Prescription Drug Monitoring Act of 2019

Air Traffic Control retirement. Air traffic control technology and modernization: Including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform.Impact of governmental shutdown.: On FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Fund Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Stabilization of Airport and Airway Trust Fund (AATF). Personal Protective Equipment (PPE). Pay Differential for Duty Related to the Coronavirus.H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. National Aviation Preparedness Plan. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. Mandatory Retirement of Federal Employees including air traffic controllers. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. H.R. 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S. 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers: Provisions relating to support for airline industry workforce during COVID-19 pandemic. Aviation Funding Stability Act of 2021: Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 3684, INVEST in America Act: Provisions relating to funding for aging air traffic control facilities. FAA's proposed reorganization.

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

Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Funding Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. Funding for Maintenance of Aging Air Traffic Control Facilities. Stabilization of Airport and Airway Trust Fund (AATF): Provisions relating to ensuring the safest possible working conditions for air traffic controllers and other essential aviation safety professionals. Personal Protective Equipment (PPE) for air traffic controllers. Pay Differential for Duty Related to the Coronavirus. Legislation establishing COVID-19 as a presumptive occupational illness to be covered under the Federal Employees Compensation Act. H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. Annuity Protection. National Aviation Preparedness Plan. COVID-19 vaccine prioritization for aviation safety professionals. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. HR 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers. Aviation Funding Stability Act of 2021: Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 3684, INVEST in America Act: Provisions relating to funding for aging air traffic control facilities.

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Fund Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Stabilization of Airport and Airway Trust Fund (AATF). Personal Protective Equipment (PPE). Pay Differential for Duty Related to the Coronavirus.H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021.: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. National Aviation Preparedness Plan. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. Mandatory Retirement of Federal Employees including air traffic controllers. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. H.R. 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S. 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers: Provisions relating to support for airline industry workforce during COVID-19 pandemic. Aviation Funding Stability Act of 2021: Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 3684, INVEST in America Act: Provisions relating to funding for aging air traffic control facilities. FAA's proposed reorganization.

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Funding Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. Funding for Maintenance of Aging Air Traffic Control Facilities. Stabilization of Airport and Airway Trust Fund (AATF): Provisions relating to ensuring the safest possible working conditions for air traffic controllers and other essential aviation safety professionals. Personal Protective Equipment (PPE) for air traffic controllers. Pay Differential for Duty Related to the Coronavirus. Legislation establishing COVID-19 as a presumptive occupational illness to be covered under the Federal Employees Compensation Act. H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. Annuity Protection. National Aviation Preparedness Plan. COVID-19 vaccine prioritization for aviation safety professionals. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. HR 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers. Aviation Funding Stability Act of 2021: Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 3684, INVEST in America Act: Provisions relating to funding for aging air traffic control facilities.

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Fund Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Stabilization of Airport and Airway Trust Fund (AATF). Personal Protective Equipment (PPE). Pay Differential for Duty Related to the Coronavirus.H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021.: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. National Aviation Preparedness Plan. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. Mandatory Retirement of Federal Employees including air traffic controllers. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. H.R. 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S. 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers: Provisions relating to support for airline industry workforce during COVID-19 pandemic. Aviation Funding Stability Act of 2021: Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 3684, INVEST in America Act: Provisions relating to funding for aging air traffic control facilities.

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Funding Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. Funding for Maintenance of Aging Air Traffic Control Facilities. Stabilization of Airport and Airway Trust Fund (AATF): Provisions relating to ensuring the safest possible working conditions for air traffic controllers and other essential aviation safety professionals. Personal Protective Equipment (PPE) for air traffic controllers. Pay Differential for Duty Related to the Coronavirus. Legislation establishing COVID-19 as a presumptive occupational illness to be covered under the Federal Employees Compensation Act. H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. Annuity Protection. National Aviation Preparedness Plan. COVID-19 vaccine prioritization for aviation safety professionals. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. HR 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers.

Air Traffic Control retirement. Air traffic control technology and modernization including NextGen. Air traffic control safety and efficiency. Air traffic control capacity and delays. Air traffic controller staffing, hiring, and training. Certification reform. Impact of governmental shutdown on FAA workforce and the national airspace system. FAA Reauthorization. FAA funding. FAA Air Traffic Controller Workforce Plan. Veterans Preference for Controller Hiring. TSA airport security. FAA employees stationed in Guam - accessibility to DOD base privileges. Remote towers. Air traffic controller fatigue. ATC facility consolidation process section 804. Air Traffic Controller Federal Employees Retirement System Supplemental Retirement. Aviation Fund Stability Act of 2019 (H.R. 1108; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Aviation Funding Stability Act of 2019 (S. 762; 116th Congress): Provisions relating to stable funding for FAA activities in the event of a government shutdown. Stabilization of Airport and Airway Trust Fund (AATF). Personal Protective Equipment (PPE). Pay Differential for Duty Related to the Coronavirus.H.R.2 - INVEST in America Act (H.R. 2; 116th Congress): Provisions relating to funding for aging air traffic control facilities. H.R. 1283 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021.: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. S. 419 Continuity for Operators with Necessary Training Required for ATC Contract Towers Act of 2021: Provisions relating to eliminating hiring barriers for Contract air traffic control towers. National Aviation Preparedness Plan. Airport and Airway Trust Fund technical correction (PL 116-159): Provisions relating to funding for the Airport and Airway Trust and continued government funding. Mandatory Retirement of Federal Employees including air traffic controllers. American Jobs Plan, President's infrastructure proposal: Provisions relating to FAA assets. H.R. 1262 Notice to Airmen Improvement Act: Amendment to clarify labor representative for air traffic controllers. H.R. 1339 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. S. 516 Advanced Air Mobility Act: Amendment to clarify labor representative for air traffic controllers. FY 2022 THUD Appropriations: Provisions relating to funding the FAA operations, facilities and maintenance, and modernization of the National Airspace System. S. Res. 96 Women in Aviation Workforce Week: Provisions relating to supporting women in the aviation industry, specifically the air traffic controller workforce. Payroll support program for aviation workers: Provisions relating to support for airline industry workforce during COVID-19 pandemic.

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,650,000 · Firm income: Not reported

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,710,000 · Firm income: Not reported

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334; H.R. 4810, the Opioid Prescription Verification Act of 2019; S. 3070, the Preventing Pill Mills Through Data Sharing Act; HR 3878, the Block, Report, and Suspend Suspicious Shipments Act of 2019; HR 4812, the Ensuring Compliance Against Drug Diversion Act; HR 4814, the Suspicious Order Identification Act of 2019

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,200,000 · Firm income: Not reported

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,570,000 · Firm income: Not reported

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334; H.R. 4810, the Opioid Prescription Verification Act of 2019; S. 3070, the Preventing Pill Mills Through Data Sharing Act; HR 3878, the Block, Report, and Suspend Suspicious Shipments Act of 2019; HR 4812, the Ensuring Compliance Against Drug Diversion Act; HR 4814, the Suspicious Order Identification Act of 2019

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $2,090,000 · Firm income: Not reported

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334; H.R. 4810, the Opioid Prescription Verification Act of 2019; S. 3070, the Preventing Pill Mills Through Data Sharing Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,600,000 · Firm income: Not reported

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Reserve System, HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334; H.R. 4810, the Opioid Prescription Verification Act of 2019; S. 3070, the Preventing Pill Mills Through Data Sharing Act

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

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.

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,320,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Reserve System, HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334; H.R. 4810, the Opioid Prescription Verification Act of 2019; S. 3070, the Preventing Pill Mills Through Data Sharing Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

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.

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.

S. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,350,000 · Firm income: Not reported

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

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. 516 Prescription Drug Monitoring Programs H.R. 2038 Prescription Drug Negotiations S. 977 Prescription Drug Costs

Client expense: $1,840,000 · Firm income: Not reported

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S. 516 Prescription Drug Monitoring Programs

Client expense: $1,540,000 · 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 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.

H.R. 127, CARERS Act of 2019; H.R. 171, the Legitimate Use of Medical Marihuana Act; H.R. 1845, ALERT Act of 2019; S. 516, Prescription Drug Monitoring Act of 2019; H.R. 1588, Ending Federal Marijuana Prohibition Act of 2019; Implementation of pharmacy provisions of Public Law No: 115-271; Implementation of Hemp provisions of Public Law No: 115-334

Client expense: $380,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S. 516 - Prescription Drug Monitoring Act of 2019 - We are monitoring this bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE