Seniors Prescription Drug Relief Act

Telehealth coverage S 464 Safe Step Act - Step therapy utilization management reform S 2327 - A bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D. (Support for out-of-pocket cap and smoothing mechanism) Education on health impact of obesity Generic Drug User Fee Amendments

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

The Medicaid & CHIP Access Prescription Digital Therapeutics Act (S. 5238); Access to Prescription Digital Therapeutics Act of 2022 (S.3791/HR 7051); Due Process Continuity of Care Act (S.2697); Seniors Prescription Drug Relief Act (S.2327); and issues related to Medicare Part D redesign's impact on low income subsidy beneficiaries.

Client expense: $350,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Metastatic Breast Cancer Access to Care Act (S. 1312 / HR 3182) Multi-Cancer Early Detection Screening Coverage Act (HR 1946/S 1873) Lymphedema Treatment Act (HR 3630/ S 1315) Breast Cancer Patient Equity Act (HR 3087/S 2051) Reducing Hereditary Cancer Act of 2021 (HR 4110) CONNECT for Health Act (S.1512/ H.R. 2903) Improving Seniors' Timely Access to Care Act (H.R.3173) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) Seniors Prescription Drug Relief Act (S.2327) Medicare coverage policy for breast cancer treatments and services Radiation Oncology Alternative Payment Model Telehealth Policies related to funding, state incentives, and federal efforts for Medicaid expansion Issues related to 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to Medicare coverage for pharmacy services and the Equitable Community Access to Pharmacist Services Act (H.R.7213) Medicare coverage policy for drugs and drug pricing H.R. 9505 - Find It Early Act; a bill to provide for health coverage with no cost-sharing for additional breast screenings for certain individuals Comments regarding the temporary increase in federal medical assistance percentage (FMAP) in response to the COVID-19 Public Health Emergency (PHE) (CMS-9912-N) Comments in response to the Medicaid Eligibility and Enrollment NPRM (CMS-2421-P) Comments in response to the RFI regarding National Directory of Healthcare Providers & Services (CMS-0058-NC) Comments in response to the RFI regarding accessing healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency (PHE)

Client expense: Not reported · Firm income: $40,000

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

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; S. 2327 - Seniors Prescription Drug Relief Act; Quality of care in skilled nursing facilities and Medicare quality measures; H.R. 5376 - Inflation Reduction Act and its implementation.

Client expense: Not reported · Firm income: $50,000

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

Inflation Reduction Act Medicare Part D 6 Protected Classes Executive Order on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program H.Res.1390, Expressing support for the protected class

Client expense: $360,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 1946/S. 1873 -Medicare Multi-Cancer Early Detections Screening and Coverage Act; bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening test H.R. 3183/S. 1312 - Metastatic Breast Cancer Access to Care Act; bill to exempt individuals with metastatic breast cancer from certain waiting periods for disability insurance benefits under the Old-Age, Survivors, and Disability Insurance program and related Medicare coverage H.R. 2903/S. 1512 - CONNECT for Health Act; a bill to expand the use of telehealth and remote patient monitoring services in Medicare H.R. 3087/S. 2051 - Breast Cancer Patient Equity Act; a bill to provide for Medicare coverage of custom fabricated breast prostheses H.R. 3630/S. 1315 - Lymphedema Treatment Act; bill to include certain lymphedema compression treatment items as covered durable medical equipment under Medicare following the surgical removal of the breast (i.e., a mastectomy), including replacements of such prostheses H.R. 4110 - Reducing Hereditary Cancer Act of 2021; a bill to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would reduce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer H.R. 4612/S. 2412 - Protecting Access to Lifesaving Screenings Act of 2021; a bill to make a series of changes relating to health insurance coverage of screening mammography including preserving Medicare coverage for screening mammography, without a requirement for coinsurance, and expands the definition of screening mammography to include any digital modality of such a procedure S. 2327 - Seniors Prescription Drug Relief Act; a bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D H.R. 3173/S. 3018 - Improving Seniors Timely Access to Care Act; a bill which establishes several requirements and standards relating to prior authorization processes under Medicare Advantage (MA) plans H.R. 5376 - Inflation Reduction Act of 2022; a budget reconciliation bill which included provisions to continue subsidies on private insurance premiums, address out of pocket costs in Medicare Part D, and more H.R. 7213, Equitable Community Access to Pharmacist Services Act; a bill to provide pharmacy reimbursement for COVID-19-related and future emergency services. Comments in response to CMS Proposed Rule on CY 2023 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS 1772-P) Comments in response to CMS Request for Information on Medicare Advantage (CMS-4203-NC ) Comments in response to CY2023 Medicare Physician Fee Schedule (CMS-1770-P) Issues related to the upcoming Notice on Benefit and Payment Parameters for FY2024 Medicare coverage policy for drugs and drug pricing Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to funding, state incentives, and federal efforts for for Medicaid expansion Coverage for telemedicine in Medicare

Client expense: $50,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office

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. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing 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 Transparency policy issues Alternative payment models 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) Provisions related to Medicare's noninterference clause

Client expense: $1,390,000 · 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

HR 5376, the Build Back Better Act, in particular Medicare Part D benefit design reform, including out-of-pocket maximum with monthly smoothing, and provisions to expand Medicaid eligibility and access; S 2327, the Seniors Prescription Drug Relief Act; HR 3089/S 1544, the Accelerating Kids Access to Care Act; HR 4640, the Close the Medigap Act; Implementation of the CLINICAL TREATMENT Act; Medicare coverage for medically-necessary dental services

Client expense: $120,000 · Firm income: Not reported

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

S 464 Safe Step Act - Step therapy utilization management reform S 2327 - A bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D. (Support for out-of-pocket cap and smoothing mechanism) Education on health impact of obesity Generic Drug User Fee Amendments

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Metastatic Breast Cancer Access to Care Act (S. 1312 / HR 3182) Multi-Cancer Early Detection Screening Coverage Act (HR 1946/S 1873) Lymphedema Treatment Act (HR 3630/ S 1315) Breast Cancer Patient Equity Act (HR 3087/S 2051) Reducing Hereditary Cancer Act of 2021 (HR 4110) CONNECT for Health Act (S.1512/ H.R. 2903) Improving Seniors' Timely Access to Care Act (H.R.3173) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) Seniors Prescription Drug Relief Act (S.2327) Medicare coverage policy for breast cancer treatments and services Radiation Oncology Alternative Payment Model Telehealth Policies related to funding, state incentives, and federal efforts for Medicaid expansion Issues related to 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to Medicare coverage for pharmacy services and the Equitable Community Access to Pharmacist Services Act (H.R.7213) Issues related to the upcoming Notice on Benefit and Payment Parameters for FY2024 Medicare coverage policy for drugs and drug pricing H.R. 5376 - Inflation Reduction Act of 2022; a budget reconciliation bill which included provisions to continue subsidies on private insurance premiums, address out of pocket costs in Medicare Part D, and more Comments in response to CMS Proposed Rule on CY 2023 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS 1772-P) Comments in response to CMS Request for Information on Medicare Advantage (CMS-4203-NC) Comments in response to CY2023 Medicare Physician Fee Schedule (CMS-1770-P)

Client expense: Not reported · Firm income: $42,000

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

Maintain access to mental health medications for the low-income subsidy (LIS) eligible population under Medicare Part D in prescription drug reform legislation; S. 2327, Seniors Prescription Drug Relief Act; H.R.5376 - Inflation Reduction Act

Client expense: Not reported · Firm income: $50,000

Government targets: 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

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. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - 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. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing 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 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 Transparency policy issues Alternative payment models 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: $7,270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

Access to Prescription Digital Therapeutics Act of 2022 (S.3791/HR 7051); Due Process Continuity of Care Act (S.2697); Seniors Prescription Drug Relief Act (S.2327); and issues related to Medicare Part D redesign's impact on low income subsidy beneficiaries.

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; S. 2327 - Seniors Prescription Drug Relief Act; Quality of care in skilled nursing facilities and Medicare quality measures; H.R. 5376 - Inflation Reduction Act.

Client expense: Not reported · Firm income: $50,000

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

Inflation Reduction Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act H.R.5376, The Build Back Better Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Expanding Medicare benefits to include dental, hearing, and vision Extending and making permanent COVID-19 telehealth flexibilities Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, capping out-of-pocket costs and smoothing, and streamlining prior authorization processes Advocating for improvements to Medicare Part C and Part D proposed rule Inflation Reduction Act of 2022 H.R. 4417, the Capping Drug Costs for Seniors Act S. 2327, the Seniors Prescription Drug Relief Act S. 828/H.R. 432, the Mental Health Access Improvement Act of 2021 H.R. 2080, the Seniors Access to Vaccine Ensured Act of 2021 H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act H.R. 4011, the Capping Drug Costs for Seniors Act of 2022 H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 2061/H.R. 4058, the Telemental Health Care Access Act of 2021 S. 1512/H.R. 2903, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 H.R. 1332/S. 368, the Telehealth Modernization Act H.R. 366, the Protecting Access to Post-COVID-19 Telehealth Act of 2021 H.R. 3733: Essential Caregivers Act of 2021 H.R. 6202, the Telehealth Extension Act of 2021 S. 3575, the Stop the Wait Act of 2022 S. 3593, the Telehealth Extension and Evaluation Act S. 3675, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) 2.0 Act H.R. 7051/S. 3791, the Access to Prescription Digital Therapeutics Act of 2022 H.R. 5375, the Inflation Reduction Act of 2022

Client expense: $31,190 · Firm income: Not reported

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

General education around pharmaceuticals related to Parkinson's disease Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, and streamlining prior authorization processes and step therapy protocols Prescription Drug User Fee Act H.R. 4417, the Capping Drug Costs for Seniors Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics Act of 2021 S. 2327, the Seniors Prescription Drug Relief Act H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021 H.R. 2163, the Safe Step Act H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 5376, the Inflation Reduction Act of 2022

Client expense: $31,190 · Firm income: Not reported

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

HR 5376, the Build Back Better Act, in particular Medicare Part D benefit design reform, including out-of-pocket maximum with monthly smoothing, and provisions to expand Medicaid eligibility and access; S 2327, the Seniors Prescription Drug Relief Act; HR 3089/S 1544, the Accelerating Kids Access to Care Act; HR 4640, the Close the Medigap Act; Implementation of the CLINICAL TREATMENT Act; Medicare coverage for medically-necessary dental services

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

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

H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 1946/S. 1873 -Medicare Multi-Cancer Early Detections Screening and Coverage Act; bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening test H.R. 3183/S. 1312 - Metastatic Breast Cancer Access to Care Act; bill to exempt individuals with metastatic breast cancer from certain waiting periods for disability insurance benefits under the Old-Age, Survivors, and Disability Insurance program and related Medicare coverage H.R. 2903/S. 1512 - CONNECT for Health Act; a bill to expand the use of telehealth and remote patient monitoring services in Medicare H.R. 3087/S. 2051 - Breast Cancer Patient Equity Act; a bill to provide for Medicare coverage of custom fabricated breast prostheses H.R. 3630/S. 1315 - Lymphedema Treatment Act; bill to include certain lymphedema compression treatment items as covered durable medical equipment under Medicare following the surgical removal of the breast (i.e., a mastectomy), including replacements of such prostheses H.R. 4110 - Reducing Hereditary Cancer Act of 2021; a bill to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would reduce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer H.R. 4612/S. 2412 - Protecting Access to Lifesaving Screenings Act of 2021; a bill to make a series of changes relating to health insurance coverage of screening mammography including preserving Medicare coverage for screening mammography, without a requirement for coinsurance, and expands the definition of screening mammography to include any digital modality of such a procedure S. 2327 - Seniors Prescription Drug Relief Act; a bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D H.R. 3173/S. 3018 - Improving Seniors Timely Access to Care Act; a bill which establishes several requirements and standards relating to prior authorization processes under Medicare Advantage (MA) plans H.R. 7213, Equitable Community Access to Pharmacist Services Act; a bill to provide pharmacy reimbursement for COVID-19-related and future emergency services. Medicare coverage policy for drugs and drug pricing Medicare coverage policy for breast cancer treatments and services Proposed waivers under Sections 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to funding, state incentives, and federal efforts for for Medicaid expansion Coverage for telemedicine in Medicare Comments in response to CMS Request for Information on Access to Coverage and Care in Medicaid and Chip Issues related to the upcoming Notice on Benefit and Payment Parameters for FY2024

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office

Maintain access to mental health medications for the low-income subsidy (LIS) eligible population under Medicare Part D in prescription drug reform legislation; S. 2327, Seniors Prescription Drug Relief Act; H.R.5376 - Build Back Better Act

