and ethical standards governing informed consent, appropriate access to health care and appropriate protection against COVID-19, causing great harm. The College urged an immediate internal investigation followed by swift and decisive corrective action as warranted should the complaint be substantiated. 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. Health IT and Telehealth: Urged that physicians be able to easily access accurate and reliable COVID-19 testing results from the various testing sites and labs. These results must contain the appropriate flags for review and should be received in standard formats, ideally within physicians existing health IT systems. The current eCase reporting to public health agencies process is time-consuming and duplicative, and EHR functionality to do eCase reporting varies widely across vendors and state public health departments. HHS should take a leadership role in making sure these programs and health IT standards projects are adopted and implemented consistently across the country. Ensure federally qualified health centers and rural health clinics can furnish telehealth services after the public health emergency.

Client expense: $264,513 · 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. Pilot test 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, to take effect in 2020, 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. 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; Advocated with regard to a complaint filed with the Department of Homeland Security Office of the Inspector General (OIG) on September 14, 2020 concerning Lack of Medical Care, Unsafe Work Practices, and Absence of Adequate Protection Against COVID-19 for Detained Immigrants and Employees Alike at the Irwin County Detention Center. The concerns raised in the complaint, if substantiated, would represent an alarming violation of patient autonomy and ethical standards governing informed consent, appropriate access to health care and appropriate protection against COVID-19, causing great harm. The College urged an immediate internal investigation followed by swift and decisive corrective action as warranted should the complaint be substantiated. 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. Health IT and Telehealth: Urged that physicians be able to easily access accurate and reliable COVID-19 testing results from the various testing sites and labs. These results must contain the appropriate flags for review and should be received in standard formats, ideally within physicians existing health IT systems. The current eCase reporting to public health agencies process is time-consuming and duplicative, and EHR functionality to do eCase reporting varies widely across vendors and state public health departments. HHS should take a leadership role in making sure these programs and health IT standards projects are adopted and implemented consistently across the country. Ensure federally qualified health centers and rural health clinics can furnish telehealth services after the public health emergency.

Client expense: $92,333 · 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)

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

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

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

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $2,620,000 · Firm income: Not reported

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

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

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $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)

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. Pilot test 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, to take effect in 2020, 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. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically, the College urged Congress to develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expand cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introduce legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care. Urged that Congress pass the Protecting Pre-existing Conditions and Making Health Care More Affordable Act of 2019 (H.R. 1884), which strengthens and expands tax credits; stops skimpy health plans that do not cover essential benefits and that discriminate against people with pre-existing conditions; and provides funding for reinsurance programs. 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; Urged that the E/M documentation requirements in the FY2019 Physician Fee Schedule should be implemented immediately and not coupled with the E/M payment policy reforms planned for 2021. 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. 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). 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. Physician Fee Schedule: Commented to CMS on its 2020 fee schedule final rule to: finalize E/M codes, current Procedural Terminology (CPT) guidelines, and RUC recommended values exactly as implemented by the CPT Editorial Panel and submitted by the RUC; finalize proposals to 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. 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. Health IT and Telehealth: Urged that physicians be able to easily access accurate and reliable COVID-19 testing results from the various testing sites and labs. These results must contain the appropriate flags for review and should be received in standard formats, ideally within physicians existing health IT systems. The current eCase reporting to public health agencies process is time-consuming and duplicative, and EHR functionality to do eCase reporting varies widely across vendors and state public health departments. HHS should take a leadership role in making sure these programs and health IT standards projects are adopted and implemented consistently across the country. Ensure federally qualified health centers and rural health clinics can furnish telehealth services after the public health emergency. Veterans Issues: Urged the Secretary of the VA to amend Directive 1899 as it relates to allowing non-physician healthcare professionals in 32 specialties to operate within the full scope of their license, registration, or certification and rescind the Memorandum as it relates to encouraging all VA medical facilities to allow CRNAs to practice without physician oversight during the national health emergency.

Client expense: $251,379 · 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), Veterans Affairs, Dept of (VA)

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. Pilot test 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, to take effect in 2020, 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. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically, the College urged Congress to develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expand cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introduce legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care. Urged that Congress pass the Protecting Pre-existing Conditions and Making Health Care More Affordable Act of 2019 (H.R. 1884), which strengthens and expands tax credits; stops skimpy health plans that do not cover essential benefits and that discriminate against people with pre-existing conditions; and provides funding for reinsurance programs. 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; Urged that the E/M documentation requirements in the FY2019 Physician Fee Schedule should be implemented immediately and not coupled with the E/M payment policy reforms planned for 2021. 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. 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). 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. Physician Fee Schedule: Commented to CMS on its 2020 fee schedule final rule to: finalize E/M codes, current Procedural Terminology (CPT) guidelines, and RUC recommended values exactly as implemented by the CPT Editorial Panel and submitted by the RUC; finalize proposals to 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. 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. Health IT and Telehealth: Urged that physicians be able to easily access accurate and reliable COVID-19 testing results from the various testing sites and labs. These results must contain the appropriate flags for review and should be received in standard formats, ideally within physicians existing health IT systems. The current eCase reporting to public health agencies process is time-consuming and duplicative, and EHR functionality to do eCase reporting varies widely across vendors and state public health departments. HHS should take a leadership role in making sure these programs and health IT standards projects are adopted and implemented consistently across the country. Ensure federally qualified health centers and rural health clinics can furnish telehealth services after the public health emergency. Veterans Issues: Urged the Secretary of the VA to amend Directive 1899 as it relates to allowing non-physician healthcare professionals in 32 specialties to operate within the full scope of their license, registration, or certification and rescind the Memorandum as it relates to encouraging all VA medical facilities to allow CRNAs to practice without physician oversight during the national health emergency.

Client expense: $94,771 · 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), Veterans Affairs, Dept of (VA)

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

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

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

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues

Client expense: $940,000 · Firm income: Not reported

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

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

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues

Client expense: $9,020,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

FDA Patent Settlement legislation Intellectual property and patent issues S. 340, H.R. 965 CREATES Act S. 1209, REMEDY Act S. 1224, H.R. 2374, Stop STALLING Act

Client expense: $1,560,000 · 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), SENATE

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Preparedness and response supplemental appropriations Act (P.L. 116-123); Families First Coronavirus Response Act (P.L. 116-127); Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146).

Client expense: $2,170,000 · Firm income: Not reported

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

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

Client expense: $540,000 · Firm income: Not reported

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

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Client expense: $940,000 · Firm income: Not reported

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

H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act. H.R. 6201, Families First Coronavirus Response Act; H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act - Discussed Medicare enrollment national open enrollment period, medical expense deduction, cost-sharing protections for commercial/private health insurance holders, telehealth access, nursing homes, virtual visitation, home and community-based services, Older Americans Act programs, Medicare home health care, and family caregiving, no-cost COVID-19 testing, equitable relief payments, retirement savings tax relief, suspensions of foreclosures and evictions, expanded unemployment benefits, paid sick and family leave, affordable broadband, and government operations, among other issues. H.R. 3, Elijah E. Cummings Lower Cost Drugs Now Act. S. 2543, the Prescription Drug Pricing Reduction Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 1499 - the Preserving Consumer Access to Generics Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. H.R. 19/S. 3129, Lower Cost More Cures Act.

Client expense: $2,210,000 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Corporation for Natl & Community Service, Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Indian Health Service, Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), 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. Pilot test 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, to take effect in 2020, 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. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically, the College urged Congress to develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expand cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introduce legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care. Urged that Congress pass the Protecting Pre-existing Conditions and Making Health Care More Affordable Act of 2019 (H.R. 1884), which strengthens and expands tax credits; stops skimpy health plans that do not cover essential benefits and that discriminate against people with pre-existing conditions; and provides funding for reinsurance programs. 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; Urged that the E/M documentation requirements in the FY2019 Physician Fee Schedule should be implemented immediately and not coupled with the E/M payment policy reforms planned for 2021. 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. Climate Change: The College educated Congress on the harmful health impacts of climate change. Climate change adaptation strategies must be established, and mitigation measures, like switching to clean, renewable energy and promoting active transportation, must be adopted. The College opposed the United States withdrawal from the Paris Agreement and urged Congress to pass the Climate Action Now Act, HR 9, which would reinstitute the U.S. in the agreement. Governments should commit to providing substantial and sufficient climate change research funding to understand, adapt to, and mitigate the human health effects of climate change. The College opposes weakening the limits on carbon emissions from new and reconstructed sources, which would open the door for more greenhouse gas emissions. Urged Congress to support the goal of a 100% clean energy economy by 2050 to protect health from the impacts of climate change. Urged congressional appropriators to increase funding for the Centers for Disease Control and Preventions Climate and Health Program to $15 million in FY 2021. 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. Women and Families: Urged that Congress improve care and services for women and families by removing barriers to care that interfere with the physician-patient relationship. Urged $400 million in funding for the Title X program, and rolling back the harmful final regulations on Title X, as included in the House FY2020 Labor-HHS-Education appropriations bill. Urged that Congress pass the Family and Medical Insurance Leave (FAMILY) Act (H.R.1185/S. 463) to establish a federal paid family leave 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). 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. Physician Fee Schedule: Commented to CMS on its 2020 fee schedule final rule to: finalize E/M codes, current Procedural Terminology (CPT) guidelines, and RUC recommended values exactly as implemented by the CPT Editorial Panel and submitted by the RUC; finalize proposals to 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. 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.

