Reduced Costs and Continued Cures Act

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)

Client expense: $42,877 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5801, Help Ensure Lower Patient Copays Act S. 2164, Lower Costs, More Cures Act of 2021 Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Prescription Drug User Fee Act (PDUFA) reauthorization Issues related to the 340B program Administration plans to combat cancer and address other public health needs

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 7667- Food and Drug Amendments of 2022, support passage S.4248- Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, support passage H.R. 5435- BRAIN Act of 2021, establishing a Neuroscience Center of Excellence at the Food and Drug Administration, support passage H.R.315 - Common Sense Cannabis Reform for Veterans, Small Business and Medical Professionals Act, monitor to support H.R. 6000 - Cures 2.0 Act, supporting the goals of Rep. Upton/DeGette's Cures 2.0 initiative aimed at accelerating medical research, patient access to novel therapeutics and authorizing the Administration's Advanced Research Projects Agency for Health (ARPA-H) proposal -support passage S. 3726- CARE for Long COVID Act- support passage S.4447 - Modernizing Accelerated Approval Act, support passage and inclusion in Senate FDASLA package. S. 3799 Prevent Pandemics Act - support passage Lisa Blunt Rochester- Long-COVID RECOVERY NOW Act, support passage (bill number forthcoming)

Client expense: $58,169 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement

Client expense: $1,170,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 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.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug 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 of 2021 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.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 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 H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, 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 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.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD 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

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815: BIOSIM Act. Implementation of the Inflation Reduction Act. H.R.6485/S.3495: Inflation Prevention Act.

Client expense: $900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 7667- Food and Drug Amendments of 2022, support passage S.4248- Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, support passage H.R. 5435- BRAIN Act of 2021, establishing a Neuroscience Center of Excellence at the Food and Drug Administration, support passage H.R.315 - Common Sense Cannabis Reform for Veterans, Small Business and Medical Professionals Act, monitor to support H.R. 6000 - Cures 2.0 Act, supporting the goals of Rep. Upton/DeGette's Cures 2.0 initiative aimed at accelerating medical research, patient access to novel therapeutics and authorizing the Administration's Advanced Research Projects Agency for Health (ARPA-H) proposal -support passage S. 3726- CARE for Long COVID Act- support passage S.4447 - Modernizing Accelerated Approval Act, support passage and inclusion in Senate FDASLA package. S. 3799 Prevent Pandemics Act - support passage Lisa Blunt Rochester- Long-COVID RECOVERY NOW Act, support passage (bill number forthcoming)

Client expense: $45,264 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $310,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Client expense: $880,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163 /S 464 "Safe Step Act," all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.

Client expense: $1,230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125 - the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -Issues related to CMMI

Client expense: $1,630,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; & Specialty Drug Issues. HR 5260 Reduced Cost & Continued Care Act of 2021.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3, Lower Drug Costs Now Act; HR 5260, Reduced Cost and Continued Care Act; Specialty Drugs and Prescription Drug Pricing, HR 19.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Medicare Observation Status Regulations 9. Proposals to streamline Medicare enrollment during the COVID-19 pandemic 10. Proposals to permit Medicare prescription drug pricing negotiations 10. S. 245, States Achieve Medicaid Expansion Act of 2021 or the SAME Act of 2021, entire bill 11. H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, entire bill 12. S. 782, Nursing Home Reform Modernization Act of 2021, entire bill 13. H.R. 4131, To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, entire bill 14. Demonstration projects for expanding home and community based services under Medicare and Medicaid 15. H.R. 4311, Medicare Dental, Vision, and Hearing Act of 2021, entire bill 16. H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021, entire bill 17. H.R. 5260, Reduced Costs and Continued Cures Act, entire bill 18. H.R. 1676, Jack Reynolds Memory Medigap Expansion Act, entire bill 19. Proposals to adjust 2022 Medicare Part B premiums 20. H.R. 3650, Improving Access to Medicare Coverage Act of 2021, entire bill 21. Medicare Direct Contracting Entity (DCE)program 22. Medicare ACO Realizing Equity, Access, and Community Health (REACH) program 23. H.R. 6698, Stop Unfair Medicaid Recoveries Act of 2022, entire bill 24. Medicare regulations under the No Surprises Act 25. Administration of ACO REACH program 26. Administration of Medicare telephone help lines 27. H.R. 5376, Inflation Reduction Act of 2022, provisions relating to Medicare drug negotiations, vaccine access and pricing, insulin pricing, out of pocket annual caps, catastrophic drug out of pocket costs 28. Expansion of Medicare coverage for medically necessary dental services

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; & Specialty Drug Issues. HR 5260 Reduced Cost & Continued Care Act of 2021.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation Amending or Repealing P.L. 111-148; Electronic Pricing; Chronic Care; PBM Disclosure; Formulary Requirements; Generic Drug Co- Payments; Preferred Pharmacy Networks and HHS Rebate Rule. S. Con. Res. 14 Budget Reconciliation. HR 5260 Reduced Cost and Continued Care Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3, Lower Drug Costs Now Act; HR 5260, Reduced Cost and Continued Care Act; Specialty Drugs and Prescription Drug Pricing, HR 19.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

Client expense: $930,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $930,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)

Client expense: $11,123 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)

Client expense: $11,123 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 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.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug 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 of 2021 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.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 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 H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, 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 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.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD 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: $1,908,258 · 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

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125 - the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -Issues related to CMMI

Client expense: $2,430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $910,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

Client expense: $910,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Elijah E. Cummings Lower Cost Drugs Now Act - provisions related to drug pricing and Medicare Part D H.R. 19, Lower Costs, More Cures Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5801, Help Ensure Lower Patient Copays Act S. 2164, Lower Costs, More Cures Act of 2021 Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 & 2023; Notice Requirement for Non-Federal Governmental Plans proposed rule Prescription Drug User Fee Act (PDUFA) reauthorization Issues related to the 340B program

Client expense: $2,370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Issues pertaining to the Healthy Futures Task Force. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. HR 5376 "Inflation Reduction Act of 2022," all provisions relating to drug pricing and taxes. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions. Issues related to the implementation of PL 115-97 (2017) "Tax Cuts and Jobs Act, all provisions.

Client expense: $1,250,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)

Client expense: $42,877 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE

Patient access and maintain six protected classes for depressions and schizophrenia under Medicare Part D; S. 2327 - Seniors Prescription Drug Relief Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R.5260 - Reduced Costs and Continued Cures Act; Prescription Drug pricing legislation - Build Back Better Act - H.R. 5376 & Senate amendments Ensure patient access to behavioral health services and treatments through telehealth H.R. 5376 - Inflation Reduction Act of 2022

Client expense: $580,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---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 ---FY 2023 Appropriations ---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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 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.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule 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.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---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.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022

Client expense: $3,220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---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 ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---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 --- In-Home Administration of Part B Drugs ---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 ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations 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.729: Strength in Diversity Act of 2021 ---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.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 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---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.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---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 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---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.153: Protecting Consumer Access to Generic Drugs 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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---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 ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---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 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---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.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---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.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---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.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: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Client expense: $850,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Potential changes to structure and reimbursement for Medicare Part D; HR 3 Elijah E. Cummings Lower Drug Costs Now Act; S. 2543 Prescription Drug Pricing Reduction Act of 2019; S.2327 - Seniors Prescription Drug Relief Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 Build Back Better Act.

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Medicare Observation Status Regulations 9. Proposals to streamline Medicare enrollment during the COVID-19 pandemic 10. Proposals to permit Medicare prescription drug pricing negotiations 10. S. 245, States Achieve Medicaid Expansion Act of 2021 or the SAME Act of 2021, entire bill 11. H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, entire bill 12. S. 782, Nursing Home Reform Modernization Act of 2021, entire bill 13. H.R. 4131, To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, entire bill 14. Demonstration projects for expanding home and community based services under Medicare and Medicaid 15. H.R. 4311, Medicare Dental, Vision, and Hearing Act of 2021, entire bill 16. H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021, entire bill 17. H.R. 5260, Reduced Costs and Continued Cures Act, entire bill 18. H.R. 1676, Jack Reynolds Memory Medigap Expansion Act, entire bill 19. Proposals to adjust 2022 Medicare Part B premiums 20. H.R. 3650, Improving Access to Medicare Coverage Act of 2021, entire bill 21. Medicare Direct Contracting Entity (DCE)program 22. Medicare ACO Realizing Equity, Access, and Community Health (REACH) program 23. H.R. 6698, Stop Unfair Medicaid Recoveries Act of 2022, entire bill 24. Medicare regulations under the No Surprises Act 25. Administration of ACO REACH program 26. Administration of Medicare telephone help lines 27. H.R. 5376, Inflation Reduction Act of 2022, provisions relating to Medicare drug negotiations, vaccine access and pricing, insulin pricing, out of pocket annual caps, catastrophic drug out of pocket costs 28. Expansion of Medicare coverage for medically necessary dental services

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; & Specialty Drug Issues. HR 5260 Reduced Cost & Continued Care Act of 2021.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation Amending or Repealing P.L. 111-148; Electronic Pricing; Chronic Care; PBM Disclosure; Formulary Requirements; Generic Drug Co- Payments; Preferred Pharmacy Networks and HHS Rebate Rule. S. Con. Res. 14 Budget Reconciliation. HR 5260 Reduced Cost and Continued Care Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3, Lower Drug Costs Now Act; HR 5260, Reduced Cost and Continued Care Act; Specialty Drugs and Prescription Drug Pricing, HR 19.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to drug pricing and reimbursement, transparency and patient access. HR 2163/S 464 "Safe Step Act, all provisions. Issues pertaining to the Healthy Futures Task Force, Request for Information. Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues pertaining to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 909 "Prescription Drug Price Relief Act," all provisions. HR 5376 "To Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14," all provisions relating to drug pricing and tax. HR 5260 "Reduced Costs and Continued Cures Act," all provisions. HR 19 Lower Costs, More Cures Act of 2021, all provisions. Issues relating to the Prescription Drug User Fee Act (PDUFA VII), Generic Drug User Fee Amendments (GDUFA III), and Biosimilar User Fee Act (BsUFA III) and the Medical Device User Fee Amendments (MDUFA V). HR 3173 "Improving Seniors' Timely Access to Care Act," all provisions. HR 6963 "Accelerated Approval Integrity Act," all provisions.

Client expense: $1,240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.3 - Elijah Cummings Lower Drug Costs Now, monitor legislation S.151- "COVID HCBS Relief Act of 2021"- support passage H.R. 4131- "To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes."- support passage H.R. 2455 - The Resetting the IMPACT Act (TRIA) of 2021." - support passage H.R. 1319- The American Rescue Plan Act of 2021, support passage H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage H.R. 5237 - "To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation.

Client expense: $42,877 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Elijah E. Cummings Lower Cost Drugs Now Act H.R. 19, Lower Costs, More Cures Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5801, Help Ensure Lower Patient Copays Act S. 2164, Lower Costs, More Cures Act of 2021 Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 & 2023; Notice Requirement for Non-Federal Governmental Plans proposed rule Prescription Drug User Fee Act (PDUFA) reauthorization Issues related to the 340B program

Client expense: $880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 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.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug 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 of 2021 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.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, 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 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.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.799: GOLD CARD 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: $1,457,755 · 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

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $1,270,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office