Client expense: Not reported · Firm income: $50,000

Government targets: SENATE

Multi-Cancer Early Detection Screening Coverage Act (HR 1946/S 1873) Lymphedema Treatment Act (HR 3630/ S 1315) Breast Cancer Patient Equity Act (HR 3087/S 2051) Reducing Hereditary Cancer Act of 2021 (HR 4110) CONNECT for Health Act (S.1512/ H.R. 2903) Improving Seniors' Timely Access to Care Act (H.R.3173) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) Seniors Prescription Drug Relief Act (S.2327) Medicare coverage policy for breast cancer treatments and services Radiation Oncology Alternative Payment Model Telehealth Policies related to funding, state incentives, and federal efforts for Medicaid expansion Issues related to 1115 and 1332 of the Social Security Act; policies related to work requirements, reinsurance and block grants in Medicaid Policies related to Medicare coverage for pharmacy services and the Equitable Community Access to Pharmacist Services Act (H.R.7213) Issues related to the upcoming Notice on Benefit and Payment Parameters for FY2024 Medicare coverage policy for drugs and drug pricing Comments in response to CMS Request for Information on Access to Coverage and Care in Medicaid and Chip

Client expense: Not reported · Firm income: $42,000

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

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. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues 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 VA drug pricing policy issues Transparency policy issues Alternative payment models 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 Medicare prescription drug payments cards and related policy issues Part B Discarded Units Refund policy issues Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

Client expense: $1,110,000 · 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

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

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. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing 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. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing 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 Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues 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 VA drug pricing policy issues Transparency policy issues Alternative payment models 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 Medicare prescription drug payments cards and related policy issues Part B Discarded Units Refund policy issues Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

Client expense: $6,340,000 · Firm income: Not reported

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

Medicare Part D Negotiation/Non-Interference Repeal Bills Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act H.R.5376, The Build Back Better Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Client expense: $530,000 · Firm income: Not reported

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

S 464 Safe Step Act - Step therapy utilization management reform legislation S 2327 - A bill to amend title XVIII of the Social Security Act to provide for a Medicare part D modernization redesign and to establish a monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards the annual out-of-pocket threshold under Medicare part D. (Support for out-of-pocket cap and smoothing mechanism) Education on health impact of obesity

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; S. 2327 - Seniors Prescription Drug Relief Act; Quality of care in skilled nursing facilities.

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

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

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 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---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 ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP 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 ---H.R.7667: The Food and Drug Amendments of 2022 ---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.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---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 ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---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 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---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.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---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 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---Restrictions on Intellectual Property Rights 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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization 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 ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 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 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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 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.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) 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 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 ---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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program 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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---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 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,120,000 · 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), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

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 Information Systems ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---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 ---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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---S.3018: Improving Seniors Timely Access to Care Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare 2023 IPPS Proposed Rule Comment Letter ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---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 ---Separate Payment Mechanism for Innovative Antimicrobials Products

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, White House Office

Access to Prescription Digital Therapeutics Act of 2022 (S.3791/HR 7051); Due Process Continuity of Care Act (S.2697); Seniors Prescription Drug Relief Act (S.2327); and issues related to Medicare Part D redesign's impact on low income subsidy beneficiaries.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education around pharmaceuticals related to Parkinson's disease Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, and streamlining prior authorization processes and step therapy protocols Prescription Drug User Fee Act H.R. 4417, the Capping Drug Costs for Seniors Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics Act of 2021 S. 2327, the Seniors Prescription Drug Relief Act H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021 H.R. 2163, the Safe Step Act H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act

Client expense: $61,153 · Firm income: Not reported

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

Expanding Medicare benefits to include dental, hearing, and vision Extending and making permanent COVID-19 telehealth flexibilities Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, capping out-of-pocket costs and smoothing, and streamlining prior authorization processes Advocating for improvements to Medicare Part C and Part D proposed rule H.R. 4417, the Capping Drug Costs for Seniors Act S. 2327, the Seniors Prescription Drug Relief Act S. 828/H.R. 432, the Mental Health Access Improvement Act of 2021 H.R. 2080, the Seniors Access to Vaccine Ensured Act of 2021 H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act H.R. 4011, the Capping Drug Costs for Seniors Act of 2022 H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 2061/H.R. 4058, the Telemental Health Care Access Act of 2021 S. 1512/H.R. 2903, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 H.R. 1332/S. 368, the Telehealth Modernization Act H.R. 366, the Protecting Access to Post-COVID-19 Telehealth Act of 2021 H.R. 3733: Essential Caregivers Act of 2021 H.R. 6202, the Telehealth Extension Act of 2021 S. 3575, the Stop the Wait Act of 2022 S. 3593, the Telehealth Extension and Evaluation Act S. 3675, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) 2.0 Act H.R. 7051/S. 3791, the Access to Prescription Digital Therapeutics Act of 2022

Client expense: $61,153 · Firm income: Not reported

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

Potential changes to structure and reimbursement for Medicare Part D; H.R. 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: $900,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE