Ensuring Seniors Access to Local Pharmacies Act of 2019

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

Client expense: $2,340,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

-Design, coverage and affordability of pharmacy benefits in Exchanges and the commercial market, including: e-Prescribing (eRx), Electronic Prescribing for Controlled Substances (EPCS), electronic prior authorization, step therapy, Pharmacy Benefit Manager (PBM) disclosure, medical loss ratio (MLR), and specialty pharmacy tiering. Implementation of biosimilars pathway from the Biologics Price Competition and Innovation Act (BPCIA). -Risk Evaluation and Mitigation Strategies (REMS) reform. H.R. 965/S. 340, the CREATES Act of 2019. -Drug patent settlements. H.R. 1499, the Protecting Consumer Access to Generic Drugs Act of 2019; S.64, the Preserve Access to Affordable Generics and Biosimilars Act. -H.R. 2279, Safe Step Act (Step Therapy Bill). -Pharmacy issues related to S. 1895, the Lower Health Care Costs Act. -Issues related to S. 1384, the Prescription Drug Rebate Reform Act of 2019. -Issues related to H.R. 3, the Lower Drug Costs Now Act of 2019. -H.R. 4946, Ensuring Seniors Access to Local Pharmacies Act of 2019. -H.R. 5281, Drug Price Transparency in Medicaid Act of 2019. -H.R. 5304, PBM Transparency in Prescription Drug Costs Act. -Issues related to drug shortages, and pharmaceutical procurement processes.

Client expense: $1,890,000 · Firm income: Not reported

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, 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.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act