New Opportunities for Value that Extend Lives Act of 2021

H.R. 8800, Supporting Medicare Providers Act of 2022, all provisions H.R. 3434, Territories Health Equity Act of 2021, all provisions H.R. 4406, Supporting Medicaid in the U.S. Territories Act of 2021, all provisions H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, provisions relating to COVID-19 flexibilities, and telemental health S. 3791, Access to Prescription Digital Therapeutics Act of 2022, provisions relating to COVID-19 flexibilities, and telemental health S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2022, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 5067, Preserving Patient Access to Home Infusion Act, provisions relating to scope of practice S. 2652, Preserving Patient Access to Home Infusion Act, provisions relating to scope of practice H.R. 8812, Improving Care and Access to Nurses (I CAN) Act, all provisions S. 5212, Improving Care and Access to Nurses (I CAN) Act, all provisions H.R. 9577, Increasing Mental Health Options Act of 2022, all provisions S. 5272, Increasing Mental Health Options Act of 2022, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 3018, Improving Seniors Timely Access to Care Act of 2021, all provisions H.R. 8487, Improving Seniors' Timely Access to Care Act of 2022, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions H.R. 1438, Opioid Workforce Act of 2021, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, provisions relating to Medicaid and CHIP, and maternal and infant mortality S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, provisions relating to Medicaid and CHIP, and maternal and infant mortality H.R. 925, Data to Save Moms Act, all provisions H.R. 959, Black Maternal Health Momnibus Act of 2021, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions S. 5249, Preserving Patient Access to Value-Based Care Act, all provisions H.R. 8879, Inpatient Psychiatric Facility Improvement Act, all provisions H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program, all provisions H.R. 432, Mental Health Access Improvement Act of 2021, all provisions H.R. 8910, Behavioral Health Integration Awareness Act of 2022, all provisions H.R. 8884, Medicare Opioid Use Disorder Outreach Act, all provisions H.R. 8890, Physician Wellness Program Act of 2022, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 7995, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2022, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 8594, Restore Protections for Dialysis Patients Act, all provisions S. 4750, Restore Protections for Dialysis Patients Act, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 9378, Sunshine Act of 2022, all provisions H.R. 6576, Small Practice, Underserved, and Rural Support Program (SURS) Extension Act of 2022, all provisions Medicare program: Medicare and CHIP Reauthorization Act (MACRA) broad reform Medicare program: MACRA implementation Medicare program: MACRA burdens Medicare program: 21st Century Cures Act implementation Medicare program: Enhancing the Mental Health Workforce Medicare program: Improvement to Medicare Inpatient Psychiatric Facility Improvement Act Medicare program: Medicare program improvement/Physician Services and Education Medicare program: Accountable Care Organizations Medicare program: Medicare Economic Index (MEI)/inflation updates Medicare program: 2% Medicare sequester moratorium Medicare program: 4.5% payment rates reduction Medicare program: Medicare Physician Fee Schedule Conversion Factor/3% increase extension Medicare program: Global and Professional Direct Contracting alternative payment model/REACH ACOs Medicare program: Medicare physician payment Medicare program: Merit-based Incentive Payment Program (MIPS) improvement Medicare program: Alternative Payment Models (APMs) Medicare program: Medicare Physician Payment Reform/primary care/specialties Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/Revalidation Medicare program: Recovery plan for Americas Physicians Medicare program: Physician-Owned Hospitals/Medicare Moratorium Medicare program: Health IT burdens Medicare program: EHR certification Medicare program: Provider Compliance/Regulatory Relief Medicare program: Quality Payment Program/physician burdens Medicare program: National provider directory Medicare program: Self-measured blood pressure (SMBP) devices/benefit category Medicare program: Information blocking Medicare program: Coding Medicare program: Skilled nursing facilities (SNF) Medicare and Medicaid programs: Cybersecurity Medicare and Medicaid programs: Puerto Rico/Medicaid caps/FMAP Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP Medicaid program: Ensuring Access to Telemental Health Services Medicaid program: Ensuring Access to Telemental Health Services Medicaid program: Enhancing the Mental Health Workforce Medicaid program: Improving Integration, Coordination, and Access to Care Medicaid program: Maternal mortality and morbidity/Equity

