State Public Option Act

assist client with issues pertaining to healthcare. HR 1277, S489 State Public Action Act;HR 3447 Public Health Funding Restoration Act; HR 1409 Transparency in All Health Care Pricing Act of 2019; H.R.3594 Healthcare Freedom Act of 2019; HR6338, S3546 Pandemic Healthcare Access Act; HR3599 Healthcare Workforce Resiliency Act; HR3580 DOD Healthcare Billing Report Act; HR 6366 Covid 19 Emergency -temporary waiver etc; HR 6474 Healthcare Broadband Expansion during Covid 19 Act; S4653 Protect Healthcare and PPACA.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019; HR 4651 American Future Healthcare Act of 2019; S470 Medicare at 50 Act; H6338,S3546 Pandemmic Healthcare Access Act; HR 6281, S3500 Medicare Wage Index Parity Act 2020; HR6674 Medicare Crisis Prograqm 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR6445,S3563 Food Assistance for Kids and Families during COVID 2020.

Client expense: Not reported · Firm income: $11,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6800 the HEROES Act re COVID relief S. 4163 re COVID Testing (Gardner) S. 4329 Continuous Health Coverage for Workers Act (McSally) HR 7472 re contract tracing (Speier) S. 4230 Telehealth Expansion Act (Wyden) HR 6395, National Defense Authorization Act S. 4049, National Defense Authorization Act HR 6666, COVID 19 Testing, Reaching and Contacting Everyone Act (TRACE Act) HR 1425, Patient Protection and Affordable Care Enhancement Act HR 6514, Worker Health Coverage Protection Act HR 6568, Coverage for COVID 19 Treatment Act HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) HR 5438, Cox, The End Valley Fever Now Act S. 2897, Warner, regarding the reauthorization of PCORI HR 5201, Matsui, regarding telehealth and behavioral health HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $200,000 · Firm income: Not reported

assist client with issues pertaining to healthcare. HR 1277, S489 State Public Action Act;HR 3447 Public Health Funding Restoration Act; HR 1409 Transparency in All Health Care Pricing Act of 2019; H.R.3594 Healthcare Freedom Act of 2019; HR6338, S3546 Pandemic Healthcare Access Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019; HR 4651 American Future Healthcare Act of 2019; S470 Medicare at 50 Act; H6338,S3546 Pandemmic Healthcare Access Act; HR 6281, S3500 Medicare Wage Index Parity Act 2020; HR6674 Medicare Crisis Prograqm 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR6445,S3563 Food Assistance for Kids and Families during COVID 2020.

Client expense: Not reported · Firm income: $11,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6395, National Defense Authorization Act S. 4049, National Defense Authorization Act HR 6666, COVID 19 Testing, Reaching and Contacting Everyone Act (TRACE Act) HR 1425, Patient Protection and Affordable Care Enhancement Act HR 6514, Worker Health Coverage Protection Act HR 6568, Coverage for COVID 19 Treatment Act HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) HR 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act (CARES Act) HR 6201, The Families First Coronavirus Response Act HR 5438, Cox, The End Valley Fever Now Act S. 2897, Warner, regarding the reauthorization of PCORI HR 5201, Matsui, regarding telehealth and behavioral health HR 2328, PCORI Reauthorization HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $160,000 · Firm income: Not reported

The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) The Coronavirus Aid, Relief, and Economic Security Act (S. 3548) Regulatory relief in light of coronavirus FY 2021 Labor-HHS Subcommittee Appropriations bill Market stabilization/Insurance Coverage Policies (Oversight of final rules on short-term, limited duration insurance (STLDI) and Association Health Plans) Coverage proposals (U.S. v Texas; Medicare X-Choice Proposal; H.R. 1384, the Medicare for All Act of 2019; S. 1129, Medicare-for-all national health insurance program; H.R. 1384 and H.R. 2452 to create a national health insurance program; H.R. 2000, H.R. 2463, and H.R. 2085 to create a federal public option; H.R. 1277 a Medicaid buy-in; H.R. 1346 and H.R. 4527 adults aged 50-64 or qualified first responders Medicare buy in; H.R. 584 Medicaid expansion) Hospital Price Transparency (surprise medical bills; public posting of hospital charges; Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First; Final Rule on Price Transparency; Transparency in Coverage Proposed Rule) Surprise Medical Bills (S. 1895 Lower Health Care Costs Act of 2019; S. 1531 Stopping the Outrageous Practice of Surprise Medical Bills Act; S. 1266 the Protecting Patients from Surprise Medical Bills Act; S. 1497, the Health Care Price Check Act; H.R.861, the End Surprise Billing Act of 2019; S. 1688 - A bill to amend the Public Health Service Act to provide for the full disclosure of billing and service information to patients; H.R. 3502 the Protecting People from Surprise Medical Bills Act; H.R. 3630, No Surprises Act; H.R. 2328, the Reauthorizing and Extending Americas Community Health Act) 340B Drug Pricing Program Drug pricing policy and drug shortages (H.R. 3, Lower Drug Costs Now Act; S. 340/H.R. 965, CREATES Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act; H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 2296, the More Efficient Tools to Realize Information for Consumers (METRIC) Act; H.R. 1781, the Payment Commission Data Act of 2019; H.R. 2115, requiring PBMs to report rebate data) HIPAA policy in mental and behavioral health information sharing (H.R. 2062, Overdose Prevention and Patient Safety Act) BLOCKING Act of 2019 (H.R. 938) To amend the Internal Revenue Code of 1986 and title XI of the Social Security Act to extend appropriations and transfers to the Patient-Centered Outcomes Research Trust Fund and to extend certain health insurance fees for such transfers, and for other purposes (H.R. 3439) H.R. 2781, the Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 H.R. 728, the Title VIII Nursing Workforce Reauthorization Act H.R. 647, the Palliative Care and Hospice Education and Training Act Hospital Star Ratings

assist client with issues pertaining to healthcare. HR 1277, S489 State Public Action Act;HR 3447 Public Health Funding Restoration Act; HR 1409 Transparency in All Health Care Pricing Act of 2019; H.R.3594 Healthcare Freedom Act of 2019; HR6338, S3546 Pandemic Healthcare Access Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1277 S489 State Public Option Act; HR 3594 Healthcare Freedom Act of 2019; HR 4651 American Future Healthcare Act of 2019; S470 Medicare at 50 Act; H6338,S3546 Pandemmic Healthcare Access Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6074 Coronavirus Preparedness and Response Supplemental Appropriations Act HR 6074 CARES Act HR 6201 The Families First Coronavirus Response Act HR 5438 Cox, The End Valley Fever Now Act S. 2897, Warner, regarding the reauthorization of PCORI HR 5201 Matsui, regarding telehealth and behavioral health HR 2328, PCORI Reauthorization HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $670,000 · Firm income: Not reported

House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470 regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129 to establish a single payer system based on Medicare for All. HR 1384 to establish a single payer health care system HR 1425 regarding reinsurance funding under the ACA HR 986 and S. 466 regarding Section 1332 state waiver guidance. HR 1010 regarding Short Term Limited Duration Insurance policies HR 1143 regarding Short Term Limited Duration Insurance policies HR 861 regarding surprise billing

Client expense: $660,000 · Firm income: Not reported

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

HR 2328, PCORI Reauthorization HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $180,000 · Firm income: Not reported

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 2081, Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 (Peters)- drugs in Part B S. 2252, Empowering States to Address Drug Costs Act (Van Hollen)- drug pricing S. 2446, Medicare Audiologist Access and Services Act of 2019 (Warren)-Medicare coverage of audiologist services S. 2650 - Medicare Prescription Drug Savings and Choice Act of 2019 (Durbin) - lowering prescription drug costs S. 2807, Hospice Care Improvement Act of 2019 (Portman) - Medicare hospice programs S. 2846, Protecting Patients Transportation to Care Act (Isakson) - Medicaid coverage of transportation S. 2911, Seniors Prescription Drug Relief Act of 2019 (Cassidy) - Part D smoothing S. 3000, Patient Shared Savings Act (Cassidy) - prescription drug plans S. 3001, Permanent Relief for Seniors and Medicare, Medicaid, Human Services Extension Act of 2019 (Toomey) - extensions S. 3029, Territories Medicare Prescription Drug Assistance Equity Act of 2019 (Menendez) - Territories, low-income Medicare part D beneficiaries S. 3078, Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2019 (Grassley) - Medicare appeals process S. 3129, Lower Costs, More Cures Act of 2019 (Crapo) - drug pricing H.R. 19, Lower Costs, More Cures Act of 2019 (Walden) - drug pricing H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan H.R. 3613, State Accountability, Flexibility, and Equity for Hospitals Act of 2019 (Bilirakis) -Medicaid DSH payments H.R. 3631, Territories Health Care Improvement Act (Soto) -Medicaid funding H.R. 3644, Independence at Home Demonstration Act of 2019 (Burgess)-Medicare demonstration program H.R. 3925, Reducing Barriers to Substance Use Treatment Act (Tonko)- Opioids H.R. 3935, Protecting Patients Transportation to Care Act (Carter)-Medicaid coverage for transportation H.R. 4378, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Lowey)-Health extenders H.R. 4453, Protecting Seniors from Health Care Fraud Act of 2019 (Ruiz)-Distributing information to Medicare beneficiaries to prevent fraud H.R. 4527, Expanding Health Care Options for Early Retirees Act (Malinowski)-Option for first responders to buy-in to Medicare H.R. 4529, Promoting Access to Broadband Act of 2019 (Maloney)-Medicaid H.R. 4583, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 (Schneider) - prescription drug affordability H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 (Peters) - biosimilars, Part B H.R. 4618, Medicare Hearing Act of 2019 (McBath) - coverage for certain hearing items and services under part B H.R. 4619, Pharmaceutical Rebates for Excessive Pricing Above Inflation Act (Schakowsky) - drug rebates, Part D H.R. 4620, More Help for Seniors Act of 2019 (Rose) - expand eligibility for low-income subsidies under Part D of the Medicare program H.R. 4621, Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2019 (Blunt Rochester) - best practices re social determinants of health H.R. 4628, Better Tools to Lower Costs Act of 2019 (Scanlon) - resource requirements H.R. 4629, Star Rating for Biosimilars Act (Tonko) - biosimilars H.R. 4632, Better Transparency in Information for Medicare Beneficiaries Act of 2019 (Kind) - provides consumers information regarding premiums under LIS benchmark plans H.R. 4649, Capping Drug Costs for Seniors Act of 2019 (Horsford) - cap on beneficiary liability under part D of the Medicare program H.R. 4650, Medicare Dental Act of 2019 (Kelly) - Medicare dental coverage H.R. 4655, Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 (Lee) - eligibility of individuals for premium and cost-sharing subsidies under part D H.R. 4661, Advancing Enrollment and Reducing Drug Costs Act of 2019 (Pappas) - Medicaid in territories H.R. 4663, Freedom from Price Gouging Act (Porter) - drug rebates, Part B H.R. 4665, Medicare Vision Act of 2019 (Schrier) - vision items and services under part B H.R. 4666, To amend title XVIII of the Social Security Act to provide certain low-income territorial residents with automatic eligibility for premium and cost-sharing subsidies under the Medicare program, and for other purposes (Shalala) - Medicare in territories H.R. 4669, Maximizing Drug Coverage for Low-Income Seniors Act of 2019 (Stevens) - auto enrollment and intelligent assignment H.R. 4671, Helping Seniors Afford Health Care Act (Kim) - Medicare affordability and low income beneficiaries H.R. 4676, Protecting Medicare Beneficiaries with Pre-Existing Conditions Act (Schneider) - Medigap H.R. 4699, To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals (Gonzales-Colon) - Part D, territories H.R. 4769, Medicare Prescription Drug Savings and Choice Act of 2019 (Schakowsky) - lowering prescription drug costs H.R. 4946, Ensuring Seniors Access to Local Pharmacies Act of 2019 (Welch) - equal access of Medicare beneficiaries to community pharmacies in underserved areas H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019 (Kelly) - State extension of Medicaid H.R. 5006, Expanding Access to Inpatient Mental Health Act (Emmer) - Medicaid coverage for SUD/mental health for institutionalized H.R. 5039, Life Sustaining Prescription Drug Price Relief Act of 2019 (Lipinski) - part D H.R. 5057, Pass- Through Technical Corrections Act (Tonko) - drug pass-through status under Medicare outpatient payment H.R. 5201, Telemental Health Expansion Act of 2019 (Matsui) - Medicare coverage of mental telehealth H.R. 5232, Road to Recovery Act (Fitzpatrick) - Medicaid and CHIP SUD treatment H.R. 5281, Drug Price Transparency in Medicaid Act of 2019 (Carter) - transparency and spread pricing affordability Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2021 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2021 Rate Notice and Call Letter; issues related to MLTSS; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

assist client with issues pertaining to healthcare. HR 1277, HR 3447 Public Health Funding Restoration Act; S489 State Public Option Act; H.R.3594 Healthcare Freedom Act of 2019; H.Res.470 Expressing support for the designation of October 1, 2019, as "National Health Literacy Day" to recognize the value of health literacy in transforming and improving health and healthcare for all people in the United States

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1277 S489 State Public Option Act; HR 3594 Healthcare Freedom Act of 2019; HR 4651 American Future Healthcare Act of 2019; S470 Medicare at 50 Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839) Improving Seniors Timely Access to Care Act (H.R. 3107) Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019 (H.R. 3253) Protect Medicaid Act (S. 131) Home Health Care Planning Improvement Act of 2019 (S. 296/H.R. 2150) Medicare at 50 Act (S. 470) State Public Option Act (S. 489/H.R. 1277) Expanding Access to Diabetes Self-Management Training Act (S. 814)

Client expense: Not reported · Firm income: $24,000

Market stabilization/Insurance Coverage Policies (Oversight of final rules on short-term, limited duration insurance (STLDI) and Association Health Plans) Coverage proposals (U.S. v Texas; Medicare X-Choice Proposal; H.R. 1384, the Medicare for All Act of 2019; S. 1129, Medicare-for-all national health insurance program; H.R. 1384 and H.R. 2452 to create a national health insurance program; H.R. 2000, H.R. 2463, and H.R. 2085 to create a federal public option; H.R. 1277 a Medicaid buy-in; H.R. 1346 and H.R. 4527 adults aged 50-64 or qualified first responders Medicare buy in; H.R. 584 Medicaid expansion) Hospital Price Transparency (surprise medical bills; public posting of hospital charges; Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First) Surprise Medical Bills (S. 1895 Lower Health Care Costs Act of 2019; S. 1531 Stopping the Outrageous Practice of Surprise Medical Bills Act; S. 1266 the Protecting Patients from Surprise Medical Bills Act; S. 1497, the Health Care Price Check Act; H.R.861, the End Surprise Billing Act of 2019; S. 1688 - A bill to amend the Public Health Service Act to provide for the full disclosure of billing and service information to patients; H.R. 3502 the Protecting People from Surprise Medical Bills Act; H.R. 3630, No Surprises Act; H.R. 2328, the Reauthorizing and Extending Americas Community Health Act) 340B Drug Pricing Program Drug pricing policy and drug shortages (H.R. 3, Lower Drug Costs Now Act; S. 340/H.R. 965, CREATES Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act; H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 2296, the More Efficient Tools to Realize Information for Consumers (METRIC) Act; H.R. 1781, the Payment Commission Data Act of 2019; H.R. 2115, requiring PBMs to report rebate data) HIPAA policy in mental and behavioral health information sharing (H.R. 2062, Overdose Prevention and Patient Safety Act) BLOCKING Act of 2019 (H.R. 938) To amend the Internal Revenue Code of 1986 and title XI of the Social Security Act to extend appropriations and transfers to the Patient-Centered Outcomes Research Trust Fund and to extend certain health insurance fees for such transfers, and for other purposes (H.R. 3439) H.R. 2781, the Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 H.R. 728, the Title VIII Nursing Workforce Reauthorization Act H.R. 647, the Palliative Care and Hospice Education and Training Act Hospital Star Ratings

HR 5438 Cox, The End Valley Fever Now Act S. 2897, Warner, regarding the reauthorization of PCORI HR 5201 Matsui, regarding telehealth and behavioral health HR 2328, PCORI Reauthorization HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $670,000 · Firm income: Not reported

HR 3: A bill to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. HR 3276: A bill to amend title XIX of the Social Security Act to exclude authorized generic drugs from calculation of the average manufacturer price for purposes of the Medicaid drug rebate program, and for other purposes. H.R. 1346: To amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes. S. 470: To amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare. H.R.2564: This bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA)-a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. S 753: A bill to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare. HR (No Bill #) Payment Commission Data Act of 2019: A bill to amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. H.R. 1158: An act making consolidated appropriations for the fiscal year ending September 30, 2020, and for other purposes. H.R. 1865: An act making consolidated appropriations for the fiscal year ending September 30, 2020, and for other purposes. H.R. 2477: A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. S. 1280: A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. H.R. 3: An act to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S. 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R. 1277: A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan S. 489: A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan H.R. 2000: A bill to establish a public health plan H.R. 2452: A bill to amend the Social Security Act to establish a Medicare for America health program to provide for comprehensive health coverage for all Americans. H.R. 2463: A bill to provide for the establishment of Medicare part E public health plans, and for other purposes. H.R. 4527: A bill to amend title XVIII of the Social Security Act to provide an option for first responders age 50 to 64 who are separated from service due to retirement or disability to buy into Medicare. H.R. 2085: A bill to amend the Public Health Service Act to establish a public health insurance option, and for other purposes.

HR 3: A bill to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. HR 4070: A bill to streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. HR 3796: A bill to amend the Internal Revenue Code of 1986 to provide that coverage under Medicare is permissible for purposes of contributions to health savings accounts. HR 861: A bill to amend title XVIII of the Social Security Act to prevent surprise billing practices, and for other purposes. HR 3276: A bill to amend title XIX of the Social Security Act to exclude authorized generic drugs from calculation of the average manufacturer price for purposes of the Medicaid drug rebate program, and for other purposes. HR 2113: A bill to a mend titles XI and XVIII of the Social Security Act to provide for drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain health care providers, and for other purposes. H.R. 2447: A bill to fully repeal the Health Insurance Tax S. 80: A bill to fully repeal the Health Insurance Tax H.R. 2782: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. The bill increases the hours of service threshold from an average of at least 30 hours of service a week to an average of at least 40 hours of service a week. S. 1510: This bill increases the hours of service required for an employee to be classified as a full-time employee for purposes of the employer mandate under the Patient Protection and Affordable Care Act to provide minimum essential health care coverage to full-time employees. The bill increases the hours of service threshold from an average of at least 30 hours of service a week to an average of at least 40 hours of service a week. H.R.2564: This bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA)-a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. H.R. 1682: This bill deems an individual receiving outpatient observation services in a hospital as an inpatient for purposes of satisfying the three-day inpatient hospital-stay requirement with respect to Medicare coverage of skilled nursing facility services. H.R. 1384: This bill establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). S. 1129: This bill establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). S. 981: A bill to establish a public health plan. H.R. 1346: To amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes. S. 470: To amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare. S. 1895: A bill to lower health care costs by preventing surprise medical bills, reducing prescription drug prices, improving transparency in health care, investing in public health and improving health information exchange. H.R. 3630: To amend title XXVII of the Public Health Service Act to protect health care consumers from surprise billing practices, and for other purposes. HR 1682: A bill to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes. S 753: A bill to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare. HR 748: A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. S 684: A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. HR 1884: A bill to amend the Patient Protection and Affordable Care Act to improve affordability of, undo sabotage with respect to, and increase access to health insurance coverage, and for other purposes. S 172: A bill to delay the reimposition of the annual fee on health insurance providers until after 2021. HR 1398: A bill to delay the reimposition of the annual fee on health insurance providers until after 2021. S 80: A bill to repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act. HR 1385: A bill to amend the Patient Protection and Affordable Care Act to preserve the option of States to implement health care marketplaces, and for other purposes HR 1386: A bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes. HR 987: A bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities. HR 986: A bill to provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect. HR 100: A bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect. HR 1425: A bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market. HR 938: A bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes HR 1520: A bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1503: A bill to amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR (No Bill #) Payment Commission Data Act of 2019: A bill to amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. HR 1499: A bill prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 965: promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. H.R. 1158: An act making consolidated appropriations for the fiscal year ending September 30, 2020, and for other purposes. H.R. 1865: An act making consolidated appropriations for the fiscal year ending September 30, 2020, and for other purposes. H.R. 2477: A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. S. 1280: A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. H.R. 3708: A bill to amend the Internal Revenue Code of 1986 to allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts, and for other purposes. S. 2999: A bill to amend the Internal Revenue Code of 1986 to allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts. H.R. 3: An act to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. S. 2543: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R. 1277: A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan S. 489: A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan H.R. 2000: A bill to establish a public health plan H.R. 2452: A bill to amend the Social Security Act to establish a Medicare for America health program to provide for comprehensive health coverage for all Americans. H.R. 2463: A bill to provide for the establishment of Medicare part E public health plans, and for other purposes. H.R. 4527: A bill to amend title XVIII of the Social Security Act to provide an option for first responders age 50 to 64 who are separated from service due to retirement or disability to buy into Medicare. H.R. 2085: A bill to amend the Public Health Service Act to establish a public health insurance option, and for other purposes.

H.R. 1277 - State Public Option Act H.R. 1346 - Medicare Buy-In and Healthcare Stabilization Act H.R. 1384 - Medicare for All Act H.R. 2477 - The Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 H.R. 3935 - The Protecting Patients Transportation to Care Act S. 2986 The Social Determinants Accelerator Act H.R. 4004 - The Social Determinants Accelerator Act S. 1399 - Title VIII Nursing Workforce Reauthorization Act of 2019 S. 1608 - Promoting Physical Activity for Americans Act S.2741- Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 H.R.4932 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 H.R.4378 - Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 5190 - Specialty Treatment to Access and Referrals (STAR) Act of 2019 S.1842 - Protecting Personal Health Data Act S.2968 - Consumer Online Privacy Rights Act S. 2629 - United States Public Health Service Modernization Act of 2019 S. 2892 - the Opioid Workforce Act H.R. 1398 - Health Insurance Tax Relief Act of 2019 S. 172 - Health Insurance Tax Relief Act of 2019 H.R. 2207- Protect Medical Innovation Act S. 692 - Protect Medical Innovation Act H.R. 2062 Overdose Prevention and Patient Safety Act H.R. 3461 - Community-Based Independence for Seniors Act of 2019 H.R. 3796 - Health Savings for Seniors Act S. 1323 - Utilizing National Data, Effectively Reforming Standards and Tools, to Address Negative Determinates of Health (UNDERSTAND) Act

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

H.R. 1277 - State Public Option Act H.R. 1346 - Medicare Buy-In and Healthcare Stabilization Act H.R. 1384 - Medicare for All Act H.R. 2477 - The Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 H.R. 3935 - The Protecting Patients Transportation to Care Act S. 2986 The Social Determinants Accelerator Act H.R. 4004 - The Social Determinants Accelerator Act S. 1399 - Title VIII Nursing Workforce Reauthorization Act of 2019 S. 1608 - Promoting Physical Activity for Americans Act S.2741- Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 H.R.4932 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 H.R.4378 - Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 5190 - Specialty Treatment to Access and Referrals (STAR) Act of 2019 S.1842 - Protecting Personal Health Data Act S.2968 - Consumer Online Privacy Rights Act S. 2629 - United States Public Health Service Modernization Act of 2019 S. 2892 - the Opioid Workforce Act H.R. 1398 - Health Insurance Tax Relief Act of 2019 S. 172 - Health Insurance Tax Relief Act of 2019 H.R. 2207- Protect Medical Innovation Act S. 692 - Protect Medical Innovation Act H.R. 2062 Overdose Prevention and Patient Safety Act H.R. 3461 - Community-Based Independence for Seniors Act of 2019 H.R. 3796 - Health Savings for Seniors Act S. 1323 - Utilizing National Data, Effectively Reforming Standards and Tools, to Address Negative Determinates of Health (UNDERSTAND) Act

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

The Senate Committee on Finance introduced S. 2543 on September 25, the Prescription Drug Pricing Reduction Act of 2019. Senator Lamar Alexander (R-TN), Chairman, and Senator Patty Murray (D-WA), Ranking Member, of the Senate Committee on Health, Education and Labor (HELP) introduced S.1895, the Lower Health Care Costs Act of 2019, on June 19, a bipartisan piece of legislation to deliver better health care at lower cost. Rep. Joe Courtney (D-CT) introduced a bill to repeal the Cadillac tax, the Affordable Care Act's forty percent tax on high-cost health plans. H.R. 748, entitled the Middle Class Health Benefits Tax Repeal Act would amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. A bill, S.61, the Safe and Affordable Drugs from Canada Act of 2019, sponsored by Senator Chuck Grassley (R-IA), was introduced. The bill would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada. S. 489, a bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan, was introduced by Senator Brian Schatz (D-HI). A companion bill has been introduced in the House, which is H.R. 1277. Rep. Marcia Fudge (D-OH) is a cosponsor. S.692, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices, was introduced by Senator Pat Toomey. S.684, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage, the Cadillac Tax was introduced by Senator Martin Heinrich (D-NM). A similar House bill has been introduced. H.R. 1398, a bipartisan bill to delay the re-imposition of the annual fee on health insurance providers, aka the Health Insurance Tax (HIT) until after 2021 was introduced. The bill was introduced by Rep. Ami Bera. (D-CA). Rep. Steve Stivers (R-OH) introduced H.R. 1366, the Responsible Additions and Increases to Sustain Employee Health Benefits Act, RAISE Act to put flexibility back in Flexible Spending Accounts and to help families pay for out of pocket health care costs. H.R. 965, the CREATES Act, was reintroduced in Congress by Rep. David Cicilline (D-RI). The bill would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Senator Rob Portman (R-OH) introduced the Biologic Patent Transparency Act. The bill would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs. S.516, the Prescription Drug Monitoring Act of 2019, was introduced by Senator Amy Klobuchar (D-MN). The bill would require the use of prescription drug monitoring programs. Senator Sherrod Brown (D-OH) introduced S. 378, the Stop Price Gouging Act. The bill would penalize pharmaceutical companies that engage in price gouging without cause, leading to price spikes for patients who rely on medication to treat illnesses. H.R. 1091 is the companion House bill, which has been cosponsored by Rep. Marcy Kaptur (D-OH). Senator Sherrod Brown introduced legislation to address prescription drug affordability. The bill, S. 377, entitled, "The Medicare Negotiation and Competitive Licensing Act," would authorize the Secretary of Health and Human Services to negotiate drug prices and if a drug company refuses to negotiate in good faith, the secretary would be enabled to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic. H.R. 965, the CREATES Act of 2019, which aims to increase competition by cracking down on brand-name drug manufacturers using tactics to keep generic manufacturers from entering the market, was advanced out of the Committee on Energy and Commerce and will be considered by the Committee on the Judiciary. Members of the Ohio delegation are co-sponsors.

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicaid Extenders Act of 2019 (H.R. 259) Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839) Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019 (H.R. 3253) Protect Medicaid Act (S. 131) Home Health Care Planning Improvement Act of 2019 (S. 296/H.R. 2150) Medicare at 50 Act (S. 470) State Public Option Act (S. 489/H.R. 1277) Expanding Access to Diabetes Self-Management Training Act (S. 814) S. 2047, providing for a two-week extension of the Medicaid community mental health services demonstration program

Client expense: Not reported · Firm income: $24,000

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 2081, Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 (Peters)- drugs in Part B S. 2252, Empowering States to Address Drug Costs Act (Van Hollen)- drug pricing S. 2446, Medicare Audiologist Access and Services Act of 2019 (Warren)-Medicare coverage of audiologist services H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments H.R. 3613, State Accountability, Flexibility, and Equity for Hospitals Act of 2019 (Bilirakis) -Medicaid DSH payments H.R. 3631, Territories Health Care Improvement Act (Soto) -Medicaid funding H.R. 3644, Independence at Home Demonstration Act of 2019 (Burgess)-Medicare demonstration program H.R. 3925, Reducing Barriers to Substance Use Treatment Act (Tonko)- Opioids H.R. 3935, Protecting Patients Transportation to Care Act (Carter)-Medicaid coverage for transportation H.R. 4378, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Lowey)-Health extenders H.R. 4453, Protecting Seniors from Health Care Fraud Act of 2019 (Ruiz)-Distributing information to Medicare beneficiaries to prevent fraud H.R. 4527, Expanding Health Care Options for Early Retirees Act (Malinowski)-Option for first responders to buy-in to Medicare H.R. 4529, Promoting Access to Broadband Act of 2019 (Maloney)-Medicaid Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2020 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1277 S489 State Public Option Act; HR 3594 Healthcare Freedom Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare. HR 1277, HR 3447 Public Health Funding Restoration Act; S489 State Public Option Act; H.R.3594 Healthcare Freedom Act of 2019; H.Res.470 Expressing support for the designation of October 1, 2019, as "National Health Literacy Day" to recognize the value of health literacy in transforming and improving health and healthcare for all people in the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2328, PCORI Reauthorization HR 2328, the No Surprises Act S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

Client expense: $160,000 · Firm income: Not reported

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicaid Extenders Act of 2019 (H.R. 259) Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839) Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019 (H.R. 3253) Protect Medicaid Act (S. 131) Home Health Care Planning Improvement Act of 2019 (S. 296/H.R. 2150) Advancing Care for Exceptional Kids (ACE Kids) Act of 2019 (S. 317/H.R. 1226) Medicare at 50 Act (S. 470) State Public Option Act (S. 489/H.R. 1277) Expanding Access to Diabetes Self-Management Training Act (S. 814) S. 2047, providing for a two-week extension of the Medicaid community mental health services demonstration program

Client expense: Not reported · Firm income: $24,000

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2020 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Senator Lamar Alexander (R-TN), Chairman, and Senator Patty Murray (D-WA), Ranking Member, of the Senate Committee on Health, Education and Labor (HELP) introduced S.1895, the Lower Health Care Costs Act of 2019, on June 19, a bipartisan piece of legislation to deliver better health care at lower cost. Rep. Joe Courtney (D-CT) introduced a bill to repeal the Cadillac tax, the Affordable Care Act's forty percent tax on high-cost health plans. H.R. 748, entitled the Middle Class Health Benefits Tax Repeal Act would amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. A bill, S.61, the Safe and Affordable Drugs from Canada Act of 2019, sponsored by Senator Chuck Grassley (R-IA), was introduced. The bill would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada. S. 489, a bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan, was introduced by Senator Brian Schatz (D-HI). A companion bill has been introduced in the House, which is H.R. 1277. Rep. Marcia Fudge (D-OH) is a cosponsor. S.692, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices, was introduced by Senator Pat Toomey. S.684, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage, the Cadillac Tax was introduced by Senator Martin Heinrich (D-NM). A similar House bill has been introduced. H.R. 1398, a bipartisan bill to delay the re-imposition of the annual fee on health insurance providers, aka the Health Insurance Tax (HIT) until after 2021 was introduced. The bill was introduced by Rep. Ami Bera. (D-CA). Rep. Steve Stivers (R-OH) introduced H.R. 1366, the Responsible Additions and Increases to Sustain Employee Health Benefits Act, RAISE Act to put flexibility back in Flexible Spending Accounts and to help families pay for out of pocket health care costs. H.R. 965, the CREATES Act, was reintroduced in Congress by Rep. David Cicilline (D-RI). The bill would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Senator Rob Portman (R-OH) introduced the Biologic Patent Transparency Act. The bill would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs. S.516, the Prescription Drug Monitoring Act of 2019, was introduced by Senator Amy Klobuchar (D-MN). The bill would require the use of prescription drug monitoring programs. Senate bill, S.475, the RxCAP Act of 2019, was introduced by Senator Ron Wyden (D-OR). The bill would amend title XVIII of the Social Security Act to prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities. Senator Sherrod Brown (D-OH) introduced S. 378, the Stop Price Gouging Act. The bill would penalize pharmaceutical companies that engage in price gouging without cause, leading to price spikes for patients who rely on medication to treat illnesses. H.R. 1091 is the companion House bill, which has been cosponsored by Rep. Marcy Kaptur (D-OH). Senator Sherrod Brown introduced legislation to address prescription drug affordability. The bill, S. 377, entitled, "The Medicare Negotiation and Competitive Licensing Act," would authorize the Secretary of Health and Human Services to negotiate drug prices and if a drug company refuses to negotiate in good faith, the secretary would be enabled to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic. Senator Ron Wyden (D-OR) introduced S.476, a bill for Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. Senator Sherrod Brown (D-OH) is one of the cosponsors. The bill would amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. At the end of January 2019, the Health and Human Services Department issued a proposed rule, Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. The proposed rule has been interpreted to eliminate safe harbor protection for rebates paid by drug manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans and Medicaid managed care plans; create a new safe harbor for drug discounts offered to patients at the point of sale, and create a new safe harbor for PBM fees charged to drug manufacturers. The proposed rule would cost the federal government over $170 billion and approximately $20 million for a plan sponsor. EGWPS plans were excluded from the proposal. A meeting with HHS occured to ask questions and provide background and a letter was sent to CMS Administrator Verma. H.R. 965, the CREATES Act of 2019, which aims to increase competition by cracking down on brand-name drug manufacturers using tactics to keep generic manufacturers from entering the market, was advanced out of the Committee on Energy and Commerce and will be considered by the Committee on the Judiciary. Members of the Ohio delegation are co-sponsors.

S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470 regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129 to establish a single payer system based on Medicare for All. HR 1384 to establish a single payer health care system HR 1425 regarding reinsurance funding under the ACA HR 986 and S. 466 regarding Section 1332 state waiver guidance. HR 1010 regarding Short Term Limited Duration Insurance policies HR 1143 regarding Short Term Limited Duration Insurance policies HR 861 regarding surprise billing

Client expense: $180,000 · Firm income: Not reported

assist client with issues pertaining to healthcare. HR 1277, S489 State Public Option Act; H.R.3594 Healthcare Freedom Act of 2019; H.Res.470 Expressing support for the designation of October 1, 2019, as "National Health Literacy Day" to recognize the value of health literacy in transforming and improving health and healthcare for all people in the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1895, the Lower Health Care Costs Act HR 987 and S. 455, regarding outreach and education activities under the ACA HR 3439, regarding the reauthorization of PCORI House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 and S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470, regarding a Medicare buy-in option for individuals aged 50-64 HR 1277 and S. 489, regarding a Medicaid buy-in option S. 1129, to establish a single payer system based on Medicare for All. HR 1384, to establish a single payer health care system HR 1425, regarding reinsurance funding under the ACA HR 986 and S. 466, regarding Section 1332 state waiver guidance. HR 1010, regarding Short Term Limited Duration Insurance policies HR 1143, regarding Short Term Limited Duration Insurance policies HR 861, regarding surprise billing

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

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicaid Extenders Act of 2019 (H.R. 259) Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839) Protect Medicaid Act (S. 131) Home Health Care Planning Improvement Act of 2019 (S. 296) Advancing Care for Exceptional Kids (ACE Kids) Act of 2019 (S. 317/H.R. 1226) Medicare at 50 Act (S. 470) State Public Option Act (S. 489/H.R. 1277) Expanding Access to Diabetes Self-Management Training Act (S. 814)

Client expense: Not reported · Firm income: $24,000

assist client with issues pertaining to healthcare policies and reform; H1551 Quality Care for Moms & Babies; . H.Res.16 Recognizing the importance of access to comprehensive, high-quality, life-affirming medical care for women of all ages;H.R.973 Violence Against Women Health Act of 2019; HR 1277,S489 State Public Option Act; HR1409 Transparency in all Healthcare Pricing Act 2019

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to healthcare. HR 1277, S489 State Public Option Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1384, Medicare for All Act (Jayapal) - Medicare for All health care system H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program Draft Medicare Advantage Quality Payment Relief Act (Kelly-Kind) - MA benchmark cap Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2019 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

The partial shutdown impacted the ability of key regulatory agencies, DOL, HHS and Treasury/IRS to move forward on reviewing comment letters pertaining to the proposed HRA Excepted Benefits Rule and decide whether to extend Limited Wraparound Plans. Discussions were held to understand the status of the comments received and when decisions might be made. Rep. David Joyce introduced H.R.383, a bill called, the Continuing Coverage for Preexisting Conditions Act of 2019, on January 9. The bill would amend the Patient Protection and Affordable Care Act to ensure that preexisting condition exclusions with respect to enrollment in health insurance coverage and group health plans continue to be prohibited. Rep. Joe Courtney (D-CT) introduced a bill on January 24 to repeal the Cadillac tax, the Affordable Care Act's forty percent tax on high-cost health plans. H.R. 748, entitled the Middle Class Health Benefits Tax Repeal Act would amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. A bill, S.61, the Safe and Affordable Drugs from Canada Act of 2019, sponsored by Senator Chuck Grassley (R-IA), was introduced on January 9. The bill would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada. S. 489, a bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan, was introduced on February 14 by Senator Brian Schatz (D-HI). A companion bill has been introduced in the House, which is H.R. 1277. Rep. Marcia Fudge (D-OH) is a cosponsor. S.692, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices, was introduced by Senator Pat Toomey (R-PA) on March 7. S.684, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage, the Cadillac Tax was introduced on March 6 by Senator Martin Heinrich (D-NM). H.R. 1398, a bipartisan bill to delay the re-imposition of the annual fee on health insurance providers, aka the Health Insurance Tax (HIT) until after 2021 was introduced on February 27. The bill was introduced by Rep. Ami Bera (D-CA). Rep. Steve Stivers (R-OH) introduced H.R. 1366, the Responsible Additions and Increases to Sustain Employee Health Benefits Act, RAISE Act to put flexibility back in Flexible Spending Accounts and to help families pay for out of pocket health care costs. On February 5, H.R. 965, the CREATES Act, was reintroduced in Congress by Rep. David Cicilline (D-RI). The bill would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Senator Rob Portman (R-OH) introduced the Biologic Patent Transparency Act. The bill would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs. S.516, the Prescription Drug Monitoring Act of 2019, was introduced by Senator Amy Klobuchar (D-MN) on February 14. The bill would require the use of prescription drug monitoring programs. Another Senate bill, S.475, the RxCAP Act of 2019, was introduced by Senator Ron Wyden (D-OR) on February 13. The bill would amend title XVIII of the Social Security Act to prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities. Senator Sherrod Brown introduced S. 378, the Stop Price Gouging Act. The bill would penalize pharmaceutical companies that engage in price gouging without cause, leading to price spikes for patients who rely on medication to treat illnesses. H.R. 1091 is the companion House bill, which has been cosponsored by Rep. Marcy Kaptur (D-OH). On February 7, Senator Sherrod Brown introduced legislation to address prescription drug affordability. The bill, S. 377, entitled, "The Medicare Negotiation and Competitive Licensing Act," would authorize the Secretary of Health and Human Services to negotiate drug prices and if a drug company refuses to negotiate in good faith, the secretary would be enabled to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic. On February 13, Senator Ron Wyden (D-OR) introduced S.476, a bill for Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. Senator Sherrod Brown is one of the cosponsors. The bill would amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. At the end of January 2019, the Health and Human Services Department issued a proposed rule, Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. The proposed rule has been interpreted to eliminate safe harbor protection for rebates paid by drug manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans and Medicaid managed care plans; create a new safe harbor for drug discounts offered to patients at the point of sale, and create a new safe harbor for PBM fees charged to drug manufacturers.

Medicaid program reforms, including possible regulations involving hospital outpatient departments Implementation of health care reform Section 340B Drug Pricing program Healthcare disparities issues generally Drug pricing reforms generally Poison Control Center funding programs generally Implementation of Public Law 115-91 (National Defense Authorization Act for Fiscal Year 2018), Section 708, regarding TRICARE policies for patient referrals involving pregnant women H.R. 1277 and S. 489 (State Public Option Act), all provisions Legislation regarding hospital billing practices H.R.501 (Poison Center Network Enhancement Act of 2019), all provisions Department of Defense policy on child abuse reporting Reauthorization of Patient-Centered Outcomes Research Institute H.R. 2076 and S.1009 (Early Detection to Stop Infant Abuse and Prevent Fatalities Act), all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

House Resolution 271, regarding the Justice Departments position in Texas v. United States HR 2062 & S. 1012, regarding 42 CFR Part 2 and confidentiality of certain health information HR 1884, with provisions to stabilize and strengthen the ACA and the nongroup insurance market. S. 470 regarding a Medicare buy-in option for individuals aged 50-64 S. 489 and HR 1277, regarding a Medicaid buy-in option S. 1129 to establish a single payer system based on Medicare for All. HR 1384 to establish a single payer health care system HR 1425 regarding reinsurance funding under the ACA HR 986 and S. 466 regarding Section 1332 state waiver guidance. HR 1010 regarding Short Term Limited Duration Insurance policies HR 1143 regarding Short Term Limited Duration Insurance policies HR 861 regarding surprise billing

Client expense: $540,000 · Firm income: Not reported

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

Medicaid program reforms, including possible regulations involving hospital outpatient departments Implementation of health care reform Section 340B Drug Pricing program Healthcare disparities issues generally Drug pricing reforms generally Poison Control Center funding programs generally Implementation of Public Law 115-91 (National Defense Authorization Act for Fiscal Year 2018), Section 708, regarding TRICARE policies for patient referrals involving pregnant women H.R. 1277 and S. 489 (State Public Option Act), all provisions Legislation regarding hospital billing practices H.R. 501 (Poison Center Network Enhancement Act of 2019), all provisions Department of Defense policy on child abuse reporting Reauthorization of Patient-Centered Outcomes Research Institutute H.R.776 - Emergency Medical Services for Children Program Reauthorization Act of 2019 S. 1173, to reauthorize the Emergency Medical Services for Children program S. 1009, Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2076, Early Detection to Stop Infant Abuse and Prevent Fatalities Act Reauthorization of Child Abuse Prevention and Treatment Act

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