Client expense: $252,903 · 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. Pilot test 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, to take effect in 2020, 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. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically, the College urged Congress to develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expand cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introduce legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care. Urged that Congress pass the Protecting Pre-existing Conditions and Making Health Care More Affordable Act of 2019 (H.R. 1884), which strengthens and expands tax credits; stops skimpy health plans that do not cover essential benefits and that discriminate against people with pre-existing conditions; and provides funding for reinsurance programs. 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; Urged that the E/M documentation requirements in the FY2019 Physician Fee Schedule should be implemented immediately and not coupled with the E/M payment policy reforms planned for 2021. 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. Climate Change: The College educated Congress on the harmful health impacts of climate change. Climate change adaptation strategies must be established, and mitigation measures, like switching to clean, renewable energy and promoting active transportation, must be adopted. The College opposed the United States withdrawal from the Paris Agreement and urged Congress to pass the Climate Action Now Act, HR 9, which would reinstitute the U.S. in the agreement. Governments should commit to providing substantial and sufficient climate change research funding to understand, adapt to, and mitigate the human health effects of climate change. The College opposes weakening the limits on carbon emissions from new and reconstructed sources, which would open the door for more greenhouse gas emissions. Urged Congress to support the goal of a 100% clean energy economy by 2050 to protect health from the impacts of climate change. Urged congressional appropriators to increase funding for the Centers for Disease Control and Preventions Climate and Health Program to $15 million in FY 2021. 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. Women and Families: Urged that Congress improve care and services for women and families by removing barriers to care that interfere with the physician-patient relationship. Urged $400 million in funding for the Title X program, and rolling back the harmful final regulations on Title X, as included in the House FY2020 Labor-HHS-Education appropriations bill. Urged that Congress pass the Family and Medical Insurance Leave (FAMILY) Act (H.R.1185/S. 463) to establish a federal paid family leave 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). 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. Physician Fee Schedule: Commented to CMS on its 2020 fee schedule final rule to: finalize E/M codes, current Procedural Terminology (CPT) guidelines, and RUC recommended values exactly as implemented by the CPT Editorial Panel and submitted by the RUC; finalize proposals to 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. 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.

Client expense: $94,046 · 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)

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act (S. 1895), a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (S. 1391) H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act

