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Pharmacy Benefit Manager Transparency Act of 2022
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
92pct
204d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Pharmacy Benefit Manager Transparency Act of 2022 This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. The bill also prohibits PBMs from arbitrarily, unfairly, or deceptively (1) clawing back reimbursement payments, or (2) increasing fees or lowering reimbursements to pharmacies to offset changes to federally funded health plans. PBMs are not subject to these prohibitions if they (1) pass along 100% of any price concession or discount to the health plan, and (2) disclose specified costs, prices, reimbursements, fees, markups, discounts, and aggregate payments received with respect to their PBM services. Further, PBMs must report annually to the Federal Trade Commission (FTC) certain information about payments received from health plans and fees charged to pharmacies. The FTC and state attorneys general are authorized to enforce the provisions of the bill.
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Filing registrants (41)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 647.
Committee on Commerce, Science, and Transportation. Reported by Senator Cantwell with an amendment in the nature of a substitute. Without written report.
Committee on Commerce, Science, and Transportation. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Commerce, Science, and Transportation.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2024 · third_quarter · Health Issues
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Client expense: $970,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2024 · second_quarter · Health Issues
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Client expense: $1,050,000 · Firm income: Not reported
2024 · first_quarter · Health Issues
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Client expense: $460,000 · Firm income: Not reported
2023 · fourth_quarter · Health Issues
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 410, S.1130, Health Care PRICE Transparency Act H.R. 830, S.1375, HELP Co-Pays Act H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act (IRA commercial spillover) H.R. 5539, Orphan Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 P.L. 111-148, Patient Protection and Affordable Care Act H.R. 5378 -The Lower Costs, More Transparency Act S. 2973 -Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines HR 6283 Delinking Revenue from Unfair Gouging "DRUG Act" E.O. 14017, America's Supply Chains E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling R.F.I. Docket Number 230831-0207, Document Number 2023-26930, Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
2023 · third_quarter · Health Issues
H.R. 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/H.R. 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Discussions regarding health equity PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023 Discussions in support of H.R.5376, Share the Savings with Seniors Act Discussions in support of H.R.5539, ORPHAN Cures Act H.R.3561, The PATIENT Act H.R.4895, Lowering Drug Costs for American Families Act Discussions in support of H.R.2880, Protecting Patients Against PBM Abuses Act H.R.2408, Access to Innovative Treatments Act of 2023
Client expense: $2,180,000 · Firm income: Not reported
| Republican |
| AR |
| Jon Tester | Democratic | MT |
| Mike Braun | Republican | IN |
| Shelley Moore Capito | Republican | WV |
| Thom Tillis | Republican | NC |
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2023 · third_quarter · Health Issues
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;
Client expense: $1,380,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Client expense: $1,250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
HR 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/HR 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Discussions regarding health equity PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023
Client expense: $2,230,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
HR 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/HR 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Proposed reconciliation bill encompassing all pharmaceutical provisions Discussions regarding health equity HR 5376, the Build Back Better Act regarding all bio-pharmaceutical provisions PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R.485, Protecting Health Care for All Patients of 2023 Act H.R.830, HELP Copays Act of 2023
Client expense: $2,410,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Client expense: $1,460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
H.R. 7213 - To amend title XVIII of the Social Security Act to provide pharmacy reimbursement for COVID-19-related and future emergency services. S 4293 - Pharmacy Benefit Manager Transparency Act of 2022
Client expense: $35,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
H.R. 7213 - To amend title XVIII of the Social Security Act to provide pharmacy reimbursement for COVID-19-related and future emergency services. S 4293 - Pharmacy Benefit Manager Transparency Act of 2022
Client expense: $35,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Issues related to e-labeling; Generic Drug User Fee Amendments reauthorization; monitor issues related to Pharmacy Benefit Manager Transparency Act of 2022 (S.4293).
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Workplace Mental Health and Wellness Issues, Including Issues Related to Funding H,R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.R. 7353, Telehealth Benefit Expansion Act of 2022 First Dollar Coverage of Telehealth Services for High Deductible Health Plans (included in H.R. 2471, Consolidated Appropriations Act of 2022) H.R. 7487, Employee Access to Worksite Health Services Act Affordability of Employer Coverage for Family Members of Employees IRS Regulations H.R. 7780, Mental Health Matters Act H.R. 4040, Advancing Telehealth Beyond COVID - 19 Act of 2021 H.R. 4058, Telemental Health Care Access Act of 2021 H.R. 5981, Telehealth Expansion Act of 2021 S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H. R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 INSULIN Act - Discussion draft released by Senator Shaheen and Senator Collins
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Pharmacy
User Fee Amendments (UFA) Reauthorization (transparency in generic drug applications). Prescription Drug User Fee Amendments (UFA). Medical Device User Fee Amendments (UFA). Generic Drug User Fee Amendments (UFA). Biosimilar User Fee Amendments (UFA). Accelerated Approval. Pharmacy Benefits Managers. S.4293 - Pharmacy Benefit Manager Transparency Act of 2022. H.R.6973/S.4351 - Enhanced Access to Affordable Medicines Act. H.R.7032/S.4338 - Increasing Transparency in Generic Drug Applications Act.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Budget/Appropriations
Public Law 117-328-Consolidated Appropriations Act, 2023, relating to oversight of PBM services and S.4293 (Pharmacy Benefit Manager Transparency Act of 2022).
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
S. 4293 Pharmacy Benefit Manager Transparency Act of 2022; H.R. 7666: "The Restoring Hope for Mental Health and Well-Being Act of 2022," Title VI, Sec. 602, Oversight of Pharmacy Benefit Manager Services.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to drug pricing; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; general issues related to vaccines; issues related to 340B; issues related to RX to OTC switch; issues related to Pandemic Preparedness in PREVENT Pandemics ACT; issues related to Reconciliation; issues related to Cosmetic Reform; issues related to S.3700 "Affordable Insulin Now Act"; issues related to S.2199 "Insulin Price Reduction Act"; issues related to Clinical Trial Diversity; issues related to Accelerated Approval; issues related to HR 6854 "Depict Act"; issues related to Out-of-Pocket Cap; general issues related to Insulin pricing; issues related to HR7667 "Food and Drug Amendments of 2022"; issues related to S.4348 "Food and Drug Administration and Landmark Advancements (FDASLA) Act; issues related to S.4293 "Pharmacy Benefit Managers Transparency Act of 2022"; issues related to HR 5376 "Inflation Reduction Act"; issues related to drug pricing in Inflation Reduction Act; issues related to cosmetics reform in the Modernization of Cosmetics Regulations Act; issues related to Copay Accumulators; issues related to Vaccine in Children Program; issues related to Q1/Q2 budget spend; issues related to ACNU "additional condition for prescription use; and issues related to HR 3656 "Vaccine Access Improvement Act".
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Price of prescription drugs; antitrust issues; Prescription Drug Pricing Reduction Act Pharmacy Benefit Manager (PBM) operations and practices, Spread Pricing Direct and Indirect Remuneration (DIR) Drug Rebate Rule/Executive Order Senate Finance Committee Prescription Drug Pricing Reduction Act Lower Drug Costs Now Act (H.R. 3) Drug Patent Reform Robinson-Patman Reform Inflation Reduction Act of 2022 (H.R. 5376) Pharmacy Benefit Manager Transparency Act (S. 4293) PBM Transparency Language in the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666) 2023 Omnibus Appropriations Bill
Client expense: $1,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Insurance
ACA 1332 Waivers Individual Market and Exchange Stabilization Prior Authorization Hospital Consolidation Transparency of Hospital Billing Act (H.R.8133) Flexibility in Hospital Ownership Act Oversight of Anti-Competitive Behavior of Non-Profit Hospitals Act Consumer Choice of Care Act Competition in State Healthcare Markets Act Addressing Anti-Competitive Contracting Clauses Act Increasing Competition for Medical Residency Act Hospital Claims Form Issues Privacy and Healthcare Cybersecurity Social Determinants of Health (SDOH) To amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios. (H.R.3969) Mental Health and Substance Use, CFR Part 2, Parity and MHPAEA Compliance Issues Mental Health Matters Act (H.R. 7780) Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666) Behavioral Health Crisis Intervention and 9-8-8 hotline services Bipartisan Safer Communities Act MAT Act Surprise Medical Billing Price of Prescription Drugs Pharmacy Benefit Manager (PBM) Operations and Practices, Spread Pricing, Pharmacy Benefit Manager Transparency Act (S. 4293) Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act Chronic Kidney Disease Conditions of Coverage Reform COVID-19 Testing, Vaccines, Treatment, Cost Sharing Medicare Sequestration Telehealth KEEP Telehealth Options Act Telehealth Expansion Act (H.R. 5981) Short Term Limited Duration Health Plans Consolidated Appropriations Act (H.R. 133) Medical Loss Ratio Federal Medical Assistance Percentages (FMAP) increase Special Enrollment Periods Hospital Claims Form Issues Build Back Better Act (H.R.5376) Inflation Reduction Act of 2022 Medicaid Eligibility Health Equity/Health Disparities Defense Health Programs (FY2022 Budget and FY2023 Budget Request) Veterans Health Care VA Community Care Network Program Veterans PACT Act Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 Achieving Equity in the Treatment of Dual Eligible Beneficiaries Act (H.R. 7997) TCPA Insurance Navigators Network Adequacy Provider Directories 2023 Omnibus Appropriations Bill Originating Site Requirements Provider and Nursing Licensing Issues Inpatient Only List Site Neutrality Biosimilar Red Tape Elimination Act Biologics Competition Act
Client expense: $1,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
ACA 1332 Waivers Individual Market and Exchange Stabilization Prior Authorization Hospital Consolidation Transparency of Hospital Billing Act (H.R.8133) Flexibility in Hospital Ownership Act Oversight of Anti-Competitive Behavior of Non-Profit Hospitals Act Consumer Choice of Care Act Competition in State Healthcare Markets Act Addressing Anti-Competitive Contracting Clauses Act Increasing Competition for Medical Residency Act Hospital Claims Form Issues Privacy and Healthcare Cybersecurity Social Determinants of Health (SDOH) To amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios. (H.R.3969) Mental Health and Substance Use, CFR Part 2, Parity and MHPAEA Compliance Issues Mental Health Matters Act (H.R. 7780) Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666) Behavioral Health Crisis Intervention and 9-8-8 hotline services Bipartisan Safer Communities Act MAT Act Surprise Medical Billing Price of Prescription Drugs Pharmacy Benefit Manager (PBM) Operations and Practices, Spread Pricing, Pharmacy Benefit Manager Transparency Act (S. 4293) Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act Chronic Kidney Disease Conditions of Coverage Reform COVID-19 Testing, Vaccines, Treatment, Cost Sharing Medicare Sequestration Telehealth KEEP Telehealth Options Act Telehealth Expansion Act (H.R. 5981) Short Term Limited Duration Health Plans Consolidated Appropriations Act (H.R. 133) Medical Loss Ratio Federal Medical Assistance Percentages (FMAP) increase Special Enrollment Periods Hospital Claims Form Issues Build Back Better Act (H.R.5376) Inflation Reduction Act of 2022 Medicaid Eligibility Health Equity/Health Disparities Defense Health Programs (FY2022 Budget and FY2023 Budget Request) Veterans Health Care VA Community Care Network Program Veterans PACT Act Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 Achieving Equity in the Treatment of Dual Eligible Beneficiaries Act (H.R. 7997) TCPA Insurance Navigators Network Adequacy Provider Directories 2023 Omnibus Appropriations Bill Originating Site Requirements Provider and Nursing Licensing Issues Inpatient Only List Site Neutrality Biosimilar Red Tape Elimination Act Biologics Competition Act
Client expense: $1,270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Draft, Hospital Competition Act of 2021 (no bill number) - procedural changes around The Mental Health Parity and Addiction Equity Act (MHPEA) litigation H.R. 19 - Lower Costs, More Cures Act of 2021- Rep. McMorris, Rodgers - prescription drug prices for Medicare and Medicaid H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 432 - Mental Health Access Improvement Act of 2021- Rep. Thompson, Mike - mental health services under Medicare H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 959 - Black Maternal Health Momnibus Act of 2021 - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option H.R. 2163 - Safe Step Act - Rep. Ruiz, Raul - commercial plans and medication step-therapy requirements H.R. 2617 - Consolidated Appropriations Act, 2023 - Rep. Connolly, Gerald - continued Medicaid and Medicare provisions and funding for FY2023 H.R. 3173 - Improving Seniors Timely Access to Care Act of 2021 - Rep. DelBene, Suzan - prior authorization in Medicare Advantage H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony - mental health parity H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act of 2021- Rep. Cheney, Liz - telehealth H.R. 4595 - Medicaid Saves Lives Act - Rep. Bourdeaux, Carolyn - Medicaid expansion H.R. 6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - Rep. Craig, Angie - continued funding for Medicare and Medicaid H.R. 7236 - Strengthen Kids Mental Health Now Act of 2022 - Rep. Eshoo, Anna - mental health and Medicaid H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. - Rep. Matsui, Doris - behavioral health and electronic health records H.R. 7512 - Protecting Patients from Deceptive Health Plans Act - Rep. Hayes, Jahana - excepted benefits coverage H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 - Rep. Pallone, Frank - reauthorization of several behavioral health programs H.R. 7667 - Food and Drug Amendments of 2022 - Rep. Eshoo, Anna - reauthorization of user fee programs H.R. 7780 - Mental Health Matters Act - Rep. DeSaulnier, Mark - changes to the procedure around MHPEA litigation H.R. 8152 - American Data Privacy and Protection Act - Rep. Pallone, Frank, Jr. - data privacy H.R. 8594 - Restore Protections for Dialysis Patients Act - Rep. Clarke, Yvette - reform of the Medicare Secondary Payer act H.R. 8876 - The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 - Rep. Davis, Danny - funding for maternal and early childhood health programs H.R. 8878 - To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. - Rep. Chu, Judy - mental health and Medicare H.R. 8879 - Inpatient Psychiatric Facility Improvement Act - Rep. Evans, Dwight - mental health and Medicare H.R. 8881 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes. - Rep. Horsford, Steven - commercial plans H.R. 8884 - To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program. - Rep. Kelly Mike - mental health and Medicare H.R. 8885 - Better Health Care Directories Act - Rep. Kildee, Daniel - commercial plans H.R. 8886 - Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act - Rep. Moore, Gwen - commercial plans H.R. 8889 - RICE Act - Rep. Plaskett, Stacey - commercial plans H.R. 8890 - Physician Wellness Program Act of 2022 - Rep. Ruiz, Raul - mental health and Medicare H.R. 8891 - No Surprises for Survivors Act of 2022 - Rep. Sanchez, Linda - requirements for group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for forensic medical exams with no cost sharing H.R. 8892 - To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes. - Rep. Sewell, Terri - commercial plans H.R. 8908 - Fighting Stimulant and other Substance Use Disorders Act - Rep. Estes, Ron - mental health and Medicare H.R. 8910 - Behavioral Health Integration Awareness Act of 2022 - Rep. Smith, Jason - mental health and Medicare S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 464 - Safe Step Act - Sen. Murkowski, Lisa - commercial plans and medication step-therapy requirements S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 1512 - CONNECT for Health Act of 2021 - Sen. Schatz, Brian - expansion of telehealth for Medicare S. 1873 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 - Sen. Crapo, Mike - Cancer screening in Medicare S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher - mental health parity S. 2164 - Lower Costs, More Cures Act of 2021 - Sen. Crapo, Mike - prescription drug prices for Medicare and Medicaid S. 2315 - Medicaid Saves Lives Act - Sen. Warnock, Raphael - Medicaid expansion S. 2499 - SAFE DATA Act - Sen. Wicker, Roger - consumer data privacy and data transparency and security S. 3018 - Improving Seniors Timely Access to Care Act of 2021 - Sen. Marshall, Roger - prior authorization in Medicare Advantage S. 3195 - Consumer Online Privacy Rights Act - Sen. Cantwell, Maria - data privacy S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness S. 3983 - PATCH Act - Sen. Cassidy, Bill - data privacy S. 4264 - Advancing Integration in Medicare and Medicaid (AIM) Act - Sen. Scott, Tim - coordinating full-benefits for dual eligible individuals S. 4293 - Pharmacy Benefit Manager Transparency Act of 2022 - Sen. Cantwell, Maria and Sen. Grassley, Chuck - scope of PBM practices S. 4306 - Improving Access to Behavioral Health Integration Act - Sen. Smith, Tina - behavioral health S. 4750 - Restore Protections for Dialysis Patients Act - Sen. Menendez, Robert - reform of MSP Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage and reproductive health; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; ACA risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.
Client expense: $2,470,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2022 · fourth_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · 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
2022 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill 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; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · 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
2022 · fourth_quarter · Medicare/Medicaid
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs and drug pricing H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169); provisions related to drug pricing S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
Client expense: $860,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
Issues related to Biden infrastructure plan and associated tax increases Issues related to HHS nominations H.R.4123, Increasing Health Coverage through HRAs Act S.1784/H.R. 3353, the Contact Lens Prescription Verification Modernization Act H.R. 3, the Lower Drug Costs Now Act S. 4293, the Pharmacy Benefit Manager Transparency Act. H.R. _, the Fiscal Year 2023 Labor, Health and Human Services, Education, and Related Agencies Funding Bill Notice Of Proposed Rulemaking (NPRM) On The Affordability Of Employer Coverage For Family Members Of Employees H.R. 7504, the Start-ups for Cures Act H.R. 7505, the More Cures Act
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
Client expense: $6,610,000 · 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 · Small Business
House Bills H.R. 842, the Protecting the Right to Organize (PRO) Act of 2021 - oppose. H.R. 1381, the Main Street Tax Certainty Act - support. H.R. 3185, the Save Local Business Act - support. Sec. 804 of H.R. 4350, the National Defense Authorization Act for Fiscal Year 2023, Minimum Wage for Employees of Department of Defense Contractors - oppose. H.R. 6161, the Employee Retention Tax Credit Reinstatement Act. - support. H.R. 1284, the Fair and Open Competition Act - support. H.R. 5743, the Ensuring Workers Get PAID Act of 2021 - support. H.R. 3425, the Saving Gig Economy Taxpayers Act - support. H.R. 6913, the Stop the Nosy Obsession with Online Payments Act (SNOOP Act) of 2022 - support. H.R. 8152, the American Data Privacy and Protection Act - oppose. H.R. 7701, the Wage Theft Prevention and Recovery Act - oppose. H.R. 6833, the Affordable Insulin Now Act - express concern. H.R. 7505, the American Innovation and Choice Online Act of 2022 - support. H.R. 8874, the Credit Card Competition Act of 2022 - support. Schakowsky amendment #3 to H.R. 7900, the National Defense Authorization Act for Fiscal Year 2023 - oppose. H.R. 8594, the Restore Protections for Dialysis Patients Act (RPDPA) - oppose. H.R. 9092, the Family and Small Business Taxpayer Protection Act - support. Senate Bills S. 53, the Raise the Wage Act of 2021 - oppose. S. 480, the Main Street Tax Certainty Act - support. S. 420, the Protecting the Right to Organize (PRO) Act of 2021 - oppose. S. 1636, the Save Local Business Act - support. S. 2239, the Unnecessary Agency Regulations Reduction Act of 2021 - support. S. 403, the Fair and Open Competition Act - support. S. 3074, the Ensuring Workers Get PAID Act of 2021 - support. S. 3889, the Employee Rights Act - support S. 3625, the Employee Retention Tax Credit Reinstatement Act - support S. 3546, the Stop the Nosy Obsession with Online Payments Act (SNOOP Act) of 2022 - support. The Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN Act) - express concern. S. 2992, the American Innovation and Choice Online Act - support. S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 - support. ENABLERS Act amendment to National Defense Authorization Act - oppose. S. 4674, the Credit Card Competition Act of 2022 - support. S. 4750/H.R. 8594, the Restore Protections for Dialysis Patients Act (RPDPA) - oppose. Braun and Hassan Amendment - FDA User Fee Reauthorization - small business user fee waiver - support. Other Issues Transparency in operations of Pharmacy Benefit Managers (PBMs) - support. Revision of the Navigable Waters Protection Rule (NWPR) - oppose. Government-mandated Project Labor Agreements - oppose. Comments Department of Labor Wage and Hour Division Notice of Proposed Rulemaking titled Employee or Independent Contractor Classification Under the Fair Labor Standards Act, RIN1235-AA43, 87 Fed. Reg. 62218 (Oct 13, 2022) Comments on NLRB Notice of Proposed Rulemaking titled Standard for Determining Joint-Employer Status, RIN 3142-AA21, 87 Fed. Reg. 54641(Sept 7, 2022), 87 Fed. Reg. 63465 (Oct 19, 2022)
Client expense: $945,000 · Firm income: Not reported
Government targets: Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA)
2022 · fourth_quarter · Medicare/Medicaid
Implementation of American Rescue Plan Act of 2021 (PL 117-2); Continued monitoring of Consolidated Appropriations Act, 2021 (PL 116-260); Extension of the Medicare Sequester; H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes; S. 748, Medicare Sequester Relief Act; Telehealth Expansion Act; Telehealth issues related to COVID-19; S. 150/H.R. 2166, Ensuring Parity in MA for Audio-Only Telehealth Act of 2021; Medicare Advantage flexibilities; Monitoring of Medicare Advantage, particularly as it relates to changes in coding intensity, benchmarks, and health risk assessments; CMS Advance Notice of Methodological Changes for Calendar Year (CY) 2023 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies; Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Issues related to the OIG, GAO, MedPAC reports on Medicare Advantage; S. 3018/H.R. 3173, Improving Seniors Timely Access to Care Act of 2021; CMS RFI on Medicare Advantage S. 4605/H.R. 8581, The Preserving Access to Home Health Act of 2022; Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule CMS-0057-P; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule CMS-4201-P; CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Requirements - Final Rule CMS-1766-F
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Medicare Advantage flexibilities; Monitoring of Medicare Advantage, particularly as it relates to changes in coding intensity, benchmarks, and health risk assessments; Inflation Reduction Act of 2022 (PL 117-169) - extending enhanced premium assistance for ACA marketplace plans through 2025; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; and possible changes to Medicare provider directory policies; extending Acute Hospital Care at Home waivers and flexibilities through December 31, 2024, increasing transparency for home health payments under Medicare, and extending adjustment to calculation of hospice cap amount under Medicare; policies related to the unwinding of the PHE with respect to the Medicaid Maintenance of Effort; Issues related to implementation of the No Surprises Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity; Bipartisan Safer Communities Act, PL 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)); Issues related to the Public Health Emergency; Continued monitoring of Rebate Rule repeal; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to the Public Health Emergency; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to the Public Health Emergency; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - Part B drug negotiation and impact on physician reimbursement; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; H.R. 8800, Supporting Medicare Providers Act of 2022; Issues related to physician payment cuts, including APM bonuses; Issues related to the Public Health Emergency; S. 368/H.R. 1332, Telehealth Modernization Act; H.R. 2163/S. 464, Safe Step Act of 2021; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - - creating Medicare negotiation of drugs, extending enhanced premium assistance for ACA marketplace plans through 2025, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments, extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024, and extending Acute Hospital Care at Home waivers and flexibilities through December 31, 2024; Healthcare workforce shortage issues; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Cybersecurity in the healthcare sector; H.R. 8152, American Data Privacy and Protection Act; Issues related to privacy in the healthcare space; Issues related to national health information technology standards; Consolidated Appropriations Act, 2022 (PL 117-103); S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: Mental Health Workforce; Bipartisan Safer Communities Act, PL 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; S. 3819, Advanced Research Project Authority for Health (ARPA-H) Act; Issues related to the White House Cancer Moonshot initiative; Issues related to the FY 2023 President's Budget; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
H.R. 8800, Supporting Medicare Providers Act of 2022; Issues related to physician payment cuts, including APM bonuses; Inflation Reduction Act of 2022 - Part B drug negotiation and impact on physician reimbursement; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; Health disparities; Issues related to the Public Health Emergency; S. 368/H.R. 1332, Telehealth Modernization Act; H.R. 7007, COVID Supplemental Appropriations Act, 2022; Issues related to the implementation of the No Surprises Act; H.R. 2163/S. 464, Safe Step Act of 2021; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - extending enhanced premium assistance for ACA marketplace plans through 2025; H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024 and possible changes to Medicare provider directory policies; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Telehealth issues related to COVID-19; S. 150/H.R. 2166, Ensuring Parity in MA for Audio-Only Telehealth Act of 2021; HELP Committee bipartisan efforts to improve public health and medical preparedness/response programs; Over the Counter Covid Testing Guidance; Test to Treat Initiative; Issues related to the implementation of the No Surprises Act; S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: Mental Health Workforce; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to FDA user fee reauthorization bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022), including accelerated approval, reimportation, and orphan drugs; Issues related to the Public Health Emergency; H.R. 7007, COVID Supplemental Appropriations Act, 2022; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
HR 1319, American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S 464/HR 2163, Safe Step Act - regarding all bio-pharmaceutical related provisions Proposed reconciliation bill encompassing all pharmaceutical provisions Discussions regarding health equity Issues regarding HR 6833, Continuing Resolution HR 5376, the Build Back Better Act regarding all bio-pharmaceutical provisions Discussions regarding HR 3173, Improving Seniors' Timely Access to Care Act PBM reform including S.4293, Pharmacy Benefit Manager Transparency Act of 2022
Client expense: $640,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2021 S. 298 - Pharmacy Benefit Manage Accountability Study Act of 2021 H.R. 596 - ACCESS ACT H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021. S. 4293 - Pharmacy Benefit Manager Transparency Act S. 155/H.R. 688 - Equal Access Care Act S. 153/H.R. 725 - Personalized Care Act of 2021 H.R. 2808 - Health Freedom and Flexibility Act H.R. 19 - Lower Costs, More Cures Act H.R.5376 - Build Back Better Act S. 4293 - Pharmacy Benefit Manager Transparency Act
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
340B drug discount program; drug pricing; importation of biopharmaceuticals; transparency; direct-to-consumer (DTC) advertising; international pharmaceutical supply chain; antimicrobial resistance legislation; PDUFA Reauthorization; S.920, The Affordable and Safe Prescription Drug Importation Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022. DoD TRICARE Pharmacy Benefits Program; FY2023 National Defense Authorization Act (H.R.7900, S.4543), S.4293, Pharmacy Benefit Manager Transparency Act of 2022. Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22) and SUPPORT for Patients and Communities Act (P.L.115-271). Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act (draft legislation). FY2023 Consolidated Appropriations Act (H.R.2617).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Issues related to drug pricing, generally; S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---National Coverage Determination
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
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 · Medicare/Medicaid
Inflation Reduction Act (H.R. 5376) Misc pharmacy benefit manager (PBM) issues including DIR fees, delaying cancer patients' treatments, step therapy (no specific bills) Pharmacy DIR Reform To Reduce Senior Drug Costs Act (S. 1909) Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) TACT Act (HR 3258) to ensure cancer patients get their oral cancer drugs from PBMs within 72 hours. Exposing hospitals not complying with HHS/CMS regulations to publish price transparency data. (no specific bills) Working on 340B legislation that ensures patients in need receive the discounts, not DSH hospital systems. Hospital and PBM consolidation. CMS/CMMI payment models, including the OCM and OCF. Inflation Reduction Act (HR 5376) CMMI Oncology Payment Reform
Client expense: $228,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Pharmacy
Prescription drug pricing generally S. 4293 (Pharmacy Benefit Manager Transparency Act of 2022), regarding prescription drug pricing
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
S.3673 + HR.7774, Commonsense Reporting Act; S.4293, The Pharmacy Benefit Manager Transparency Act; S.4750 + HR.8594, The Restore Protections for Dialysis Patients Act (RPDPA); HR.7740, The Employee and Retiree Access to Justice Act; HR.7767, The Strengthening Behavioral Health Benefits Act; HR.7780, The Mental Health Matters Act of 2022; Authorize small business health plans; preserve employee exclusion; Preserve ERISA Preemption; Cost-sharing reduction payments under ACA; Surprise Billing Medical legislation; Issues related to employer-sponsored coverage; Issues related to the Affordable Care Act, health reform and health care costs; Issues related to the taxation of employer-sponsored coverage; Issues related to consumer-directed health products, including HRAs, ICHRAs, HSAs; Issues related to single payer, Medicare for All, Medicare buy-in, public option; Issues related to insulin pricing and price transparency reform; Issues related to Telehealth; Safer Federal Workforce Task Force guidance pursuant to Executive Order 14042; Surprise Billing Medical Legislation
Client expense: $156,166 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE
2022 · fourth_quarter · Budget/Appropriations
Public Law 117-328-Consolidated Appropriations Act, 2023, relating oversight of PBM services and S.4293 (Pharmacy Benefit Manager Transparency Act of 2022).
Client expense: Not reported · Firm income: $30,000
Government targets: SENATE
2022 · fourth_quarter · Labor Issues/Antitrust/Workplace
S. 225, the Competition and Antitrust Law Enforcement Reform Act of 2021; S. 1388, the Prescription Pricing for the People Act of 2021; H.R. 603 / S. 53, the Raise the Wage Act of 2021; H.R. 7, the Paycheck Fairness Act; Promoting Competition in the American Economy Executive Order; UnitedHealth Group proposed merger of Change Healthcare; Unfair Competition and Anticompetitive Contract Terms; Occupational exposure to COVID-19 and vaccine mandates; FTC 6(b) Study of Pharmacy Benefit Managers; S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022; S. 288/ H.R. 3843, the Merger Filing Fee Modernization Act of 2022
Client expense: $320,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), SENATE, White House Office
2022 · fourth_quarter · Health Issues
1.Contacted Senate offices to discuss S. 4293 and many of the abuses by PBMs of the 340B drug discount that the legislation targets. 2.Met with Administrator of Health Resources and Services Administration to discuss data collection for the Ryan White program. 3.Contacted Senate and House members to discuss the issue of global vaccination.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE