Value-Based Insurance Design Seniors Copayment Reduction Act of 2015

H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 546, ACE Kids Act (Barton) - Medicaid Childrens Care Coordination Program H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.R. 5273, Helping Hospitals Improve Patient Care Act (Tiberi) - MA issues, site-neutral payments H.R. 5506, Dialysis PATIENT Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 5659, ESRD Choice Act (Smith) - option for ESRD patients to enroll in MA plans H.R. 5942, Dialysis PATIENTS Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 6265, Medigap Reforms (McDermott) S. 298, ACE Kids Act (Grassley) - Medicaid Childrens Care Coordination Program S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services S. 2864, RxCAP Act (Wyden) - Medicare Part D cost-sharing S. 3090, Dialysis PATIENT Demonstration Act (Heller) - demonstration program for Medicare beneficiaries with ESRD 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' proposed substantial revisions to the managed care regulations, new 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.

H.R. 546, ACE Kids Act (Barton) - Medicaid Childrens Care Coordination Program H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.R. 5273, Helping Hospitals Improve Patient Care Act (Tiberi) - MA issues, site-neutral payments H.R. 5506, Dialysis PATIENT Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD Draft Bill on Option for ESRD Patients to Enroll in MA Plans (Ways and Means Committee) H.Con.Res. 125, Budget Resolution (Price) - Medicare, Medicaid issues S. 298, ACE Kids Act (Grassley) - Medicaid Childrens Care Coordination Program S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services S. 2864, RxCAP Act (Wyden) - Medicare Part D cost-sharing S. 3090, Dialysis PATIENT Demonstration Act (Heller) - demonstration program for Medicare beneficiaries with ESRD 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' proposed substantial revisions to the managed care regulations, new 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; 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.

H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;

Client expense: $2,600,000 · Firm income: Not reported

H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;

Client expense: $26,000,000 · Firm income: Not reported

H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; Expanded Access to (draft legislation);

Client expense: $1,700,000 · Firm income: Not reported

Independence at Home Act of 2016 (S. 3130), Value-based Insurance Design Seniors Copayment Reduction Act of 2015 (S.1396), Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 205 (H.R. 2570) (Value-Based Insurance Design in Medicare Advantage), oral health

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.Con.Res. 125, Budget Resolution (Price) - Medicare, Medicaid issues S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, 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, 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, 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 the Capitated Financial Alignment Demonstration; Medicaid managed care regulations and policies, including CMS' proposed substantial revisions to the managed care regulations, new 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 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; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;

Client expense: $2,570,000 · Firm income: Not reported

H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;

Client expense: $2,630,000 · Firm income: Not reported

Medicare Independence at Home program, Value-Based Insurance Design Demonstration (S. 1396, H.R.2570), Oral health

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

H.R. 6, 21st Century Cures Act (Upton) - timing of certain Medicare Part D payments H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - rulemaking schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, 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, 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, SSA and CMS premium withhold processing issues, enrollment rules, 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 Special Needs Plans (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); Medication Therapy Management Program requirements; 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; implementation issues for the Medicare Retiree Drug Subsidy program; 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; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including the Capitated Financial Alignment Demonstration; Medicaid managed care regulations and policies, including 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 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; 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. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. __, S. __: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to Hospital Outpatient Department (HOPD) reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 1314, Bipartisan Budget Act - Medicare Part B premium and deductible, Medicare sequestration cuts H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3696, Protecting Medicare Beneficiaries Act (Titus) - Medicare Part B premiums and deductibles H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3831, Securing Fairness in Regulatory Timing Act (Brady) - revised schedule for MA payment rates H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2148, Protecting Medicare Beneficiaries Act (Wyden) - Medicare Part B premiums and deductibles S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2351, Securing Fairness in Regulatory Timing Act (Isakson) - revised schedule for MA payment rates Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, 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, 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, SSA and CMS premium withhold processing issues, enrollment rules, 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 Special Needs Plans (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); Medication Therapy Management Program requirements; 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; implementation issues for the Medicare Retiree Drug Subsidy program; 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; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including the Capitated Financial Alignment Demonstration; Medicaid managed care regulations and policies, including 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 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; socioeconomic status impacts on star ratings related to MA and Part D programs; Center for Medicare and Medicaid Innovation demonstrations for MA and PDP plans; and other issues relating to health care reform implementation. *Add MACPAC to Agency List

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs

H.R. 6, 21st Century Cures Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015;

Client expense: $1,180,000 · Firm income: Not reported

Medicare Independence at Home Medical Practice Demonstration Improvement Act of 2015 (S.971, H.R.2196), Value-Based Insurance Design Demonstration (S. 1396, H.R.2570)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

H.R. 6, 21st Century Cures Act (Upton) - timing of certain Medicare Part D payments H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - rulemaking schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, 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, 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, SSA and CMS premium withhold processing issues, enrollment rules, 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 Special Needs Plans (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); Medication Therapy Management Program requirements; 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; implementation issues for the Medicare Retiree Drug Subsidy program; 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; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including the Capitated Financial Alignment Demonstration; Medicaid managed care regulations and policies, including 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 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; 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. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 3244: Providing Innovative Care for Complex Cases Demonstration Act of 2015 - Provisions relating to changes to the Part D benefit Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Final Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare Part D rebates issues Drug cost and pricing issues Medication adherence policy issues Alternative payment models policy issues

Medicare Independence at Home Medical Practice Demonstration Improvement Act of 2015 (S.971, H.R.2196), Value-Based Insurance Design Demonstration (S. 1396, H.R.2570)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

no specific bills - issues pertaining to Medicare/Medicaid reimbursement HR 2570 "The Strengthening Medicare Advantage through Innovation & Transparency for Seniors Act of 2015" - entire bill S. 1396 "Value-Based Insurance Design Seniors Copayment Reduction Act of 2015" - entire bill

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, 21st Century Cures Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 2031, TEST Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Proposals to improve viral hepatitis screening and testing; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; Implementation of The Prescription Drug User Fee Act (PDUFA); H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; Proposals to address chronic care coordination; Discussions on international health policy including World Health Organization resolutions;

Client expense: $930,000 · Firm income: Not reported

H.R. 2, Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform, CHIP funding, Medigap, Medicare Advantage Special Needs Plans, Medicare Cost Plans, fraud provisions, QI and TMA programs H.R. 6, 21st Century Cures Act (Upton) - timing of certain Medicare Part D payments H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 1892, Trade Adjustment Assistance Reauthorization Act (Reichert) - Medicare sequestration cuts H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - rulemaking schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.Con.Res. 27, Budget Resolution (Price) - Medicare, Medicaid, health policy issues S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1268, Trade Adjustment Assistance Reauthorization Act (Hatch) - Medicare sequestration cuts S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S.Con.Res. 11, Budget Resolution (Enzi) - Medicare, Medicaid, health policy issues Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, encounter data and other data-related issues, Recovery Audit Contractor (RAC) audits, Part D prescriber enrollment requirement, and provider directories 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, 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, SSA and CMS premium withhold processing issues, enrollment rules, 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 Special Needs Plans (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); ICD-10; Value-Based Insurance Design; Medication Therapy Management Program requirements; 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; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval and other operational issues; implementation issues for the Medicare Retiree Drug Subsidy program; 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; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including the Capitated Financial Alignment Demonstration; Medicaid managed care regulations and policies, including 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 Medigap coverage financing for infectious disease; and other issues relating to health care reform implementation. *Add MACPAC to Agency List

H.R. 6, 21st Century Cures Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 2031, TEST Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Proposals to improve viral hepatitis screening and testing; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; Implementation of The Prescription Drug User Fee Act (PDUFA); H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; Proposals to address chronic care coordination; Discussions on international health policy including World Health Organization resolutions;

Client expense: $970,000 · Firm income: Not reported

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues

no specific bills - issues pertaining to Medicare/Medicaid reimbursement HR 2570 "The Strengthening Medicare Advantage through Innovation & Transparency for Seniors Act of 2015" - entire bill S. 1396 "Value-Based Insurance Design Seniors Copayment Reduction Act of 2015" - entire bill

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

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Medicare Independence at Home Medical Practice Demonstration Improvement Act of 2015 (S.971, H.R.2196), Value-Based Insurance Design Demonstration (S. 1396, H.R.2570)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act (H.R. 6), Innovation for Healthier Americans, Medicare Advantage Value Based Insurance Design Demo (S. 1396, H.R. 2570), Independence at Home (S. 971, H.R. 2196)

Client expense: Not reported · Firm income: Not reported

21st Century Cures Act (H.R. 6), Innovation for Healthier Americans, Medicare Advantage Value Based Insurance Design Demo (S. 1396, H.R. 2570), Independence at Home (S. 971, H.R. 2196)

Client expense: Not reported · Firm income: Not reported