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Mitigating Emergency Drug Shortages Act
Legislative Progress
Introduced
October 29, 2019
Latest Action
October 29, 2019
Primary Sponsor
Susan M. CollinsRepublican(ME)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,086 other S bills in the 116th — cohort avg 30d
Mitigating Emergency Drug Shortages Act This bill requires the Food and Drug Administration (FDA) to prioritize the review of life-saving or life-sustaining drugs that are facing shortages. The bill also requires manufacturers to report certain information to the FDA when there is a permanent discontinuance or interruption in the manufacture of active pharmaceutical ingredients for such drugs.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (20)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S6245-6246)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2021 · first_quarter · Health Issues
Repeal of the Affordable Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program 340B dug pricing program CMS OPPS 340B rule moratorium-related legislation 42 CFR Part 2 CREATES Act-H.R.965 Cassidy Surprise Billing Draft Protecting Patients from Surprise Medical Bills Excellence in Metal Health Act (S.824/H.R.1767) Patient Centered Outcomes Research Institute Funding No Surprises Act Lower Health Care Costs Act Surprise Medical Bills H.R.4004 - Social Determinants Accelerator Act of 2019 S.2986 - Social Determinants Accelerator Act of 2019 H.R.2328 - Reauthorizing and Extending America's Community Health Act S.2723 - Mitigating Emergency Drug Shortages Act H.R.4995 - Maternal Health Quality Improvement Act of 2019 H.R.2889 - Closing Loopholes for Orphan Drugs Act 340B drug pricing program eligibility (Matsui-Stewart Dear Colleague letter) Relief for Rural Providers During Emergencies Act (S. 3631) Improving Social Determinants of Health Act (H.R. 6561) Liability reform Issues related to COVID-19 regulatory and financial relief COVID-19 Provider Relief Fund Resolution recognizing racism as public health issue - S. Res. 655 COVID-19 Bias and Anti-Racism Training Act - S. 4248 Protecting 340B eligibility during the pandemic - S. 4160 and HR 7838 Protect Telehealth Access Act of 2020 (HR 7391) Improving Social Determinants of Health Act - S. 4440 Maternal health 340B contract pharmacies (McKinley-DeGette-Gianforte-Matsui-Johnson-Welch Dear Colleague letter) 340B contract pharmacies (Baldwin-Capito-Cardin-Portman-Stabenow-Thune Dear Colleague letter) Delivering Immediate Relief to Americas Families, Schools and Small Businesses Act Health disparities COVID-19 payroll tax credits oIssues related to 340B drug pricing program oCOVID-19 liability protection oSkilled immigration/employment visas oIssues related to telehealth oIssues related to disparities in health and health care oIssues related to maternal health oHR 959 - Black Maternal Health Momnibus Act oHR 379/S. 104 - Improving Social Determinants of Health Act oHR 2054 - No Surprise for New Moms Act oHR 526 - Ensuring Coverage in Public Health Emergencies Act oHR 736 - Community Immunity During COVID-19 Act oHR 853 - Closing orphan drug loophole in 340B oHR 786 - Supporting State and Local Leaders Act oIssues related to 340B contract pharmacies and third-party vendors oIssues related to prescription drug prices
Client expense: $435,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · first_quarter · Health Issues
S.3548, CARES Act: To provide emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic; Practice Support/Grants to Practice S.3599, Healthcare Workforce Resilience Act: Foreign physician immigration status H.R. 7059, Coronavirus Provider Protection Act: Liability protection for healthcare providers Public Law No: 116-142, Paycheck Protection Program Flexibility Act of 2020 S.3201, Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act: Letter to Congressional Leadership regarding Fentanyl S.2723, Mitigating Emergency Drug Shortages Act: reducing drug shortages H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills H.R. 2500, National Defense Authorization Act for Fiscal Year 2020: Krishnamoorthi amdt on drug shortages H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019: pre-authorization S. 1895, Lower Health Care Costs Act H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs S.4349, Dr. Lorna Breen Health Care Provider Protection Act: physician health Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Outside Witness Testimony Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 H.R. 1554, REDI Act: student loan debt repayment for residents H.R.842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and opioid abuse; Brain health Certified Anesthesiologist Assistants Blood management COVID-19: Increased supply of PPE and ventilators, Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, Scope of Practice (Waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Centre for Clinical and Applied Services Provision Research
2020 · second_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
2020 · fourth_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
2020 · third_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
| Democratic |
| MN |
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $810,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $85,311 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020
Client expense: $550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets"; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements; Support S 4349, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support S. 3595Ensuring Understanding of COVID-19 to Protect Public Health Act, a bill that directs the NIH to conduct a longitudinal study on mild, moderate, and severe cases of COVID-19 on a diverse patient population.
Client expense: $4,460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Health Issues
Repeal of the Affordable Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program 340B dug pricing program CMS OPPS 340B rule moratorium-related legislation 42 CFR Part 2 CREATES Act-H.R.965 Cassidy Surprise Billing Draft Protecting Patients from Surprise Medical Bills Excellence in Metal Health Act (S.824/H.R.1767) Patient Centered Outcomes Research Institute Funding No Surprises Act Lower Health Care Costs Act Surprise Medical Bills H.R.4004 - Social Determinants Accelerator Act of 2019 S.2986 - Social Determinants Accelerator Act of 2019 H.R.2328 - Reauthorizing and Extending America's Community Health Act S.2723 - Mitigating Emergency Drug Shortages Act H.R.4995 - Maternal Health Quality Improvement Act of 2019 H.R.2889 - Closing Loopholes for Orphan Drugs Act 340B drug pricing program eligibility (Matsui-Stewart Dear Colleague letter) Relief for Rural Providers During Emergencies Act (S. 3631) Improving Social Determinants of Health Act (H.R. 6561) Liability reform Issues related to COVID-19 regulatory and financial relief COVID-19 Provider Relief Fund Resolution recognizing racism as public health issue - S. Res. 655 COVID-19 Bias and Anti-Racism Training Act - S. 4248 Protecting 340B eligibility during the pandemic - S. 4160 and HR 7838 Protect Telehealth Access Act of 2020 (HR 7391) Improving Social Determinants of Health Act - S. 4440 Maternal health 340B contract pharmacies (McKinley-DeGette-Gianforte-Matsui-Johnson-Welch Dear Colleague letter) 340B contract pharmacies (Baldwin-Capito-Cardin-Portman-Stabenow-Thune Dear Colleague letter) Delivering Immediate Relief to Americas Families, Schools and Small Businesses Act Health disparities COVID-19 payroll tax credits 340B rebate Dear Colleague letter (Spanberger-McKinley-Axne-Johnson-Matsui-Katko)
Client expense: $370,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · fourth_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
S.3548, CARES Act: To provide emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic; Practice Support/Grants to Practice S.3599, Healthcare Workforce Resilience Act: Foreign physician immigration status H.R. 7059, Coronavirus Provider Protection Act: Liability protection for healthcare providers Public Law No: 116-142, Paycheck Protection Program Flexibility Act of 2020 S.3201, Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act: Letter to Congressional Leadership regarding Fentanyl S.2723, Mitigating Emergency Drug Shortages Act: reducing drug shortages H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills H.R. 2500, National Defense Authorization Act for Fiscal Year 2020: Krishnamoorthi amdt on drug shortages H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019: pre-authorization S. 1895, Lower Health Care Costs Act H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs S.4349, Dr. Lorna Breen Health Care Provider Protection Act: physician health Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Outside Witness Testimony Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 H.R. 1554, REDI Act: student loan debt repayment for residents 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and opioid abuse; Brain health Certified Anesthesiologist Assistants Blood management COVID-19: Increased supply of PPE and ventilators, Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, Scope of Practice (Waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Centre for Clinical and Applied Services Provision Research
Client expense: $410,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Health Issues
Work on medical supply chain issues related to HR 133, the Consolidated Appropriations Act. Advocate for market-based reforms concerning inpatient drug shortages including, S.2723 the Mitigating Emergency Drug Shortages Act; HR 6080, the Preventing Drug Shortages Act; and S. 3343, the Medical Supply Chain Security Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
2020 · third_quarter · Pharmacy
H.R. 3, Lower Drug Costs Now Act of 2019 Issue: Support policies to reduce prescription drug prices H.R. 6080, Preventing Drug Shortages Act S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support legislation to reduce drug shortages
Client expense: $1,095,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office
2020 · third_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134, Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs
Client expense: $590,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · third_quarter · Health Issues
Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements.
Client expense: $4,860,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · third_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $219,650 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act.
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Pharmacy
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Repeal of the Affordable Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program 340B dug pricing program CMS OPPS 340B rule moratorium-related legislation 42 CFR Part 2 CREATES Act-H.R.965 Cassidy Surprise Billing Draft Protecting Patients from Surprise Medical Bills Excellence in Metal Health Act (S.824/H.R.1767) Patient Centered Outcomes Research Institute Funding No Surprises Act Lower Health Care Costs Act Surprise Medical Bills H.R.4004 - Social Determinants Accelerator Act of 2019 S.2986 - Social Determinants Accelerator Act of 2019 H.R.2328 - Reauthorizing and Extending America's Community Health Act S.2723 - Mitigating Emergency Drug Shortages Act H.R.4995 - Maternal Health Quality Improvement Act of 2019 H.R.2889 - Closing Loopholes for Orphan Drugs Act 340B drug pricing program eligibility (Matsui-Stewart Dear Colleague letter) Relief for Rural Providers During Emergencies Act (S. 3631) Improving Social Determinants of Health Act (H.R. 6561) Liability reform Issues related to COVID-19 regulatory and financial relief COVID-19 Provider Relief Fund Resolution recognizing racism as public health issue - S. Res. 655 COVID-19 Bias and Anti-Racism Training Act - S. 4248 Protecting 340B eligibility during the pandemic - S. 4160 and HR 7838 Protect Telehealth Access Act of 2020 (HR 7391) Improving Social Determinants of Health Act - S. 4440 Maternal health 340B contract pharmacies (McKinley-DeGette-Gianforte-Matsui-Johnson-Welch Dear Colleague letter) 340B contract pharmacies (Baldwin-Capito-Cardin-Portman-Stabenow-Thune Dear Colleague letter) Delivering Immediate Relief to Americas Families, Schools and Small Businesses Act Health disparities COVID-19 payroll tax credits
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · third_quarter · Health Issues
S.3548, CARES Act: To provide emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic; Practice Support/Grants to Practice S.3599, Healthcare Workforce Resilience Act: Foreign physician immigration status H.R. 7059, Coronavirus Provider Protection Act: Liability protection for healthcare providers Public Law No: 116-142, Paycheck Protection Program Flexibility Act of 2020 S.3201, Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act: Letter to Congressional Leadership regarding Fentanyl S.2723, Mitigating Emergency Drug Shortages Act: reducing drug shortages H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills H.R. 2500, National Defense Authorization Act for Fiscal Year 2020: Krishnamoorthi amdt on drug shortages H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019: pre-authorization S. 1895, Lower Health Care Costs Act H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Outside Witness Testimony Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 H.R. 1554, REDI Act: student loan debt repayment for residents 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and opioid abuse; Brain health Certified Anesthesiologist Assistants Blood management COVID-19: Increased supply of PPE and ventilators, Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, Scope of Practice (Waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · third_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $2,710,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · third_quarter · Health Issues
Advocate for market-based reforms concerning inpatient drug shortages including, S.2723 the Mitigating Emergency Drug Shortages Act; HR 6080, the Preventing Drug Shortages Act; and S. 3343, the Medical Supply Chain Security Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
2020 · second_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
Client expense: $850,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2020 · second_quarter · Health Issues
H.R. 748, CARES Act H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R.1730, Cancer Drug Parity Act of 2019 H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S1872/HR5076, Protecting Seniors Through Immunization Act H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals 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. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing HR6711, Medical Supply Transparency and Delivery Act, DPA impact on Rx manufacturers H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes - Provisions related to prescription drug research and development and transparency H.R. 7296: To require any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing 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. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S3780, HOME Act S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers H.R. 7288: Taxpayer Research and Coronavirus Knowledge (TRACK) Act of 2020 - Provisions related to database of federal biomedical investment information for COVID-19 H.R. 7296: Make Medicines Affordable by Preventing Pandemic Pricegouging (MMAPPP) Act of 2020 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 Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors FDA modernization policy issues PDUFA policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients CARES ACT-Monograph Reform Support for Arthritis Caucus
Client expense: $870,000 · 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)
2020 · second_quarter · Pharmacy
H.R. 985, The Fair Access for Safe and Timely (FAST) Generics Act of 2019 H.R. 3, Lower Drug Costs Now Act of 2019 Issue: Support policies to reduce prescription drug prices H.R. 6080, Preventing Drug Shortages Act S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support legislation to reduce drug shortages
Client expense: $1,316,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office
2020 · second_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act
Client expense: $550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR), White House Office
2020 · second_quarter · Health Issues
Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets";Letter of support for the Senate Workgroups efforts to ensure consumer protections by addressing surprise medical bills and comments on the development of legislation to protect patients from surprise medical bills; Letter urging Congress and the Administration to take further action to help reduce input and administrative costs, as well as maximize the number of insured patients; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states.
Client expense: $4,260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · second_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $110,174 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE