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.

H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Executive Order on Lowering Drug Prices by Putting America First and Most Favored Nation (MFN) model Interim Final Rule H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Home administration for Part B medicines due to COVID-19 Reimbursement for biologics/biosimilars Issues related to Part D redesign Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance) S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act of 2019

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

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

Administration drug pricing proposals. HCV testing, screening and linkage to care programs. Medicaid and Medicare coverage, access and reimbursement issues for Hepatitis C, HIV, and oncology products, including Medicare Part B proposals, and Medicare Part D reform and benefit redesign. CMS rules related to Notice of Benefit and Payment Parameters (NBPP), hospital inpatient payments, and Value-Based Purchasing arrangements. H.R.3 - Lower Drug Costs Now Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.259 - Medicaid Extenders Act of 2019 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 S.2543 - The Prescription Drug Pricing Reduction Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 H.R. 133 - Consolidated Appropriations Act, 2021

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Implementation of the Affordable Care Act Surprise medical billing Accumulator adjustor issues H.R. 7647, the Preserving Patient Savings on Drug Costs Act Coverage for Telehealth Services Policies related to COVID and immunocompromised populations Proposed waivers under Sections 1115 and 1332 of the Social Security Act Proposed rule related to Securing Updated and Necessary Statutory Evaluations Timely Proposed rule on Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency Proposed rules on Notice of Benefit and Payment Parameters Interim final rule on Most Favored Nation policy Proposed rule related to prior authorization policies in Medicaid and private plans

Client expense: Not reported · Firm income: $51,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE

PL 116-260 FY2021 Omnibus and COVID Relief and Response Act - support for telehealth expansion, Part B home infusion expansion, limits on copays, support for CMS waiver authority HR 2279/ S 2546 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide an exceptions process for any medication step therapy protocol, and for other purposes. (Step Therapy Reform) HR 3107 - Improving Seniors Timely Access to Care Act (prior authorization reform) HR 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. Various telehealth bills (education)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1425, Patient Protection and Affordable Care Enhancement Act - provisions relating to pharmaceutical price controls H.R.6383, Uterine Fibroid Research and Education Act of 2020 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 340B drug discount program policy issues Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans proposed rule

Client expense: $650,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 3215/ S. 1754 - Disaster Relief Medicaid Act, support passage 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, support passage H.R. 2293, the Protecting Access to Wheelchairs Act, support passage H.R. 3107, Improving Seniors Timely Access to Care Act of 2019, support passage S. 1223, the Protecting Beneficiary Access to Complex Rehab Technology Act, support passage S. 1280/HR 2477 - Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act, support passage S. 691 - Medicare Extra Rx Help Act- support passage S. 2543 - Prescription Drug Price Reduction Act of 2019 - support passage oMenendez - Lankford- Cardin-Daines Amendment 1 Incentivizing Generic and Biosimilar Use in Medicare Part D - support adoption oMenendez -Lankford - Cardin --Daines Amendment 2 Incentivizing Generic Use in Medicare Part D, support adoption S.2911, the Seniors Prescription Drug Relief Act of 2019, support passage. S.4468, COVID-19 Treatment Coverage 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

Notice of Benefit and Payment Parameters Telehealth - H.R. 884 the Medicare Mental Health Access Act Telehealth - H.R. 945 the Mental Health Access Improvement Act of 2019 Telehealth - H.R. 5201 the Telemental Health Expansion Act of 2019 340B Drug Pricing Program Executive Order on Lowering Drug Prices by Putting America First Most Favored Nation Model Rule - Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements H.R. 7647 the Preserving Patient Savings on Drug Costs Act

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Title VII, Public Health Service Act - Biosimilars - Surprise Medical Billing - H.R. 3630 No Surprises Act - H.R. 133 Consolidated Appropriations Act - H.R. 2279 / S. 2546, Safe Step Act of 2019 - S. 1895, Lower Health Care Costs Act - H.R 3, Lower Drug Costs Now Act of 2019 - H.R. 748, the CARES Act - S. 2496 and H.R. 4386' Stop the Wait Act - H.R. 7647

Client expense: $75,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), 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, Veterans Affairs, Dept of (VA)

H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency 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. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency 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. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 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, 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) Executive Order 13937, Access to Affordable Life-saving Medications (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

Client expense: $1,210,000 · 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)

Medicare Part D policies. H.R. 3 - Lower Drug Costs Now Act of 2019 S.2543, Prescription Drug Pricing Reduction Act of 2019 H.R. 7647 - Preserving Patient Savings on Drug Costs Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Administration drug pricing proposals. HCV testing, screening and linkage to care programs. Medicaid and Medicare coverage, access and reimbursement issues for Hepatitis C, HIV, and oncology products. Medicare Part D reform and benefit redesign. CMS rules related to Notice of Benefit and Payment Parameters (NBPP), hospital inpatient payments, and value-based purchasing arrangements. H.R.3 - Lower Drug Costs Now Act of 2019 H.R.19 - Lower Costs, More Cures Act of 2019 H.R.259 - Medicaid Extenders Act of 2019 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 S.2543 - The Prescription Drug Pricing Reduction Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019

Client expense: $1,810,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

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. FY 2021 Notice of Benefits and Payment Parameters proposed rule. CMS proposed rule on Medicaid Drug Rebate program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6800 - HEROES (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 2021 Notice of Benefit and Payment Parameters (NBPP) rule and cost-sharing assistance H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Issues related to Most Favored Nation (MFN)/International Pricing Index (IPI) Executive Order, no specific bill H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Medicare Part B coverage and reimbursement issues Home administration for Part B medicines due to COVID-19 Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign Issues related to Part D rebate reform Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to Direct to Consumer Advertisement Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance)

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

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

H.R. 1425, Patient Protection and Affordable Care Enhancement Act - provisions relating to pharmaceutical price controls H.R.6383, Uterine Fibroid Research and Education Act of 2020 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. 340B drug discount program policy issues Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans proposed rule

Client expense: $1,430,000 · Firm income: Not reported

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

H.R. 2507: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 4439: CREATING HOPE REAUTHORIZATION ACT; ALL PROVISIONS OF THE BILL H.R. 4712: FAIRNESS IN ORPHAN DRUG EXCLUSIVITY ACT; ALL PROVISIONS OF THE BILL H.R. 7567: HELPING EXPERTS ACCELERATE RARE TREATMENTS (HEARTS) ACT OF 2020; ALL PROVISIONS OF THE BILL 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; ALL PROVISIONS OF THE BILL S. 2158: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL S. 4010: CREATING HOPE REAUTHORIZATION ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING FOOD & DRUG ADMINISTRATION'S COMPLETE RESPONSE LETTER; BREAKTHROUGH THERAPY PROGRAM; HEALTH INNOVATION; NEWBORN SCREENING; VALUE BASED ARRANGEMENTS

Client expense: $230,000 · Firm income: Not reported

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

COVID relief packages - support for telehealth expansion, Part B home infusion expansion, limits on copays, support for CMS waiver authority HR 2279/ S 2546 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide an exceptions process for any medication step therapy protocol, and for other purposes. (Step Therapy Reform) HR 3107 - Improving Seniors Timely Access to Care Act - prior authorization reform HR 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.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency 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. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency 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. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Transparency policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 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, 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) Executive Order 13937, Access to Affordable Life-saving Medications (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

Client expense: $5,960,000 · Firm income: Not reported

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

H.R. 748 - CARES Act - Courtney - COVID-19 coverage H.R. 1418 - Competitive Health Insurance Reform Act of 2020 - DeFazio - antitrust laws, health insurance H.R. 3630 - No Surprises Act - Pallone - surprise medical billing H.R. 3784 - Air Ambulance Affordability Act of 2019 - Neguse - air ambulances H.R. 4223 - Protecting Patients from Surprise Medical Bills Act - Spano - surprise medical billing H.R. 5121 - Healthcare Cost Transparency Act - Beyer - provider price comparison tool H.R. 5239 - Prescription Drug Price Reporting Act - Joyce - reporting on drug expenditures and price changes under group health plans H.R. 5575 - Primary and Behavioral Health Care Access Act of 2020 -Underwood - coverage of primary care and behavioral health visits H.R. 6005 - Know the Price Act - Malinowski - health plan transparency H.R. 6173 - Covering Coronavirus Test Act of 2020 - DeGette - COVID-19 testing coverage H.R. 6193 - Medication Access in Emergencies Act of 2020 - Pappas - coverage of prescription drugs during emergency periods H.R. 6201 - Families First Coronavirus Response Act - Lowey - includes several provisions related to COVID-19 testing coverage H.R. 6213 - No Cost for COVID-19 Testing Act - Wilson - COVID-19 testing coverage H.R. 6214 - To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program - Kind - Medicare Advantage coverage of COVID-19 related visits and testing H.R. 6222 - Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Schakowsky - coverage of certain new preventative services related to COVID-19 H.R. 6231 - Ensuring Access to COVID-19 Preventive Care Act of 2020 - Bucshon - coverage of certain vaccines and testing services during the COVID-19 emergency H.R. 6299 - Rapid Coverage of COVID-19 Vaccine Act of 2020 - Courtney - COVID-19 coverage H.R. 6317 - To provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Doggett - special enrollment periods in public health emergency H.R. 6338 - To waive high deductible health plan requirements for health savings accounts -Budd - HDHP coverage during COVID H.R. 6486 - Care for COVID-19 Act 2.0 -Ruiz - COVID H.R. 6514 - Worker Health Coverage Protection Act - Scott - COVID H.R. 6518 - Stop Health Premium Spikes Act of 2020 - Peters - risk corridors H.R. 6532 - COVID Special Enrollment Act of 2020 - Doggett - COVID H.R. 6568 - Coverage for COVID-19 Treatment Act of 2020 - Rochester - COVID H.R. 6644 - To require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for services furnished via telehealth if such services would be covered if furnished in-person during the COVID-19 emergency. -Schrier - COVID H.R. 6674 - Medicare Crisis Program Act of 2020 -Jayapal - COVID H.R. 6712 - American Healthshare Plans Act of 2020 - Curtis - health share pools H.R. 6810 - Health Care Protection Act -Davis - COVID H.R. 7006 - Improving Care in Home Health Agencies Act - Velazquez - home health services H.R. 7267 - To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to prohibit a group health plan and a health insurance issuer offering group or individual health insurance coverage from reducing contracted rates, or terminating contracts, with health care providers during a public health emergency. - Porter - ERISA H.R. 7475 - Ensuring FEHBP Coverage During Pandemic Act - Vela - special enrollment period H.R. 7539 - Strengthening Behavioral Health Parity Act - Kennedy - strengthen mental health and SUD benefits 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 - McEachin - drug manufacturer support applied to patient out-of-pocket limit H.R. 7659 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 - Sewell - inclusion of certain audio-only diagnoses in the determination of risk adjustment for MA plans H.R. 7676 - Health Care Prices Revealed and Information to Consumers Explained Transparency Act - Flores - hospital and insurer price transparency H.R. 7722 - Matts Act - Fortenberry - limit price of insulin drugs accessible for those enrolled in group or indiv. health insurance coverage, group health plans, uninsured H.R. 7921 - Connecting Communities to Grant Opportunities Act of 2020 - Velazquez - navigator programs H.R. 7942 - Public Health Emergency COBRA Extension Act -Sanchez - COBRA extension H.R. 8060 - Tele-Mental Health Improvement Act - Trone - parity in mental health and SUD service under private insurance H.R. 8181 - Jack Reynolds Memory MediGap Expansion - Axne - Medigap coverage for Medicare ESRD H.R. 8308 - Telehealth Coverage and Payment Parity Act - Phillips - coverage for services furnished through telehealth H.R. 8330 - No Surprise Bills for New Moms Act - Porter - health coverage of newborns S. 1531 - STOP Surprise Medical Bills Act - Cassidy-Bennet - surprise medical billing S. 1948 - Chronic Disease Management Act - Thune - pre-deductible coverage of chronic disease prevention services S. 2546 - Safe Step Act - Murkowski - Step therapy exceptions S. 3200 - Chronic Disease Management Act of 2020 - Thune - coverage of chronic disease prevention services S. 3383 - Continuing Coverage for Preexisting Conditions Act of 2020 -Kennedy - preexisting conditions S. 3499 - A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Smith - COVID-19 cost -sharing S. 3505 - A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Jones - rapid COVID-19 coverage S. 3536 - A bill to provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Casey - COVID-19 coverage S. 3610 - American Healthshare Plans Act of 2020 - Paul - health share pools S. 3631 - Relief for Rural Providers During Emergencies Act - Sasse - COVID S. 3741 - Health Care at Home Act of 2020 - Smith - COVID S. 3792 - Tele-Mental Health Improvement Act - Smith - parity S. 3821 - Affordable Health Care Options Act of 2020 - Loeffler - affordability S. 3991 - Coronavirus 2019 Special Enrollment Period Act - Duckworth - SEP S. 4106 - A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency - Braun - price transparency S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - Wicker - establish an IDR for air ambulance S. 4198 - Affordable Coronavirus Testing Act - Scott - coverage for COVID serology testing S. 4255 - Katherines Lung Cancer Early Detection and Survival Act of 2020 - Smith - group health plans, group and indiv coverage benefits for lung cancer screenings S. 4329 - Continuous Health Coverage for Workers Act - McSally - COBRA continuation coverage S. 4469 - COVID-19 Treatment Coverage Act - Smith - COVID treatment Medicaid/MA/Private/Medicare coverage S. 4506 - Pre-Existing Conditions Protection Act of 2020 - Gardner - coverage of pre-ex conditions under private insurance S. 4521 - Health Care Improvement Act of 2020 - Warner - expand ACA coverage S. 4557 - COVid Enrollment Response Act - Baldwin - assistance enrolling in health care coverage S. 4609 - Vaccine And Coverage Certainty Act - Wyden - coverage of COVID vaccine under Medicare/Medicaid, CHIP S. 4653 - A bill to prevent efforts of the Department of Justice to advocate courts to strike down the Patient Protection and Affordable Care Act - Schumer - ACA S. 4761 - A bill to amend the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide for 3 primary care visits and 3 behavioral health care visits without application of any cost-sharing requirement - King - coverage and cost-sharing Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

Client expense: $2,230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Implementation of the Affordable Care Act Surprise medical billing Accumulator adjustor issues H.R. 7647, the Preserving Patient Savings on Drug Costs Act Coverage for Telehealth Services S. 4557, The COVER Act Proposed Rule related to Grandfathered Plans Proposed Rule related to IRS policies for Medicare Care Arrangements Policies related to COVID and immunocompromised populations

Client expense: Not reported · Firm income: $51,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE

HR 7647-COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance; other issues and proposals related to COVID-19; and issues related to prescription drug pricing.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding Medicaid 340B drug discount program Discussions regarding H.R.7647, to provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group heath plans and individual and small group health insurance coverage Discussions related to S.4295, Public Health Emergency Pass-Through Payment Fairness Act of 2020

Client expense: $1,150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

H.R. 3215/ S. 1754 - Disaster Relief Medicaid Act, support passage H.R. 7647 H.R. 2293, the Protecting Access to Wheelchairs Act, support passage H.R. 3107, Improving Seniors Timely Access to Care Act of 2019, support passage S. 1223, the Protecting Beneficiary Access to Complex Rehab Technology Act, support passage S. 1280/HR 2477 - Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act, support passage S. 691 - Medicare Extra Rx Help Act- support passage S. 2543 - Prescription Drug Price Reduction Act of 2019 - support passage oMenendez - Lankford- Cardin-Daines Amendment 1 Incentivizing Generic and Biosimilar Use in Medicare Part D - support adoption oMenendez -Lankford - Cardin --Daines Amendment 2 Incentivizing Generic Use in Medicare Part D, support adoption S.2911, the Seniors Prescription Drug Relief Act of 2019, support passage. S.4468, COVID-19 Treatment Coverage Act, support passage

Client expense: $57,579 · Firm income: Not reported

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

Eliminating Out of Pocket Costs/cost-sharing in Medicare Parts A, B, C, and D for COVID-19 treatment services; Medicare Part D Smoothing; Medicare Part D Out of Pocket Costs; H.R. 7647, Preserving Patient Savings on Drug Costs Act.

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

- Title VII, Public Health Service Act - Biosimilars - Surprise Medical Billing - H.R. 2279 / S. 2546, Safe Step Act of 2019 - S. 1895, Lower Health Care Costs Act - H.R 3, Lower Drug Costs Now Act of 2019 - H.R. 748, the CARES Act - S. 2496 and H.R. 4386' Stop the Wait Act - H.R. 7647

Client expense: $75,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), 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, Veterans Affairs, Dept of (VA)