Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Changes to the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

Client expense: $6,030,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.771: Improving Access to Affordable Prescription Drugs ---General Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018

Client expense: $2,500,000 · Firm income: Not reported

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 1909, BENES Act (Casey) - notifications of Medicare eligibility S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2051, Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 3702, Right Rebate Act (Wyden-Grassley) - Medicaid drug rebate program Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 695, Continuing Appropriations Act (Schiff) - Money Follows the Person demonstration, spousal impoverishment protections H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2575, BENES Act (Ruiz) - notifications of Medicare eligibility H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person demonstration H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology H.R. 7122, Shared Accountability for Improved Patient Outcomes Act (Paulsen) - value-based payment and delivery arrangements H.R. 7217, IMPROVE Act (Barton) - Money Follows the Person demonstration, ACE Kids Act, Medicare drug rebate program, spousal impoverishment protections H.R. 7223, Right Rebate Act (Schrader-Welch) - Medicaid drug rebate program H.R. 7247, Incentivizing Shared Risk in Medicare Advantage Act (Brady) - MA prior authorization H.R. 7249, Better Prior Authorization Notification Act (Reed) - MA prior authorization H.R. 7250, Prior Authorization Improvement Act (Kelly) - MA prior authorization 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 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; 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; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act S. 2908: Legislation to improve electronic prior authorization use in Medicare Advantage S. 2051/H.R. 4206: Medicare Care Coordination Improvement Act H.R. 4841: Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Qualified clinical data registries (QCDR) measure licensing; Step Therapy in Medicare Advantage; CMS proposed rule altering Evaluation and Management billing codes; appropriate use criteria for imaging services; CDC Neurological Conditions Surveillance System funding; Medicare coverage of oxygen therapy for cluster headaches.

Client expense: Not reported · Firm income: $140,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3635: Local Coverage Deteremination Clarification Act of 2018 H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare Part D Doughnut Hole Medicare Part D Cliff S 974/HR 2212 - CREATES Act340B Drug Pricing Program Medicare Part D Six Protected Classes

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018

Client expense: $2,480,000 · Firm income: Not reported

S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act S. 2908: Legislation to improve electronic prior authorization use in Medicare Advantage S. 2051/H.R. 4206: Medicare Care Coordination Improvement Act H.R. 4841: Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Step Therapy in Medicare Advantage; CMS proposed rule altering Evaluation and Management billing codes; appropriate use criteria for imaging services; Medicare coverage of oxygen therapy for cluster headaches.

Client expense: Not reported · Firm income: $250,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 3635: Local Coverage Determination Clarification Act of 2018 H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program Draft Bills: Prior Authorization in Medicare Advantage (House Ways and Means Committee) - prior authorization notifications, report to Congress S. 2051: Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act of 2017 (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person Act H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology 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 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 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; 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' 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; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation. *Add MACPAC to Agency List.

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues Draft Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 195, Extension of Continuing Appropriations Act - CHIP funding extension for 2018-2023 and related provisions H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1892, Bipartisan Budget Act (Larson) - permanent authorization of Medicare Advantage Special Needs Plans; MA chronic care reforms: telehealth, supplemental benefits, value-based insurance design, star ratings; changes to Medicare Part D coverage gap and related discounts; CHIP funding extension for 2024-2027; funding for Puerto Ricos Medicaid program H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues 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 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 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; 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' 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; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6142/S. 2042: Reducing Drug Waste Act

Client expense: $2,520,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) Biosimilars ---Access to Samples for Testing ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---S. 974/H.R. 2212: CREATES Act of 2017 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6142/S. 2042: Reducing Drug Waste Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues Draft Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 195, Extension of Continuing Appropriations Act - CHIP funding extension for 2018-2023 and related provisions H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1892, Bipartisan Budget Act (Larson) - permanent authorization of Medicare Advantage Special Needs Plans; MA chronic care reforms: telehealth, supplemental benefits, value-based insurance design, star ratings; changes to Medicare Part D coverage gap and related discounts; CHIP funding extension for 2024-2027; funding for Puerto Ricos Medicaid program H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues 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 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 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; 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' 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; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

H.R.1546 - Rural Wireless Access Act of 2017; H.R.1581 - Tribal Digital Access Act of 2017; H.R.1625 - Consolidated Appropriations Act of 2018 (rural broadband provisions); H.R.1865 - Allow States and Victims to Fight Online Sex Trafficking Act of 2017; H.R.2479 - Leading Infrastructure for Tomorrows America Act (especially access to broadband Internet); H.R.2520 - Balancing the Rights of Web Surfers Equally and Responsibly Act of 2017; H.R.2903 - Rural H.R.3787 - Small Entity Regulatory Relief Act; H.R.3994 - ACCESS BROADBAND Act; H.R.4287 - Broadband Infrastructure Finance and Renovation Act of 2017; H.R.4795 - Communications Facility Deployment Act; H.R.4802 - Streamlining and Expediting Approval for Communications Technologies Act; H.R.4986 - FCC Reauthorization Act/the RAY BAUM Act; S.19 - MOBILE NOW Act (to facilitate installation of broadband infrastructure, including wireless); S.1363/H.R.4847 - Broadband Deployment Streamlining Act; S.1682 - AIRWAVES Act (Spectrum Pipeline Legislation); S.1688 - SPEED Act (to streamline broadband infrastructure permitting on established public rights-of-way, and for other purposes); S.1693 - Stop Enabling Sex Traffickers Act of 2017; S.2234 - IOT Consumer TIPS Act of 2017; S. 2418/H.R.2903 - Rural Reasonable and Comparable Wireless Access Act of 2018 (requiring the FCC to monitor Broadband speeds in rural areas to ensure that there is parity with speeds in urban areas); S.2510/H.R.4682 - Open Internet Preservation Act; S.2520 - Inmate Calling Technical Corrections Act of 2018; and S.JRes.52/H.J.Res129 - Providing for Congressional disapproval under chapter 8 of Title 5, U.S.Code, of the rule submitted by the FCC relating to Restoring Internet Freedom. General Lobbying on the following issues: Net Neutrality & Open Internet; privacy legislation; cybersecurity; 5G wireless infrastructure; FCC reauthorization; smart cities/communities; FirstNET & Public Safety Communications; spectrum interference; access to public lands/national parks for cell site placement; ATVA(American Television Association)/Advanced Systems Television Committee (ATSC) 3.0 (Next Generation TV Standard); rural broadband deployment, policy and infrastructure; small cell deployment; NTIA oversight; diversity in technology; STEM education and Digital Divide; data breach and security notification reform; NEPA/NHPA updates (pending legislation); and siting reform.

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations for FY 2018

Client expense: $2,370,000 · Firm income: Not reported

340B Drug Discount Program ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples for Testing ---Columbia Biologics Regulation ---Coding ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---H.R. 2871: Preserving Patient Access to Compound Medications Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 International Biosecurity Policies Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Orphan Drug Issues ---Technical Amendments ---Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors Access to Medicare Act - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: CHAMPIONING HEALTHY KIDS Act - CHIP and CHC reauthorization H.J.Res. 51: Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Patient Advisory Board (IPAB) S. 260: Protecting Seniors Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program S.J.Res. 16: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S.J.Res. 17: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors Access to Medicare Act - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: CHAMPIONING HEALTHY KIDS Act - CHIP and CHC reauthorization H.J.Res. 51: Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Patient Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program S.J.Res. 16: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S.J.Res. 17: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration Draft Medicare Extenders Bill (Senate Finance Committee) - continuation of expiring Medicare provisions H.R. 195, Extension of Continuing Appropriations Act - CHIP funding extension for 2018-2023 and related provisions H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1892, Bipartisan Budget Act (Larson) - permanent authorization of Medicare Advantage Special Needs Plans; MA chronic care reforms: telehealth, supplemental benefits, value-based insurance design, star ratings; changes to Medicare Part D coverage gap and related discounts; CHIP funding extension for 2024-2027; funding for Puerto Ricos Medicaid program H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding Medicare Extenders Package (House Ways and Means Committee) - reauthorization of Special Needs Plans, telehealth, CMS authority to terminate MA contracts 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 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); proposed calendar year 2019 policy and technical regulation for MA and Part D; 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' 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; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

HR 1316 To amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes. HR 1038, S 413 Improving Transparency and Accuracy in Medicare Part D Spending Act HR 1939 To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes. HR 592, S 109 To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services. S 1688 Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 S 1899 Community Health Investment, Modernization, and Excellence Act of 2017

Client expense: $34,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 771/HR 1776-Improving access to affordable Prescription Drugs act, S 2157-Drug Price transparency in Communications Act, S 2011/HR 4138-Medicare drug price negotiation act of 2017, S 1688-Empowering medicare seniors to negotiate drug prices of 2017, S 252-Medicare drug savings act of 2017, S 1369/HR 2974-Stop Price gouging act, S 124-Preserve access to affordable generics act, S 974/HR 2212-CREATES Act of 2017, S 495-Medical Innovation and Prize Fund Act, S 1131/HR 2439-FAIR drug pricing act, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2018, HR 4117-Competitive DRUGS Act of 2017), HR 2051- FAST Generics Act of 2017), Prescription drug pricing, PACED Act, S 771/HR 1776 (Improving access to affordable prescription drugs act, S 1509/HR 1223 OPEN Act), S 1309-Stronger patents act, HR 5150 Protecting Medicare from excessive price increases act, S 2476-Expanding access to low cost generics act, S 637 (c-thru act), S 1348-SPIKE act,

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

Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

H.R.1546 - Rural Wireless Access Act of 2017; H.R.1581 - Tribal Digital Access Act of 2017; H.R.2331 - Connected Government Act; H.R.1865 - Allow States and Victims to Fight Online Sex Trafficking Act of 2017; H.R.2479 - Leading Infrastructure for Tomorrows America Act (especially access to broadband Internet); H.R.2520 - Balancing the Rights of Web Surfers Equally and Responsibly Act of 2017; H.R.3787 - Small Entity Regulatory Relief Act; H.R.3994 - ACCESS BROADBAND Act; H.R.3995 - Improving Broadband Access for Veterans Act of 2017; H.R.4287 - Broadband Infrastructure Finance and Renovation Act of 2017; S.19 - MOBILE NOW Act (to facilitate installation of broadband infrastructure, including wireless); S.1682 - AIRWAVES Act; S.1688 - SPEED Act (to streamline broadband infrastructure permitting on established public rights-of-way, and for other purposes); and S.1693 - Stop Enabling Sex Traffickers Act of 2017. General Lobbying on the following issues: Net Neutrality & Open Internet; Title II Broadband regulation and Net Neutrality; wireless broadband infrastructure, siting and conduit development; privacy/cybersecurity; spectrum pipeline; 5G development and testing; Internet of Things (IoT); FCC reauthorization; smart cities/communities; FirstNet & Public Safety Communications; data breach/data security; California wild fires; access to public lands and national parks for cell site placement; ATVA/ATSC 3.0 (American Television Association); UNIVISION/VERIZON retransmission issue; rural broadband deployment and infrastructure; and spectrum interference.

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

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: Championing Healthy Kids Act - CHIP and CHC reauthorization H.R.394 Restoring Access to Medication Act of 2017 H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal HR 3922 - Community Health and Medical Professionals Improve Our Nation Act of 2017-Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4192-P) HR 4392-Repeal of Medicare HOPPS Rule-340B

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act

Client expense: $2,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: Championing Healthy Kids Act - CHIP and CHC reauthorization H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4192-P)

Better Care Reconciliation Act (Enzi) - ACA repeal and replace issues; Medicaid provisions S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 870, CHRONIC Care Act (Hatch-Wyden) - chronic care reforms, Medicare Advantage and Part D provisions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration Draft Medicare Extenders Bill (Senate Finance Committee) - continuation of expiring Medicare provisions H.R. 352, State Health Flexibility Act (Rokita) - Medicaid block grants H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1370, Continuing Resolution (Frelinghuysen) - 6-month CHIP funding extension, community health center funding, paygo exemption to prevent sequestration cuts H.R. 1628, American Health Care Act (Black) - ACA repeal and replace issues; Medicaid provisions H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding H.J.Res. 123, Continuing Resolution (Frelinghuysen) - redistribution of unused CHIP allotments H.J.Res. 124, Continuing Resolution (Frelinghuysen) -extension of federal CHIP funding Medicare Extenders Package (House Ways and Means Committee) - reauthorization of Special Needs Plans, telehealth, CMS authority to terminate MA contracts 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 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); proposed calendar year 2019 policy and technical regulation for MA and Part D; 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) 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' 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; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

S.2011 and S. 1688 and any other legislation pertaining to removal of the noninterference clause in Medicare Part D. HR 1898 - legislation to amend the Social Security Act to improve access to and utilization of bone mass measurement.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1316 To amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes. HR 1038, S 413 Improving Transparency and Accuracy in Medicare Part D Spending Act HR 1939 To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes. HR 592, S 109 To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services. S 1688 Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 S 1899 Community Health Investment, Modernization, and Excellence Act of 2017 S 1827 KIDS Act of 2017

Client expense: $34,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. __: Stark Law Modernization Act of 2017 - Provisions related to Stark and Anti-Kickback policy issues H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Proposed Rule; Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CMS-1678-P) (July 13, 2017) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018

340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety

Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications

Client expense: $2,380,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office

Better Care Reconciliation Act (Enzi) - ACA repeal and replace issues; Medicaid provisions S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 870, CHRONIC Care Act (Hatch-Wyden) - chronic care reforms, Medicare Advantage and Part D provisions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 352, State Health Flexibility Act (Rokita) - Medicaid block grants H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1628, American Health Care Act (Black) - ACA repeal and replace issues; Medicaid provisions H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding 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 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); 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) 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' 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; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. __: Stark Law Modernization Act of 2017 - Provisions related to Stark and Anti-Kickback policy issues H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Proposed Rule; Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CMS-1678-P) (July 13, 2017) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018

HR 1316 To amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes. HR 1038, S 413 Improving Transparency and Accuracy in Medicare Part D Spending Act HR 1939 To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes. HR 592, S 109 To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services. S 1688 Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 S 1899 Community Health Investment, Modernization, and Excellence Act of 2017 S 1827 KIDS Act of 2017

Client expense: $34,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H. Con. Res. 71 Fiscal Year 2018 Budget Resolution H. Res. 142/S. Res. 63 National Obesity Care Week Resolution S. J. Res. 16 a joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the independent payment Medicare advisory board H.J. Res 51/S. J. Res 17 Independent Payment Advisory Board Repeal H.R 1995 Value Based Insurance Design for Better Care Act H.R. 1004 Regulatory Integrity Act H.R. 1009/S. 676 OIRA Insight, Reform, and Accountability Act H.R. 1038/S. 413 Improving Transparency and Accuracy in Medicare Part D Spending H.R. 1072/S. 222 Obamacare Replacement Act H.R. 1101 Small Business Health Fairness Act H.R. 1121 Pre-Existing Conditions Protection Act H.R. 1148/S. 431 Furthering Access to Stroke Telemedicine (FAST) Act H.R. 1215 Protecting Access to Care Act H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1267/S. 482 Personal Health Investment Today Act H.R. 1304 Self-Insurance Protection Act H.R. 1313 Preserving Employee Wellness Programs Act H.R. 1554/S. 581 Jessie's Law H.R. 1565 Saving Lives, Saving Costs Act H.R. 1617 Promoting Access to Diabetic Shoes Act H.R. 1628 American Health Care Act H.R. 1703 Medical Product Communications Act H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act H.R. 184 Protect Medical Innovation Act H.R. 1953/S. 830 Treat and Reduce Obesity Act H.R. 2192/S. 1569 to eliminate the non-application of certain state waiver provisions to members of Congress and Congressional staff H.R. 2212/S. 974 Creating and Restoring Equal Access to Equivalent Samples Act H.R. 2267/S. 1301 Resident Physician Shortage Reduction Act H.R. 2372 Veterans Equal Treatment Ensures Relief and Access Now Act H.R. 246/S. 183 Jobs and Premium Protection Act H.R. 2550 Medicare Telehealth Parity Act H.R. 2556/S. 1016 CONNECT for Health Act H.R. 2579 Broader Options for Americans Act H.R. 2581 Verify First Act H.R. 2797/S. 1334 Patient Choice and Quality Care Act H.R. 2824 Increasing Opportunity and Success for Children and Parents Through Evidence -Based Home Visiting Act H.R. 284/S. 1291 Advancing Medical Resident Training in Community Hospitals Act H.R. 2953 Preventive Health Savings Act H.R. 3044 to expand supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees H.R. 3059/S. 1441 Community Health Center and Primary Care Workforce Expansion Act H.R. 309/S. 920 National Clinical Care Commission Act H.R. 3120 to reduce the volume of future electronic health record-related significant hardship requests H.R. 3124/S. 1299 Preventing Diabetes in Medicare Act H.R. 3168 to provide continued access to Medicare Advantage plans for special needs H.R. 3224 Critical Access and Rural Equity Act H.R. 3245 Medicare Civil and Criminal Penalties Act H.R. 3263 to extend the Medicare independence at home medical demonstration program H.R. 3271/S. 1914 Protecting Access to Diabetes Supplies Act H.R. 3358/S. 1771 Fiscal Year 2018 Labor-Health and Human Services-Education Appropriations Bill H.R. 3394 Teaching Health Centers Graduate Medical Education Extension Act H.R. 3447 Furthering Access to Coordinated Treatment for Seniors Act H.R. 3536/S.1681 to require persons who undertake federally funded research and development of drugs to enter into reasonable pricing agreements H.R. 372 Competitive Health Insurance Reform Act H.R. 3726 Stark Administrative Simplification Act of 2017 H.R. 3728 Empowering Medical Professionals and Optimizing Workforce Efficiency and Readiness Act H.R. 3820/S. 977 Medicare Home Health Flexibility Act H.R. 3862 National Health Service Corps Strengthening Act H.R. 3921 Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act H.R. 4006 Community-Based Independence for Seniors Act of 2017 H.R. 592/S. 109 Pharmacy and Medically Underserved Areas Enhancement Act H.R. 706 Plan Verification and Fairness Act H.R. 741/S. 243 Rural Hospital Regulatory Relief Act H.R. 749 Lower Drug Costs Through Competition Act H.R. 766 Amend Title XVII of the Social Security Act to expand telehealth in Medicare H.R. 849/S. 260 Protecting Seniors' Access to Medicare Act H.R. 908 Medicare Advantage Quality Payment Relief Act H.R. 998 Searching for and Cutting Regulations that are Unnecessarily Burdensome(SCRUB) Act H.R.3545 Overdose Prevention and Patient Safety Act H.R.3727 To amend title XVIII of the Social Security Act to include additional telehealth services for purposes of MA organization bids, and for other purposes Introduction of the Stark Law Modernization Act of 2017 Pub L. 114-198 Comprehensive Addiction and Recovery Act Pub L. 115-31 Fiscal Year 2017 Consolidated Appropriations Act Pub. L. 102-143 Telephone Consumer Protection Act Pub. L. 111-148 Patient Protection and Affordable Care Act (PPACA) Pub. L. 111-5 The American Recovery and Reinvestment Act Pub. L. 114-10 Medicare Access and CHIP Reauthorization Act (MACRA) Pub. L. 114-255, 21st Century Cures Act Pub. L. 114-270 Expanding Capacity for Health Outcomes Act (ECHO) Pub. L. 114-329 American Innovation and Competitiveness Act Pub L. 115-63 Disaster Relief & Airway Extension Act S. 108 Medical Device Access and Innovation Protection Act S. 297 Increasing Competition in Pharmaceuticals Act S. 1688 Empowering Medicare Seniors to Negotiate Drug Prices Act S. 1754 Training the Next Generation of Primary Care Doctors Act S. 1804 Medicare for All Act S. 1827 Keep Kids' Insurance Dependable and Secure Act S. 1829 Strong Families Act S. 1850 Protecting Jessica Grubbs Legacy Act, (The Legacy Act) S. 1859 Healthcare Tax Relief Act S. 1899 to reauthorize and extend funding for community health centers and the National Health Service Corps S. 191 Patient Freedom Act S. 251 Protecting Medicare from Executive Action Act S. 309 Community Based Independence for Seniors Act S. 464 Independence at Home Act S. 64 Safe and Affordable Drugs from Canada Act H .R. 1933/S. 761 Health Care Options Act of 2017 S. 787 Telehealth Innovation and Improvement Act S. 870 Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act S. Con. Res. 3 Budget Resolution

S. J. Res. 16 a joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the independent payment Medicare advisory board H.J. Res 51/S. J. Res 17 Independent Payment Advisory Board Repeal H.R. 1038Improving Transparency and Accuracy in Medicare Part D Spending S. 413 Improving Transparency and Accuracy in Medicare Part D Spending H.R. 1148 Furthering Access to Stroke Telemedicine (FAST) Act S. 431 Furthering Access to Stroke Telemedicine (FAST) Act H.R. 2550 Medicare Telehealth Parity Act H.R. 2556 CONNECT for Health Act S. 1016 CONNECT for Health Act H.R. 3044 to expand supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees H.R. 3124 Preventing Diabetes in Medicare Act S. 1299 Preventing Diabetes in Medicare Act H.R. 3168 to provide continued access to Medicare Advantage plans for special needs H.R. 3245 Medicare Civil and Criminal Penalties Act H.R. 3263 to extend the Medicare independence at home medical demonstration program H.R. 3447 Furthering Access to Coordinated Treatment for Seniors Act H.R. 3726 Stark Administrative Simplification Act of 2017 H.R. 3820 Medicare Home Health Flexibility Act S. 977 Medicare Home Health Flexibility Act H.R. 4006 Community-Based Independence for Seniors Act of 2017 H.R. 766 Amend Title XVII of the Social Security Act to expand telehealth in Medicare H.R. 849 Protecting Seniors' Access to Medicare Act S. 260 Protecting Seniors' Access to Medicare Act H.R. 908 Medicare Advantage Quality Payment Relief Act H.R.3727 To amend title XVIII of the Social Security Act to include additional telehealth services for purposes of MA organization bids, and for other purposes Introduction of the Stark Law Modernization Act of 2017 S. 1688 Empowering Medicare Seniors to Negotiate Drug Prices Act S. 251 Protecting Medicare from Executive Action Act S. 309 Community Based Independence for Seniors Act S. 464 Independence at Home Act S. 787 Telehealth Innovation and Improvement Act S. 870 Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act