Medicare Prescription Drug Price Negotiation Act of 2013

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; Medicare payment proposals;

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H.R. 3261 & S. 1884, Medicare Prescription Drug Savings and Choice Act of 2015; Medicare payment proposals;

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2298, Medicare Patient Safety and Drug Abuse Prevention Act; H.R. 2914, Promoting Integrity in Medicare Act; H.R. 1190 & S. 141, Protecting Seniors' Access to Medicare Act of 2015; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; H.R. 3061 & S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act; H. R. 3742, Access to Marketplace Insurance Act; Medicare payment proposals;

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

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

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2298, Medicare Patient Safety and Drug Abuse Prevention Act; H.R. 2914, Promoting Integrity in Medicare Act; S. 141, Protecting Seniors' Access to Medicare Act of 2015 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act;

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; H.R. 2298, Medicare Patient Safety and Drug Abuse Prevention Act; H.R. 2914, Promoting Integrity in Medicare Act; S. 141, Protecting Seniors' Access to Medicare Act of 2015 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act; S. 31, Medicare Prescription Drug Price Negotiation Act of 2015; H.R. 1102 & S. 117, Medicare Prescription Drug Price Negotiation Act; H.R. 2005 & S. 1083, Medicare Drug Savings Act;

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks H.R. 5113, Protecting Seniors' Medicare Choices from Obamacare Act (Coffman) - MA stabilization program H.R. 5183, Value Based Insurance Design for Better Care Act (Black) - MA demonstration to test VBID methodologies H.R. 5364, CHIP Extension and Improvement Act (Pallone) - federal CHIP funding Draft Bill, Protecting the Integrity of Medicare Act (Brady) - preventing fraud in Medicare and Medicaid S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues S. 25 (Hatch) - extension of Medicare sequestration cuts S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud S. 2461, CHIP Extension Act (Rockefeller) --- federal CHIP funding S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks S. 2783, Value Based Insurance Design for Better Care Act (Thune) - MA demonstration to test VBID methodologies 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; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval and other operational issues; Medicare creditable drug coverage reporting requirements; 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 relating to "meaningful use" requirements for health information technology; and other issues relating to health care reform implementation.

Client expense: $2,010,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Treasury, Dept of, White House Office

Policies to enhance patient access to medicines in Medicare; Medicare payment proposals, S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013; S. 740 / H.R. 1588, Medicare Drug Savings Act of 2013; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013;

Client expense: $1,520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding and Reimbursement Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative PolicyChanges re: Medicare Part B and Average Sales Price Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program Implementation of American Taxpayer Relief Act of 2012 H.R. 413, to eliminate two-year delay including oral-only ESRD-related drugs in the Medicate ESRD prospective payment system S. 77, Prescription Drug and Health Improvement Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 800, to exclude prompt pay discounts from the average sales price for drugs and biologics under Medicare Part B H.R. 1416, Cancer Patient Protection Act of 2013 H.R. 4302, Protecting Access to Medicare Act of 2014 21st Century Cures Initiatives

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

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

Policies to enhance patient access to medicines in Medicare; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013; S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013;

Client expense: $1,010,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes H.R. 1024, Medication Therapy Management Empowerment Act (McMorris Rodgers) - medication therapy management programs H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks H.R. 5113, Protecting Seniors' Medicare Choices from Obamacare Act (Coffman) - MA stabilization program H.R. 5183, Value Based Insurance Design for Better Care Act (Black) - MA demonstration to test VBID methodologies H.R. 5364, CHIP Extension and Improvement Act (Pallone) - federal CHIP funding Draft Bill, Protecting the Integrity of Medicare Act (Brady) - preventing fraud in Medicare and Medicaid S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues S. 25 (Hatch) - extension of Medicare sequestration cuts S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud S. 2461, CHIP Extension Act (Rockefeller) --- federal CHIP funding S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks S. 2783, Value Based Insurance Design for Better Care Act (Thune) - MA demonstration to test VBID methodologies 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; 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 such as Ebola; and other issues relating to health care reform implementation. *AddMACPACtoAgencyList

Client expense: $2,230,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits. H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi). H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes. H.R. 1024, Medication Therapy Management Empowerment Act (McMorris Rodgers) - medication therapy management programs. H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care. H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations. H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs. H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse. H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules. H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives. H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives. H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review. H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period. H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions. H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay. H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule. H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders . H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans. H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks. H.R. 5113, Protecting Seniors' Medicare Choices from Obamacare Act (Coffman) - MA stabilization program. H.R. 5183, Value Based Insurance Design for Better Care Act (Black) - MA demonstration to test VBID methodologies. H.R. 5364, CHIP Extension and Improvement Act (Pallone) - federal CHIP funding. Draft Bill, Protecting the Integrity of Medicare Act (Brady) - preventing fraud in Medicare and Medicaid. S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues. S. 25 (Hatch) - extension of Medicare sequestration cuts. S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations. S. 324, Puerto Rico Medicare Part B Equity Act (Schumer). S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes. S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care. S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse. S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives. S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations. S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs. S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions. S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment. S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms. S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders. S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal. S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud. S. 2461, CHIP Extension Act (Rockefeller) --- federal CHIP funding. S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks. S. 2783, Value Based Insurance Design for Better Care Act (Thune) - MA demonstration to test VBID methodologies.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 83, Consolidated and Further Continuing Appropriations, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

Client expense: $2,180,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to Office of Inspector General (OIG) enforcement of fraud and abuse laws H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models H.R. 5780, Protecting Integrity in Medicare Act of 2014: Provisions related to addressing fraud and prescription drug abuse S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Hospital Improvements for Payment (HIP) Act of 2014: Provisions related to Medicare reform (no bill number) Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence

Client expense: $3,960,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues

Client expense: $580,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Medicare Part D issues. H.R. 928 Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to patent issues. Medicare Drug Savings Act: Part D Issues S. 117 Medicare Prescription Drug Price Negotiation Act of 2013. S. 351 Protecting Seniors Access to Medicare Act of 2013 S. 408 Medicare Prescription Drug Saving and Choice Act of 2013. 340B Drug Program Issues related to changes to the Medicare Part B reimbursement of perscription drugs; issues related to coverage and reimbursementfor those who are covered by the Medicaid program and the Medicare program, including the Part D prescription drug benefit; and general issues related to the Medicare Part D program.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare medicaid legislationH.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative PolicyChanges re: Medicare Part B and Average Sales Price Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program 340B Issues Implementation of American Taxpayer Relief Act of 2012 H.R. 413, to eliminate two-year delay including oral-only ESRD-related drugs in the Medicate ESRD prospective payment system S. 77, Prescription Drug and Health Improvement Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 800, to exclude prompt pay discounts from the average sales price for drugs and biologics under Medicare Part B H.R. 1516, Cancer Patient Protection Act of 2013 H.R. 4302, Protecting Access to Medicare Act of 2014 21st Century Cures Initiatives

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

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

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence Protecting Integrity in Medicare Act of 2014 (no bill number): Provisions related to addressing fraud, prescription drug abuse, and other issues Lock-in concepts generally

Client expense: $3,680,000 · Firm income: Not reported

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

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks H.R. 5113, Protecting Seniors' Medicare Choices from Obamacare Act (Coffman) - MA stabilization program H.R. 5183, Value Based Insurance Design for Better Care Act (Black) - MA demonstration to test VBID methodologies H.R. 5364, CHIP Extension and Improvement Act (Pallone) - federal CHIP funding Draft Bill, Protecting the Integrity of Medicare Act (Brady) - preventing fraud in Medicare and Medicaid S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues S. 25 (Hatch) - extension of Medicare sequestration cuts S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud S. 2461, CHIP Extension Act (Rockefeller) --- federal CHIP funding S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks S. 2783, Value Based Insurance Design for Better Care Act (Thune) - MA demonstration to test VBID methodologies 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; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval and other operational issues; Medicare creditable drug coverage reporting requirements; 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 relating to "meaningful use" requirements for health information technology; and other issues relating to health care reform implementation.

Client expense: $2,010,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Treasury, Dept of, White House Office

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

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

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits. H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi). H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes. H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care. H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations. H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs. H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse. H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules. H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives. H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives. H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review. H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period. H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions. H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay. H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule. H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders. H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans. H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks. H.R. 5113, Protecting Seniors' Medicare Choices from Obamacare Act (Coffman) - MA stabilization program. H.R. 5183, Value Based Insurance Design for Better Care Act (Black) - MA demonstration to test VBID methodologies. H.R. 5364, CHIP Extension and Improvement Act (Pallone) - federal CHIP funding. Draft Bill, Protecting the Integrity of Medicare Act (Brady) - preventing fraud in Medicare and Medicaid. S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues. S. 25 (Hatch) - extension of Medicare sequestration cuts. S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations. S. 324, Puerto Rico Medicare Part B Equity Act (Schumer). S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes. S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care. S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse. S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives. S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations. S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs. S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions. S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment. S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms. S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders. S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal. S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud. S. 2461, CHIP Extension Act (Rockefeller) --- federal CHIP funding. S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks. S. 2783, Value Based Insurance Design for Better Care Act (Thune) - MA demonstration to test VBID methodologies.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies to enhance patient access to medicines in Medicare; Medicare payment proposals, S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013; S. 740 / H.R. 1588, Medicare Drug Savings Act of 2013; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013;

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues

Client expense: $1,140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Medicare Part D issues. H.R. 928 Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to patent issues. Medicare Drug Savings Act: Part D Issues S. 117 Medicare Prescription Drug Price Negotiation Act of 2013. S. 351 Protecting Seniors Access to Medicare Act of 2013 S. 408 Medicare Prescription Drug Saving and Choice Act of 2013. 340B Drug Program Issues related to changes to the Medicare Part B reimbursement of perscription drugs; issues related to coverage and reimbursementfor those who are covered by the Medicaid program and the Medicare program, including the Part D prescription drug benefit; and general issues related to the Medicare Part D program.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage. S. 2552: provisions to establish necessary protections for seniors enrolled in Medicare Advantage plans. Medicare Protection Act. S. 2087, S. 2491: provisions protecting Medicare beneficiaries from changes that would reduce benefits or restrict eligibility. Medicare Benefit Redesign. (No bill.) Proposals to combine Part A and B deductibles along with a catastrophic cap on Medicare out-of-pocket spending to be paid for by increased out-of-pocket costs for Medicare beneficiaries. Medicare Drug Savings. S. 740, H.R. 1588: provisions to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by people eligible for both Medicare and Medicaid (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Equality. H.R. 5182: provisions to require recognition of same-sex marriage for the purposes of Medicare benefits eligibility. Medicare Fraud, Waste and Abuse. S. 2361: provisions to require the Centers for Medicare and Medicaid Services (CMS) to verify that health care providers wishing to participate in Medicare have not owned a company that previously defrauded the government, allow private insurers to share information about potentially fraudulent providers with Medicare and require new medical coding systems to be tested before they are deployed to ensure Medicares fraud prevention systems function properly. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Premium Support. H. Con. Res. 96: proposals to privatize Medicare. Medicare Income-Relating. H. Con. Res. 96: proposals to increase the cost of Medicare to higher-income beneficiaries. Medicare Eligibility Age. H. Con. Res. 96: proposals to increase the Medicare eligibility age. Medicare Part D Negotiation of Drug Prices. S. 117, S. 408, H.R. 1102, H.R. 928: proposals to create a Medicare-operated prescription drug plan, allowing or requiring the Secretary of the Department of Health and Human Services to negotiate price concessions from pharmaceutical manufacturers for drugs purchased under the Part D program. Medicare Physician Fees and Extenders. H.R. 4015, S. 2157: provisions relating to a permanent fix of the sustainable growth rate (SGR) formula used to determine physician fees under Part B; the extension the Qualified Individual (QI) program; and the therapy caps. Medicare Supplemental Health Insurance. (No bill.) Proposals to increase costs for Medicare beneficiaries who purchase Medigap insurance. Medicare Observation Status. S. 569, H.R. 1179: legislation to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Comprehensive Health Care Reform. P.L. 111-148, P.L. 111-152: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Federal Coordinated Health Care Office (Medicare-Medicaid Coordination Office). (No bill.) Proposals related to the activities of the Federal Coordinated Health Care Office intended to improve the quality of care for recipients receiving benefits from both Medicare and Medicaid, i.e., dual-eligibles. Registered Nurses. H.R. 5373: provisions to require nursing homes and skilled nursing facilities that receive Medicare and/or Medicaid reimbursement to have at least one direct care registered nurse (RN) on duty 24 hours a day, 7 days per week. The Commission on Long-Term Care. (No bill). Proposals and recommendations made to Congress by the Long-Term Care Commission, established under Section 643 of the American Taxpayer Relief Act of 2012 (P.L. 112-240).

Client expense: $210,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative PolicyChanges re: Medicare Part B and Average Sales Price Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program 340B Issues Implementation of American Taxpayer Relief Act of 2012 H.R. 413, to eliminate two-year delay including oral-only ESRD-related drugs in the Medicate ESRD prospective payment system S. 77, Prescription Drug and Health Improvement Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 800, to exclude prompt pay discounts from the average sales price for drugs and biologics under Medicare Part B H.R. 1516, Cancer Patient Protection Act of 2013 H.R. 4302, Protecting Access to Medicare Act of 2014

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

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

Policies to enhance patient access to medicines in Medicare; Medicare payment proposals, S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013; S. 740 / H.R. 1588, Medicare Drug Savings Act of 2013; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013;

Client expense: $880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill)

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

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 162, Medicaid Integrity Act (Bachmann) Medicaid health plan audits16. Specific Lobbying Issues (continued): H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) Medicare Part D changes H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) MA payment and enrollment issues, wellness incentives H.R. 2810, Medicare Patient Access and Quality Improvement Act (Burgess/Camp) SGR repeal, quality- and value-based payment reforms H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) MA open enrollment period H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) delivery models for Medicare beneficiaries with chronic conditions H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) blocking Medicare Part D proposed rule H.R. 4302, Protecting Access to Medicare Act (Pitts) 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) MA special needs plans H.R. 4998, MA Participant Bill of Rights Act (DeLauro) MA plan provider networks H.Con.Res. 96, Budget Resolution (Ryan) Medicare, Medigap, Medicaid, ACA issues S. 11, Fiscal Sustainability Act (Corker) Medicare, Medigap, Medicaid issues S. 25 (Hatch) extension of Medicare sequestration cuts S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) delivery models for Medicare beneficiaries with chronic conditions S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) 12 month continuous enrollment S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) SGR repeal, quality- and value-based payment reforms S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal S. 2361, Stop SCAMS Act (Nelson-Collins) reducing Medicare fraud S. 2461, CHIP Extension Act (Rockefeller) --- CHIP reauthorization S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) MA plan provider networks16. Specific Lobbying Issues (continued): 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); 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 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; Medicare creditable drug coverage reporting requirements; 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 relating to "meaningful use" requirements for health information technology; and other issues relating to health care reform implementation. 17. Houses of Congress and Federal Agencies (continued): Medicaid and CHIP Payment and Access Commission (MACPAC)

Client expense: $2,530,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Social Security Administration (SSA), Treasury, Dept of, White House Office

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issuesH.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence

Client expense: $4,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; provisions related to Part D No bill # assigned - Legislative proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues

Client expense: $1,020,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicare Part D issues. H.R. 928 Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to patent issues. Medicare Drug Savings Act: Part D Issues S. 117 Medicare Prescription Drug Price Negotiation Act of 2013. S. 351 Protecting Seniors Access to Medicare Act of 2013 S. 408 Medicare Prescription Drug Saving and Choice Act of 2013. 340B Drug Program Issues related to changes to the Medicare Part B reimbursement of perscription drugs; issues related to coverage and reimbursementfor those who are covered by the Medicaid program and the Medicare program, including the Part D prescription drug benefit; and general issues related to the Medicare Part D program.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits. H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi). H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes. H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care. H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations. H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs. H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse. H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules. H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives. H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives. H.R. 2810, Medicare Patient Access and Quality Improvement Act (Burgess/Camp) - SGR repeal, quality- and value-based payment reforms. H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review. H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period. H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions. H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule. H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders." H.R. 4484, Strengthening Healthcare Options for Vulnerable Populations Act (Sinema) - MA special needs plans. H.R. 4998, MA Participant Bill of Rights Act (DeLauro) - MA plan provider networks. H.Con.Res. 96, Budget Resolution (Ryan) - Medicare, Medigap, Medicaid, ACA issues. S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues. S. 25 (Hatch) - extension of Medicare sequestration cuts. S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations. S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes. S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care. S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse. S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives. S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations. S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs. S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions. S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment. S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Senate Finance Committee) - SGR repeal, quality- and value-based payment reforms. S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders." S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal. S. 2361, Stop SCAMS Act (Nelson-Collins) - reducing Medicare fraud S. 2461, CHIP Extension Act (Rockefeller) --- CHIP reauthorization. S. 2552, MA Participant Bill of Rights Act (Brown-Blumenthal) - MA plan provider networks.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Protection Act. S. 2087, S. 2491: provisions protecting Medicare beneficiaries from changes that would reduce benefits or restrict eligibility. Medicare Benefit Redesign. (No bill.) Proposals to combine Part A and B deductibles along with a catastrophic cap on Medicareout-of-pocket spending to be paid for by increased out-of-pocket costs for Medicare beneficiaries. Medicare Drug Savings. S. 740, H.R. 1588: provisions to extend the application of Medicaid drug rebates to prescription drugs paid for by Medicare and used by people eligible for both Medicare and Medicaid (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Fraud, Waste and Abuse. S. 2361: provisions to require the Centers for Medicare and Medicaid Services (CMS) to verify that health care providers wishing to participate in Medicare have not owned a company that previously defrauded the government, allow private insurers to share information about potentially fraudulent providers with Medicare and require new medical coding systems to be tested before they are deployed to ensure Medicares fraud prevention systems function properly. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Premium Support. H. Con. Res. 96: proposals to privatize Medicare. Medicare Income-Relating. H. Con. Res. 96: proposals to increase the cost of Medicare to higher-income beneficiaries. Medicare Eligibility Age. H. Con. Res. 96: proposals to increase the Medicare eligibility age. Medicare Part D Negotiation of Drug Prices. S. 117, S. 408, H.R. 1102, H.R. 928: proposals to create a Medicare-operated prescription drug plan, allowing or requiring the Secretary of the Department of Health and Human Services to negotiate price concessions from pharmaceutical manufacturers for drugs purchased under the Part D program. Medicare Supplemental Health Insurance. (No bill.) Proposals to increase costs for Medicare beneficiaries who purchase Medigap insurance. Medicare Observation Status. S. 569, H.R. 1179: legislation to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Medicare Advantage Payment Rate. (No bill). Proposals to decrease Medicare Advantage (MA) 2015 payment rates. Comprehensive Health Care Reform. P.L. 111-148, P.L. 111-152: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; and providing expanded Medicaid coverage. Federal Coordinated Health Care Office (Medicare-Medicaid Coordination Office). (No bill.) Proposals related to the activities of the Federal Coordinated Health Care Office intended to improve the quality of care for recipients receiving benefits from both Medicare and Medicaid, i.e., dual-eligibles. The Commission on Long-Term Care. (No bill). Proposals and recommendations made to Congress by the Long-Term Care Commission, established under Section 643 of the American Taxpayer Relief Act of 2012 (P.L. 112-240).

Client expense: $240,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

ESRD "Bundling Issues" and ESRD Drug Reimbursement Issues HCPCS Coding Decisions Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act Least Costly Alternative PolicyChanges re: Medicare Part B and Average Sales Price Medicare Secondary Payor for ESRD Services Extension of Rebates on Medicare Part D Drugs Performance Measures for Bone and Mineral Metabolism for ESRD Program 340B Issues Implementation of American Taxpayer Relief Act of 2012 H.R. 413, to eliminate two-year delay including oral-only ESRD-related drugs in the Medicate ESRD prospective payment system S. 77, Prescription Drug and Health Improvement Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 800, to exclude prompt pay discounts from the average sales price for drugs and biologics under Medicare Part B H.R. 1516, Cancer Patient Protection Act of 2013 S. 1871, Sustainable Growth Rate (SGR) Repeal and Medicare Beneficiary Access Act of 2013 H.R. 4302, Protecting Access to Medicare Act of 2014

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions

Client expense: $1,990,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Policies to enhance patient access to medicines in Medicare; Medicare payment proposals, S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013; S. 740 / H.R. 1588, Medicare Drug Savings Act of 2013; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013;

Client expense: $1,450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part DH.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

Client expense: $4,680,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013, provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013, provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013, provisions related to Part D issuesH.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013, Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013, provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013, provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D, provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act, provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014, provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014, provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013, provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013, provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013, provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013, provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013, provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013, provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act, provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014, provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014, provisions related to SGR reform No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues, provisions related to Medicare No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues

Client expense: $1,630,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicare Part D issues. H.R. 928 Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to patent issues. Medicare Drug Savings Act: Part D Issues S. 117 Medicare Prescription Drug Price Negotiation Act of 2013S. 351 Protecting Seniors Access to Medicare Act of 2013 S. 408 Medicare Prescription Drug Savings and Choice Act of 2013 340B Drug Program Issues related to changes to the Medicare Part B reimbursement of prescription drugs; issues related to coverage and reimbursement for those who are covered by the Medicaid program and the Medicare program, including the Part D prescription drug benefit; and general issues related to the Medicare Part D program.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 162, Medicaid Integrity Act (Bachmann) Medicaid health plan audits16. Specific Lobbying Issues (continued): H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) Medicare Part D changes H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) MA payment and enrollment issues, wellness incentives H.R. 2810, Medicare Patient Access and Quality Improvement Act (Burgess/Camp) SGR repeal, quality- and value- based payment reforms H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) MA open enrollment period H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) delivery models for Medicare beneficiaries with chronic conditions H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay H.R. 4160, Keep the Promise to Seniors Act (Ellmers) blocking Medicare Part D proposed rule H.R. 4302, Protecting Access to Medicare Act (Pitts) 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders H.J.Res. 59, Bipartisan Budget Act (Rogers) MA Special Needs Plans, Cost Plans, Medicare physician payment, QI and TMA programs S. 11, Fiscal Sustainability Act (Corker) Medicare, Medigap, Medicaid issues S. 25 (Hatch) extension of Medicare sequestration cuts S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Baucus) SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) delivery models for Medicare beneficiaries with chronic conditions S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) 12 month continuous enrollment S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Baucus) SGR repeal, quality- and value-based payment reforms S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal U.S. Senate Special Committee on Aging Draft of Stop SCAMS Act (not yet introduced) - anti-fraud activities, including coding, Healthcare Fraud Prevention Partnership, and MEDPAC report16. Regulatory Issues (continued): 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); 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 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; Medicare creditable drug coverage reporting requirements; 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; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues; 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 relating to "meaningful use" requirements for health information technology; and other issues relating to health care reform implementation. 17. Houses of Congress and Federal Agencies (continued): Medicaid and CHIP Payment and Access Commission (MACPAC) 18. Name of Lobbyists (con't): C. Lawrence: Assistant, Legislative Director for Rep. Bill Cassidy (LA-6); May 2008-July 200: Staff Assistant, Legislative Correspondent for Rep. Tom Price (GA-6)

Client expense: $2,430,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

H.R. 162, Medicaid Integrity Act (Bachmann) - Medicaid health plan audits; H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi); H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) - Medicare Part D changes; H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) - Medicare coverage of skilled nursing care; H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) - Medicare Part D price negotiations; H.R. 1853, Medicaid Accountability and Care Act (Cassidy) -federal financing of state Medicaid programs; H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - fighting fraud and abuse; H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment rules; H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) - wellness incentives; H.R. 2753, Securing Care for Seniors Act (Black) - MA payment and enrollment issues, wellness incentives; H.R. 2810, Medicare Patient Access and Quality Improvement Act (Burgess/Camp) - SGR repeal, quality- and value-based payment reforms; H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) - Part D drug utilization review; H.R. 3512, Seniors' Health Care Choice Act (Heck) - MA open enrollment period; H.R. 3890, Better Care, Lower Cost Act (Paulsen-Welch) - delivery models for Medicare beneficiaries with chronic conditions; H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act (Burgess) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate delay; H.R. 4160, Keep the Promise to Seniors Act (Ellmers) - blocking Medicare Part D proposed rule; H.R. 4302, Protecting Access to Medicare Act (Pitts) - 12-month Medicare SGR patch, Medicare Advantage Special Needs Plans, Appropriate Use Criteria for Advanced Diagnostic Imaging, Medicare sequestration cuts, Other Medicare-Medicaid Extenders; H.J.Res. 59, Bipartisan Budget Act (Rogers) - MA Special Needs Plans, Cost Plans, Medicare physician payment, QI and TMA programs; S. 11, Fiscal Sustainability Act (Corker) - Medicare, Medigap, Medicaid issues; S. 25 (Hatch) - extension of Medicare sequestration cuts; S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) - Medicare Part D price negotiations; S. 324, Puerto Rico Medicare Part B Equity Act (Schumer); S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) - Medicare Part D changes; S. 569, Improving Access to Medicare Coverage Act (Brown) - Medicare coverage of skilled nursing care; S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) - fighting fraud and abuse; S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) - wellness incentives; S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) - medical loss ratio requirement for Medicaid managed care organizations; S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Baucus) - SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs; S. 1932, Better Care, Lower Cost Act (Wyden-Isakson) - delivery models for Medicare beneficiaries with chronic conditions; S. 1980, Medicaid and CHIP Continuous Quality Act (Rockefeller) - 12 month continuous enrollment; S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act (Baucus) - SGR repeal, quality- and value-based payment reform; S. 2110, SGR Repeal and Medicare Provider Payment Modernization Act (Wyden) - SGR repeal, quality- and value-based payment reforms, Medicare and Medicaid extenders; S. 2122, Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act (Hatch) - SGR repeal, quality- and value-based payment reforms, ACA individual mandate repeal.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Benefit Redesign. (No bill.) Proposals to combine Part A and B deductibles along with a catastrophic cap on Medicare out-of-pocket spending to be paid for by increased out-of-pocket costs for Medicare beneficiaries. Medicare Drug Savings. S. 740, H.R. 1588: provisions to extend the application of Medicaid drug rebates to prescription drugspaid for by Medicare and used by people eligible for both Medicare and Medicaid (dual-eligibles), and by people receiving the Medicare Part D Low-Income Subsidy. Medicare Home Health Benefits. (No bill.) Proposals pertaining to copayments for beneficiaries receiving the Medicare home health benefit. Medicare Premium Support. (No bill.) Proposals to privatize Medicare. Medicare Income-Relating. (No bill.) Proposals to increase the cost of Medicare to higher-income beneficiaries. Medicare Eligibility Age. (No bill.): Proposals to increase the Medicare eligibility age. Medicare Part D Negotiation of Drug Prices. S. 117, S. 408, H.R. 1102, H.R. 928: proposals to create a Medicare-operated prescription drug plan, allowing or requiring the Secretary of the Department of Health and Human Services to negotiate price concessions from pharmaceutical manufacturers for drugs purchased under the Part D program. Medicare Supplemental Health Insurance. (No bill.) Proposals to increase costs for Medicare beneficiaries who purchase Medigap insurance. Medicare Physician Fees and Extenders. H.R. 2810, S. 1871, S. 2110, S. 2157: provisions relating to a permanent fix of the sustainable growth rate (SGR) formula used to determine physician fees under Part B; the extension the Qualified Individual (QI) program; and the therapy caps. Medicare Physician Fees and Extenders. H.R. 4302 ( P.L.113-93): provisions pertaining to extending physician payments through March 2015; extending the Qualified Individual program through March 2015; and extending the therapy cap exceptions process through March 2015. Medicare Observation Status. S. 569, H.R. 1179: legislation to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Medicare Fraud. H.R. 3616: legislation requiring an annual report to Congress and the public on health care fraud schemes targeted to seniors and steps being taken to combat such schemes and to educate seniors about them. Medicare Advantage Payment Rate. (No bill). Proposals to decrease Medicare Advantage (MA) 2015 payment rates. Medicare Advantage and Medicare Part D. (No bill). Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs: Proposals related to: Medicare Part D six protected drug classes, plan consolidation, oversight, drug price fairness, accuracy and affordability. Comprehensive Health Care Reform. P.L. 111-148, P.L. 111-152: implementation of provisions reducing Medicare Advantage plan payments; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); expanding coverage of prevention services; testing payment and delivery system reforms; establishing a Medicare Commission; providing expanded Medicaid coverage; authorizing the collection of data regarding disparities in the provision of care; providing safeguards and subsidies to assure affordability of health coverage for seniors. Federal Coordinated Health Care Office (Medicare-Medicaid Coordination Office). (No bill.) Proposals related to the activities of the Federal Coordinated Health Care Office intended to improve the quality of care for recipients receiving benefits from both Medicare and Medicaid, i.e, "dual-eligibles." The Commission on Long-Term Care. (No bill). Proposals and recommendations made to Congress by the Long-Term Care Commission, established under Section 643 of the American Taxpayer Relief Act of 2012 (P.L. 112-240).

Client expense: $220,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

H.Con.Res. 25, House Budget Resolution (Ryan) public program issues, deficit reduction proposals16. Specific Lobbying Issues (continued): S.Con.Res. 8, Senate Budget Resolution (Murray) public program issues, deficit reduction proposals H.R. 162, Medicaid Integrity Act (Bachmann) Medicaid health plan audits H.R. 670, Puerto Rico Medicare Part B Equity Act (Pierluisi) H.R. 928, Medicare Prescription Drug Savings and Choice Act (Schakowsky) Medicare Part D changes H.R. 1179, Improving Access to Medicare Coverage Act (Courtney) Medicare coverage of skilled nursing care H.R. 1102, Medicare Prescription Drug Price Negotiation Act (Welch) Medicare Part D price negotiations H.R. 1853, Medicaid Accountability and Care Act (Cassidy) federal financing of state Medicaid programs H.R. 2305, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) fighting fraud and abuse H.R. 2453, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) MA enrollment rules H.R. 2524, Medicare Better Health Rewards Program Act (Paulsen-Kind) wellness incentives H.R. 2753, Securing Care for Seniors Act (Black) MA payment and enrollment issues, wellness incentives H.R. 2810, Medicare Patient Access and Quality Improvement Act (Burgess/Camp) SGR repeal, quality- and value-based payment reforms H.R, 2960, Medicare Prescription Drug Integrity Act of 2013 (Pallone) Part D drug utilization review H.R. 3512, Seniors' Health Care Choice Act (Heck) MA open enrollment period H.J.Res. 59, Bipartisan Budget Act (Rogers) MA Special Needs Plans, Cost Plans, Medicare physician payment, QI and TMA programs S. 11, Fiscal Sustainability Act (Corker) Medicare, Medigap, Medicaid issues S. 117, Medicare Prescription Drug Price Negotiation Act (Klobuchar) Medicare Part D price negotiations S. 324, Puerto Rico Medicare Part B Equity Act (Schumer) S. 408, Medicare Prescription Drug Savings and Choice Act (Durbin) Medicare Part D changes S. 569, Improving Access to Medicare Coverage Act (Brown) Medicare coverage of skilled nursing care S. 1123, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Coburn) fighting fraud and abuse S. 1228, Medicare Better Health Rewards Program Act (Wyden-Portman) wellness incentives S. 1787, Medicaid Managed Care Responsibility and Equity Act (Rockefeller) medical loss ratio requirement for Medicaid managed care organizations S. 1871, SGR Repeal and Medicare Beneficiary Access Act (Baucus) SGR repeal, quality- and value-based payment reforms, MA Special Needs Plans, Cost Plans, QI and TMA programs 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); 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; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA 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; Medicare creditable drug coverage reporting requirements; 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;Regulatory Issues (con't): 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; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues; 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 relating to "meaningful use" requirements for health information technology; and other issues relating to health care reform implementation. 17. Houses of Congress and Federal Agencies (con't): Medicaid and CHIP Payment and Access Commission (MACPAC)

Client expense: $3,630,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

Policies to enhance patient access to medicines in Medicare; Medicare payment proposals, S. 117 / H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013; S. 740 / H.R. 1588, Medicare Drug Savings Act of 2013; H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)