Right Rebate Act of 2018

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.

Client expense: $1,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act

Access to Contraception for Women Servicemembers and Dependents Act (H.R. 2180) Health Equity and Accountability Act of 2018 (H.R. 5942/S. 3660) A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury, Secretary of Labor, and Secretary of Health and Human Services relating to "Short-Term, Limited Duration Insurance". (S.J. Res 63) 21st Century Women's Act (Not Yet Introduced) ENROLL Act (H.R. 7102) Preventing Maternal Deaths Act of 2017 (H.R. 1318) Maternal Health Accountability Act (S. 1112) Right Rebate Act of 2018 (S. 3702) IMPROVE Act (H.R. 7217) Improving Access to Maternity Care Act (H.R. 315) Excellence in Mental Health and Addiction Treatment Expansion Act (S. 1905)

Client expense: $57,905 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

Monitor and advocate on legislative and regulatory issues regarding healthcare. Legislative monitoring and outreach related to the H.R. 6, SUPPORT for Patients and Communities Act (P.L. 115-271). H.R. 6071, SERV Communities Act. H.R. 6082, Overdose Prevention and Patient Safety Act. Legislative monitoring and outreach related to the H.R. 6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L. 115-245). H.R. 6733, Know the Cost Act of 2018. H.R. 7052, No Federal Funds for Public Charge Act of 2018. H.R. 7217, IMPROVE Act. S. 2553, Know the Lowest Price Act of 2018. S. 2554, Patient Right to Know Drug Prices Act. S. 2680, Opioid Crisis Response Act of 2018. S. 3120, HEAL Act of 2018. S. 3702, Right Rebate Act of 2018.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES

S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act