Client expense: $5,060,000 · Firm income: Not reported

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

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)

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; S. 3791/H.R. 7051 - Access to Prescription Digital Therapeutics Act of 2022; 21st Century CURES Act 2.0 discussion draft; and H.R. 7008 - Pre-approval Information Exchange (PIE) Act of 2022. Section 810 in the Food and Drug Amendments of 2022 (H.R. 7667) and in Consolidated Appropriations Act, 2023 (PL 117-328).

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

Government targets: 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 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

H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, NOPAIN Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions S. 1512, CONNECT for Health Act of 2021, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 7995, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2022, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, MOMMAs Act, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 3018, Improving Seniors Timely Access to Care Act of 2021, all provisions H.R. 8487, Improving Seniors Timely Access to Care Act of 2022, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Substance Use Disorder Workforce Act, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, provisions related to scope of practice H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 8800, Supporting Medicare Providers Act of 2022, all provisions H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2022, all provisions H.R. 8850, Fair Access In Residency (FAIR) Act, all provisions S. 2173, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 4873, Improving Access to Advance Care Planning Act, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions H.R. 8594, Restore Protections for Dialysis Patients Act, all provisions S. 4750, Restore Protections for Dialysis Patients Act, all provisions H.R. 8188, Saving Access to Laboratory Services Act (SALSA), all provisions S. 4449, SALSA Act, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, all provisions H.R. 3434, Territories Health Equity Act of 2021, all provisions H.R. 4406, Supporting Medicaid in the U.S. Territories Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, all provisions S. 3791, Access to Prescription Digital Therapeutics Act of 2022, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 7878, Kidney Health Connect Act of 2022, all provisions S. 4307, Kidney Health Connect Act of 2022, all provisions H.R. 6202, Telehealth Extension Act of 2021, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions H.R. 8879, Inpatient Psychiatric Facility Improvement Act, all provisions H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program, all provisions H.R. 432, Mental Health Access Improvement Act of 2021, all provisions H.R. 8910, Behavioral Health Integration Awareness Act of 2022, all provisions H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program, all provisions S. 987, CARA 3.0 Act of 2021, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 7475, Mamas First Act, all provisions H.R. 5067, Preserving Patient Access to Home Infusion Act, all provisions S. 2652, Preserving Patient Access to Home Infusion Act, all provisions H.R. 8812, To amend titles XVIII and XIX of the Social Security Act and the Bipartisan Budget Act of 2018 to increase access to services provided by advanced practice registered nurses under the Medicare and Medicaid programs, and for other purposes, provisions related to scope of practice Medicare program: 21st Century Cures Act/implementation Medicare program: EHR Certification Medicare program: Medicare and CHIP Reauthorization Act (MACRA) Reform Medicare program: MACRA implementation Medicare program: Laboratory testing/Diagnostics/PAMA Medicare program: Merit-based Incentive Payment System (MIPS) quality/cost/improvement activities/promoting interoperability Medicare program: Merit-based Value Pathway Medicare program: Physician Fee Schedule (PFS) inflation updates/budget neutrality rules Medicare program: 2023 Medicare Physician Fee Schedule/4.5% cut Medicare program: Accountable specialty care/payments Medicare program: Alternative Payment Models/incentive payments Medicare program: Telehealth/COVID flexibilities Medicare program: Health IT burdens Medicare program: Self-measured blood pressure devices/benefit category Medicare program: Coding Medicare program: Primary Care First models Medicare program: Appropriate Use Criteria Medicare program: Opioids Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Dental benefits Medicaid program: Uninsured and healthcare coverage/COVID-19 Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/revalidation Medicare program: Open Payments Medicaid program: Special Enrollment Period Medicaid program: Sickle Cell Disease Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP/draft Medicare program: Provider compliance and regulatory relief Medicare program: Medicare Administrative Contractors (MACs)/Downcoding Medicare and Medicaid programs: Health Equity Medicare and Medicaid programs: Modifier 25, Impossible Day Medicare and Medicaid programs: Connected health technologies Medicare and Medicaid programs: Diabetes

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)

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

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)

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. H.R. 7008 - Pre-approval information exchange act of 2022 - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products H.R. 7667 - PDUFA Reauthorization - lobbying for the inclusion of HR 7008 in HR 7667 and passage.

Client expense: $100,000 · Firm income: Not reported

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $100,000 · Firm income: Not reported

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; S. 3791/H.R. 7051 - Access to Prescription Digital Therapeutics Act of 2022; 21st Century CURES Act 2.0 discussion draft; and H.R. 7008 - Pre-approval Information Exchange (PIE) Act of 2022. Section 810 in the Food and Drug Amendments of 2022 (H.R. 7667).

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

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

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $90,000 · Firm income: Not reported

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. H.R. 7008 - Pre-approval information exchange act of 2022 - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products H.R. 7667 - PDUFA Reauthorization - lobbying for the inclusion of HR 7008 in HR 7667 and passage.

Client expense: $90,000 · Firm income: Not reported

H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, provisions relating to Graduate Medical Education S. 2094, Physician Shortage GME Cap Flex Act of 2021, provisions relating to Graduate Medical Education H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, provisions relating to Prior Authorization and attachment standards S. 3018, Improving Seniors Timely Access to Care Act of 2021, provisions relating to Prior Authorization and attachment standards H.R. 7995, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2022, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NO PAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NO PAIN) Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions H.R. 2256, Resident Physician Shortage Reduction Act, all provisions S. 834, Resident Physician Shortage Reduction Act, all provisions H.R. 1218, Data Mapping to Save Moms Lives Act, all provisions S. 198, Data Mapping to Save Moms Lives Act, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, all provisions H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, all provisions H.R. 3348, SOS: Sustaining Outpatient Services Act, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, all provisions S. 3791, Access to Prescription Digital Therapeutics Act of 2022, all provisions H.R. 7878, Kidney Health Connect Act of 2022, all provisions S. 4307, Kidney Health Connect Act of 2022, all provisions H.R. 6202, Telehealth Extension Act of 2021, all provisions S. 987, CARA 3.0 Act of 2021, all provisions H.R. 1438, Opioid Workforce Act of 2021, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 7475, Mamas First Act, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, provisions related to menstrual products coverage in Medicaid Medicare program: Physician Payment and Delivery Reform Medicare program: Impending Medicare payment cuts Medicare program: Medicare Evaluation and Management/budget neutrality Medicare program: Statutory PAYGO/Sequester Relief Medicare program: Accountable Care Organizations/specialty care Medicare program: Alternative Payment Models Medicare program: AMA Recovery Plan for Americas Physicians/payment reform Medicare program: Global and Professional Direct Contracting alternative payment model/REACH ACOs Medicare program: Appropriate Use Criteria and Prior Authorization Medicare program: Medicare Advantage/prior authorization regulation Medicare program: Automatic blood pressure measurement devices/coverage Medicare program: Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) Medicare program: MIPS/Promoting Interoperability/Cost/Improvement Activities Medicare program: MIPS/data sharing/transparency Medicare program: MACRA physician burdens Medicare program: Quality Payment Program Medicare program: Health IT burden Medicare program: Public Health Emergency COVID-19 /Accelerated and Advance Payments Medicare program: Primary Care First models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Modifier 25 Medicare program: Split/shared billing Medicare program: Interoperability/data blocking/HIPAA Medicare program: Coding Medicare program: Provider compliance/Regulatory relief Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS) Enrollment/Revalidation Medicare program: Open Payments Medicare program: Prescription drug pricing/Pharmacy Benefits Managers Medicare program: Step Therapy Medicare and Medicaid programs: Medicare Access and Chip Reauthorization Act (MACRA)/implementation Medicare and Medicaid programs: MACRA Oversight Medicaid program: Improving Access to Physical and Mental Health Care for Children and Youth Under Medicaid and CHIP draft Medicare and Medicaid programs: Health Equity Medicaid program: Maternal Mortality Medicaid program: Uninsured and healthcare coverage/COVID-19 Medicaid program: Special Enrollment Period Medicaid program: Sickle Cell Disease

S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination

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

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

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; S. 3791/H.R. 7051 - Access to Prescription Digital Therapeutics Act of 2022; 21st Century CURES Act 2.0 discussion draft; and H.R. 7008 - Pre-approval Information Exchange (PIE) Act of 2022.

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

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

H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, all provisions S. 2061, Telemental Health Care Access Act of 2021, all provisions S. 801, Connected Maternal Online Monitoring Act, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 3018, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency (CARE) Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency (CARE) Act of 2021, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 6202, Telehealth Extension Act of 2021, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 2807, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 2173, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions H.R. 5804, Expanding Access to Diabetes Self-Management Training Act of 2021, all provisions S. 2203, Expanding Access to Diabetes Self-Management Training Act of 2021, all provisions S. 596, Treat and Reduce Obesity Act of 2021, all provisions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 7051, Access to Prescription Digital Therapeutics Act of 2022, all provisions S. 3791, Access to Prescription Digital Therapeutics Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 987, CARA 3.0 Act of 2021, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions H.R. 6583, Stop the Wait Act of 2022, all provisions S. 224, Stop the Wait Act of 2022, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 7213, Equitable Community Access to Pharmacist Services Act, all provisions Medicare program: Gold Card Act/draft Medicare program: 21st Century Cures Act Medicare program: Protecting Access to Medicare Act (PAMA)/Laboratory testing/diagnostics Medicare program: Small Practice, Underserved, and Rural Support Program (SURS) Extension Act of 2022 Medicare program: Telehealth and dialysis centers/COVID-19 flexibilities continuation Medicare program: Telehealth/telephone visit codes/equity/quality Medicare program: Physician Payment Reform Medicare program: MEDPAC Report Medicare program: 2% Medicare sequester moratorium/continuation Medicare program: 4% Medicare sequester/Statutory PAYGO Medicare program: Physician payment/inflation index Medicare program: Medicare Physician Fee Schedule Conversion Factor/extension of 3% increase Medicare program: Medicare Diabetes Prevention Program (MDPP) model Medicare program: Global and Professional Direct Contracting Model (GPDC)/Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Medicare program: Evaluation and Management (E/M)/budget neutrality Medicare program: Prior authorization Medicare program: Interoperability Medicare program: EFT fees Medicare program: Merit-based Incentive Payment System (MIPS)/Quality/Cost/Improvement activities Medicare program: MIPS Value Pathways (MVPs) Medicare program: MIPS draft cost measures/field testing extension Medicare program: Value-based care acceleration/transparency/stability Medicare program: Virtual credit cards Medicare program: Primary Care First models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: RVS Update Committee (RUC)/Current Procedural Terminology (CPT) Medicare program: Split/shared billing Medicare program: PECOS Enrollment/Revalidation Medicare program: Open Payments Medicare program: Step Therapy Medicare program: Public health emergency/accelerated and advance payments Medicare program: MACRA oversight Medicare program: MACRA/physician burdens Medicare program: Alternative payment models (APMs) Medicare and Medicaid programs: Medicare Access and CHIP Reauthorization Act (MACRA)/implementation/Accountable Care Organizations Medicare and Medicaid programs: Information blocking/Patient privacy Medicare and Medicaid programs: COVID-19 response Medicare and Medicaid programs: Mental Health Parity and Addiction Equity Act (MHPAEA)/patient protection Medicare and Medicaid programs: Health equity/COVID-19 Medicare and Medicaid programs: Drug overdose epidemic Medicare and Medicaid programs: Health IT burdens Medicaid program: Medicaid funding in US territories Medicaid program: Uninsured individuals/COVID-19 Medicaid program: Special enrollment period Medicaid program: Sickle Cell Disease

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; S. 3791/H.R. 7051 - Access to Prescription Digital Therapeutics Act of 2022; 21st Century CURES Act 2.0 discussion draft; and H.R. 7008 - Pre-approval Information Exchange (PIE) Act of 2022.

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

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

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $110,000 · Firm income: Not reported

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

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

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

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

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

H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 5612, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes, all provisions H.R. 6020, Supporting Medicare Providers Act of 2021, all provisions S. 3314, Supporting Medicare Providers Act of 2021, all provisions S. 610, Protecting Medicare and American Farmers from Sequester Cuts Act, provisions relating to averting Medicare physician fee schedule cuts H.R. 6144, Removing Waste and Protecting Medicare Act, all provisions H.R. 6048, Medicare Stability for Patients and Providers Act, all provisions H.R. 1332, Telehealth Modernization Act, provisions related to permanently lifting Medicare telehealth restrictions S. 368, Telehealth Modernization Act, provisions related to permanently lifting Medicare telehealth restrictions H.R. 2903, CONNECT for Health Act of 2021, provisions related to permanently lifting Medicare telehealth restrictions S. 1512, CONNECT for Health Act of 2021, provisions related to permanently lifting Medicare telehealth restrictions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 4058, Telemental Health Care Access Act of 2021, provisions related to permanently lifting Medicare telehealth restrictions S. 2061, Telemental Health Care Access Act of 2021, provisions related to permanently lifting Medicare telehealth restrictions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 6000, Cures 2.0 Act, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions S. 3018, Improving Seniors Timely Access to Care Act of 2021, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 987, CARA 3.0 Act of 2021, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions H.R. 3407, MOMMAs Act, all provisions S. 411, MOMMAs Act, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 6308, ACO Assignment Improvement Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, all provisions H.R. 4034, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 2144, Access to Genetic Counselor Services Act of 2021, provisions relating to scope of practice S. 1450, Access to Genetic Counselor Services Act of 2021, provisions relating to scope of practice H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, provisions relating to scope of practice H.R. 2305, Improving Access to Mental Health Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions S. 801, Connected MOM Act, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H. R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, provisions relating to Medicare and Medicaid S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, provisions relating to Medicare and Medicaid Medicare program: No Surprises Act/implementation Medicare program: CY 2021 Physician Fee Schedule/3.75% payment adjustment Medicare program: Physician Payment Reform Medicare program: 2022 physician payment Medicare program: Alternative payment models (APMs) Medicare program: Health equity Medicare program: Medicare Diabetes Prevention Program Medicare program: Prescription drug prices Medicare program: Cybersecurity Medicare program: Medicare expansion/dental, vision, hearing coverage Medicare program: Physician payment/PAYGO and sequester Medicare program: Barriers to patient care Medicare program: 2020 Physician spending/COVID-19 Impact Medicare program: Evaluation and Management (E/M)/budget neutrality Medicare program: Pharmacy Benefit Managers/Rx drug price transparency Medicare program: Merit-Based Incentive Payment System (MIPS) program Medicare program: MIPS/Value Pathways (MVPs) Medicare program: MIPS/cost, promoting interoperability, improvement activities Medicare program: Quality Payment Program (QPP) Medicare program: Health IT physician burdens Medicare program: Primary Care First models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Open Payments Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS) Enrollment/Revalidation Medicare program: Telehealth policies Medicare program: RVS Update Committee (RUC) - physician payment Medicare program: Coding - CPT Panel Medicare program: Accountable Care Organizations (ACOs)/Pre-COVID Benchmarks Medicare program: Federal Gold Carding Medicare and Medicaid programs: Medicare Access and CHIP Reauthorization Act (MACRA)/implementation/Accountable Care Organizations Medicare and Medicaid programs: MACRA Oversight Medicare and Medicaid programs: MACRA physician burdens Medicare and Medicaid programs: Prior authorization Medicare and Medicaid programs: COVID-19 public health emergency/accelerated and advance payments Medicare and Medicaid programs: Electronic funds transfer (EFT) standard/Enforcement Medicare and Medicaid programs: Provider Relief Fund Medicare and Medicaid programs: Telehealth Extension and Evaluation Act/draft Medicare and Medicaid programs: Telehealth and Dialysis centers Medicare and Medicaid programs: COVID-19 telehealth flexibilities continuation Medicare and Medicaid programs: Primary and Virtual Health Care Affordability Act Medicare and Medicaid programs: Data Privacy Medicare and Medicaid programs: Social determinants of health Medicare and Medicaid programs: Information blocking/privacy Medicare and Medicaid programs: Information blocking/privacy of adolescents Medicare and Medicaid programs: Opioids Medicaid program: Medicaid funding in U.S. Territories Medicaid program: Medicaid expansion Medicaid program: Maternal mortality Medicaid program: COVID-19/uninsured healthcare coverage Medicaid program: Medicaid Special Enrollment Period

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; 21st Century CURES Act 2.0 discussion draft.

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

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

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

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

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

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

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

H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, all provisions H.R. 315, Medicare Sequester COVID Moratorium Act, all provisions H.R. 1332, Telehealth Modernization Act, all provisions S. 368, Telehealth Modernization Act, all provisions H.R. 2903, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions S. 1512, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, all provisions H.R. 366, Protecting Access to Post-COVID-19 Telehealth Act of 2021, all provisions H.R. 2166, Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021, all provisions H.R. 2228, Rural Behavioral Health Access Act of 2021, all provisions H.R. 3447, Permanency for Audio-Only Telehealth Act, all provisions H.R. 5241, Linking Seniors to Needed Legal Services Act of 2021, all provisions H.R. 3173, Improving Seniors Timely Access to Care Act of 2021, all provisions H.R. 3259, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 586, Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, all provisions S. 987, CARA 3.0 Act of 2021, all provisions H.R. 3441, Substance Use Disorder Workforce Act, all provisions S. 1438, Opioid Workforce Act of 2021, all provisions H.R. 3407, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act, all provisions H.R. 925, Data to Save Moms Act, all provisions H.R. 2256, Resident Physician Shortage Reduction Act of 2021, all provisions S. 834, Resident Physician Shortage Reduction Act of 2021, all provisions H.R. 4014, Physician Shortage GME Cap Flex Act of 2021, all provisions S. 2094, Physician Shortage GME Cap Flex Act of 2021, all provisions H.R. 3746, Accountable Care in Rural America Act, all provisions H.R. 4587, Value in Health Care Act of 2021, all provisions H.R. 4755, Seniors Chronic Care Management Improvement Act of 2021, all provisions H.R. 1330, Patient Access to Higher Quality Health Care Act of 2021, all provisions H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions H.R. 4043, Ensuring Patient Access to Critical Breakthrough Products Act of 2021, all provisions S. 2416, NOVEL Act of 2021, all provisions H.R. 2144, Access to Genetic Counselor Services Act of 2021, provisions relating to scope of practice S. 1450, Access to Genetic Counselor Services Act of 2021, provisions relating to scope of practice H.R. 2654, Chiropractic Medicare Coverage Modernization Act of 2021, provisions relating to scope of practice H.R. 5370, Medically Tailored Home-Delivered Meals Demonstration Pilot Act of 202, all provisions H.R. 2807, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 2173, Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions S. 748, Medicare Sequester Relief Act, all provisions H.R. 955, Medicaid Reentry Act of 2021, all provisions S. 285, Medicaid Reentry Act of 2021, all provisions H.R. 19, Lower Costs, More Cures Act of 2021, provisions relating to pharmacy benefits managers and drug price transparency S. 801, Connected MOM Act, all provisions S. 346, Black Maternal Health Momnibus Act of 2021, all provisions H.R. 1738, Stabilize Medicaid and CHIP Coverage Act, all provisions H.R. 1025, Kids Access to Primary Care Act of 2021, all provisions H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act, all provisions S. 2214, Promote Responsible Oversight and Targeted Employee background Check Transparency for Seniors (PROTECTS) Act, all provisions H.R. 5125, Strengthening Innovation in Medicare and Medicaid Act, all provisions H.R. 1587, Medicare Audiologist Access and Services Act of 2021, all provisions S. 2691, Strengthening the Vaccines for Children Program Act of 2021, all provisions Medicare program: No Surprises Act/implementation Medicare program: Physician payment Medicare program: 2022 Physician Fee Schedule/audio-only telehealth expansion Medicare program: Telehealth Extension and Evaluation Act Medicare program: Alternative payment models Medicare program: National Coverage Determination/self-measured blood pressure monitoring devices Medicare program: Physician payment issues/PAYGO and Sequester/3.75% Conversion Factor increase Medicare program: Evaluation and Management (E/M)/budget neutrality Medicare program: Physician-owned hospitals/hospital consolidation Medicare program: Medicare expansion/dental, vision, hearing coverage Medicare program: Diabetes Prevention Medicare program: Surprise Medical Billing/Price transparency Medicare program: Merit-Based Incentive Payment System (MIPS) program Medicare program: MIPS Value Pathways Medicare program: Quality Payment Program Medicare program: Information blocking/interoperability/data segmentation Medicare program: Cybersecurity and HIPAA Medicare program: Measure Application Partnership (MAP) Medicare program: COVID-19 Public Health Emergency/Accelerated and Advance Payments Medicare program: Primary Care First (PCF) models Medicare program: Medicare Shared Savings Program (MSSP) Medicare program: Physician payment/globals Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/Revalidation Medicare program: Open Payments Medicare program: Prescription Drug Prices Medicare program: Chronic Care Management code Medicare program: Graduate Medical Education (GME) Medicare program: Step Therapy Medicare and Medicaid programs: Medicare Access and CHIP Reauthorization Act (MACRA)/implementation/Accountable Care Organizations Medicare and Medicaid programs: MACRA/physician burdens Medicare and Medicaid programs: Drug overdose epidemic Medicare and Medicaid programs: 21st Century Cures 2.0 Medicare and Medicaid programs: Waste, fraud, and abuse in telehealth Medicare and Medicaid programs: Prior authorization Medicare and Medicaid programs: Public Option Medicare and Medicaid programs: Electronic Health Records (EHR) certification Medicare and Medicaid programs: Physician Health IT burdens Medicare and Medicaid programs: Data privacy Medicare and Medicaid programs: Provider compliance and regulatory relief Medicaid program: COVID-19/Provider Relief Fund Medicaid program: Funding for U.S. territories Medicaid program: Medicaid expansion Medicaid program: Work requirements Medicaid program: COVID-19/Uninsured and healthcare coverage/child 12 month continuous eligibility Medicaid program: Pediatric mental health care access/behavioral health services Medicaid program: Special enrollment period Medicaid program: Proprietary Laboratory Analysis (PLA) codes

Issues related to managed care pharmacists; S. 2416 - NOVEL Act of 2021; Issues related to the development and utilization of digital therapeutics; 21st Century CURES Act 2.0 discussion draft.

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

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