Fair Accountability and Innovative Research Drug Pricing Act of 2019

S. 1391 - Fair Accountability and Innovative Research Drug Pricing Act. Prescription drug pricing issues. Patent abuse issues. Ensuring Innovation Act and the Advancing Education on Biosimilars Act of 2021. Drug-price Transparency for Competition (DTC) Act.

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

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

S.1391 - Fair Accountability and Innovative Research Drug Pricing Act. Prescription drug pricing issues. Patent abuse issues. Ensuring Innovation Act and the Advancing Education on Biosimilars Act of 2021. Drug-price Transparency for Competition (DTC) Act.

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

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

Prescription drug pricing issues. Continued monitoring of the implementation of Families First Coronavirus Response Act (PL 116-127); Issues of prescription drug pricing in Medicare and Medicaid. Rebate rule. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Continued monitoring of implementation of Families First Coronavirus Response Act (PL 116-127); Issues of prescription drug pricing in Medicare and Medicaid. Rebate rule. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019. Prescription drug pricing issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019. Prescription drug pricing issues.

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

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

The Affordable Care Act (P.L. 111-148, P.L. 111-152): Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), from the 116th Congress, to promote greater drug pricing transparency. Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), from the 116th Congress, which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), from the 116th Congress, which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2021, which passed the House in 2021, to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border under the last administration; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the following legislation from the 116th Congress: the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), from the 116th Congress, which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for a variety of COVID-related bills from the 116th Congress as follows: the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.

Client expense: $170,367 · Firm income: Not reported

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

The Affordable Care Act (P.L. 111-148, P.L. 111-152): Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes; Advocated against a December 2018 ruling by a federal judge in Texas that the entire Affordable Care Act (ACA) is unconstitutional. Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Medicare Payments to Physicians: Urged that Congress provide incentives to physicians who transform their practices into Advanced Alternative Payment Models and continue to provide stability for physicians in the MIPS program. Specifically, Congress should extend the five percent Qualified Alternative Payment Model participant bonus beyond the 2022 performance year, replace the zero percent baseline payment updates under Medicare with positive updates. Urged congressional committees with jurisdiction over Medicare to exercise their oversight authority and urge CMS to expedite approval of more Advanced APMS, particularly those that work for small and specialty practices and to simplify the scoring structure and reporting requirements under the Merit-Based Incentive Payment System (MIPS) in order to fulfill Congress intent of a more streamlined program that reduces burdens on physicians; Supported S.2648, the Rural ACO Improvement Act, amends title XVIII of the Social Security Act to improve the benchmarking process for the Medicare Shared Savings Program (MSSP) to ensure that all ACOs have an equal opportunity to share in savings regardless of their geographic location; Provided recommendations to CMS on the Merit-based Incentive Payment System Value Pathway (MVP), which aims to reduce reporting burden and complexity within MIPS while improving the accuracy and effectiveness of performance measurement. The College noted specifically that a robust, multi-year transition period will be critical to the success of the MVP, that it does not support making the MVP mandatory, that CMS should continue to support numerous reporting mechanisms, including qualified registries and clinical data registries, which have been instrumental in developing specialty-specific performance measures, among other things. Urged support for H.R. 8505, a bill to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule; Urged that any legislation to hold some Medicare physician payment codes harmless from budget neutrality do so for just one year and to allow evaluation and management increases, along with GPC1X codes to go into effect. Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: streamlining the prior authorization process, better integrating clinical data into clinicians electronic health records (EHRs), and working with CMS in their effort to overhaul clinical documentation guidelines; Urged Congress to cosponsor and pass the Safe Step Act (H.R. 2279), to require health insurers to provide an exceptions process for any medication step therapy protocol based on clinical decision-making, medical necessity, and other patient needs. Prescription Drug Costs: The College advocated for greater transparency in drug pricing, the elimination of anti-competitive industry practices that create barriers to generics coming to market, the importance of accounting for value in payment and coverage for prescriptions, and providing authority to the federal government to negotiate drug discounts under the Medicare Part D program. Specifically, the College urged Congress to pass the Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275/S. 62) from the 116th Congress, which allows the Secretary of Health and Human Services to negotiate covered Part D drug prices on behalf of Medicare beneficiaries. Also urged that Congress pass the Reforming Evergreening and Manipulation that Extends Drug Years, REMEDY Act (S. 1209), from the 116th Congress, to aid in the approval of more generic drug applications by the FDA and therefore improve patient access to those medications. Also urged that Congress pass the Prescription Drug STAR Act (H.R. 2113), and the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 2296/S. 1391), from the 116th Congress, to promote greater drug pricing transparency. Firearms-Related Injury and Death: The College advocated for lawmakers to pass measures to strengthen the criminal background check system, ban assault weapons and high capacity magazines, prevent the unlawful transfer of firearms to those who cannot legally purchase them, and remove restrictions on, and provide dedicated funding for, research by federal agencies on prevention of firearms-related injuries and death. Specifically, the College urged passage of the Bipartisan Background Checks Act of 2019 (H.R. 8), from the 116th Congress, which would strengthen the accuracy and reporting of the National Instant Criminal Background Check System (NICS) as well as expand Brady background checks to cover all firearm sales, including unlicensed firearms sellers currently not required to use background checks, and the Gun Violence Prevention Research Act (H.R. 674/S. 184), from the 116th Congress, which would authorize funding for the Centers for Disease Control and Prevention (CDC) to study firearms safety and gun violence prevention. Also urged Congress to pass the Violence Against Women (VAWA) Reauthorization Act of 2021, which passed the House in 2021, to provide protections for domestic violence victims by restricting access to firearms by those deemed a threat to them. Also urged Congress to pass the Assault Weapons Ban of 2019 (S. 66/H.R. 1296), from the 116th Congress, to ban the sale of semi-automatic weapons and high-capacity magazines. Urged support for the enactment of extreme risk protection orders (ERPO) to allow families and law enforcement to obtain a ruling from an impartial judge within 72 hours to temporarily remove guns from individuals at imminent risk of using them to harm themselves or others, with due process. Immigration: The College advocated against family separation at the U.S. border. Specifically, the College urged support for bills from the 116th Congress such as H.R. 541 - the Keep Families Together Act, which would help ensure that children are not separated from their parents when families unlawfully cross over the border into the United States and would ensure that the Department of Homeland Security would not be able to implement the zero tolerance policy that separated families at the border under the last administration; urged congressional oversight of family separation policies. Also urged that Congress pass H.R. 6, the Dream and Promise Act of 2019, which would provide a pathway to U.S. citizenship for undocumented children who came to the United States due to the action of their parents, also known as Dreamers. Graduate Medical Education: Urged that Congress support medical education training and debt relief for primary care physicians and other specialties facing shortages by passing the following legislation from the 116th Congress: the Resident Physician Shortage Reduction Act of 2019 (S. 348, H.R. 1763), to lift the GME caps as needed to permit training an adequate number of primary care physicians, including internal medicine specialists, and physicians in other specialties facing shortages; passing the Resident Education Deferred Interest Act (H.R. 1554), to save physicians in residency programs thousands of dollars in interest on their loans and help incentivize the opening of practices in underserved areas; pass legislation to combine DGME and IME into a single, more functional payment program, and broaden the GME financing structure to include all payers; support funding for GME/IME and programs within the Veterans Health Administration that provide graduate medical education to ensure that physicians are adequately trained with the skills needed to treat an aging population. Urged Congress to pass the Opioid Workforce Act of 2019 (H.R. 3414), which would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. Urged Congress to pass S. 1203 and H.R. 2441, the What You Can Do For Your Country Act, which would improve and reform the Public Service Loan Forgiveness (PSLF) Program. Vaccines: Urged Congress to pass the Vaccines Act (HR 2862), from the 116th Congress, which would provide federal funding for vaccine hesitancy surveillance at the Centers for Disease Control and Prevention (CDC), and outline a national public messaging campaign informed by this research to help improve vaccination rates. Physician Fee Schedule: Commented to CMS and to Congress to fully implement payment increases for all evaluation and management codes, as finalized by CMS, and as scheduled for implementation on Jan. 1, 2021. Reduce the documentation burden for E/M services by allowing choice of medical decision making or time, and work to develop additional clarity and guidance on acceptable documentation to operationalize these important proposals; examination room desktop computers should be counted as a direct medical equipment cost; care management should be promoted by increasing the values of services like Transitional Care Management (TCM) and Chronic Care Management and implementing Principle Care Management (PCM) codes; require additional survey and review for any requests to increase non-outpatient E/M or other services; work with the physician community prior to finalizing any policy affecting eligibility to participate in the Medicare program; Urged congressional committees of jurisdiction to support: Higher physician work relative value units (RVUs) for new and established office visit codes, leading to increased payments for them, Reduced documentation requirements for office visit codes, which enables physicians to select and document for each visit based on medical decision-making or total time, Expanded and improved payment for care management services. Urged Congress to support waiving budget neutrality, applicable to the calendar year 2021 physician fee schedule. COVID-19: Urged congressional appropriators to provide the highest possible funding level for research, prevention, control, and treatment of illnesses associated with the virus that is commensurate with the public health emergency that the virus represents. Urged the administration to explore regulatory and other actions that would make COVID-19 testing free-of-charge to patients covered by both public and private insurance plans, including ACA-compliant plans offered through the insurance exchanges, and to waive co-pays and deductibles for patients seeing physicians for symptoms that may be indicative of COVID-19 or who are hospitalized for treatment. Urged CMS to utilize a national disaster recovery program that would pay doctors 110% of Medicare rates for caring for uninsured patients who have been infected with SARS-CoV-2. Expressed support to Congress and the administration for a variety of COVID-related bills from the 116th Congress as follows: the Families First Coronavirus Response Act, H.R. 6201, and other stimulus reforms related to COVID-19 including: Emergency paid leave benefits, paid sick days for public health emergencies, coverage of testing for COVID-19, waiving of cost sharing under Medicare, Medicare Advantage, Medicaid, and CHIP, increasing the federal FMAP under Medicaid, providing reimbursement for CPT codes 99441 - 99443, which are telephone evaluation and management services, expediting entrance of international medical graduates who are citizens of other nations (non-US IMGs) into the country and ensuring that lawfully present non-U.S. IMGs are not negatively impacted by the COVID-19 pandemic, funding for physician practices under the Public Health and Social Service Emergency Fund (PHSSEF), providing tax relief, grants, and loans to small and medium size practices impacted by COVID-19, increasing funding for personal protective equipment (PPE), ensuring Medicaid pay parity with Medicare for primary care services; Urged HHS and Congress to make a targeted allocation out of the Provider Relief Fund (PRF) to support primary care physicians and their practices, sufficient to keep their doors open, by offsetting lost revenue from the COVID-19 pandemic, similar to the targeted allocation for rural hospitals; Urged support for the Student Loan Forgiveness for Frontline Health Workers Act, H.R. 6720, introduced May 5, 2020 by Representative Carolyn B. Maloney (D-NY) which would eliminate graduate school debt for healthcare workers, including physicians and medical students, who are providing direct patient care in response to the COVID-19 pandemic; Urged support for H.R. 7059, the Coronavirus Provider Protection Act, which extend liability protections to those who provide care in good faith during the COVID-19 public health emergency (plus a reasonable time, such as 60 days, after the emergency declaration ends), and not in situations of gross negligence or willful misconduct. The College also urged that pay parity between telephone claims and in-person visits and between all telehealth and in-person visits be maintained after the PHE is lifted. This extension-either continued by CMS or mandated by Congress-should last at least through the end of 2021, or until such a time when effective vaccines and treatments are widely available, with an option to extend it even further, or consider making permanent, based on the experience and learnings of patients and physicians who are utilizing these visits. Urged Congress to support a targeted allocation from the Provider Relief Fund specifically for primary care services. Priorities for the Biden Administration: Urged the Biden Administration to identify and appoint physicians to health care leadership positions within his Administration. Implement approval, distribution, and funding of a safe and effective COVID-19 vaccine based on recommendations from the Advisory Committee on Immunization Practices (ACIP). Provide support to physicians and other frontline health care workers, including ensuring access and distribution of personal protective equipment (PPE) to health care workers. Fund COVID-19 testing and contact tracing efforts. Reverse regulations that allow the sale of extended short-term, limited duration plans, association health plans. Take action to defend the Affordable Care Act from any litigation, including California v. Texas, that would undermine coverage and patient protections. Expand premium tax credits and cost-sharing reductions. Establish a federal public option to inject competition into the health insurance marketplace. Expand Medicaid eligibility and oppose expansion waivers that limit benefits and apply high cost sharing. Permanently increase payment for Medicaid primary care services to the level of Medicare. Restore the Deferred Action for Childhood Arrivals, consistent with a recent ruling from a federal judge, and identify executive actions that can be taken to ensure that it is not vulnerable to being eliminated in the future. Pursue executive actions to preserve the principles of patient autonomy regarding reproductive decision-making rights. Reverse the Title X gag rule and restore funding to family planning clinics. Establish universal access to at least six weeks of paid family and medical leave that is flexible to accommodate care for a diverse array of family structures, including updating the Family Medical and Leave Act to include grandparents or in-laws. Re-introduce and pass the George Floyd Act and other legislation focused on eliminating racism and police violence. Rejoin the Paris Agreement. Telehealth: Urged Congress to continue existing Public Health Emergency flexibilities and waivers-including pay parity for audio-only phone calls-to support making telehealth an ongoing and continued part of medical care now and in the future, allowing time for further evaluation on which ones should be maintained as is, revised or expanded. Urged Congress to permanently extend the policy to waive geographical and originating-site restrictions after the conclusion of the PHE. Urged Congress or CMS to continue to provide flexibility in the Medicare and Medicaid programs for physician practices to reduce or waive cost-sharing requirements for telehealth services, while also making up the difference between these waived copays and the Medicare allowed amount of the service. Urged Congress or CMS to extend the interim policy to allow Remote Patient Monitoring services to be furnished to patients without an established relationship. Urged support for the Temporary Reciprocity to Ensure Access to Treatment Act or the TREAT Act (S. 168/H.R. 708), which would provide temporary licensing reciprocity for telehealth and interstate health care treatment. American Rescue Plan (ARP) Act (H.R. 1319): Urged support for various provisions within the ARP to provide incentives for states to expand Medicaid by temporarily increasing the states base FMAP by five percentage points for two years for states that newly expand Medicaid. Urged support for allowing states, for five years, to extend Medicaid eligibility (and CHIP eligibility) to women for 12 months postpartum. Urged support to require Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing with vaccines matched at a 100 percent federal medical assistance percentage (FMAP) through one year after the end of the PHE. Urged support for $46 billion to HHS to detect, diagnose, trace, and monitor COVID-19 infections, and for other activities necessary to mitigate the spread of COVID-19. Urged support to subsidize the health coverage of people earning up to 150 percent of the federal poverty level (FPL) under the ACA and those on unemployment insurance for a period of two years. Urged support for waiving VA cost sharing and copayments for medical treatment until September 30, 2021.

Client expense: $92,741 · Firm income: Not reported

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

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)

BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA

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

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

BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA

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

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

BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA

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

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

BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable prescription drugs, 340B Program; HR985 FAST Generics Act of 2019; Appropriate and accurate payment for healthcare; Site Neutral payment policies; S. 1895 - Lower Health Care Costs Act; S. 340 - CREATES Act, H.R. 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act; S. 1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019; Surprise billing: S. 1531 - Stop the Outrageous Practice of Surprise Medical Bills Act of 2019; HR 3, the Lower Drug Costs Now Act; H.R.2149 - Exposing the Financing of Human Trafficking Act; H.R.508 - Trafficking Victims Housing Act of 2019; H.R. 1520 - Purple Book Continuity At of 2019; H.R. 1503 - Orange Book Transparency Act of 2019; S.2543 - Prescription Drug Pricing Reduction Act of 2019; Health care privacy; patient privacy; H.R. 647, S.2080 - Palliative Care and Hospice Education and Training Act; Conrad 30 and the Physician Access Reauthorization Act, S 948; Issues related to the Medicaid Fiscal Accountability Regulation (MFAR); HR 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act; HR 6201 - Families First Coronavirus Response Act - Public Law No: 116-127; HR 748 - Coronavirus Aid, Relief, and Economic Security (CARES) Act; response to the COVID-19 public health emergency; S. 178 - HEALS Act; H.R. 1425, Patient Protection and Affordable Care Enhancement Act; H.R. 6800 - HEROES Act; H.R. 266, Paycheck Protection Program and Health Care Enhancement Act; issues related to coverage of virtual car; Financial support for providers for diagnosis and treatment related to COVID-19, coverage of COVID-19 related conditions, and access to PPE and other materials and equipment related to the treatment of patients with COVID-19; H.R. 133 - Consolidated Appropriations Act; Issues related to social determinants of health; H.R. 6561 - Improving Social Determinants of Health Act ; S. 4421- Temporary Reciprocity to Ensure Access to Treatment Act; liability relief for health care providers

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), Vice President of the U.S.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act

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

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

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

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

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

H.R. 985, Fair Access for Safe and Timely Generics Act of 2019 (FAST Generics Act), support passage. H.R. 2035/S. 995, Lifespan Respite Care Reauthorization Act, support reauthorization H.R. 3208/ S.1755 - Real Emergency Access for Aging and Disability Inclusion for Disasters Act, support passage H.R. 2781 - Empower for Health Act of 2019, support passage H.R. 2296/S.1391 - FAIR Drug Pricing Act of 2019, support passage H.R. 3630 - No Surprises Act, support passage H.R. 1010, To provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect, support passage. H.R. 986, The Protecting Americans with Preexisting Conditions Act of 2019, support passage. H.R.1386, Expand Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act of 2019, support passage. H.R. 2408, the Ensuring Access to Quality Complex Rehabilitation technology Act, support passage. H.R 3 - Lower Drug Costs Now Act of 2019, support passage H.R. 19 - Lower Costs, More Cures Act of 2019, support passage H.R. 2387, the Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019, support passage H.R. 6417, Protecting Cures Act of 2020, support passage H.R. 5800, Ban Surprise Billing Act, support passage H.R. 1595, Secure and Fair Enforcement Banking Act (SAFE Banking Act), support passage S. 1935, Family Coverage Act, support passage. S.1556, No Junk Plans Act, support passage. S.475, Reducing Existing Costs Associated with Pharmaceuticals for Seniors Act of 2019 (RX Cap Act), support passage S. 637, Combatting Unreasonable Rises and Excessively High Drug Prices Act (CURE High Drug Prices Act), support passage S.366, Forcing Limits on Abusive and Tumultuous Prices (FLAT Prices) Act, support passage S. 63, Preserve Access to Affordable Generics and Biosimilars Act, support passage S. 659, Biologic Patent Transparency Act, support passage S.1895 - Lower Health Care Costs Act, support passage S. 2543 - Prescription Drug Price Reduction Act of 2019 - support passage S. 1801, Low Cost Generics Act of 2019, support passage H.R. 1425 Patient Protection and Affordable Care Enhancement Act, support H.R. 6514, Worker Health Coverage Protection Act, Support H.R. 3832, S. 1257, Legacy IRA Act, Support H.R. 6408 - Save the Organizations that Serve America Act S.3544/H.R.6305 - Coronavirus Relief for Seniors and People with Disabilities Act of 2020, support S. 3815, RESTART Act, Oppose S. 3833/H.R. 7010/H.R.6886, Paycheck Protection Program Flexibility Act of 2020, Support S. 4032/H.R. 7324, Universal Giving Pandemic Response Act. Support passage H.R. 6892-Help Charities Protect Communities Act, Support - S.Amdt. 1566 to the CARES Act, Charitable Giving oAmendment Increases the $300 limit on the charitable giving deduction to one-third of the standard deduction ($4,000 for an individual filer/$8,000 for married joint filers) for the remainder of 2020. Support. H.R. 7663-Protecting Access to Post-COVID-19 Telehealth Act, support passage H.R. 6644/S. 3741 - Health Care At Home Act, support passage H.R. 7391- the Protect Telehealth Access Act, support passage S. 3998- the Enhancing Preparedness Through Telehealth Act, support passage

Client expense: $48,803 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 H.R.748 - CARES Act Critical infrastructure and supply chain HR 8837 -- Continuing Appropriations Act, 2021 and Other Extensions Act H.R.133 - Consolidated Appropriations Act, 2021

Client expense: $146,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of, Vice President of the U.S.

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)

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to 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

Affordable prescription drugs, 340B Program, HR985 FAST Generics Act of 2019, Appropriate and accurate payment for healthcare, Site Neutral payment policies, S. 1895 - Lower Health Care Costs Act, S. 340 - CREATES Act, H.R. 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act, S. 1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019, Surprise billing: S. 1531 - Stop the Outrageous Practice of Surprise Medical Bills Act of 2019; HR 3, the Lower Drug Costs Now Act; H.R.2149 - Exposing the Financing of Human Trafficking Act; H.R.508 - Trafficking Victims Housing Act of 2019; H.R. 1520 - Purple Book Continuity At of 2019; H.R. 1503 - Orange Book Transparency Act of 2019; S.2543 - Prescription Drug Pricing Reduction Act of 2019; Health care privacy; H.R. 647, S.2080 - Palliative Care and Hospice Education and Training Act; Conrad 30 and the Physician Access Reauthorization Act, S 948; Issues related to the Medicaid Fiscal Accountability Regulation (MFAR); HR 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act; HR 6201 - Families First Coronavirus Response Act; HR 748 - Coronavirus Aid, Relief, and Economic Security (CARES) Act; response to the COVID-19 public health emergency; S. 178 - HEALS Act; H.R. 1425, Patient Protection and Affordable Care Enhancement Act; H.R. 6800 - HEROES Act; H.R. 266, Paycheck Protection Program and Health Care Enhancement Act; issues related to coverage of virtual care

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), Vice President of the U.S.

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

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

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

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

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

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

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

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

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

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

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

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

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

Client expense: $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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800 - Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act S. 3548 - CARES Act H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act

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

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

BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA

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

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