Client expense: $2,200,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act

Client expense: $2,400,000 · Firm income: Not reported

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

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues

Client expense: $700,000 · Firm income: Not reported

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

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019 S. 2997, Title VII Health Care Workforce Reauthorization Act of 2019 Issue: Support the reauthorization of Health Resources and Services Administrations Title VII health professions workforce programs. P.L 116-94, Further Consolidated Appropriations Act, 2020, Division N P.L. 116-59, Continuing Appropriations Act 2020, and Health Extenders Act of 2019 P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 S.1895, Lower Health Care Costs Act S. 106, H.R. 1983, H.R.2328, Community Health Investment, Modernization, and Excellence Act of 2019 S. 192, Community and Public Health Programs Extension Act S. 692, H.R. 1943, Community Health Center and Primary Care Workforce Expansion Act of 2019 Issue: Support the reauthorization of the National Health Service Corps, Community Health Centers, and Teaching Health Centers mandatory appropriation funds. Issue: Support initiatives of hospitals to promote affordable housing in local communities and eliminate other social determinants of health to improve health equity. Issues: Educate Congress and the administration about academic medicines response to the opioid epidemic. Support funding for training on substance use disorders, pain management, and safe prescribing practices. P.L. 116-94, The Further Consolidated Appropriations Act, 2020, Division N P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3439, Protecting Access to Information for Effective and Necessary Treatment Act H.R. 2328, Reauthorizing and Extending Americas Community Health (REACH) Act S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act Draft Senate Finance Committee Health Extenders Legislation Issue: Support long-term reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Oppose restrictions on fetal tissue research. Urge changes to HHS and NIH policy on fetal tissue research. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issues: Support high-quality affordable health insurance. Support programs and funds for safety-net providers. Issue: Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including instituting a moratorium, increasing reporting requirements on covered entities, and imposing user fees Draft, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Draft, Diagnostic Accuracy and Innovation Act (DAIA) Issue: Oppose burdensome regulation of Laboratory Developed Tests S. 1895, Lower Health Care Costs Act H.R. 3630, No Surprises Act S. 1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 H.R. 3502, Protecting People From Surprise Medical Bills Act Issues: Educate Congress on surprise medical bills and price transparency. Support general principles for surprise medical bills draft legislation. Oppose statutory benchmark rate setting. Oppose Senate hospital/insurer contracting provisions and onerous reporting burden. S. 1895, Lower Health Care Costs Act, Title IV Issues: Prescription drug pricing, public health, and health information technology. P.L. 116-94, the Further Consolidated Appropriations Act, 2020, Division N H.R. 2328, Community Health Investment, Modernization, and Excellence Act of 2019 Issue: Support legislation providing stable and predictable funding for quality measurement activities carried out by the National Quality Forum Issue: Development of Enhanced Primary Care Pilot Act proposal Issue: Educate Congress about medical education on nutrition, consent, implicit bias, and maternal health. Issue: Support efforts to address maternal health S. 1416, Affordable Prescriptions for Patients Act S. 1224, H.R. 2374, Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440, Preserving Access to Cost Effective Drugs Act H.R. 2296 / S.1391, The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2019 S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113, Prescription Drug STAR Act US-Mexico-Canada Agreement Issue: Support measures to lower prescription drug cost H.R. 4004, S.2986, Social Determinants Accelerator Act of 2019 Issue: Support grants to address social determinants of health Issue: Support aligning 42 CFR Part 2 regulations with the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of treatment, payment, and healthcare operations. Draft, firearm safety legislation Issue: Support universal background checks, violence prevention programs, extreme risks protection orders, child access safety laws, and reinstating assault weapons ban. H.R. 8, Bipartisan Background Checks Act of 2019 Issue: Support universal background checks Issue: Support nomination of Stephen Hahn, MD, as FDA commissioner. H.R. 1888, Expanding Nutritions Role in Curricula and Healthcare (ENRICH Act) Issue: Support legislation to create or expand nutrition and physical activity curricula. Draft Cures 2.0 Legislation Issue: Support efforts to modernize health care coverage and ensure access to scientific break-throughs through electronic health records, addressing health disparities, harnessing data, and supporting the physician workforce. Issue: Addressing preparedness for influenza. S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support efforts to mitigate drug shortages and develop market-based incentives to help ensure a stable supply of medications critical for patient care Draft Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health

Client expense: $1,137,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Director of National Intelligence (ODNI), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues

Client expense: $6,450,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Inter Partes Review (IPR) Process. Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. Section 101 of the Patent Act. Patent Examination and Quality Improvement Act (Bill number not yet assigned). S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Client expense: $1,580,000 · Firm income: Not reported

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

H.R. 397 - The Rehabilitation for Multiemployer Pensions Act S. 617 - Tax Extenders & Disaster Relief Act. H.R. 1230, the Protecting Older Workers Against Discrimination Act (POWADA). H.R. 2730/S. 1443 - The Credit for Caring Act. S. 1209 - REMEDY ACT. S. 972/H.R. 100 - The Retirement Enhancement & Savings Act. H.R. 1994 - Setting Every Community Up for Retirement Enhancement Act. H.R. 5306/S. 2989, Know Your Social Security Act. H.R. 5446, Improving Social Securitys Service to Victims of Identity Theft Act. Submitted comments to the Social Security Administration on their rulemaking on the Advanced Designation of Representative Payees. H.R. 4540, the Public Servants Protection and Fairness Act, and H.R. 3934, the Equal Treatment of Public Servants Act - Discussed Windfall Elimination Provision legislation. H.R. 5380 - The Senior Guardianship Social Security Protection Act. No bill number - Discussed the Social Security system and paid family leave. H.R. 5392 - The Social Security Enhancement and Protection Act. H.R. 4610/S. 3795 the Receiving Electronic Statements to Improve Retiree Earnings (RETIRE) Act. No bill number - Discussed private sector retirement reform issues. No bill number - Discussed State retirement savings programs for private sector workers. No bill number -Discussed part-time worker, independent contractor, contingent worker and personal/individual plan retirement issues. No bill number - Discussed student loans and retirement saving issues. No bill number - Discussed retirement plan data collection and dissemination issues. No bill number - Discussed small employer and pooled retirement plan issues. No bill number - Discussed small retirement account cash out issues. No bill number - Discussed retirement reforms related to permitting early access to retirement savings. No bill number - Discussed Individual Retirement Account (IRA) issues. No bill number - Discussed access to retirement savings for dependent care expenses. No bill number - Discussed savings for emergency expenses. No bill number - Discussed options to spend down retirement savings after retirement. Submitted comments to DOL on multiple employer plans and delivery of required retirement disclosures via the internet.

Client expense: $2,140,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, White House Office