Legislative Progress
Introduced
November 1, 2021
Latest Action
November 2, 2021
Primary Sponsor
A. Donald McEachinDemocratic(VA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
43pct
1d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Help Ensure Lower Patient Copays Act or the HELP Copays Act This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements.
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 (36)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2024 · second_quarter · Health Issues
Education and legislation related to reform of the 340(b) program. H.R.5801: HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · first_quarter · Health Issues
Monitored issues and legislation related to the 340(b) program. H.R.5801: HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
2023 · fourth_quarter · Health Issues
Monitored issues and legislation related to the 340(b) program. H.R.5801: HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
2023 · third_quarter · Health Issues
Monitored issues and legislation related to the 340(b) program. H.R.5801: HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
2023 · second_quarter · Health Issues
Patient Access Issues Healthcare Appropriations The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| NJ |
| Angie Craig | Democratic | MN |
| Barbara Lee | Democratic | CA |
| Bobby L. Rush | Democratic | IL |
| Bonnie Watson Coleman | Democratic | NJ |
| Brian K. Fitzpatrick | Republican | PA |
| Chellie Pingree | Democratic | ME |
| Chrissy Houlahan | Democratic | PA |
| Colin Z. Allred | Democratic | TX |
| Darren Soto | Democratic | FL |
| David J. Trone | Democratic | MD |
| David N. Cicilline | Democratic | RI |
| Dean Phillips | Democratic | MN |
| Deborah K. Ross | Democratic | NC |
| Derek Kilmer | Democratic | WA |
| Diana DeGette | Democratic | CO |
| Dina Titus | Democratic | NV |
| Doris O. Matsui | Democratic | CA |
| Dwight Evans | Democratic | PA |
| Earl Blumenauer | Democratic | OR |
| Earl L. "Buddy" Carter | Republican | GA |
| Eleanor Holmes Norton | Democratic | DC |
| Emanuel Cleaver | Democratic | MO |
| Eric Swalwell | Democratic | CA |
| Frederica S. Wilson | Democratic | FL |
| Gerald E. Connolly | Democratic | VA |
| Glenn Grothman | Republican | WI |
| Jake Auchincloss | Democratic | MA |
| Joe Courtney | Democratic | CT |
| Joe Neguse | Democratic | CO |
| John Garamendi | Democratic | CA |
| John P. Sarbanes | Democratic | MD |
| Joseph D. Morelle | Democratic | NY |
| Josh Gottheimer | Democratic | NJ |
| Kaiali’i Kahele | Democratic | HI |
| Kathy Castor | Democratic | FL |
| Lucille Roybal-Allard | Democratic | CA |
| Madeleine Dean | Democratic | PA |
| Marc A. Veasey | Democratic | TX |
| Mark DeSaulnier | Democratic | CA |
| Mark Pocan | Democratic | WI |
| Mike Levin | Democratic | CA |
| Mike Quigley | Democratic | IL |
| Mondaire Jones | Democratic | NY |
| Nanette Diaz Barragán | Democratic | CA |
| Paul Tonko | Democratic | NY |
| Pete Aguilar | Democratic | CA |
| Raja Krishnamoorthi | Democratic | IL |
| Rodney Davis | Republican | IL |
| Stephen F. Lynch | Democratic | MA |
| Susan Wild | Democratic | PA |
| Ted Lieu | Democratic | CA |
| Terri A. Sewell | Democratic | AL |
| Thomas R. Suozzi | Democratic | NY |
| Tom Malinowski | Democratic | NJ |
| Tom O’Halleran | Democratic | AZ |
| Troy A. Carter | Democratic | LA |
| Vicente Gonzalez | Democratic | TX |
| Yvette D. Clarke | Democratic | NY |
2022 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $1,760,000 · 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, White House Office
2022 · fourth_quarter · Health Issues
Issues related to drug pricing reform Public law 117-1769 Inflation Reduction Act HR 2617 Consolidated Appropriations Act of 2023, --issues related to cardiovascular disease, --Issues related to FTC, --FDA issues (Food and Drug Omnibus Reforms Act) --Issues related to Pharmacy Benefit Manger transparency --Issues related to clinical trial diversity S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act Issues related to 340B H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters HR 8588 Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act
Client expense: $2,140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
-Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. -CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. - Inflation Reduction Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; the establishment Advanced Research Projects Agency for Health (ARPA-H); provisions related to extending marketplace subsidies under the Patient Protection and Affordable Care Act; and provisions related to an out-of-pocket maximum for Medicare beneficiaries' prescription drugs. - Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19. - HELP Copays Act (H.R.5801) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs.
Client expense: $25,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 8594/S. 4750, the Restore Protections for Dialysis Patients Act H.R. 7845/ the NIH Clinical Trial Diversity Act H.R. 1255/S. 377, the Living Donor Protection Act H.R. 1676, the Jack Reynold Medigap Expansion Act H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021 Health disparities S. 1002, the Junk Plan Accountability and Disclosure Act of 2021 H.R. 4065/S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act of 2021. H.R. 3893, the CARE for All Kidneys Act FY 2023, Labor-HHS-Education Appropriations Act H.R. 7585, the Health Equity and Accountability Act of 2022 (HEAA) H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 7667, the Food and Drug Amendments of 2022 H.R. 7506, the New Era for Preventing End-Stage Kidney Disease Act of 2022 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry Request for Information on ways to strengthen and improve the Organ Procurement and Transplantation Network
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Insurance
H.R. 4612/S. 2412 - Protecting Access to Lifesaving Screenings Act of 2021; a bill to make a series of changes relating to health insurance coverage of screening mammography H.R. 5769/S. 1067 - Access to Breast Cancer Diagnosis Act; bill to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging H.R. 2163/S. 464 - Safe Step Act; bill to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes H.R. 4385/S.3080 - Cancer Drug Parity Act; bill to require health plans that cover anticancer medications administered by a health care provider to provide no less favorable cost sharing for patient-administered anticancer medications. H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act; a bill to amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 7045/S. 3796 - Closing Health Coverage Gaps for Public Servants Act; a bill to eliminate the opt-out for nonfederal governmental health plans, including the opt-out for coverage for full mastectomy and reconstruction care Administrative actions necessary to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging Issues related to regulation of short-term limited duration plans Implementation of the No Surprises Act Implementation of the Inflation Reduction Act Implementation of the Affordable Care Act Policies regarding White House Cancer Moonshot implementation Public and private insurance adjustments and other policy changes due to the COVID-19 emergency, including those impacting the immunocompromised populations S. 942 - No Junk Plans Act; bill to overturn previous administration rule expanding non-comprehensive health insurance plans that dont have to provide healthcare coverage for people with pre-existing conditions S. 1002 - Junk Plan Accountability and Disclosure Act; a bill which establishes requirements for certain noncomprehensive health insurance coverage and provides for additional outreach activities to increase enrollment in qualified health plans Policies related to co-pay assistance programs Comments in response to the RFI on Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals (CMS9900-NC) Comments regarding Section 1557 Nondiscrimination in Health Programs and Activities (RIN 0945-AA17)
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office
2022 · fourth_quarter · Budget/Appropriations
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 S.5194 - Protecting Medicare Patients and Physicians Act H.R. 8800 - Protecting Medicare Patients and Physicians Act H.R.9424 - Creating Access to Residency Education Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023 Fiscal Year 2023 Omnibus
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Medicare Part D policies. H.R.5801 - HELP Copays Act H.R.5376 - Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Insurance
H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 9303: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2022; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Transparency. Copay Accumulators/Maximizers. Benefit Design. Quality-Adjusted Life Years. Home Health Services. National Coverage Determination H.R.5376 - Inflation Reduction Act of 2022. H.R.2163/S464 - Safe Step Act. H.R.3173/S.3018 - Improving Seniors Timely Access to Care Act. H.R.5801 - HELP Copays Act. H.R.7667 - Food and Drug Amendments of 2022. H.R.4472/S.373 - BENEFIT Act of 2021. H.R.7634 - Protecting Health Care for All Patients Act. H.R.8581/S.4605 - Preserving Access to Home Health Act. S.4348 - FDASLA Act of 2022. H.R.5067/S.2652 - Preserving Access to Home Infusion Act. H.R.8800 - Medicare Providers Act.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Federal Step Therapy Reform: Safe Step Act (HR 2163/S 464). The bill reforms step therapy insurance protocols to ensure patients and providers have access to a clear exemption process. It establishes a patient and provider friendly step therapy guidelines in ERISA regulated health insurance plans. Federal copay accumulator reform: HELP Copays Act (HR 5801). The bill ensures that all copays count by requiring insurers to count all third-party copay assistance towards a patients deductible or out-of-pocket maximum.
Client expense: $14,517 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5801, Help Ensure Lower Patient Copays Act S. 2164, Lower Costs, More Cures Act of 2021 Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Prescription Drug User Fee Act (PDUFA) reauthorization Issues related to the 340B program Administration plans to combat cancer and address other public health needs
Client expense: $970,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, "To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.", regarding all provisions - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021", regarding all provisions - S 3799 - "PREVENT Pandemics Act", regarding all provisions - HR 3932/S 2076 - "PASTEUR Act of 2021", regarding all provisions - HR 5376 - "Inflation Reduction Act", regarding provisions on drug pricing and provisions related to revenue - HR 7559 - Prescription Information Modernization Act of 2022, regarding all provisions - HR 2617 - "Consolidated Appropriations Act, 2023", regarding provisions related to pharmaceuticals, medical devices, mental health, and tax - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation
Client expense: $2,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Resident Physician Shortage Reduction Act (H.R. 2256/S. 834) Healthcare Workforce Resilience Act (H.R. 2255/S. 1024) Implementation of the Patient Protection and Affordable Care Act (P.L. 111-148) Hematology/oncology drug research and approval issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical trials regulations and coverage Issues impacting coverage for hematologic diseases and conditions Issues related to CAR-T/cellular and gene therapies Issues impacting opioid access/use for patients with hematologic disease and disorders Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues related to health equity/disproportionate impact of COVID-19 on minority populations Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Implementation of No Surprises Act (P.L. 116-260) Cancer Patient Equity Act of 2021 (H.R.5377) HELP Copays Act (H.R. 5801) Cancer Drug Parity Act of 2021 (H.R. 4385 / S. 3080) Sickle cell disease/trait issues Sickle Cell Disease Comprehensive Care Act (H.R. 6216 / S.3389) Impact of climate change on health Resolution expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors (H.Res. 909) Sickle Cell Care Expansion Act (H.R. 7177/S.4425) Women's Health Protection Act (S. 1975/ H.R. 3755/S. 4132) Newborn Screening Saves Lives Reauthorization Act (H.R. 482/S. 350) Prior authorization Improving Seniors Timely Access to Care Act (H.R. 3173/S. 3018) Health Equity and Accountability Act (H.R. 7585) Issues related to maternal health care and abortion access Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348) Affordability of employer coverage for family members/"family glitch Sickle Cell Disease Treatment Centers Act of 2022 (S. 4866/ H.R. 8855) Advancing Telehealth Beyond COVID Act (H.R. 4040) Resolution supporting the designation of September 2022 as "Sickle Cell Disease Awareness Month" (H.Res.1330/S.Res.868) Let Doctors Provide Reproductive Health Care Act (S. 4723/H.R. 8650) FY2023 Consolidated Appropriations Act (H.R. 2617)
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
Legislative and regulatory policies affecting biotechnology including: pharmaceutical development; biodefense; and diagnostics. H.R. 8295, Labor/HHS/Education Appropriations for FY2023, provisions regarding pandemic response. H.R. 5801, HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
HR 7666, Restoring Hope for Mental Health & Well Being Act of 2022; S. 4170, Mental Health Reform Reauthorization Act of 2022; H.R. 7232, 9-8-8 and Parity Assistance Act of 2022; HR 6000, Cures 2.0 Act; S.3427, the Neuroscience Center of Excellence Act of 2021; HR 5801, HELP Copays Act; Mental Health Reform Act reauthorization; H.R. 5376, Inflation Reduction Act of 2022 (provisions related to pharmaceuticals); issues relating to diversity in clinical trials, agitation in Alzheimers disease, chronic kidney disease and early detection, PTSD, and mental health as a chronic condition.
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $880,000 · 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, White House Office
2022 · fourth_quarter · Insurance
Access to Breast Cancer Diagnosis (ABCD) Act (S. 1067/ H.R. 5769) Metastatic Breast Cancer Access to Care Act (S. 1312 / HR 3182) Cancer Drug Coverage Parity Act (HR 4385) Protecting Access to Lifesaving Screening (PALS) Act(HR 4612/S.2412) Safe Step Act (H.R. 2163/S. 464) The Closing Health Coverage Gaps for Public Servants Act (H.R. 7045/S. 3796) Implementation of the Affordable Care Act Implementation of the No Surprises Act Policies related to insurance coverage and COVID-19 Junk Plan Accountability and Disclosure Act (S. 1002) No Junk Plans Act (S. 942) HELP Copays Act (H.R.5801), accumulator adjustor issues Cancer survivorship issues Issues related to prescription drug affordability for patients Administrative actions necessary to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging Issues related to regulation of short-term limited duration plans H.R. 9505 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals Comments in response to the RFI on Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals (CMS9900-NC) Implementation of the No Surprises Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE
2022 · fourth_quarter · Insurance
Implementation of the Affordable Care Act The HELP Copays Act (HR 5801) Policies related to insurance coverage and COVID-19 Coverage of hemophilia treatments and services in private insurance plans, including the alternative funding model Safe Step Act (HR 2163 / S 464) Policies to make Advance Premium Tax Credits Permanent Implementation of the No Surprises Act Policies related to short-term, limited duration insurance Comments in response to the RFI on Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals (CMS9900-NC) Section 1557, Nondiscrimination in Health Programs and Activities (RIN Number 0945-AA17) Request for Information on establishing a National Directory of Healthcare Providers and Services
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE
2022 · fourth_quarter · Insurance
Affordable Care Act implementation Coverage of hemophilia treatments and services in private insurance plans, including alternative funding model The HELP Copays Act (HR 5801) The Protect 340B Act (HR 4390) Private insurance policies that discriminate coverage for high cost drugs and use of patient assistance programs, also known as the (Alternative Payment Model)
Client expense: Not reported · Firm income: $40,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns. S. 3626 To improve access to the Program of All-Inclusive Care for the Elderly (PACE) HR 7236 To expand the availability of mental, emotional, and behavioral health services under the Medicaid program HR 7353 To treat telehealth services as excepted benefits HR 7961 To protect hospital personnel from violence S 4352 To require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic S 3189 To provide a pathway to health careers through health profession opportunity grants HR 7666 Reauthorizes, expands, and modifies programs, grants, and activities that focus on mental and behavioral health
Client expense: $200,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Issues related to drug pricing reform Public law 117-1769 Inflation Reduction Act HR 2617 Consolidated Appropriations Act of 2023, --issues related to cardiovascular disease, --Issues related to FTC, --FDA issues (Food and Drug Omnibus Reforms Act) --Issues related to Pharmacy Benefit Manger transparency --Issues related to clinical trial diversity S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act Issues related to 340B H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters HR 8588 Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act
Client expense: $2,140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
- S. 464 / H.R. 2163 - Safe Step Act of 2021 - S. 779 Protecting Americans with Pre-Existing Conditions Act - H.R. 3 - H.R. 19 - S. 1681 the Advancing Education on Biosimilars Act - Out-of-pocket costs - H.R. 6000, Cures 2.0 Act - H.R. 5801, HELP Copays Act - Affordable Care Act - Pediatric Subspecialty Loan Repayment Program - Seniors Prescription Drug Relief Act - Build Back Better Act - Reconciliation - H.R. 7213, Equitable Community Access to Pharmacist Services Act - Health Equity - Healthcare Reform - Clinical Trial Diversity
Client expense: $75,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Insurance
Patient protections from copay accumulator adjusters (HR 5801) Affordability and nondiscrimination Medicaid; fix for Medicaid coverage gap Pharmacy benefits manager regulation
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Patient protections from copay accumulator adjusters (HR 5801) Medicaid; fix for the Medicaid coverage gap Pharmacy benefits manager regulation
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
H.R.4373 - Further Additional Continuing Appropriations and Extensions Act, 2023 as it relates to FDA policy riders. Education about the 340(b) program. H.R.5801 - HELP Copays Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES
2022 · fourth_quarter · Health Issues
Prohibiting copay accumulators in ACA Exchange plans; addressing social determinants of health; H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act.
Client expense: Not reported · Firm income: $30,000
2022 · fourth_quarter · Health Issues
Discussions related to health care reform, access to health care, drug pricing, PDUFA Reauthorization, and international access to medicines; Implementation of H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169); H.R.5801, HELP Copays Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Monitored issues and legislation related to the 340(b) program. H.R.5801 - HELP Copays Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
2022 · fourth_quarter · Health Issues
S 464/HR 2163 Safe Step Act - implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 1550 - PREVENT HPV Cancers Act of 2021 HR 3258 - TACT Act of 2021- improve patient access to anti-cancer oral medications HR 4385/S 3080- Cancer Drug Parity Act of 2021- oral parity HR 5801- HELP Copays Act- copay accumulator programs S 3039/HR 2503- Social Determinants Accelerator Act of 2021- SDOH HR 5030/S 2706- DIVERSE Trials Act- access to clinical trials HR 6584- DEPICT Act- access to clinical trials HR 6000- Cures 2.0 HR 5963/S 3611- Provider Relief Fund Improvement Act- extends deadlines, expands the uses of, and makes other changes pertaining to the Provider Relief Fund HR 4450/S 2352- Access to Infertility Treatment and Care Act- requires private insurance to cover fertility preservation services ARPA-H FDA User Fee Agreement policy riders: increasing diversity in clinical trials, improvements to accelerated approval pathway, expanded use of real world data, and in vitro clinical tests HR 7630/S 4120- Childhood Cancer STAR Reauthorization Act of 2022- reauthorizes the STAR Act through FY2028 S 4293- Pharmacy Benefit Manager Transparency Act of 2022- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 4430- Interagency Patent Coordination and Improvement Act of 2022- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 5295/HR 9565- Comprehensive Cancer Survivorship Act- addresses the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment HR 4128/S 2209- VALID Act of 2021- requires FDA to regulate in vitro clinical tests
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to patient access, Issues related to pharmaceutical manufacturing, Issues related to treatment of endometriosis, Patent reform H.R.5801 - HELP Copays Act H.R.5376 Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to patient access, Issues related to pharmaceutical manufacturing, Issues related to treatment of endometriosis, Patent reform H.R.5801 - HELP Copays Act H.R.5376 Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Bills -H.R. 2163/S. 464 - Safe Step Act -S.1773 - Prescription Drug Pricing Dashboard Act -H.R. 5376 - Build Back Better Act -H.R. 3684- Infrastructure Investment and Jobs Act -H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -S.2076/H.R. 3932 PASTEUR Act -S. 3799- PREVENT Pandemics Act -H.R.4521 - COMPETES Act of 2022 -S.1260 - United States Innovation and Competition Act of 2021 -H.R.6963 - Accelerated Approval Integrity Act of 2022 -H.R.6996 - Accelerating Access for Patients Act of 2022 -H.R. 2565 / S.2952 the FDA Modernization Act -H.R. 6972 - Give Kids a Chance Act -H.R. 1730 - STAT Act -H.R. 7032 - Increasing Transparency in Generic Drug Applications Act -H.R. 5030/S. 2706 - DIVERSE Trials Act -H.R. 6584 - DEPICT Act -H.R. 9476- Influenza Act of 2022 Issues -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response -Issues related to awareness about diabetic eye diseases in minority populations
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Pharmacy
H.R. 2163/S. 464 - Safe Step Act H.R. 5376 - Build Back Better Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Drug pricing issues -Prescription Drug User Fee Act reauthorization -Issues related to prescription drug value -Issues related to the 340B Drug Discount Program
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to health care and prescription drug pricing in H.R. 5376 - Build Back Better Act, Inflation Reduction Act of 2022 (PL 117-169); H.R. 5801 - HELP Copays Act; H.R. 7506 - New Era of Preventing End-Stage Kidney Disease Act; S .586/H.R.3259 - NOPAIN Act, H.R.2617 - Consolidated Appropriations Act, 2023.
Client expense: $370,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Insurance
H.R. 4612/S. 2412 - Protecting Access to Lifesaving Screenings Act of 2021; a bill to make a series of changes relating to health insurance coverage of screening mammography H.R. 5769/S. 1067 - Access to Breast Cancer Diagnosis Act; bill to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging H.R. 2163/S. 464 - Safe Step Act; bill to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes H.R. 4385/S.3080 - Cancer Drug Parity Act; bill to require health plans that cover anticancer medications administered by a health care provider to provide no less favorable cost sharing for patient-administered anticancer medications. H.R. 5376 - Inflation Reduction Act of 2022; a budget reconciliation bill which included provisions to continue subsidies on private insurance premiums, address out of pocket costs in Medicare Part D, and more H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act; a bill to amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 7045/S. 3796 - Closing Health Coverage Gaps for Public Servants Act; a bill to eliminate the opt-out for nonfederal governmental health plans, including the opt-out for coverage for full mastectomy and reconstruction care Administrative actions necessary to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging Issues related to regulation of short-term limited duration plans Implementation of the Affordable Care Act Policies regarding White House Cancer Moonshot implementation Public and private insurance adjustments and other policy changes due to the COVID-19 emergency, including those impacting the immunocompromised populations S. 942 - No Junk Plans Act; bill to overturn previous administration rule expanding non-comprehensive health insurance plans that dont have to provide healthcare coverage for people with pre-existing conditions S. 1002 - Junk Plan Accountability and Disclosure Act; a bill which establishes requirements for certain noncomprehensive health insurance coverage and provides for additional outreach activities to increase enrollment in qualified health plans Policies related to co-pay assistance programs Policies related to the extension of Advanced Premium Tax Credits provided by the American Rescue Plan Comments on future rulemaking for the 2024 Notice on Benefit and Payment Parameters
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office
2022 · third_quarter · Health Issues
Transparency. Copay Accumulators/Maximizers. Benefit Design. Quality-Adjusted Life Years. Home Health Services. H.R.5376 - Inflation Reduction Act of 2022. H.R.2163 - Safe Step Act. H.R.3173 - Improving Seniors Timely Access to Care Act. H.R.5801 - HELP Copays Act. H.R.7667 - Food and Drug Amendments of 2022. H.R.4472 - BENEFIT Act of 2021. H.R.7634 - Protecting Health Care for All Patients Act. H.R.8581 - Preserving Access to Home Health Act. S.464 - Safe Step Act. S.3018 - Improving Seniors Timely Access to Care Act. S4348 - FDASLA Act of 2022. S.373 - BENEFIT Act of 2021. S.4605 - Preserving Access to Home Health Act.
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Medicare/Medicaid
Medicare Part D policies. H.R.5801 - HELP Copays Act H.R.5376 - Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Budget/Appropriations
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. Monitoring and outreach on legislative and administrative activity related to infrastructure. Monitoring and outreach on legislative and administrative activity related to reconciliation and the congressional budget resolution. H.R. 4432 - Department of Defense Appropriations Act, FY2022. Senate Draft, Department of Defense Appropriations Act, FY2022 P.L. 116-136, CARES Act P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act P.L. 117-2, American Rescue Plan Act of 2021 H.R. 3684 - Infrastructure Investment and Jobs Act S. 464 - Safe Step Act H.R. 2163 - Safe Step Act H.R. 1319 - American Rescue Plan Act of 2021 S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R. 1868 - To prevent across-the-board direct spending cuts, and for other purposes H.R. 315 - Medicare Sequester COVID Moratorium Act S. 368 - Telehealth Modernization Act H.R. 1332 - Telehealth Modernization Act H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 S. 1024 - Healthcare Workforce Resilience Act H.R. 2255 - Healthcare Workforce Resilience Act H.R. 1819 - Pharmacy Benefit Manager Accountability Study Act H.R. 3107 - The Improving Seniors Timely Access to Care Act H.R. 3517 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 315 - The Medicare Sequester COVID Moratorium Act S. 748 - Medicare Sequester Relief Act H.R. 5067 - Preserving Patient Access to Home Infusion Act S. 2652 - Preserving Patient Access to Home Infusion Act H.R. 3541 - Conrad State 30 and Physician Access Reauthorization Act S. 1810 - Conrad State 30 and Physician Access Reauthorization Act H.R. 5376 - Build Back Better Act S. 3314 - Supporting Medicare Providers Act H.R. 6020 - Supporting Medicare Providers Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S. 4408 Health and Location Data Protection Act of 2022 H.R. 4122 - Resident Education Deferred Interest Act or the REDI Act S. 3658 - Resident Education Deferred Interest Act or the REDI Act H.R.8800 - Supporting Medicare Providers Act of 2022 FY2023 Labor Health and Human Services Appropriations content Draft House, Department of Defense Appropriations Act, FY2023 Draft Senate, Department of Defense Appropriations Act, FY2023
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE