Loading…
Ensuring the Value of the 340B Program Act of 2018
Legislative Progress
Introduced
February 27, 2018
Latest Action
February 27, 2018
Primary Sponsor
Chuck GrassleyRepublican(IA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 3,805 other S bills in the 115th — cohort avg 41d
Ensuring the Value of the 340B Program Act of 2018 This bill requires a hospital participating in the 340B drug discount program to include, in any Medicare cost report to the Centers for Medicare & Medicaid Services, information on: (1) the aggregate acquisition costs of the hospital for drugs acquired under the program; and (2) the aggregate revenues the hospital received from all payors for such drugs, disaggregated by insurance status.
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 (30)
Read twice and referred to the Committee on Finance.
Introduced in Senate
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
Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues, no specific bill
Client expense: $3,250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
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
ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed the proposed public charge rule and adding Medi-Cal to the list of programs that would be considered in making a public charge determination.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2018 · fourth_quarter · Health Issues
ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed proposed public charge rule, which would punish children with disabilities and complex medical conditions, and make it harder for them to pursue lawful citizenship.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2018 · fourth_quarter · Medicare/Medicaid
Stopping the application of the sequester cut (current and new) to Medicare Part B drug reimbursement (no bill). Fixing the 340B drug discount program, including PAUSE Act (H.R. 4710), HELP Act (S. 2312, and Ensuring the Value of the 340B Program Act (S. 2453) and other legislation in progress. Fixing Medicare Part B drug reimbursement by eliminating the manufacturer-to-wholesaler prompt pay discount from the calculation of average sales price, the basis of Part B drug reimbursement (H.R. 1920, S. 1304). Moving Medicare Part B to Part D (no bill). Misc. issues dealing with pharmacy benefit managers and patient and pharmacy abuses (includes bills H.R 1316 - Prescription Drug Price Transparency Act; H.R.1038 - Improving Transparency and Accuracy in Medicare Part D Spending Act; and H.R. 5958 - Phair Pricing Act of 2018}. Oncology Care Model (CMS/CMMI; no bill). Various drug pricing/costs (no bill). STEP therapy (no bill). International Pricing Index Model (no bill)
Client expense: $138,700 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Medicare/Medicaid
Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act H.R. 4710 Protecting Access for the Underserved and Safety-Net Entities H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act Issues related to Part D coverage gap, no specific bill
Client expense: $2,700,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · fourth_quarter · Health Issues
H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Client expense: $920,000 · 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), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues 340B drug discount program policy issues
Client expense: $1,820,000 · Firm income: Not reported
Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.
2018 · fourth_quarter · Medicare/Medicaid
340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act S. 2453, Ensuring the Value of the 340B Program Act
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Client expense: $6,030,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Issued relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); and the Ensuring the Value of the 340B Program Act (S. 2453). Biodefense research, development and procurement issues; Pandemic All Hazards Preparedness Act (PAHPA) reauthorization; pandemic flu; MCM priority review voucher program Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally, including the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare Part B Issues related to Medicare Part D Coding and reimbursement for oncology drugs/biologics/biosimilars Issues relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); the Ensuring the Value of the 340B Program Act (S. 2453), and the 340B Optimization Act (H.R. 5598)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
H.R. 4710 - 340B PAUSE Act; provisions relating to 340B drug pricing S. 2453 - Ensuring the Value of the 340B Program Act of 2018; provisions relating to 340B drug pricing S. 2312 - HELP Act; provisions relating to 340B drug pricing H.R. 6071 - SERV Communities Act; provisions relating to 340B drug pricing 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; provisions related to 340B drug pricing. Centers for Medicare and Medicaid Services' FY2019 Inpatient Prospective Payment System (IPPS) Final Rule comments/CAR-T therapy reimbursement Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule/Physician Fee Schedule proposed rule comments Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction, CMS-3346-P, proposed rule comments Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations - Pathways to Success, CMS-1701-P, proposed rule comments
Client expense: $40,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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
Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored 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. Monitored HR6 SUPPORT for Patients and Communities Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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 · 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 · Religion
S.2453 - Ensuring the Value of the 340B Program Act of 2018
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
S.2453 - Ensuring the Value of the 340B Program Act of 2018
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
S.2453 - Ensuring the Value of the 340B Program Act of 2018
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Budget/Appropriations
S.2453 - Ensuring the Value of the 340B Program Act of 2018
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Monitor legislation affecting Medicare 340B payments. H.R. 4392 which would impose a permanent moratorium on the new medicare policy that would reduce payments to 340B eligible entities by 27% and HR 4710 which would freeze the 340B program to new entrants well as create onerous new reporting systems for all hospitals, HR 4710, 340B PAUSE Act. would stop new disproportionate share hospitals from enrolling in the Medicare 340B program , stop registration for new child sites and establish new reporting requirements for dSH, cancer and childrens hospitals ; S 2453, Ensuring the Value of the 340B program Act of 2018, and S.2312, The HELP Act/. Also monitor MACPAC proposal to modify the Medicaid DSH allocation reduction statute. Monitor proposed CMS regulations affecting medicare outpatient payments for 340B and monitor congressional action on 340B.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, 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 · fourth_quarter · Health Issues
Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored 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 Monitored HR 6 SUPPORT for Patients and Communities Act
Client expense: Not reported · Firm income: $130,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed the proposed public charge rule and adding Medi-Cal to the list of programs that would be considered in making a public charge determination.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2018 · fourth_quarter · Health Issues
ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed proposed public charge rule, which would punish children with disabilities and complex medical conditions, and make it harder for them to pursue lawful citizenship.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2018 · second_quarter · Medicare/Medicaid
H.R. 4710 - 340B PAUSE Act; provisions relating to 340B drug pricing S. 2453 - Ensuring the Value of the 340B Program Act of 2018; provisions relating to 340B drug pricing S. 2312 - HELP Act; provisions relating to 340B drug pricing H.R. 6071 - SERV Communities Act; provisions relating to 340B drug pricing 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; provisions related to 340B drug pricing Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule comments/CAR-T therapy reimbursement
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored 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. Monitored HR6 SUPPORT for Patients and Communities Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation 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 Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Client expense: $1,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
Issued relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); and the Ensuring the Value of the 340B Program Act (S. 2453). Biodefense research, development and procurement issues; Pandemic All Hazards Preparedness Act (PAHPA) reauthorization; pandemic flu; MCM priority review voucher program Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally, including the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Medicare/Medicaid
Issues related to Medicare Part B Issues related to Medicare Part D Coding and reimbursement for oncology drugs/biologics/biosimilars Issues relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); the Ensuring the Value of the 340B Program Act (S. 2453), and the 340B Optimization Act (H.R. 5598)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Client expense: $2,480,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
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
H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues 340B drug discount program policy issues
Client expense: $600,000 · Firm income: Not reported
Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.
2018 · third_quarter · Medicare/Medicaid
H.R. 4710 - 340B PAUSE Act; provisions related to 340B drug pricing S. 2453 - Ensuring the Value of the 340B Program Act of 2018; provisions related to 340B drug pricing S. 2312 - HELP Act; provisions related to 340B drug pricing H.R. 6071 - SERV Communities Act; provisions related to 340B drug pricing 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; provisions related to 340B drug pricing Center for Medicare and Medicaid Services' FY2019 Inpatient Prospective Payment System (IPPS) Proposed Rule comments/CAR-T therapy reimbursement/E/M/Codes/HOPD Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule/Physician Fee Schedule proposed rule comments
Client expense: $50,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation 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 Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Client expense: $5,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE