The Newborn Screening Saves Lives Reauthorization Act of 2019

Regulatory and legislative health care issues impacting pricing and access; issues related to diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinson's Disease; Issues related to Telehealth; S. 2061 Telemental Healthcare Access Act of 2021; H.R. 4439/S.4010, Creating Hope Reauthorization Act; H.R. 2507/S.2158, Newborn Screening Saves Lives Reauthorization Act; H.R. 6000 Cures 2.0.

Client expense: $730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access; issues related to diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinson's Disease; Issues related to Telehealth; S. 2061 Telemental Healthcare Access Act of 2021; H.R. 4439/S.4010, Creating Hope Reauthorization Act; H.R. 2507/S.2158, Newborn Screening Saves Lives Reauthorization Act; H.R. 6000 Cures 2.0.

Client expense: $730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access; issues related to diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinson's Disease; Issues related to Telehealth; S. 2061 Telemental Healthcare Access Act of 2021; H.R. 4439/S.4010, Creating Hope Reauthorization Act; H.R. 2507/S.2158, Newborn Screening Saves Lives Reauthorization Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access; issues related to diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinson's Disease; Telehealth; H.R. 4439/S. 4010, Creating Hope Reauthorization Act; H.R. 2507 / S. 2158, Newborn Screening Saves Lives Reauthorization Act; and S. 2061, Telemental Healthcare Access Act of 2021.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives; drug pricing proposals; access to rare disease and gene therapy drugs; and FDA approvals of drugs designed to treat rare diseases, including gene therapies. Issues pertaining to newborn screening and gene panel screening, including, H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019 and S. 2158, the Newborn Screening Saves Lives Reauthorization Act of 2019 (116th Congress). Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021.

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

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.

Client expense: $420,000 · Firm income: Not reported

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.

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

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

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated on the Promising Pathway Act (S.3872) and the ACT for ALS Act (H.R.7071). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. H.R. 6800, HEROES Act and related COVID-19 packages, support various provisions relevant to people with NMDs including increased federal support for state Medicaid programs; Medicaid maintenance of effort provisions; nationwide reopening of Marketplace special enrollment period; expansion of paid sick leave and paid family and medical leave; making permanent flexibilities to allow Medicare beneficiaries to continue accessing healthcare through telehealth; more resources to enhance testing and contact tracing in underserved communities; opposing waivers from IDEA and the Rehab Act; and better data collection on the impact of COVID-19 on people with disabilities. Continuing to support passage of legislation and proposals to protect patients from surprise medical billing and hold patients harmless.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

H.R. 133: Consolidated Appropriations Act, 2021; Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 8920: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 4421: Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; all provisions S. 4557: COVID Enrollment Response (COVER) Act; all provisions S. 4760: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.J. Res. 110: Extension of Continuing Appropriations Act, 2021; provisions related to funding for Health and Human Services and related agencies, Food and Drug Administration and related agencies, funding for nutrition assistance programs, and medical expense deduction H.R. 133: Consolidated Appropriations Act, 2021; Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research, funding for Department of Health and Human Services (HHS) and related agencies, Food and Drug Administration (FDA) and related agencies H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; Provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 8920: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 4760: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act 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 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; 304B drug discount program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.

Client expense: $410,000 · Firm income: Not reported

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

Maternal and child health legislation, emergency preparedness and COVID-19 response efforts, tobacco control, opioids legislation and neonatal abstinence syndrome (NAS), environmental health, vaccination, newborn screening, Healthy Start, maternal mental health. Specific legislation includes: H.R. 4995, Maternal Health Quality Improvement Act of 2020, H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2020, Newborn Screening Saves Lives Reauthorization Act of 2019 (HR 2507, S. 2158). Black Maternal Health Momnibus Act of 2020 (HR 6142)including the Social Determinants for Moms Act (HR 6132), the Protecting Moms who Served Act (HR 6164), the Data to Save Moms Act (HR 6165), the Moms MATTER Act (HR 6143), and Kira Johnson Act (HR 6144). Mothers and Newborns Success Act (S.4269), Maternal Health Pandemic Response Act of 2020 (H.R. 8027), Community Immunity During COVID-19 Act of 2020 (H.R. 8061), Maternal Immunization Enhancement Act (S.4690), Public Health Infrastructure Saves Lives Act (PHISLA), COVID-19 Treatment Coverage Act (S.4469)

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Postal Regulatory Commission, SENATE, Small Business Administration (SBA), Treasury, Dept of, U.S. Postal Service (USPS)

Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues; HR 133, Consolidated Appropriations Act of 2021

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

Drug pricing, gene therapy, and rare disease funding generally; H.R. 4393 - Advancing Access to Precision Medicine; H.R. 2507/S. 2158 Newborn Screening Saves Lives Reauthorization Act; H.R. 8045 - Genome Editing Threat Assessment Act; HR 2501 - Medical Nutrition Equity Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access; Diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinsons Disease; Issues related to Telehealth; H.R. 4439/S.4010, Creating Hope Reauthorization Act; H.R. 2507/S.2158, Newborn Screening Saves Lives Reauthorization Act.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives; drug pricing proposals; access to rare disease and gene therapy drugs, including S. 2543, The Prescription Drug Pricing Reduction Act of 2019, H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, H.R. 19, the Lower Costs, More Cures Act of 2019, H.R. 5882, the GENE Therapy Payment Act, and H.R. 4439, Creating Hope Reauthorization Act; newborn screening and gene panel screening, including, H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019 and S. 2158, the Newborn Screening Saves Lives Reauthorization Act of 2019; H.R. 4439, Creating Hope Reauthorization Act; and FDA approvals of drugs designed to treat rare diseases; Health care policies in P.L. 116- 123, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; P.L. 116-127, the Families First Coronavirus Response Act; P.L. 116-136, the Coronavirus Aid, Relief, and Economic Security Act of CARES Act; P.L. 116-139, the Paycheck Protection Program and Health Care Enhancement Act; H.R. 6800, the Heroes Act; H.R. 8406, the Heroes Act; Senate Amendment 2652 related to COVID-19 relief; P.L. 116-159, the Continuing Appropriations Act, 2021 and Other Extensions Act; and P.L.116-260, Consolidated Appropriations Act, 2021.

Client expense: Not reported · Firm income: $40,000

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

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated on the Promising Pathway Act (S.3872) and the ACT for ALS Act (H.R.7071). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. H.R. 6800, HEROES Act and related COVID-19 packages, support various provisions relevant to people with NMDs including increased federal support for state Medicaid programs; Medicaid maintenance of effort provisions; nationwide reopening of Marketplace special enrollment period; expansion of paid sick leave and paid family and medical leave; making permanent flexibilities to allow Medicare beneficiaries to continue accessing healthcare through telehealth; more resources to enhance testing and contact tracing in underserved communities; opposing waivers from IDEA and the Rehab Act; and better data collection on the impact of COVID-19 on people with disabilities. Continuing to support passage of legislation and proposals to protect patients from surprise medical billing and hold patients harmless.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.

Client expense: $1,160,000 · Firm income: Not reported

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

H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; Provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 7269: Promising Pathway Act; all provisions H.R. 8337: Continuing Appropriations Act, 2021 and Other Extensions Act; Provisions related to funding for the National Institutes of Health (NIH), Food and Drug Administration (FDA), and related agencies S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 3872: Promising Pathway Act; all provisions Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research (Draft) 21st Century Cures 2.0; all provisions of the draft (Draft) Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions of the draft (Draft) Labor, Health and Human Services (LHHS) Appropriations for Fiscal Year 2021; provisions related to funding for Health and Human Services and related agencies (Draft) Draft Agriculture Appropriations for Fiscal Year 2021; provisions related to funding for the Food and Drug Administration and related agencies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 7269: Promising Pathway Act; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 3872: Promising Pathway Act; all provisions S. 4421: Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; all provisions S. 4557: COVID Enrollment Response (COVER) Act; all provisions Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research (Draft) 21st Century Cures 2.0; all provisions of the draft (Draft) Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions of the draft

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues

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

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

Maternal and child health legislation,focusing on National Children's Study (ECHO), Zika preparedness, tobacco control, opioids legislation and neonatal abstinence syndrome (NAS), antibiotic resistance, environmental health, vaccination, newborn screening, Healthy Start, maternal mental health. Specific legislation includes: MOMMAs Act (H.R. 1897/S. 916, MOMs Act (S. 116),MOMMIES Act (H.R. 2602, S. 1343), Quality Care for Moms and Babies Act (H.R. 1551/S. 1960), Maternal CARE Act (H.R. 6698/S. 1600), The Healthy Maternity and Obstetric Medicine Act (Healthy MOM Act) (H.R. 2778/S. 1481), Rural Maternal and Obstetric Modernization of Services (MOMS) Act (S. 2373), the Maternal Outcomes Matter Act of 2019 (S. 2586), Healthy Maternity and Obstetric Medicine Act (H.R. 2778, S. 1481), H.R. 4995, Maternal Health Quality Improvement Act of 2019, H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019, Reversing the Youth Tobacco Epidemic Act (H.R. 2339), Public Health Funding Restoration Act (H.R. 3447, S. 1944), and the Comprehensive Addiction Resources Emergency CARE Act (H.R. 2569, S. 1365), Newborn Screening Saves Lives Reauthorization Act of 2019 (HR 2507/S. 2158), Traveling Parents Screening Consistency Act (HR 3246), the Tobacco Tax Equity Act (S. 2517), EQUIP Act of 2020 (HR 6178), and the Protecting American Lungs Act of 2019 (HR 4742). Black Maternal Health Momnibus Act of 2020 (HR 6142)including the Social Determinants for Moms Act (HR 6132), the Protecting Moms who Served Act (HR 6164), the Data to Save Moms Act (HR 6165), the Moms MATTER Act (HR 6143), and Kira Johnson Act (HR 6144). Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), Families First Coronavirus Response Act (P.L. 116-127), Coronavirus Aid, Relief, and Economic Security (CARES) Act (HR 748) (P.L. 116-136), and HEROES Act (H.R. 6800). Mothers and Newborns Success Act (S.4269), Maternal Health Pandemic Response Act of 2020 (H.R. 8027), Community Immunity During COVID-19 Act of 2020 (H.R. 8061), Maternal Immunization Enhancement Act (S.4690), Public Health Infrastructure Saves Lives Act (PHISLA), COVID-19 Treatment Coverage Act (S.4469)

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Postal Regulatory Commission, SENATE, Treasury, Dept of, U.S. Postal Service (USPS)

S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act 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 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access; Diagnosis and treatment of Tardive Dyskinesia; Diagnosis and treatment of Parkinsons Disease; Issues related to Telehealth; H.R. 4439/S.4010, Creating Hope Reauthorization Act; H.R. 2507/S.2158, Newborn Screening Saves Lives Reauthorization Act.

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives; drug pricing proposals; access to rare disease and gene therapy drugs, including S. 2543, The Prescription Drug Pricing Reduction Act of 2019, H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, H.R. 19, the Lower Costs, More Cures Act of 2019, H.R. 5882, the GENE Therapy Payment Act, and H.R. 4439, Creating Hope Reauthorization Act; newborn screening and gene panel screening, including, H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019 and S. 2158, the Newborn Screening Saves Lives Reauthorization Act of 2019; and FDA approvals of drugs designed to treat rare diseases. Health care policies in P.L. 116- 123, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; P.L. 116-127, the Families First Coronavirus Response Act; P.L. 116-136, the Coronavirus Aid, Relief, and Economic Security Act of CARES Act; P.L. 116-139, the Paycheck Protection Program and Health Care Enhancement Act; H.R. 6800, the Heroes Act; H.R. 8406, the Heroes Act; Senate Amendment 2652 related to COVID-19 relief; and H.R. 8337, the Continuing Appropriations Act, 2021 and Other Extensions Act.

Client expense: Not reported · Firm income: $40,000

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

Drug pricing and gene therapy, generally; H.R. 4393 - Advancing Access to Precision Medicine; H.R. 2507/S. 2158 Newborn Screening Saves Lives Reauthorization Act; H.R. 8045 - Genome Editing Threat Assessment Act; HR 2501 - Medical Nutrition Equity Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Maternal and child health legislation,focusing on National Children's Study (ECHO), Zika preparedness, tobacco control, opioids legislation and neonatal abstinence syndrome (NAS), antibiotic resistance, environmental health, vaccination, newborn screening, Healthy Start, maternal mental health. Specific legislation includes: MOMMAs Act (H.R. 1897/S. 916, MOMs Act (S. 116),MOMMIES Act (H.R. 2602, S. 1343), Quality Care for Moms and Babies Act (H.R. 1551/S. 1960), Maternal CARE Act (H.R. 6698/S. 1600), The Healthy Maternity and Obstetric Medicine Act (Healthy MOM Act) (H.R. 2778/S. 1481), Rural Maternal and Obstetric Modernization of Services (MOMS) Act (S. 2373), the Maternal Outcomes Matter Act of 2019 (S. 2586), Healthy Maternity and Obstetric Medicine Act (H.R. 2778, S. 1481), H.R. 4995, Maternal Health Quality Improvement Act of 2019, H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019, Reversing the Youth Tobacco Epidemic Act (H.R. 2339), Public Health Funding Restoration Act (H.R. 3447, S. 1944), and the Comprehensive Addiction Resources Emergency CARE Act (H.R. 2569, S. 1365), Newborn Screening Saves Lives Reauthorization Act of 2019 (HR 2507/S. 2158), Traveling Parents Screening Consistency Act (HR 3246), the Tobacco Tax Equity Act (S. 2517), EQUIP Act of 2020 (HR 6178), and the Protecting American Lungs Act of 2019 (HR 4742). Black Maternal Health Momnibus Act of 2020 (HR 6142)including the Social Determinants for Moms Act (HR 6132), the Protecting Moms who Served Act (HR 6164), the Data to Save Moms Act (HR 6165), the Moms MATTER Act (HR 6143), and Kira Johnson Act (HR 6144). Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), Families First Coronavirus Response Act (P.L. 116-127), Coronavirus Aid, Relief, and Economic Security (CARES) Act (HR 748) (P.L. 116-136), and HEROES Act (H.R. 6800).

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Postal Regulatory Commission, SENATE, Treasury, Dept of, U.S. Postal Service (USPS)

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 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 CONTROLLED SUBSTANCE UTILIZATION REVIEW AND EVALUATION SYSTEM 2.0: GENERAL DISCUSSIONS REGARDING INNOVATION GENERAL DISCUSSIONS REGARDING GENE THERAPY AND OFFICE OF BIOTECHNOLOGY ACTIVITIES GENERAL DISCUSSIONS REGARDING ORPHAN DRUG ACT

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated on the Promising Pathway Act (S.3872) and the ACT for ALS Act (H.R.7071). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. H.R. 6800, HEROES Act and Senate-led COVID-19 package, support various provisions relevant to people with NMDs including increased federal support for state Medicaid programs; Medicaid maintenance of effort provisions; nationwide reopening of Marketplace special enrollment period; expansion of paid sick leave and paid family and medical leave; making permanent flexibilities to allow Medicare beneficiaries to continue accessing healthcare through telehealth; more resources to enhance testing and contact tracing in underserved communities; opposing waivers from IDEA and the Rehab Act; and better data collection on the impact of COVID-19 on people with disabilities. H.R. 6420/S. 3652 All Dependents Count Act, support passage. H.R. 3630, No Surprises Act; S. 1895, Lower Health Care Costs Act; S. 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; H.R. 5800, Ban Surprise Billing Act; H.R. 5826 Consumer Protections Against Surprise Medical Bills Act, support passage of legislation to protect patients from surprise medical billing that holds patients harmless H.R. 127, Compassionate Access, Research Expansion and Respect States (CARERS) Act, support passage

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;

Client expense: $1,330,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives; drug pricing proposals; access to rare disease and gene therapy drugs, including S. 2543, The Prescription Drug Pricing Reduction Act of 2019, H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, H.R. 19, the Lower Costs, More Cures Act of 2019, and H.R. 5882, the GENE Therapy Payment Act; newborn screening and gene panel screening, including, H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019 and S. 2158, the Newborn Screening Saves Lives Reauthorization Act of 2019; and FDA approvals of drugs designed to treat rare diseases. Health care policies in P.L. 116-123, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; P.L. 116-127, the Families First Coronavirus Response Act; P.L. 116-136, the Coronavirus Aid, Relief, and Economic Security Act of CARES Act; and P.L. 116-139, the Paycheck Protection Program and Health Care Enhancement Act.

Client expense: Not reported · Firm income: $40,000

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

Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; issues related kidney care

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

FY20 Agriculture Appropriation bill (HR3164/S2522) S.9 Traditional Cigar Manufacture and Jobs Preservation Act S.1541/H.R.2411, S2158, S1541, HR2339, S655, HR1498

Client expense: $186,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

general issues related to drug pricing; issues related to cosmetic regulations; issues related to insulin pricing;issues related to s.102 "Prescription Drug Price Relief Act of 2019"; issues related to International Reference pricing; issues related to OTC Monograph Reform in CARES Act; issues related to HSA/FSA in CARES Act; issues related to Vaccine provisions in CARES Act; issues related to prescription to over-the-counter switch; issues related to Drug Importation;issues related to H.R. 3 "Lower Drug Costs Now Act of 2019"; issues related to S. 2740 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019"; issues related to influenza vaccines; issues related to the Executive Order on Flu; issues related to Coronavirus COVID-19; issues related to Copay Accumulators; issues related to RSV access; issues related to HR.3433- Over the counter Monograph Safety, Innovation and Reform Act 2019; issues related to S.2158- Newborn Screening Saves Lives; and issues related to CMMI- Insulin Demo.

Client expense: $1,750,000 · Firm income: Not reported

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; provisions related to the Department of Health and Human Services and Health-related line items H.R. 6201: Families First Coronavirus Response Act; provisions related to the Department of Health and Human Services and Health-related line items S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2543: Prescription Drug Pricing Reduction Act of 2019; all provisions (Draft) Labor, Health and Human Services (LHHS) appropriations for Fiscal Year 2021; provisions related to funding for Health and Human Services and related agencies (Draft) Draft Agriculture Appropriations for Fiscal Year 2021; provisions related to funding for the Food and Drug Administration and related agencies

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.J. Res. 74: Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers"; all provisions H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act; all provisions H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 3630: No Surprises Act; all provisions H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; provisions related to the Department of Health and Human Services and Health-related line items H.R. 6201: Families First Coronavirus Response Act; provisions related to the Department of Health and Human Services and Health-related line items Ways & Means and Energy & Commerce discussion draft on capping Medicare Part D out-of-pocket costs; all provisions S.J. Res. 52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers"; all provisions S. 110:Medical Expense Savings Act; all provisions S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019; all provisions S. 1531: Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2543: Prescription Drug Pricing Reduction Act of 2019; all provisions

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of the Medical Nutrition Equity Act (H.R.2501). Advocated for Members to join the Rare Disease Caucus and the ALS Caucus. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated for the continuance of the Rare Pediatric Disease Priority Review Voucher Program within the context of the Creating Hope Reauthorization Act (H.R.4439) Advocated for passage of Families First Coronavirus Response Act (HR 6201) and Coronavirus Preparedness and Response Supplemental Appropriations Act (HR 6704). Advocated for a joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers" (H.J. Res. 74 / S.J. Res. 52).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Maternal and child health legislation,focusing on National Children's Study (ECHO), Zika preparedness, tobacco control, opioids legislation and neonatal abstinence syndrome (NAS), antibiotic resistance, environmental health, vaccination, newborn screening, Healthy Start, maternal mental health. Specific legislation includes: MOMMAs Act (H.R. 1897/S. 916, MOMs Act (S. 116),MOMMIES Act (H.R. 2602, S. 1343), Quality Care for Moms and Babies Act (H.R. 1551/S. 1960), Maternal CARE Act (H.R. 6698/S. 1600), The Healthy Maternity and Obstetric Medicine Act (Healthy MOM Act) (H.R. 2778/S. 1481), Rural Maternal and Obstetric Modernization of Services (MOMS) Act (S. 2373), the Maternal Outcomes Matter Act of 2019 (S. 2586), Healthy Maternity and Obstetric Medicine Act (H.R. 2778, S. 1481), H.R. 4995, Maternal Health Quality Improvement Act of 2019, H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019, Reversing the Youth Tobacco Epidemic Act (H.R. 2339), Public Health Funding Restoration Act (H.R. 3447, S. 1944), and the Comprehensive Addiction Resources Emergency CARE Act (H.R. 2569, S. 1365), Newborn Screening Saves Lives Reauthorization Act of 2019 (HR 2507/S. 2158), Traveling Parents Screening Consistency Act (HR 3246), the Tobacco Tax Equity Act (S. 2517), EQUIP Act of 2020 (HR 6178), and the Protecting American Lungs Act of 2019 (HR 4742). Black Maternal Health Momnibus Act of 2020 (HR 6142)including the Social Determinants for Moms Act (HR 6132), the Protecting Moms who Served Act (HR 6164), the Data to Save Moms Act (HR 6165), the Moms MATTER Act (HR 6143), and Kira Johnson Act (HR 6144). Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), Families First Coronavirus Response Act (P.L. 116-127), and Coronavirus Aid, Relief, and Economic Security (CARES) Act (HR 748) (P.L. 116-136).

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Postal Regulatory Commission, SENATE, Treasury, Dept of, U.S. Postal Service (USPS)

H.R. 2507: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 6238: CAMERON'S LAW; ALL PROVISIONS OF THE BILL S 2158: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING PRESCRIPTION DRUG PRICING AND GENE THERAPY GENERAL DISCUSSIONS REGARDING ORPHAN DRUG ACT

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

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

S.2158 - Newborn Screening Saves Lives Reauthorization Act of 2019

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

Government targets: SENATE

Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2022 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law

Client expense: $360,000 · Firm income: Not reported

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