Maternal Vaccinations Act

Draft, Hospital Competition Act of 2021 (no bill number) - procedural changes around The Mental Health Parity and Addiction Equity Act (MHPEA) litigation H.R. 19 - Lower Costs, More Cures Act of 2021- Rep. McMorris, Rodgers - prescription drug prices for Medicare and Medicaid H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 432 - Mental Health Access Improvement Act of 2021- Rep. Thompson, Mike - mental health services under Medicare H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 959 - Black Maternal Health Momnibus Act of 2021 - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option H.R. 2163 - Safe Step Act - Rep. Ruiz, Raul - commercial plans and medication step-therapy requirements H.R. 3173 - Improving Seniors Timely Access to Care Act of 2021 - Rep. DelBene, Suzan - prior authorization in Medicare Advantage H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony - mental health parity H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act of 2021- Rep. Cheney, Liz - telehealth H.R. 4595 - Medicaid Saves Lives Act - Rep. Bourdeaux, Carolyn - Medicaid expansion H.R. 7236 - Strengthen Kids Mental Health Now Act of 2022 - Rep. Eshoo, Anna - mental health and Medicaid H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. - Rep. Matsui, Doris - behavioral health and electronic health records H.R. 7512 - Protecting Patients from Deceptive Health Plans Act - Rep. Hayes, Jahana - excepted benefits coverage H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 - Rep. Pallone, Frank - reauthorization of several behavioral health programs H.R. 7667 - Food and Drug Amendments of 2022 - Rep. Eshoo, Anna - reauthorization of user fee programs H.R. 7780 - Mental Health Matters Act - Rep. DeSaulnier, Mark - changes to the procedure around MHPEA litigation H.R. 8152 - American Data Privacy and Protection Act - Rep. Pallone, Frank, Jr. - data privacy H.R. 8594 - Restore Protections for Dialysis Patients Act - Rep. Clarke, Yvette - reform of the Medicare Secondary Payer act H.R. 8876 - The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022 - Rep. Davis, Danny - funding for maternal and early childhood health programs H.R. 8878 - To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program. - Rep. Chu, Judy - mental health and Medicare H.R. 8879 - Inpatient Psychiatric Facility Improvement Act - Rep. Evans, Dwight - mental health and Medicare H.R. 8881 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes. - Rep. Horsford, Steven - commercial plans H.R. 8884 - To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program. - Rep. Kelly, Mike - mental health and Medicare H.R. 8885 - Better Health Care Directories Act - Rep. Kildee, Daniel - commercial plans H.R. 8886 - Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act - Rep. Moore, Gwen - commercial plans H.R. 8889 - RICE Act - Rep. Plaskett, Stacey - commercial plans H.R. 8890 - Physician Wellness Program Act of 2022 - Rep. Ruiz, Raul - mental health and Medicare H.R. 8891 - No Surprises for Survivors Act of 2022 - Rep. Sanchez, Linda - requirements for group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for forensic medical exams with no cost sharing H.R. 8892 - To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes. - Rep. Sewell, Terri - commercial plans H.R. 8908 - Fighting Stimulant and other Substance Use Disorders Act - Rep. Estes, Ron - mental health and Medicare H.R. 8910 - Behavioral Health Integration Awareness Act of 2022 - Rep. Smith, Jason - mental health and Medicare S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 464 - Safe Step Act - Sen. Murkowski, Lisa - commercial plans and medication step-therapy requirements S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 1512 - CONNECT for Health Act of 2021 - Sen. Schatz, Brian - expansion of telehealth for Medicare S. 1873 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 - Sen. Crapo, Mike - Cancer screening in Medicare S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher - mental health parity S. 2164 - Lower Costs, More Cures Act of 2021 - Sen. Crapo, Mike - prescription drug prices for Medicare and Medicaid S. 2315 - Medicaid Saves Lives Act - Sen. Warnock, Raphael - Medicaid expansion S. 2499 - SAFE DATA Act - Sen. Wicker, Roger - consumer data privacy and data transparency and security S. 3018 - Improving Seniors Timely Access to Care Act of 2021 - Sen. Marshall, Roger - prior authorization in Medicare Advantage S. 3195 - Consumer Online Privacy Rights Act - Sen. Cantwell, Maria - data privacy S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness S. 3983 - PATCH Act - Sen. Cassidy, Bill - data privacy S. 4264 - Advancing Integration in Medicare and Medicaid (AIM) Act - Sen. Scott, Tim - coordinating full-benefits for dual eligible individuals S. 4293 - Pharmacy Benefit Manager Transparency Act of 2022 - Sen. Cantwell, Maria and Sen. Grassley, Chuck - scope of PBM practices S. 4306 - Improving Access to Behavioral Health Integration Act - Sen. Smith, Tina - behavioral health S. 4750 - Restore Protections for Dialysis Patients Act - Sen. Menendez, Robert - reform of MSP Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage and reproductive health; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Client expense: $3,230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce HR 3655, Vaccine Injury Compensation Modernization Act

Client expense: $10,000 · Firm income: Not reported

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

Closing the "rent-a-bank" loophole to bypass state regulations on usury caps Increased supervision and enforcement of BNPL and EWA Eliminating excessive banking fees, including overdraft Lender robosigning on collections for consumer credit CFPB rules of practice for adjudication proceedings Review merger of TD Bank Principles for responsible consumer and small business loans to prevent predatory lending Review and regulation of "junk fees" CFPB Examination of Nonbank mortgage, private loan, and payday loan entities Applicability of CFPB 1071 Rule to Farm Credit System Mandatory arbitration by credit monitoring agencies on reportable FCRA/FCBA complaints Urge CFPB reexamination of current late fee safe harbor amounts on credit cards H.R.5912 - Close the ILC Loophole Act, a bill to reform the regulation of industrial loan companies and their parent companies H.R.5974 / S.2508 - Veterans and Consumers Fair Credit Act, a bill to amend the Truth in Lending Act to extend the consumer credit protections provided to members of the Armed Forces and their dependents under title 10, United States Code, to all consumers S. 2677 - Stop Overdraft Profiteering Act, a bill to prohibit depository institutions from engaging in certain acts in connection with overdraft coverage S. 345 / H.R. 4277 - Overdraft Protection Act, a bill to prohibit a financial institution from engaging in unfair or deceptive acts in connection with overdraft coverage H.R. 2543 - FFederal Reserve Racial and Economic Equity Act, a bill to address access to financial services, diversity in various financial institutions and establishments, and other related issues H.R.6889 - Credit Union Board Modernization Act, a bill to amend the Federal Credit Union Act to modify the frequency of board of directors meetings, and for other purposes Nomination of Michael Barr to the Federal Reserve Board of Governors Namination of Lael Brainard to Federal Reserve Board of Governors Nomination of Lisa Cook to the Federal Reserve Board of Governors Nomination of Todd Harper to the National Credit Union Administration

Ensuring people are current on missed vaccines. H.R.951/S.345 - Maternal Vaccination Act, and and provisions from the act included in H.R.959/S.345, Black Maternal Health Momnibus Act of 2021. Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2). S.3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act. H.R.6000 - Cures 2.0 Act.

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

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

H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. - Rep. Matsui, Doris - behavioral health and electronic health records H.R. 7512 - Protecting Patients from Deceptive Health Plans Act - Rep. Hayes, Jahana - excepted benefits coverage H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 - Rep. Pallone, Frank - reauthorization of behavioral health programs H.R. 7667 - Food and Drug Amendments of 2022 - Rep. Eshoo, Anna - reauthorization of user fee programs H.R. 7780 - Mental Health Matters Act - Rep. DeSaulnier, Mark - behavioral health programs for early schooling S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness S. 4264 - Advancing Integration in Medicare and Medicaid (AIM) Act - Sen. Scott, Tim - coordinating full-benefits for dual eligible individuals S. 4293 - Pharmacy Benefit Manager Transparency Act of 2022 - Sen. Cantwell, Maria and Sen. Grassley, Chuck - scope of PBM practices S. 4306 - Improving Access to Behavioral Health Integration Act - Sen. Smith, Tina - behavioral health Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage and reproductive health; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

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

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce

Client expense: $10,000 · Firm income: Not reported

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

H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - Social Determinants of Health H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - Virtual Community Support Act of 2021 - Rep. Cardenas, Tony - mental health and SUD grants for community peer support H.R. 1647 - TREATS Act - Rep. McKinley, David - increase use of telehealth for SUD treatment H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - Broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - LIFT America Act - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - Medicare for All Act of 2021 - Rep. Jayapal, Pramila - public option H.R. 1985 - Nursing Home Reform Modernization Act of 2021 - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - Public Option Deficit Reduction Act- Rep. DeFazio, Peter - public option S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 512 - Equitable Data Collection and Disclosure on COVID-19 Act of 2021- Sen. Warren, Elizabeth - COVID-19 Data Collection S. 586 - NOPAIN Act - Sen. Capito, Shelley Moore - non-opioid treatment S. 674 - Public Health Infrastructure Saves Lives Act- Sen. Murray, Patty - public health infrastructure S. 708 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - Accessible, Affordable Internet for All Act - Sen. Klobuchar, Amy - broadband S. 779 - Protecting Americans with Pre-Existing Conditions Act of 2021- Sen. Warner, Mark R. - state innovation waivers S. 782 - Nursing Home Reform Modernization Act of 2021- Sen. Casey, Robert P., Jr. - nursing home quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - Social Determinants for Moms Act- Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - Tech to Save Moms Act- Sen. Menendez, Robert - maternal health S. 983 - CHOICE Act - Sen. Whitehouse, Sheldon - public option S. 987 - TREATS Act - Sen. Portman, Rob - SUD prevention and treatment S. 1010 - Turn the Tide Act - Sen. Shaheen, Jeanne - Substance Use Disorder S. 1042 - Kira Johnson Act - Sen. Warnock, Raphael - maternal health S. 3799 - Prevent Pandemics Act - Sen. Murray, Patty - pandemic preparedness Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---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 the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---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.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---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 ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---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 Drug Manufacturing, Quality & Distribution ---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. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---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.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.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the 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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms 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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit 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.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

Access to immunizations. H.R.951/S.345 - Maternal Vaccination Act, and and provisions from the act included in H.R.959/S.345, Black Maternal Health Momnibus Act of 2021. H.R.550 - Immunization Infrastructure Modernization Act of 2021. Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2). S.3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act. H.R.6000 - Cures 2.0 Act.

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

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

Closing the "rent-a-bank" loophole to bypass state regulations on usury caps Increased supervision and enforcement of BNPL and EWA Restore the 2017 payday loan rule and supervise the larger installment, line of credit and vehicle title lenders, especially high-cost lenders Eliminating excessive banking fees, including overdraft Data-driven technologies, including algorithmic decision making, artificial intelligence, and machine learning CFPB's online complaint system acess for consumers with Limited English Proficiency Lender robosigning on collections for consumer credit Treatment of new and existing Industrial Loan Corporations H.R.5912 - Close the ILC Loophole Act, a bill to reform the regulation of industrial loan companies and their parent companies H.R.5974 / S.2508 - Veterans and Consumers Fair Credit Act, a bill to amend the Truth in Lending Act to extend the consumer credit protections provided to members of the Armed Forces and their dependents under title 10, United States Code, to all consumers S. 2677 - Stop Overdraft Profiteering Act, a bill to prohibit depository institutions from engaging in certain acts in connection with overdraft coverage S. 345 / H.R. 4277 - Overdraft Protection Act, a bill to prohibit a financial institution from engaging in unfair or deceptive acts in connection with overdraft coverage HR. 2547 - Comprehensive Debt Collection Improvement Act, a bill to provide additional financial protections for consumers and places restrictions on debt collection activities Nominations for FRB

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

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce

Client expense: $10,000 · Firm income: Not reported

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

Vaccines, Public Health, Vaccine Confidence, Increased Funding for Immunization Programs HR 2437/S 2691, Strengthening the Vaccines for Children Act HR 2170/S 581, Helping Adults Protect Immunity Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act

Client expense: Not reported · Firm income: Not reported

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - Social Determinants of Health Data Analysis Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - SDOH H.R. 4387 - Maternal Health Quality Improvement Act of 2021 - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 - Rep. DeLauro, Rosa L. [D-CT-3] - health care funding H.R. 4918 - Rural Telehealth Expansion Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - telehealth and rural health H.R. 5376 - Build Back Better Act - Rep. Yarmuth, John A. [D-KY-3] - health care funding H.R. 5506 - Rural Telehealth Access Task Force Act - Rep. Pence, Greg [R-IN-6] - telehealth and rural health H.R. 5837 - To amend title XVIII of the Social Security Act to expand access to telehealth services relating to substance use disorder treatment - Rep. Curtis, John R. [R-UT-3] - telehealth SUD services S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth S. 2779 - TRIUMPH for New Moms Act of 2021 - Sen. Hassan, Maggie [D-NH] - maternal health and mental health S. 3039 - Social Determinants Accelerator Act of 2021 - Sen. Young, Todd [R-IN] - SDOH S. 3062 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 - Sen. Murray, Patty [D-WA] - HHS 2022 appropriations Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Access to immunizations; Maternal immunizations; Immunization infrastructure; Health information technology/immunization information systems (IIS); Vaccine equity; Vaccine education/confidence; Quality measures; Community Immunity During COVID-19 Act of 2021 (H.R. 736/S. 167); Immunization Infrastructure Modernization Act (H.R. 550); Maternal Vaccinations Act (H.R. 951/S. 345), and provisions from the act included in the Black Maternal Health Momnibus (H.R. 959/S. 345); Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2); The PREVENT HPV Cancers Act of 2021 (H.R. 1550).

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

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief 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 the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Supply Chain Issues ---TRIPS IP Waiver 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 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---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 ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---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. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---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.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.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the 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 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit 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.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - Social Determinants of Health Data Analysis Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - SDOH H.R. 4387 - Maternal Health Quality Improvement Act of 2021 - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 - Rep. DeLauro, Rosa L. [D-CT-3] - health care funding H.R. 4918 - Rural Telehealth Expansion Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - telehealth and rural health H.R. 5376 - Build Back Better Act - Rep. Yarmuth, John A. [D-KY-3] - health care funding S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth S. 2779 - TRIUMPH for New Moms Act of 2021 - Sen. Hassan, Maggie [D-NH] - maternal health and mental health Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Access to immunizations; Maternal immunizations; Immunization infrastructure; Health information technology/IIS; Vaccine equity; Vaccine education/confidence; Quality measures; H.R. 736/S. 167, Community Immunity During COVID-19 Act of 2021; H.R. 550, Immunization Infrastructure Modernization Act; H.R. 951/S. 345, Maternal Vaccinations Act, and provisions from the act included in H.R. 959/S. 345, Black Maternal Health Momnibus; Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2); H.R. 1550, the PREVENT HPV Cancers Act of 2021.

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

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

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - To require the Comptroller General of the United States to submit to Congress a report on actions taken by the Secretary of Health and Human Services to address social determinants of health - Rep. Burgess, Michael C. [R-TX-26] - SDOH S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Access to immunizations; Maternal immunizations; Immunization infrastructure; Health information technology/IIS; Vaccine equity; Vaccine education/confidence; Quality measures; H.R. 736/S. 167, Community Immunity During COVID-19 Act of 2021; H.R. 550, Immunization Infrastructure Modernization Act; H.R. 951/S. 345, Maternal Vaccinations Act, and provisions from the act included in H.R. 959/S. 345 Black Maternal Health Momnibus; Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2); H.R. 1550, the PREVENT HPV Cancers Act of 2021.

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

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

H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz - SDOH H.R. 778 - Secure Data and Privacy for Contact Tracing Act of 2021 - Rep. Speier, Jackie - digital contact tracing for COVID-19 H.R. 908 - MORE Health Education Act - Rep. Blunt Rochester, Lisa - federally facilitated exchanges H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa - maternal mental health conditions and SUD H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy -SDOH and maternal health H.R. 1212 - Kira Johnson Act - Rep. Adams, Alma - maternal health outcomes H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. -maternal health data H.R. 1268 - Building COVID-19 Vaccine Confidence Act of 2021 - Rep. Velazquez, Nydia - COVID-19 H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John - COVID-19 relief H.R. 1350 - Supporting Best Practices for Healthy Moms Act - Rep. Kelly, Robin - maternal health outcomes H.R. 1364 - Parity Enforcement Act of 2021 - Rep. Norcross, Donald - mental health and SUD H.R. 1400 - COVID-19 Health Disparities Action Act of 2021 - Rep. Cardenas, Tony -COVID-19 and health disparities H.R. 1406 - COVID-19 Emergency Telehealth Impact Reporting Act of 2021 - Rep. Curtis, John - telehealth and COVID-19 H.R. 1544 - To authorize the HHS to award grants to facilitate the funding of community-based mental health and substance use disorder services and peer support programs - Rep. Cardenas, Tony - mental health and SUD H.R. 1647 - To amend title XVIII of the Social Security Act to increase the use of telehealth for substance use disorder treatment and mental health services - Rep. McKinley, David - telehealth and SUD H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse - Rep. Veasey, Marc - broadband H.R. 1835 - COVID Community Care Act - Rep. Lee, Barbara - COVID-19 response H.R. 1848 - To rebuild and modernize the Nation's infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes - Rep. Pallone, Frank, Jr. - broadband and public health infrastructure H.R. 1872 - To amend the Patient Protection and ACA to provide for Federal Exchange outreach and educational activities, and for other purposes - Rep. Blunt Rochester, Lisa - Federal Exchange outreach and educational activities H.R. 1976 - To establish an improved Medicare for All national health insurance program - Rep. Jayapal, Pramila - public option H.R. 1985 - To amend titles XVIII and XIX of the Social Security Act to modernize Federal nursing home protections and to enhance care quality and transparency for nursing home residents and their families - Rep. Pascrell, Bill, Jr. - quality and transparency H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter - public option S. 24 - Protecting Personal Health Data Act - Sen. Klobuchar, Amy - privacy S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina - health disparities S. 199 - Secure Data and Privacy for Contact Tracing Act of 2021 - Sen. Schatz, Brian - digital contact tracing for COVID-19 S. 201 - Improving Access to Health Care in Rural and Underserved Areas Act - Sen. Rosen, Jacky - rural health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert - maternal health S. 340 - TREATS Act - Sen. Portman, Rob - telehealth, SUD and mental health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory - maternal health and health disparities S. 347 - Data to Save Moms Act - Sen. Smith, Tina - maternal health data S. 352 - Health Care Improvement Act of 2021 - Sen. Warner, Mark - health care costs and coverage S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard - maternal health S. 512 - A bill to require the Centers for Disease Control and Prevention to collect and report certain data concerning COVID-19 - Sen. Warren, Elizabeth - COVID-19 S. 586 - A bill to amend title XVIII of the Social Security Act to combat the opioid crisis by promoting access to non-opioid treatments in the hospital outpatient setting - Sen. Capito, Shelley Moore - SUD S. 674 - A bill to support public health infrastructure - Sen. Murray, Patty - public health infrastructure S. 708 - A bill to direct HHS to convene a task force to advise the Assistant Secretary for Mental Health and Substance Use on a national strategy for preventing mental health and substance use crises during a public health emergency - Sen. Kelly, Mark - mental health and SUD national strategy S. 745 - A bill to make high-speed broadband internet service accessible and affordable to all Americans, and for other purposes - Sen. Klobuchar, Amy - broadband S. 779 - A bill to provide that certain rules and guidance related to waivers for State innovation under the Patient Protection and ACA shall have no force or effect - Sen. Warner, Mark R. - state innovation waivers S. 782 - A bill to amend titles XVIII and XIX of the Social Security Act to modernize Federal nursing home protections and to enhance care quality and transparency for nursing home residents and their families - Sen. Casey, Robert P., Jr. - quality and transparency S. 783 - COVID Community Care Act - Sen. Warren, Elizabeth - COVID-19 response S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard - SDOH and maternal health S. 893 - A bill to support the use of technology in maternal health care - Sen. Menendez, Robert - maternal health S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon - public option S. 987 - A bill to provide support with respect to the prevention of, treatment for, and recovery from, substance use disorder - Sen. Portman, Rob - SUD S. 1010 - A bill to provide funding for programs and activities under the SUPPORT for Patients and Communities Act - Sen. Shaheen, Jeanne - SUD S. 1042 - A bill to prevent maternal mortality and serve maternal morbidity among Black pregnant and postpartum individuals and other underserved populations, to provide training in respectful maternity care, to reduce and prevent bias, racism, and discrimination in maternity care settings, and for other purposes - Sen. Warnock, Raphael - maternal health Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Access to immunizations; Maternal immunizations; Immunization infrastructure; Health information technology/IIS; Vaccine equity; Vaccine education/confidence; Quality measures; H.R. 2862, VACCINES Act; H.R. 736/S. 167 Community Immunity During COVID-19 Act of 2021; H.R. 550 Immunization Infrastructure Modernization Act; Vaccine provisions in H.R. 959/S. 345 Black Maternal Health Momnibus; Funding for vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2).

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

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