Drug Discount Accountability Act
Legislative Progress
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Drug Discount Accountability Act This bill requires the Health Resources and Services Administration to collect a user fee from certain entities participating in the 340B drug pricing program, including critical access hospitals, for activities relating to program oversight and improvement.
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Filing registrants (13)
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2019 · third_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES 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.
Client expense: $2,620,000 · 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
2019 · third_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation
Client expense: $2,620,000 · Firm income: Not reported
2019 · second_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES 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.
Client expense: $1,620,000 · Firm income: Not reported
2019 · second_quarter · Medicare/Medicaid
S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D
Client expense: $1,620,000 · Firm income: Not reported
2019 · third_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES 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.
Client expense: $2,610,000 · 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
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
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
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
2019 · third_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation
Client expense: $2,610,000 · 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
2019 · second_quarter · Medicare/Medicaid
S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D
Client expense: $1,610,000 · 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
2019 · second_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES 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.
Client expense: $1,610,000 · 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
2019 · first_quarter · Medicare/Medicaid
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D
Client expense: $2,950,000 · 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
2019 · first_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES 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
Client expense: $2,950,000 · 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
2018 · fourth_quarter · Medicare/Medicaid
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to Part D Medicare Program including coverage gap and other offsets
Client expense: $1,480,000 · 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
2018 · fourth_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 - 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
Client expense: $1,480,000 · 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
2018 · fourth_quarter · Health Issues
Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs P.L. 115-241, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development S. 3660 / H.R. 5942, Health Equity and Accountability Act Issue: Support workforce grants to medical schools to improve health equity Issue: Oppose regulatory proposals to narrow the definition of sex Issue: Educate Congress and the administration, support training on substance use disorders, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid addiction Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. P.L. 115-176/H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. P.L. 115-271 SUPPORT for Patients and Communities Act H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education, and reauthorizing the Patient Centered Outcomes Research Institute. Provide grants to regional Centers of Excellence in substance use disorder education. Support policy eliminating Medicaid IMD exclusion and revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). H.R. 7328/ H.R. 6378/S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program S. 3366, Maternal CARE Act Issue: Support efforts to reduce preventable maternal mortality Issue: Support national preparedness infrastructure.
Client expense: $892,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office
2018 · fourth_quarter · Health Issues
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Client expense: $1,400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Support for Graduate Medical Education (GME) funding including the Resident Physician Shortage Reduction Act (S. 1301/H.R. 2267) and the Opioid Workforce Act of 2018 (H.R. 5818/S. 2843) Support for legislation to address opioid epidemic (SUPPORT for Patients and Communities Act (H.R. 6)) including bills to modify to institute of mental disease exclusion (H.R. 5797) and to align 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (H.R. 6082) and policies to expand ability to prescribe buprenorphine treatment Support for full protection of Critical Access Hospital payments Support for REMC Act of 2018 (H.R. 5678) Support for Fairness in Liver Allocation Act (H.R. 6517) Support for changes to Medicare Volume Decrease Adjustment calculation Support for correction of erroneous reductions of GME residency positions Opposition to 340B program reductions in Centers for Medicare and Medicaid Services (CMS) 2018 Outpatient Prospective Payment System (OPPS) proposed rule [CMS-1678-P] and support for legislation (H.R. 4392, H.R. 6071) to halt these payment cut Opposition to changes to 340B program (H.R. 4710, H.R. 6240) Opposition to site-neutral payment reductions to hospital outpatient departments proposed in CMS 2019 OPPS proposed rule [CMS-1695-P] Support for policies to preserve Medicare Disproportionate Share Hospital funding as part of CMS 2019 Inpatient Prospective Payment System proposed rule [CMS-1694-P] Opposition to Department of Homeland Security Proposed Rule on Inadmissibility on Public Charge Grounds [DHS Docket No. USCIS-2010-0012]
Client expense: $150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations S.3770 (Medicaid Drug Decisions Transparency Act), all provisions Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), All provisions, and H.R. 5598 (340B Optimization Act), all provisions and H.R. 6240 (drug Discount accountability act), all provisions Sickle Cell Disease Research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease research, Surveillance, prevention and treatment act of 2017), all provisions S. 2465 (Sickle cell disease and other heritable blood disorders research, surveillance, Prevention and treatment act of 2018), all provisions H.R. 3325 (ACE kids Act), all provisions S. 428 (Ace Kids Act of 2017), all provisions H.R. 1676 (Palliative Care and Hospice Education and Training Act), all provisions Organ Transplant policy generally, including transplant distribution methodology H.R. 7217 (Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act - IMPROVE act), Title I, regarding coordinated care
Client expense: $132,091 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations S. 3770 (Medicaid Drug Decisions Transparency Act), all provisions Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), all provisions, H.R. 5598 (340B Optimization Act), all provisions, and H.R. 6240 (Drug Discount Accountability Act), all provisions Sickle cell disease research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017), all provisions S. 2465 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018), all provisions H.R. 3325 (ACE Kids Act), all provisions S. 428 (ACE Kids Act of 2017), all provisions H.R. 1676 (Palliative Care and Hospice Education and Training Act), all provisions Organ transplant policy generally, including liver transplant distribution methodology H.R. 7217 (Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act - IMPROVE Act), Title I, regarding coordinated care
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
The 340B Drug Pricing Program; FY19 LHHS Appropriations; final 2018 and proposed 2019 Outpatient Prospective Payment System Rule; proposed and final rules regarding 340B ceiling price calculations and manufacturer civil monetary penalties; delay of 340B ceiling price database; S.2312, S.2453, H.R.4710, H.R.4392, H.R.5598, H.R.6071, H.R.6240, H.R.6273, and other legislation relevant to the 340B drug pricing program
Client expense: $231,609 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
2018 · fourth_quarter · Medicare/Medicaid
340B Drug Pricing Program - Opposed Medicare reimbursement reductions for hospitals eligible for the 340B drug pricing program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Outpatient Prospective Payment System Site-Neutral Payment Reductions - Opposed implementation of Medicare payment changes that would reduce reimbursement for hospital outpatient facilities.
Client expense: $190,000 · 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
2018 · fourth_quarter · Health Issues
Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. 340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392 and H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Drug Shortages - Engaged in discussions around how ongoing shortages of prescription drugs are impacting hospitals and possible solutions. Advocated for the Drug Enforcement Agency to modify total annual production quotas to address hospital shortage of injectable opioid solutions. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Supported H.R. 6082. Children's Hospital GME Support Reauthorization Act (H.R.5385, S.2597) - Endorsed passage of legislation to reauthorize the Children's Hospital GME program. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.
Client expense: $190,000 · 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
2018 · fourth_quarter · Health Issues
No bill, lobbied to raise awareness about Atrial Fibrillation and stroke prevention. No bill, lobbied regarding biosimilars issues including naming, labeling and interchangeability. H.R. 1245 and S. 469, Affordable and Safe Prescription Drug Importation Act, lobbied regarding all biopharmaceutical provisions. H.R. 1703, Medical Product Communications Act of 2017, regarding all biopharmaceutical related provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues Act of 2017, regarding all biopharmaceutical related provisions No bill, lobbied for changes to the 340B Drug Discount Program. H.R. 4710, 340B PAUSE Act, lobbied regarding all biopharmaceutical provisions. H.R. 4392, a bill to repeal the HOPPS final regulation related to changes in the payment amount for certain drugs under the 340B program, lobbied regarding all biopharmaceutical provisions. H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act of 2017, lobbied regarding all biopharmaceutical provisions. S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act, regarding all biopharmaceutical related provisions. S.2453, Ensuring the Value of the 340B Program Act of 2018, regarding all biopharmaceutical related provisions. H.R. 5598 340B Optimization Act, regarding all biopharmaceutical related provisions. H.R. 6071 SERV Communities Act, regarding all biopharmaceutical related provisions. H.R. 6240, Drug Discount Accountability Act, regarding all biopharmaceutical related provisions. H.R. 6143, S. 2554, Patient Right to Know Drug Prices Act, regarding all biopharmaceutical related provisions. H.R. 6, SUPPORT for Patients and Communities Act, regarding all biopharmaceutical related provisions.
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Health Issues
Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs P.L. 115-241, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Educate Congress and support training on substance use disorders, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid addiction Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. P.L. 115-176/H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education. Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 Issue: Provide grants to regional Centers of Excellence in substance use disorder education. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). H.R. 6378/S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program S. 3366, Maternal CARE Act Issue: Support efforts to reduce preventable maternal mortality H.R. 6, SUPPORT for Patients and Communities Act Issue: Support policy eliminating Medicaid IMD exclusion and revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations and investing in research and education, and reauthorizing the Patient Centered Outcomes Research Institute.
Client expense: $857,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office
2018 · third_quarter · Medicare/Medicaid
HR 4392 - To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes - regarding cuts to 340B program (entire bill) H.R.4710 - 340B PAUSE Act -- To amend the Public Health Service Act to establish a moratorium on the registration of certain new 340B hospitals and associated sites, and for other purposes (entire bill) S.2453 - To require hospitals to provide the Secretary with information on the hospital's acquisition costs for 340B drugs and the total revenues received by the hospital for such drugs (entire bill) S. 2312 - The HELP Act, to provide a moratorium on registration of new non-rural section 340B hospitals and associated sites, and for other purposes (entire bill) H.R. 5598 - 340B Optimization Act (entire bill) H.R. 6071 - Stretching Entity Resources for Vulnerable Communities Act (entire bill) H.R.6273 - To amend the Public Health Service Act to ensure appropriate care by certain 340B covered entities for victims of sexual assault, and for other purposes (entire bill) H.R.6240 - Drug Discount Accountability Act (entire bill) H.R. 6506 - Medicare Negotiation and Competitive Licensing Act of 2018 (entire bill)
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), SENATE
2018 · third_quarter · Health Issues
implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), All provisions, and H.R. 5598 (340B Optimization Act), all provisions and H.R. 6240 (drug Discount accountability act), all provisions H.R. 5385 (Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act of 2018), all provisions S. 2597 (Children's Hospital GME Support Reauthorization act of 2018), all provisions Sickle Cell Disease Research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities H.R. 6560 (ChiPACC Act of 2018), all provisions Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease research, Surveillance, prevention and treatment act of 2017), all provisions S. 2465 (Sickle cell disease and other heritable blood disorders research, surveillance, Prevention and treatment act of 2018), all provisions H.R. 6 (support for patients and Communities Act), section 1004 regarding Medicaid drug review and utilization H.R. 6458 (National Organ Transplant Act Amendments of 2018), all provisions H.R. 3325 (ACE kids Act), all provisions S. 428 (Ace Kids Act of 2017), all provisions
Client expense: $137,852 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Insurance market policies (Bipartisan Health Care Stabilization Act; Short-term, Limited Duration Health Insurance rule; Association Health Plans rule) Risk adjustment payments Cost sharing reduction payments Insurance navigator funding 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; S. 2554 / H.R. 6143, Patient Right to Know Drug Prices Act; S. 2553, Know the Lowest Price Act; H.R. 6733, Know the Cost Act) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Consumer Directed Health Plans Legislation (H.R. 6311 would modify the definition of a qualified health plan and allow individuals purchasing health insurance in the individual market to purchase a "copper" plan or use the premium tax credit to buy off-marketplace coverage; H.R. 6301 to allow CDHPs to provide coverage for services like telehealth, chronic disease management, or primary care visits below the minimum deductible; H.R. 6317 to allow coverage of direct primary care service arrangements; H.R. 6305 to permit use of CDHPs to receive certain employment-related health services like onsite clinics; H.R. 6309 to allow individuals only enrolled in Medicare Part A to contribute to health savings accounts; H.R. 6199 to include certain over-the-counter medical products as qualified medical expenses; H.R. 6306 to increase the current contribution limits for HSAs; H.R. 6312, Personal Health Investment Today (PHIT) Act to count sports equipment and exercise costs toward medical expenses; H.R. 6313 to allow carry-forward of flexible spending account balances each year; H.R. 6314 to allow bronze and catastrophic plans in connection with health savings accounts, allowing plans categorized as catastrophic and bronze in the individual and small group markets to qualify for HSA contributions) H.R. 4616 to delay the implementation of the excise tax on high cost employer-sponsored health coverage; and place a moratorium on the employer mandate Liver allocation policy
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Client expense: $1,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), all provisions, H.R. 5598 (340B Optimization Act), all provisions, and H.R. 6240 (Drug Discount Accountability Act), all provisions H.R. 5385 (Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act of 2018), all provisions S. 2597 (Children's Hospital GME Support Reauthorization Act of 2018), all provisions Sickle cell disease research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities H.R. 6560 (ChiPACC Act of 2018), all provisions Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017), all provisions S. 2465 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018), all provisions H.R. 6 (SUPPORT for Patients and Communities Act), Section 1004 regarding Medicaid drug review and utilization H.R. 6458 (National Organ Transplant Act Amendments of 2018), all provisions H.R. 3325 (ACE Kids Act), all provisions S. 428 (ACE Kids Act of 2017), all provisions
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.
Client expense: $155,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Medicare/Medicaid
340B Drug Pricing Program - Opposed Medicare reimbursement reductions for hospitals eligible for the 340B drug pricing program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Supported partial relaxation of the IMD Exclusion for substance abuse disorder included in H.R. 6, the SUPPORT Communities Act. Children's Hospital GME Support Reauthorization Act (H.R.5385, S.2597) - Endorsed passage of legislation to reauthorize the Children's Hospital GME program. Supported implementation of a competitive acquisition program for prescription drugs under Medicare Part B.
Client expense: $155,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, FY2019, Medical Center related initiatives; and Opioid related issues Medical Center related initiatives H.R.4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes, 340B issues H.R.4710, 340B Protecting Access for the Underserved and Safety-net Entities (PAUSE) Act, generally S.2453, Ensuring the Value of the 340B Program Act of 2018, generally H.R.2889, Closing Loopholes for Orphan Drugs Act, generally S.2312, Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act, generally S.356/H.R.1027, Hallways to Health Act, generally H.R.5150, Protecting Medicare from Excessive Price Increases Act of 2018, generally H.R.5598, 340B Optimization Act, generally H.R.6071, Stretching Entity Resources for Vulnerable (SERV) Communities Act, generally H.R.5498, Rural Hospital Frontier Fairness Act, generally H.R.6, SUPPORT for Patients and Communities Act, generally H.R.6240, Drug Discount Accountability Act, generally H.R.6273, To amend the Public Health Service Act to ensure appropriate care by certain 340B covered entities for victims of sexual assault, and for other purposes, generally H.R.6082, Overdose Prevention and Patient Safety Act, generally
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE
2018 · third_quarter · Medicare/Medicaid
Support for Graduate Medical Education (GME) funding including the Resident Physician Shortage Reduction Act (S. 1301/H.R. 2267) and the Opioid Workforce Act of 2018 (H.R. 5818/S. 2843) Support for legislation to address opioid epidemic (SUPPORT for Patients and Communities Act (H.R. 6)) including bills to modify to institute of mental disease exclusion (H.R. 5797) and to align 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (H.R. 6082) and policies to expand ability to prescribe buprenorphine treatment Support for full protection of Critical Access Hospital payments Support for REMC Act of 2018 (H.R. 5678) Support for Fairness in Liver Allocation Act (H.R. 6517) Support for changes to Medicare Volume Decrease Adjustment calculation Support for correction of erroneous reductions of GME residency positions Opposition to 340B program reductions in Centers for Medicare and Medicaid Services (CMS) 2018 Outpatient Prospective Payment System (OPPS) proposed rule [CMS-1678-P] and support for legislation (H.R. 4392, H.R. 6071) to halt these payment cut Opposition to changes to 340B program (H.R. 4710, H.R. 6240) Opposition to site-neutral payment reductions to hospital outpatient departments proposed in CMS 2019 OPPS proposed rule [CMS-1695-P] Support for policies to preserve Medicare Disproportionate Share Hospital funding as part of CMS 2019 Inpatient Prospective Payment System proposed rule [CMS-1694-P]
Client expense: $140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Medicare/Medicaid
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) Issues related to Medicare and Medicaid coverage and reimbursement including Part B payment, step therapy policy proposal in Medicare Advantage, implementation of value-based reimbursement models Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Issues related to Part D Medicare Program including coverage gap and other offsets
Client expense: $1,370,000 · 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
2018 · third_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 Issues related to the 340B Drug Discount Program Issues relating to drug pricing, reimbursement, step therapy, anti-kickback statute, biosimilars 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
Client expense: $1,370,000 · 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
2018 · third_quarter · Pharmacy
The 340B Drug Pricing Program; FY19 LHHS Appropriations; final 2018 and proposed 2019 Outpatient Prospective Payment System Rule; proposed and final rules regarding 340B ceiling price calculations and manufacturer civil monetary penalties; delay of 340B ceiling price database; S.2312, S.2453, H.R.4710, H.R.4392, H.R.5598, H.R.6071, H.R.6240, H.R.6273, and other legislation relevant to the 340B drug pricing program
Client expense: $251,997 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
2018 · third_quarter · Medicare/Medicaid
General issues relating to Medicare and Medicaid, issues relating to opioid legislation (HR 6), issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
General issues relating to Medicare and Medicaid, issues relating to opioid legislation (HR 6), issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Medicare/Medicaid
General issues relating to Medicare and Medicaid, issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
General issues relating to Medicare and Medicaid, issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues: Issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Medicare/Medicaid
Issues: Issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
No bill, lobbied to raise awareness about Atrial Fibrillation and stroke prevention. No bill, lobbied regarding biosimilars issues including naming, labeling and interchangeability. H.R. 1245 and S. 469, Affordable and Safe Prescription Drug Importation Act, lobbied regarding all biopharmaceutical provisions. H.R. 1703, Medical Product Communications Act of 2017, regarding all biopharmaceutical related provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues Act of 2017, regarding all biopharmaceutical related provisions No bill, lobbied for changes to the 340B Drug Discount Program. H.R. 4710, 340B PAUSE Act, lobbied regarding all biopharmaceutical provisions. H.R. 4392, a bill to repeal the HOPPS final regulation related to changes in the payment amount for certain drugs under the 340B program, lobbied regarding all biopharmaceutical provisions. H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act of 2017, lobbied regarding all biopharmaceutical provisions. S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act, regarding all biopharmaceutical related provisions. S.2453, Ensuring the Value of the 340B Program Act of 2018, regarding all biopharmaceutical related provisions. H.R. 5598 340B Optimization Act, regarding all biopharmaceutical related provisions. H.R. 6071 SERV Communities Act, regarding all biopharmaceutical related provisions. H.R. 6240, Drug Discount Accountability Act, regarding all biopharmaceutical related provisions. H.R. 6143, S. 2554, Patient Right to Know Drug Prices Act, regarding all biopharmaceutical related provisions. H.R. 6, SUPPORT for Patients and Communities Act, regarding all biopharmaceutical related provisions.
Client expense: $960,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2018 · second_quarter · Medicare/Medicaid
340B program policy proposals included within the 2018 Outpatient Payment System final rule HR 4392 - To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes - regarding cuts to 340B program H.R.4710 - 340B PAUSE Act -- To amend the Public Health Service Act to establish a moratorium on the registration of certain new 340B hospitals and associated sites, and for other purposes. S.2453 - To require hospitals to provide the Secretary with information on the hospital's acquisition costs for 340B drugs and the total revenues received by the hospital for such drugs. S. 2312 - The HELP Act, to provide a moratorium on registration of new non-rural section 340B hospitals and associated sites, and for other purposes. H.R. 5598 - 340B Optimization Act H.R.6071 - SERV Communities Act H.R.6273 - To amend the Public Health Service Act to ensure appropriate care by certain 340B covered entities for victims of sexual assault, and for other purposes. H.R.6240 - Drug Discount Accountability Act
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE
2018 · second_quarter · Health Issues
Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs H.R.5385, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Educate Congress and support training on substance abuse, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid dependence Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund P.L. 114-255, 21st Century Cures Act Issue: Support Implementation of 21st Century Cures Act Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) Pandemic and All-Hazards Preparedness Reauthorization Act of 2018 (Draft House legislation) Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 Issue: Provide grants to regional Centers of Excellence in substance use disorder education. Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program
Client expense: $1,339,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office
2018 · second_quarter · Medicare/Medicaid
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Medicare payments for inpatient antimicrobials Issues related to Right to Try Issues related to drug importation Issues related to Part D Medicare Program including coverage gap and other offsets
Client expense: $1,530,000 · 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
2018 · second_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 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 Issues related to public health protection including influenza development and preparedness
Client expense: $1,530,000 · 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
2018 · second_quarter · Health Issues
H.R. 1892, Bipartisan Budget Act of 2018 Insurance market policies (Bipartisan Health Care Stabilization Act; S. 2052/H.R. 4200, Healthcare Market Certainty and Mandate Relief Act; H.R. 4666, the Premium Relief Act; 2019 Payment Notice Rule; Short-term, Limited Duration Health Insurance proposed rule; Association Health Plans proposed rule) Cost sharing reduction payments 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs) HIPAA policy in mental and behavioral health information sharing Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act)
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Pharmacy
The 340B Drug Pricing Program; FY19 LHHS Appropriations; final 2018 Outpatient Prospective Payment System Rule; proposed and final rules regarding 340B ceiling price calculations and manufacturer civil monetary penalties; delay of 340B ceiling price database; S.2312, S.2453, H.R.4710, H.R.4392, H.R.5598, H.R.6071, H.R.6240, H.R.6273, and other legislation relevant to the 340B drug pricing program
Client expense: $270,946 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
2018 · second_quarter · Health Issues
340B Drug Pricing Program - Highlighted importance of the 340B Drug Pricing program for safety net hospitals and monitored ongoing discussions around reforming the program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Opioid Abuse - Supported House passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements. Medical Device Cybersecurity - Urged additional steps to promote enhanced cybersecurity for networked medical devices.
Client expense: $175,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Medicare/Medicaid
340B Drug Pricing Program - Raised opposition to Medicare reimbursement reductions for hospitals eligible for the 340B drug pricing program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Supported Limited Repeal of the IMD Exclusion for substance abuse disorder that was included in H.R. 6, the SUPPORT Communities Act. Children's Hospital GME Support Reauthorization Act (H.R.5385, S.2597) - Endorsed passage of legislation to reauthorize the Children's Hospital GME program.
Client expense: $175,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE