Keep the Promise to Seniors Act of 2014

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557 / H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid; Pharmacy, and Health Care General H.R. 4418, Expanding the Availability of Medicare Data to Medicare/Medicaid

Client expense: $788,488 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557 / H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid; Pharmacy, and Health Care General H.R. 4418, Expanding the Availability of Medicare Data to Medicare/Medicaid

Client expense: $788,488 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Support H.R. 351 and S.351 to repeal the Medicare Independent Payment Advisory Board mandated by the Affordable Care Act Oppose any reduction of Medicare Part B drug and biologic reimbursement payments that will harm patients. Support robust Part D formularies and continued coverage of the six protected classes. Support raising the Part D specialty tier cost-sharing threshold above the $600 minimum, and to at least index it to inflation.Support strong Part D oversight and improved transparency for consumers, as well as a better process for notice of non-coverage, for appeals, and exceptions to provide the best access to necessary, life-saving prescription medications. Support changes to the Part D Program that would address gaps in coverage, eliminate onerous cost-shifting through the use of specialty tiers and restrictive utilization management tools. Support any changes that improve the effectiveness of the program for those receiving low income subsidies. Support the most stringent safety requirements for any substitution of biosimilar drugs for any prescribed biologic, including notification of both the patient and the prescribing physician. Oppose any cuts to the Medicare Part D Program or any legislation requiring the Secretary of Health and Human Services to "negotiate" Part D prices or rebates that will forever limit access to the best drugs and biologics for Medicare beneficiaries. Support "Fight Fraud First" efforts (rather than Medicare benefit cuts or fee increases) to reduce overall Medicare spending. Oppose any changes to the Medicare Part D program that would shift additional costs to beneficiaries or create barriers to access, both of which actions would lead to cost increases in other parts of the Medicare program. Oppose all proposed cuts to Medicare reimbursements rates for critical home health services under the Home Health Prospective Payment System (HHPPS). Support the "Part D Beneficiary Appeals Fairness Act," H.R. 2827 and S. 1365. Opposed CMS efforts to institute a 700-page Medicare Part D Prescription Drug Plan "proposed rule" that included harmful changes to the critical "Six Protected Classes" of drugs and attempted to limit drug plan choices for patients. The proposed rule threatened destructive government interference in this successful program that could only result in fewer options and higher costs for beneficiaries. Support H.R. 4160, the Keep the Promise to Seniors Act. Support H.R. 3320, a measure to broaden coverage to include more Medicare beneficiaries who could benefit from the use of a ventricular assist device (VAD). Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Supported the nomination of Kirsten Axelsen to the position of Commissioner on the Medicare Payment Advisory Commission (MedPAC). Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Urged changes to the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 that would allow telehealth to reach its full potential, including relaxed reimbursement restrictions, increased coverage, and removal of other barriers to use such as state licensure barriers. Support the Advisory Committee on Immunization Practices (ACIP) recommendations to the Centers for Medicare and Medicaid Services (CMS) related to the 13-valent pneumococcal conjugate vaccine (PCV13), including:1) Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23; 2) Adults 65 years of age or older who have not previously received PCV13 and who have previously received one or more doses of PPSV23 should receive a dose of PVC13; 3)The recommendations for routine PVC13 use among adults 65 years and older should be re-evaluated in 2018 and revised as needed. To protect at risk and high risk Medicare beneficiaries, the ACIP recommendations should be adopted and implemented without delay. Support MAPRx coalition December comments and principles regarding the Medicare Part D prescription Drug Program and the 21st Century Cures Initiative in a letter to the House Energy and Commerce Committee. Joined numerous other organizations in a letter urging the Medicare Payment Advisory Committee (MedPAC) to conduct a comprehensive analysis of the Medicare Part D exceptions and appeals process and to issue recommendations to improve it. Support H.R. 4302.

Client expense: $25,533 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., 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. 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

H.R. 4, Jobs for America Act H.R. 45, To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 523, Protect Medical Innovation Act of 2013 H.R. 581, First Responder Medical Device Tax Relief Act H.R. 582, Healthcare Tax Relief and Mandate Repeal Act H.R. 763, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 781, Medicare Identity Theft Prevention Act of 2013 H.R. 903 / S. 399, American Job Protection Act H.R. 1248 / S. 610, Family Health Care Flexibility Act H.R. 1254, Auto Enroll Repeal Act H.R. 1295, Medical Device Tax Elimination Act H.R. 1558 / S. 24, Small Business Health Relief Act of 2013 H.R. 1735, In It All Together Act H.R. 1780, To provide that the only health plans that the Federal Government may make available to the President, Vice President, Members of Congress, and Federal employees are those created under the Patient Protection and Affordable Care Act or offered through a health insurance exchange H.R. 2575, Save American Workers Act H.R. 2667, Authority for Mandate Delay Act H.R. 2668, Fairness for American Families Act H.R. 2674, Job Creation Act of 2013 H.R. 2835, Restoring Access to Medication Act of 2013 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 H.R. 2988 / S. 701 / S. 1188, Forty Hours Is Full Time Act of 2013 H.R. 3077, TELE-MED Act of 2013 H.R. 3121, American Health Care Reform Act of 2013 H.R. 3124, Investing in Permanency for Youth in Foster Care Act H.R. 3204, Drug Quality and Security Act H.R. 3367, To amend section 9010 of the Patient Protection and Affordable Care Act to delay the application of the health insurance provider annual fee until 2016 and to provide a process to return to consumers any amounts attributable to the expected application of the annual fee to 2014 or 2015 H.R. 3419, Small Business Fairness in Obamacare Act H.R. 3462 / S. 1735, Self-Insurance Protection Act H.R. 3522, Employee Health Care Protection Act of 2013 H.R. 4118, Suspending the Individual Mandate Penalty Law Equals Fairness (SIMPLE) Act H.R. 4160, Keep the Promise to Seniors Act of 2014 H.R. 4302, Protecting Access to Medicare Act of 2014 H.R. 4414, Expatriate Health Coverage Clarification Act of 2014 H.R. 5183 / S. 2783, Value Based Insurance Design for Better Care Act of 2014 H.R. 5557, Streamlining Verification for Americans Act H.R. 5860, Small Business Healthcare Relief Act of 2014 S. 232, Medical Device Access and Innovation Protection Act S. 603, Jobs and Premium Protection Act S. 612, Social Security Number Protection Act of 2011 S. 1031, Family and Retirement Health Investment Act of 2013 S. 1488, A bill to delay the application of the individual health insurance mandate, to delay the application of the employer health insurance mandate, and for other purposes S. 1647, Restoring Access to Medication Act Final Regulation on Incentives for Nondiscriminatory Wellness Programs in Group Health Plans (78 Fed. Reg. 33,157-33,176, June 3, 2013) (to be codified at 26 C.F.R. pt. 54) Proposed Regulation on the Patient Protection and Affordable Care Act; standards related to Essential Health Benefits, Actuarial Value, and Accreditation (77 Fed. Reg. 70,644-70,676, November 26, 2012) (to be codified at 45 C.F.R. pts. 147, 155, 156) Proposed Regulation on the Health Insurance Market Rules; Rate Review (77 Fed. Reg. 70,584-70,617, November 26, 2012) (to be codified at 45 C.F.R. pts. 144, 147, 150) Proposed Regulation on the HHS Notice of Benefit and Payment Parameters for 2014 (77 Fed. Reg. 73,118-73,218, December 7, 2012) (to be codified at 45 C.F.R. pts. 153, 155, 156, 157, 158) Proposed Regulation on Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing (78 Fed. Reg. 4,594-4,724, January 22, 2013) (to be codified at 42 C.F.R. Parts 430, 431, 433, 435, 440, 447, 457) Proposed Regulation on Shared Responsibility for Employers Regarding Health Coverage (78 Fed. Reg. 218-253, January 2, 2013) (to be codified at 26 C.F.R. pts. 1, 54, 301) Proposed Regulation on Information Reporting of Minimum Essential Coverage (78 Fed. Reg. 54,986-54,996, September 9, 2013) (to be codified at 26 C.F.R. pts. 1, 301) Proposed Regulation on Information Reporting by Applicable Large Employers on Health Insurance Coverage Offered Under Employer-Sponsored Plans (78 Fed. Reg. 54,996-55,013, September 9, 2013) (to be codified at 26 C.F.R. pt. 301) Proposed Regulation regarding the Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program (78 Fed. Reg. 15,553-15,558, March 11, 2013) (to be codified at 45 C.F.R. pts. 155, 156) Proposed Regulation on the Health Insurance Providers Fee (78 Fed. Reg. 14,034-14,046, March 4, 2013) (to be codified at 26 C.F.R. pt. 57) Proposed Regulation on Minimum Value of Eligible Employer-Sponsored Plans and Other Rules Regarding the Health Insurance Premium Tax Credit (78 Fed. Reg. 25,909-25,916, May 3, 2013) (to be codified at 26 C.F.R. pt. 1) Proposed Regulation on Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Program, (79 Fed. Reg. 1,918-2,073, January 10, 2014) (to be codified at 42 C.F.R. pts. 409, 417, 422 et al.) Proposed Regulation on Exchange and Insurance Market Standards for 2015 and Beyond (79 Fed. Reg. 15,808-15,879, March 21, 2014) (to be codified at 45 C.F.R. pts. 146, 147, 148 et al.) Proposed Regulation on Minimum Essential Coverage and Other Rules Regarding Shared Responsibility Payment for Individuals (79 Fed. Reg. 4,302-4,308, January 27, 2014) (to be codified at 26 C.F.R. pt. 1) Proposed Regulation on HHS Notice of Benefit and Payment Parameters for 2016 (79 Fed. Reg. 70,674-70,760, November 26, 2014) (to be codified at 45 C.F.R. pts. 144, 147 et al.) Various issues relating to the Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152), including caps on compensation deductibility required under section 9014, implementation of regulatory process, legislative corrections, coverage, financing, delivery reform, 1099 reporting, Grandfathering, health savings accounts (HSAs) and flexible spending accounts (FSAs) changes, CMS claims database, IPAB, CLASS program, employer mandate, medical loss ratio, medical malpractice reform, exchanges, impact on small business, provider network adequacy, definition of small group market, reporting requirements for issuers and applicable large employers, premium stabilization programs, the Small Business Tax Credit, incompleteness or inaccuracy of cost impact analyses, lack of quantified benefit analysis, need for empirical data sources on which to base costs and benefits, ERISA preemption, HSA and FSA accounts; Public Health Service Act (P.L. 78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), including regulatory process and legislative corrections to the ERISA preemption; deliver reform changes to Medicare Advantage and Medicare Prescription Drug (Part D) programs, including rebates and non-interference with prescription drug prices; entitlement reform; health information technology; legal protections against certain self-referral to physician owned hospitals

Client expense: $21,250,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service, U.S. Trade Representative (USTR), White House Office

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 2810 Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 H.R. 4302 - Protecting Access to Medicare Act of 2014 H.R. 4160 - Keep the Promise to Seniors Act of 2014, medicare regulation ***, no specific bill(s), Medicare, Medicare and Medicaid Fraud, Medicare Advantage, Medicare Part D, Medicaid, Electronic Prescribing, Dual Eligibles, Medigap reform, claims resolution, risk adjustment, Delivery System Reform, Special Needs Plans, Star Ratings, call letter, program integrity, Alzheimer's care

Client expense: Not reported · Firm income: $90,000

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

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 H.R. 4302 - Protecting Access to Medicare Act of 2014 H.R. 4160 - Keep the Promise to Seniors Act of 2014, medicare regulation ***, no specific bill(s), Medicare, Medicare Fraud, Medicare Advantage, Medicaid, Electronic Prescribing, Health Care Reform Implementation, Medigap reform, Physician Payment Reform, Delivery System Reform, medical review, ICD-10, Benefit design, prescription drug safety

Client expense: Not reported · Firm income: $100,000

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

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 See addendum on additional Medicare/Medicaid issues...Additional Medicare/Medicaid Issues: HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4930 Introduced June 20, 2014 by Joe Barton (R-TX) Advancing Care for Exceptional Kids Act of 2014 or the ACE Kids Act of 2014 - Amends titles XIX (Medicaid) and XXI (Children's Health Insurance) (CHIP) of the Social Security Act to extend medical assistance to payment for items and services furnished under a Medicaid Children's Care Coordination (MCCC) Program which the state may elect to provide to eligible children with complex medical conditions HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5083 Introduced July 11, 2014 by Renee Ellmers (R-NC) Medicare DMEPOS Audit Improvement and Reform (AIR) Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish a Medicare Administrative Contractor Payment Outreach and Education Program for DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) suppliers HR 5010 Introduced June 26, 2014 by Jackie Speier (D-CA) To provide greater clarity in the regulation of electronic nicotine delivery systems, including electronic cigarettes, cigars, cigarillos, pipes, and hookahs, and for other purposes. as introduced. HR 5460 Introduced September 11, 2014 by Greg Walden (R-OR) To amend title XVIII of the Social Security Act to increase access to ambulance services under the Medicare program and to reform payments for such services under such program. as introduced. (See following page on additional Medicare/Medicaid issues...)HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) To ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) To amend title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of Health and Human Services (HHS) to exclude from participation in any federal health care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity. HR 647 - ABLE Act Introduced February 13, 2013 by Ander Crenshaw (R-FL) Achieving a Better Life Experience Act of 2014 or the ABLE Act of 2014 - Title I: Qualified ABLE Programs - (Sec. 101) States as the purposes of this title to: (1) encourage and assist individuals and families in saving private funds for the purpose of supporting individuals with disabilities to maintain health, independence, and quality of life; and (2) provide secure funding for disability-related expenses of beneficiaries with disabilities that will supplement, but not supplant, benefits provided through private insurance, title XVI (Supplemental Security Income) and title XIX (Medicaid) of the Social Security Act, the beneficiary's employment, and other sources. HR 4994 Introduced June 26, 2014 by Dave Camp (R-MI) Title XVIII amendments of Social Security Act Other Medicare/Medicaid Issues: Delivery reform and network design; Qualified Health Plan Survey; CHIP Reauthorization;, Medicare co-pay limits

Client expense: $2,030,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under Part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage-Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII(Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5083 Introduced July 11, 2014 by Renee Ellmers (R-NC) Medicare DMEPOS Audit Improvement and Reform (AIR) Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish a Medicare Administrative Contractor Payment Outreach and Education Program for DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) suppliers. HR 5460 Introduced September 11, 2014 by Greg Walden (R-OR) to amend title XVIII of the Social Security Act to increase access to ambulance services under the Medicare program and to reform payments for such services under such program as introduced. HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) to ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting. HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) to amend Title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes. HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of HHS to exclude from participation in any federal care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity. HR 645 - /ABLE Act Introduced February 13, 2013 by Ander Crenshaw (R-FL) Achieving a Better Life Experience Act of 2014 or the ABLE Act of 2014 - Title I: Qualified ABLE Programs - (Sec. 101) States as the purposes of this title to: (1) encourage and assist individuals and families in saving private funds for the purpose of supporting individuals with disabilities to maintain health, independence, and quality of life; and (2) provide secure funding for disability-related expenses of beneficiaries with disabilities that will supplement, but not supplant, benefits provided through private insurance, title XVI (Supplemental Security Income) and title XIX (Medicaid) of the Social SEcurity Act, the beneficiary's employment, and other sources. HR 4994 Introduced June 26, 2014 by Dave Camp (R-MI) Title XVIII amendments of Social Security Act. Other Medicare/Medicaid Issues: Delivery reform and network design; Qualified Health Plan Survey; CHIP Reauthorization; Medicare co-pay limits

Client expense: Not reported · Firm income: Not reported

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

HR 2190 & S 1206 - Medicare Drug Savings Act of 2011: To amend title XVIII of the Social Security Act to require drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals under the Medicare prescription drug benefit program. HR 2753 - Securing Care for Seniors Act of 2013: To amend title XVIII of the Social Security Act to improve Medicare Advantage and for other purposes. HR 2810 - Medicare Patient Access and Quality Improvement Act of 2013: Amend title XVIII of the Social Security Act to reform the sustainable growth rate and Medicare payment for physicians services and for other purposes. HR 3077 - TELE-MED Act of 2013: Amend title XVIII of the Social Security Act to permit certain Medicare providers licensed in a state to provide telemedicine services to Medicare beneficiaries in a different state. HR 3890 - Better Care Lower Cost Act: To amend title XVIII of the Social Security Act to establish a Medicare Better Care Program to provide integrated care for Medicare beneficiaries with chronic conditions. HR 4160 - Keep the Promise to Seniors Act of 2014: To prohibit further action on the proposed rule regarding change to the Medicare prescription drug benefit program. HR 4998 - Medicare Advantage Participation Bill of Rights Acts of 2014: To enhance beneficiary and provider protections and improve transparency in the Medicare Advantage market and for other purposes. HR 5183 & S 2783 - Value Based Insurance Design for Better Care Act of 2011: To establish a demonstration program requiring the utilization of value based insurance design to demonstrate that reducing the copayment or co-insurance charged to Medicare beneficiaries for selected high-value prescription medications and clinical services can increase their utilization and ultimately improve clinical outcomes and lower health care expenditures. HR 5380 - Medicare Telehealth Parity Act of 2014: To amend title XVIII of the Social Security Act to provide for a phased in expansion of telehealth coverage under Medicare program. S 1932 - Better Care and Lower Costs Act: Amend title XVIII of the Social Security Act to establish a Medicare Better Care Program to provide integrated care for Medicare beneficiaries with chronic conditions, and for other purposes. S 2000 - The SGR Repeal and Medicare Provider Payment Modernization Act: Amend title XVIII of the Social Security Act to repeal the Medicare sustainable growth rate and improve Medicare payments for physicians and other professionals and for other purposes. S 2552 - Medicare Advantage Participant Bill of Rights Act of 2014: To enhance beneficiary & provider protections and improve transparency in the Medicare Advantage market and for other purposes.

Client expense: $1,510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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)

Support H.R. 351 and S.351 to repeal the Medicare Independent Payment Advisory Board mandated by the Affordable Care Act Oppose any reduction of Medicare Part B drug and biologic reimbursement payments that will harm patients. Support robust Part D formularies and continued coverage of the six protected classes. Support raising the Part D specialty tier cost-sharing threshold above the $600 minimum, and to at least index it to inflation.Support strong Part D oversight and improved transparency for consumers, as well as a better process for notice of non-coverage, for appeals, and exceptions to provide the best access to necessary, life-saving prescription medications. Support changes to the Part D Program that would address gaps in coverage, eliminate onerous cost-shifting through the use of specialty tiers and restrictive utilization management tools. Support any changes that improve the effectiveness of the program for those receiving low income subsidies. Support the most stringent safety requirements for any substitution of biosimilar drugs for any prescribed biologic, including notification of both the patient and the prescribing physician. Oppose any cuts to the Medicare Part D Program or any legislation requiring the Secretary of Health and Human Services to "negotiate" Part D prices or rebates that will forever limit access to the best drugs and biologics for Medicare beneficiaries. Support "Fight Fraud First" efforts (rather than Medicare benefit cuts or fee increases) to reduce overall Medicare spending. Oppose any changes to the Medicare Part D program that would shift additional costs to beneficiaries or create barriers to access, both of which actions would lead to cost increases in other parts of the Medicare program. Oppose all proposed cuts to Medicare reimbursements rates for critical home health services under the Home Health Prospective Payment System (HHPPS). Support the "Part D Beneficiary Appeals Fairness Act," H.R. 2827 and S. 1365. Opposed CMS efforts to institute a 700-page Medicare Part D Prescription Drug Plan "proposed rule" that included harmful changes to the critical "Six Protected Classes" of drugs and attempted to limit drug plan choices for patients. The proposed rule threatened destructive government interference in this successful program that could only result in fewer options and higher costs for beneficiaries. Support H.R. 4160, the Keep the Promise to Seniors Act. Support H.R. 3320, a measure to broaden coverage to include more Medicare beneficiaries who could benefit from the use of a ventricular assist device (VAD). Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Supported the nomination of Kirsten Axelsen to the position of Commissioner on the Medicare Payment Advisory Commission (MedPAC). Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Urged changes to the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 that would allow telehealth to reach its full potential, including relaxed reimbursement restrictions, increased coverage, and removal of other barriers to use such as state licensure barriers. Support the Advisory Committee on Immunization Practices (ACIP) recommendations to the Centers for Medicare and Medicaid Services (CMS) related to the 13-valent pneumococcal conjugate vaccine (PCV13), including:1) Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23; 2) Adults 65 years of age or older who have not previously received PCV13 and who have previously received one or more doses of PPSV23 should receive a dose of PVC13; 3)The recommendations for routine PVC13 use among adults 65 years and older should be re-evaluated in 2018 and revised as needed. To protect at risk and high risk Medicare beneficiaries, the ACIP recommendations should be adopted and implemented without delay. Support MAPRx coalition December comments and principles regarding the Medicare Part D prescription Drug Program and the 21st Century Cures Initiative in a letter to the House Energy and Commerce Committee. Joined numerous other organizations in a letter urging the Medicare Payment Advisory Committee (MedPAC) to conduct a comprehensive analysis of the Medicare Part D exceptions and appeals process and to issue recommendations to improve it. Support H.R. 4302.

Client expense: Not reported · Firm income: $7,838

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., SENATE

HR 81, HR 105, HR.RES.17, HR 344, HR 544, HR 582, HR 607, HR 675, HR 762, HR 763, HR 903, HR 1076, HR 1200, HR 1205, HR 1239, HR 1248, HR 1254, HR 1342, HR 1549, HR 1558, HR 2328, HR 2527, HR 2575, HR 2577, HR 2667, HR 2995, HR 2988, HR 3362, HR 3367, HR 4244, HR 4128, HR 4144, HR 2453, HR 4160, HR 4302, HR 1179, HR 5183, HR 5557, S.CON. RES.8, S24, S351, S399, S.AMDT.409, S482, S603, S650, S701, S764, S1188, S1729, S2069, S2173, S2174, S2175, S2546,S2783, H.R.5860, H.R. 3512

Client expense: $45,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

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

H.R. 4, Jobs for America Act H.R. 45, To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 523, Protect Medical Innovation Act of 2013 H.R. 581, First Responder Medical Device Tax Relief Act H.R. 582, Healthcare Tax Relief and Mandate Repeal Act H.R. 763, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 781, Medicare Identity Theft Prevention Act of 2013 H.R. 903 / S. 399, American Job Protection Act H.R. 1248 / S. 610, Family Health Care Flexibility Act H.R. 1254 /S. 2546, Auto Enroll Repeal Act H.R. 1295, Medical Device Tax Elimination Act H.R. 1558 / S. 24, Small Business Health Relief Act of 2013 H.R. 1735, In It All Together Act H.R. 1780, To provide that the only health plans that the Federal Government may make available to the President, Vice President, Members of Congress, and Federal employees are those created under the Patient Protection and Affordable Care Act or offered through a health insurance exchange H.R. 2194 / S. 1031, Family and Retirement Health Investment Act of 2013 H.R. 2575, Save American Workers Act H.R. 2667, Authority for Mandate Delay Act H.R. 2668, Fairness for American Families Act H.R. 2674, Job Creation Act of 2013 H.R. 2835, Restoring Access to Medication Act of 2013 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 H.R. 2988 / S. 701 / S. 1188, Forty Hours Is Full Time Act of 2013 H.R. 3077, TELE-MED Act of 2013 H.R. 3121, American Health Care Reform Act of 2013 H.R. 3124, Investing in Permanency for Youth in Foster Care Act H.R. 3204, Drug Quality and Security Act H.R. 3367, To amend section 9010 of the Patient Protection and Affordable Care Act to delay the application of the health insurance provider annual fee until 2016 and to provide a process to return to consumers any amounts attributable to the expected application of the annual fee to 2014 or 2015 H.R. 3419, Small Business Fairness in Obamacare Act H.R. 3462 / S. 1735, Self-Insurance Protection Act H.R. 3522, Employee Health Care Protection Act of 2013 H.R. 4118, Suspending the Individual Mandate Penalty Law Equals Fairness (SIMPLE) Act H.R. 4160, Keep the Promise to Seniors Act of 2014 H.R. 4302, Protecting Access to Medicare Act of 2014 H.R. 4414, Expatriate Health Coverage Clarification Act of 2014 H.R. 5183 / S. 2783, Value Based Insurance Design for Better Care Act of 2014 H.R. 5213, Simplifying Technical Aspects Regarding Seasonality (STARS) Act of 2014 H.R. 5557, Streamlining Verification for Americans Act S. 232, Medical Device Access and Innovation Protection Act S. 603, Jobs and Premium Protection Act S. 612, Social Security Number Protection Act of 2011 S. 1031, Family and Retirement Health Investment Act of 2013 S. 1488, A bill to delay the application of the individual health insurance mandate, to delay the application of the employer health insurance mandate, and for other purposes S. 1647, Restoring Access to Medication Act Proposed Regulation on the Patient Protection and Affordable Care Act; standards related to Essential Health Benefits, Actuarial Value, and Accreditation (77 Fed. Reg. 70,644-70,676, November 26, 2012) (to be codified at 45 C.F.R. pts. 147, 155, 156) Proposed Regulation on the Health Insurance Market Rules; Rate Review (77 Fed. Reg. 70,584-70,617, November 26, 2012) (to be codified at 45 C.F.R. pts. 144, 147, 150) Proposed Regulation on the HHS Notice of Benefit and Payment Parameters for 2014 (77 Fed. Reg. 73,118-73,218, December 7, 2012) (to be codified at 45 C.F.R. pts. 153, 155, 156, 157, 158) Proposed Regulation on the Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation, (77 Fed. Reg. 70,644-70,676, November 26, 2012) (to be codified at 45 C.F.R. pts. 147, 155, 156) Proposed Regulation on Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing (78 Fed. Reg. 4,594-4,724, January 22, 2013) (to be codified at 42 C.F.R. pts. 430, 431, 433, 435, 440, 447, 457) Proposed Regulation on Incentives for Nondiscriminatory Wellness Programs in Group Health Plans (77 Fed. Reg. 70,620-70,642, November 26, 2012) (to be codified at 26 C.F.R. pt. 54) Proposed Regulation on Shared Responsibility for Employers Regarding Health Coverage (78 Fed. Reg. 218-253, January 2, 2013) (to be codified at 26 C.F.R. pts. 1, 54, 301) Proposed Regulation on Information Reporting of Minimum Essential Coverage (78 Fed. Reg. 54,986-54,996, September 9, 2013) (to be codified at 26 C.F.R. pts. 1, 301) Proposed Regulation on Information Reporting by Applicable Large Employers on Health Insurance Coverage Offered Under Employer-Sponsored Plans (78 Fed. Reg. 54,996-55,013, September 9, 2013) (to be codified at 26 C.F.R. pt. 301) Proposed Regulation regarding the Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program (78 Fed. Reg. 15,553-15,558, March 11, 2013) (to be codified at 45 C.F.R. pts. 155, 156) Proposed Regulation on the Health Insurance Providers Fee (78 Fed. Reg. 14,034-14,046, March 4, 2013) (to be codified at 26 C.F.R. pt. 57) Proposed Regulation on Minimum Value of Eligible Employer-Sponsored Plans and Other Rules Regarding the Health Insurance Premium Tax Credit (78 Fed. Reg. 25,909-25,916, May 3, 2013) (to be codified at 26 C.F.R. pt. 1) Proposed Regulation on HHS Notice of Benefit and Payment Parameters for 2015 (78 Fed. Reg. 72,322-72,392, December 2, 2013) (to be codified at 45 C.F.R. pts. 144, 147, 153, 155, 156) Proposed Regulation on Amendments to Excepted Benefits (78 Fed. Reg. 77,632-77,642, December 24, 2013) (to be codified at 29 C.F.R. pt. 2590) Proposed Regulation on Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Program, (79 Fed. Reg. 1,918-2,073, January 10, 2014) (to be codified at 42 C.F.R. pts. 409, 417, 422 et. al.) Proposed Regulation on Exchange and Insurance Market Standards for 2015 and Beyond (79 Fed. Reg. 15,808-15,879, March 21, 2014) (to be codified at 45 C.F.R. pts. 146, 147, 148 et al.) Proposed Regulation on Ninety-Day Waiting Period Limitation (79 Fed. Reg. 10,320-10,325, February 24, 2014) (to be codified at 29 C.F.R. pt. 2590; 45 C.F.R. pt. 147; and 26 C.F.R. pt. 147) Proposed Regulation on Minimum Essential Coverage and Other Rules Regarding Shared Responsibility Payment for Individuals (79 Fed. Reg. 4,302-4,308, January 27, 2014) (to be codified at 26 C.F.R. pt. 1) Draft Guidance Notices on Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (79 Fed. Reg. 829-830, January 7, 2014) Statement for the Record in Response to a Notice of Meeting on Employee welfare and Pension Benefit Plans (79 Fed. Reg. 28,555-28,556, May 16, 2014) Various issues relating to the Patient Protection and Affordable Care Act (P.L. 111-148), including implementation of regulatory process, legislative corrections, coverage, financing, delivery reform, 1099 reporting, ERISA preemption, Grandfathering, health savings accounts (HSAs), health reimbursement accounts (HRAs), and flexible spending accounts (FSAs) changes, CMS claims database, IPAB, CLASS program, employer mandate, reporting requirements, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, caps on compensation deductibility required under section 9014; Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including regulatory process and legislative corrections to the ERISA preemption, the impact on small business, the small business tax credit, insurance coverage, financing, delivery reform; changes to Medicare Advantage and Medicare Prescription Drug (Part D) programs non-interference with prescription drug prices; entitlement reform; forty-hour work week; health information technology

Client expense: $28,350,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service, U.S. Trade Representative (USTR), White House Office

Support H.R. 351 and S.351 to repeal the Medicare Independent Payment Advisory Board mandated by the Affordable Care Act Oppose any reduction of Medicare Part B drug and biologic reimbursement payments that will harm patients. Support robust Part D formularies and continued coverage of the six protected classes. Support raising the Part D specialty tier cost-sharing threshold above the $600 minimum, and to at least index it to inflation.Support strong Part D oversight and improved transparency for consumers, as well as a better process for notice of non-coverage, for appeals, and exceptions to provide the best access to necessary, life-saving prescription medications. Support changes to the Part D Program that would address gaps in coverage, eliminate onerous cost-shifting through the use of specialty tiers and restrictive utilization management tools. Support any changes that improve the effectiveness of the program for those receiving low income subsidies. Support the most stringent safety requirements for any substitution of biosimilar drugs for any prescribed biologic, including notification of both the patient and the prescribing physician. Oppose any cuts to the Medicare Part D Program or any legislation requiring the Secretary of Health and Human Services to "negotiate" Part D prices or rebates that will forever limit access to the best drugs and biologics for Medicare beneficiaries. Support "Fight Fraud First" efforts (rather than Medicare benefit cuts or fee increases) to reduce overall Medicare spending. Oppose any changes to the Medicare Part D program that would shift additional costs to beneficiaries or create barriers to access, both of which actions would lead to cost increases in other parts of the Medicare program. Oppose all proposed cuts to Medicare reimbursements rates for critical home health services under the Home Health Prospective Payment System (HHPPS). Support the "Part D Beneficiary Appeals Fairness Act," H.R. 2827 and S. 1365. Opposed CMS efforts to institute a 700-page Medicare Part D Prescription Drug Plan "proposed rule" that included harmful changes to the critical "Six Protected Classes" of drugs and attempted to limit drug plan choices for patients. The proposed rule threatened destructive government interference in this successful program that could only result in fewer options and higher costs for beneficiaries. Support H.R. 4160, the Keep the Promise to Seniors Act. Support H.R. 3320, a measure to broaden coverage to include more Medicare beneficiaries who could benefit from the use of a ventricular assist device (VAD). Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Supported the nomination of Kirsten Axelsen to the position of Commissioner on the Medicare Payment Advisory Commission (MedPAC). Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Urged changes to the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 that would allow telehealth to reach its full potential, including relaxed reimbursement restrictions, increased coverage, and removal of other barriers to use such as state licensure barriers. Support the Advisory Committee on Immunization Practices (ACIP) recommendations to the Centers for Medicare and Medicaid Services (CMS) related to the 13-valent pneumococcal conjugate vaccine (PCV13), including:1) Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23; 2) Adults 65 years of age or older who have not previously received PCV13 and who have previously received one or more doses of PPSV23 should receive a dose of PVC13; 3)The recommendations for routine PVC13 use among adults 65 years and older should be re-evaluated in 2018 and revised as needed. To protect at risk and high risk Medicare beneficiaries, the ACIP recommendations should be adopted and implemented without delay.

Client expense: $23,832 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., 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)

Monitor and advocate regarding pharmacy issues impacting Long Term Care and Post Acute Care providers and patients. Keep the Promise to Seniors Act of 2014, H.R. 4160

Client expense: $95,997 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA)

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

Issues related to the corporate business model, smoking cessation, Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms including telehealth, cost containment, medication adherence, restrictions on PBM cost saving tools like mail order, generics and restrictions on PBM audit practices. Issues related to Federal Employees Health Benefits Plan.Issues relating to the use of protected health information. HR 1367 - FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act S 867-Medicare Prescription Drug Program Integrity and Transparency Act HR 3392-Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013 HR 4302 Protecting Access to Medicare Act of 2014 HR 4160 The Keep your Promise to Seniors Act HR 1024-Medication Therapy Management Empowerment Act of 2013 S 557-Medication Therapy Management Empowerment Act of 2013

Client expense: $4,290,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, 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

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 H.R. 4302 - Protecting Access to Medicare Act of 2014 H.R. 4160 - Keep the Promise to Seniors Act of 2014, medicare regulation ***, no specific bill(s), Medicare, Medicare Fraud, Medicare Advantage, Medicaid, Electronic Prescribing, Health Care Reform Implementation, Medigap reform, Physician Payment Reform, Delivery System Reform, medical review, ICD-10, Benefit design, prescription drug safety

Client expense: Not reported · Firm income: $100,000

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

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 2810 Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 H.R. 4302 - Protecting Access to Medicare Act of 2014 H.R. 4160 - Keep the Promise to Seniors Act of 2014, medicare regulation ***, no specific bill(s), Medicare, Medicare and Medicaid Fraud, Medicare Advantage, Medicare Part D, Medicaid, Electronic Prescribing, Dual Eligibles, Medigap reform, claims resolution, risk adjustment, Delivery System Reform, Special Needs Plans, Star Ratings, call letter, program integrity

Client expense: Not reported · Firm income: $90,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 See addendum on additional Medicare/Medicaid issues...Addtional Medicare/Medicaid Issues: HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) To ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) To amend title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of Health and Human Services (HHS) to exclude from participation in any federal health care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 See addendum on additional Medicare/Medicaid issues...Addtional Medicare/Medicaid Issues: HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4930 Introduced June 20, 2014 by Joe Barton (R-TX) Advancing Care for Exceptional Kids Act of 2014 or the ACE Kids Act of 2014 - Amends titles XIX (Medicaid) and XXI (Children's Health Insurance) (CHIP) of the Social Security Act to extend medical assistance to payment for items and services furnished under a Medicaid Children's Care Coordination (MCCC) Program which the state may elect to provide to eligible children with complex medical conditions HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5083 Introduced July 11, 2014 by Renee Ellmers (R-NC) Medicare DMEPOS Audit Improvement and Reform (AIR) Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish a Medicare Administrative Contractor Payment Outreach and Education Program for DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) suppliers HR 5010 Introduced June 26, 2014 by Jackie Speier (D-CA) To provide greater clarity in the regulation of electronic nicotine delivery systems, including electronic cigarettes, cigars, cigarillos, pipes, and hookahs, and for other purposes. as introduced. HR 5460 Introduced September 11, 2014 by Greg Walden (R-OR) To amend title XVIII of the Social Security Act to increase access to ambulance services under the Medicare program and to reform payments for such services under such program. as introduced. (See following page on additional Medicare/Medicaid issues...)HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) To ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) To amend title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of Health and Human Services (HHS) to exclude from participation in any federal health care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity.

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, 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. 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)

HR 2190 & S 1206 - Medicare Drug Savings Act of 2011: To amend title XVIII of the Social Security Act to require drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals under the Medicare prescription drug benefit program. HR 2753 - Securing Care for Seniors Act of 2013: To amend title XVIII of the Social Security Act to improve Medicare Advantage and for other purposes. HR 2810 - Medicare Patient Access and Quality Improvement Act of 2013: Amend title XVIII of the Social Security Act to reform the sustainable growth rate and Medicare payment for physicians services and for other purposes. HR 3077 - TELE-MED Act of 2013: Amend title XVIII of the Social Security Act to permit certain Medicare providers licensed in a state to provide telemedicine services to Medicare beneficiaries in a different state. HR 3890 - Better Care Lower Cost Act: To amend title XVIII of the Social Security Act to establish a Medicare Better Care Program to provide integrated care for Medicare beneficiaries with chronic conditions. HR 4160 - Keep the Promise to Seniors Act of 2014: To prohibit further action on the proposed rule regarding change to the Medicare prescription drug benefit program. HR 4998 - Medicare Advantage Participation Bill of Rights Acts of 2014: To enhance beneficiary and provider protections and improve transparency in the Medicare Advantage market and for other purposes. HR 5183 & S 2783 - Value Based Insurance Design for Better Care Act of 2011: To establish a demonstration program requiring the utilization of value based insurance design to demonstrate that reducing the copayment or co-insurance charged to Medicare beneficiaries for selected high-value prescription medications and clinical services can increase their utilization and ultimately improve clinical outcomes and lower health care expenditures. HR 5380 - Medicare Telehealth Parity Act of 2014: To amend title XVIII of the Social Security Act to provide for a phased in expansion of telehealth coverage under Medicare program. S 1932 - Better Care and Lower Costs Act: Amend title XVIII of the Social Security Act to establish a Medicare Better Care Program to provide integrated care for Medicare beneficiaries with chronic conditions, and for other purposes. S 2000 - The SGR Repeal and Medicare Provider Payment Modernization Act: Amend title XVIII of the Social Security Act to repeal the Medicare sustainable growth rate and improve Medicare payments for physicians and other professionals and for other purposes. S 2552 - Medicare Advantage Participant Bill of Rights Act of 2014: To enhance beneficiary & provider protections and improve transparency in the Medicare Advantage market and for other purposes.

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. Issues related to the compounding of certain drugs. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid; Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data Act to Medicare/Medicaid

Client expense: $788,458 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557 / H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid; Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data Act to Medicare/Medicaid

Client expense: $788,458 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

HR 81, HR 105, HR.RES.17, HR 344, HR 544, HR 582, HR 607, HR 675, HR 762, HR 763, HR 903, HR 1076, HR 1200, HR 1205, HR 1239, HR 1248, HR 1254, HR 1342, HR 1549, HR 1558, HR 2328, HR 2527, HR 2575, HR 2577, HR 2667, HR 2995, HR 2988, HR 3362, HR 3367, HR 4244, HR 4128, HR 4144, HR 2453, HR 4160, HR 4302, HR 1179, HR 5183, HR 5557, S.CON. RES.8, S24, S351, S399, S.AMDT.409, S482, S603, S650, S701, S764, S1188, S1729, S2069, S2173, S2174, S2175, S2546,S2783

Client expense: $45,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

Support H.R. 351 and S.351 to repeal the Medicare Independent Payment Advisory Board mandated by the Affordable Care Act Oppose any reduction of Medicare Part B drug and biologic reimbursement payments that will harm patients. Support robust Part D formularies and continued coverage of the six protected classes. Support raising the Part D specialty tier cost-sharing threshold above the $600 minimum, and to at least index it to inflation.Support strong Part D oversight and improved transparency for consumers, as well as a better process for notice of non-coverage, for appeals, and exceptions to provide the best access to necessary, life-saving prescription medications. Support changes to the Part D Program that would address gaps in coverage, eliminate onerous cost-shifting through the use of specialty tiers and restrictive utilization management tools. Support any changes that improve the effectiveness of the program for those receiving low income subsidies. Support the most stringent safety requirements for any substitution of biosimilar drugs for any prescribed biologic, including notification of both the patient and the prescribing physician. Oppose any cuts to the Medicare Part D Program or any legislation requiring the Secretary of Health and Human Services to "negotiate" Part D prices or rebates that will forever limit access to the best drugs and biologics for Medicare beneficiaries. Support "Fight Fraud First" efforts (rather than Medicare benefit cuts or fee increases) to reduce overall Medicare spending. Oppose any changes to the Medicare Part D program that would shift additional costs to beneficiaries or create barriers to access, both of which actions would lead to cost increases in other parts of the Medicare program. Oppose all proposed cuts to Medicare reimbursements rates for critical home health services under the Home Health Prospective Payment System (HHPPS). Support the "Part D Beneficiary Appeals Fairness Act," H.R. 2827 and S. 1365. Opposed CMS efforts to institute a 700-page Medicare Part D Prescription Drug Plan "proposed rule" that included harmful changes to the critical "Six Protected Classes" of drugs and attempted to limit drug plan choices for patients. The proposed rule threatened destructive government interference in this successful program that could only result in fewer options and higher costs for beneficiaries. Support H.R. 4160, the Keep the Promise to Seniors Act. Support H.R. 3320, a measure to broaden coverage to include more Medicare beneficiaries who could benefit from the use of a ventricular assist device (VAD). Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Supported the nomination of Kirsten Axelsen to the position of Commissioner on the Medicare Payment Advisory Commission (MedPAC). Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Urged changes to the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 that would allow telehealth to reach its full potential, including relaxed reimbursement restrictions, increased coverage, and removal of other barriers to use such as state licensure barriers. Support the Advisory Committee on Immunization Practices (ACIP) recommendations to the Centers for Medicare and Medicaid Services (CMS) related to the 13-valent pneumococcal conjugate vaccine (PCV13), including:1) Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23; 2) Adults 65 years of age or older who have not previously received PCV13 and who have previously received one or more doses of PPSV23 should receive a dose of PVC13; 3)The recommendations for routine PVC13 use among adults 65 years and older should be re-evaluated in 2018 and revised as needed. To protect at risk and high risk Medicare beneficiaries, the ACIP recommendations should be adopted and implemented without delay.

Client expense: Not reported · Firm income: $6,683

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., SENATE

HR 4160 "The Keep the Promise to Seniors Act of 2014," all provisions relating to protected classes and non-interference provision.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to general healthcare coverage and reimbursement. Issues relating to the implementation of P.L. 111-148 "Patient Protection and Affordable Care Act of 2010," all provisions. H.R. 460 "Patients Access to Treatment Act of 2013," all provisions. H.R. 4160 "The Keep the Promise to Seniors Act of 2014," all provisions. Issues relating to the Ways and Means Discussion Draft, Tax Reform Act of 2014, all provisions. H.R.4985 "Stop Corporate Expatriation and Invest in America's Infrastructure Act of 2014," all provisions. S.2360 "Stop Corporate Inversions Act of 2014," all provisions.

Client expense: Not reported · Firm income: Not reported

Issues relating to general healthcare coverage and reimbursement. Issues relating to the implementation of P.L. 111-148 "Patient Protection and Affordable Care Act of 2010," all provisions. H.R. 460 "Patients Access to Treatment Act of 2013," all provisions. H.R. 4160 "The Keep the Promise to Seniors Act of 2014," all provisions. Issues relating to the Ways and Means Discussion Draft, Tax Reform Act of 2014, all provisions. H.R.4985 "Stop Corporate Expatriation and Invest in America's Infrastructure Act of 2014," all provisions. S.2360 "Stop Corporate Inversions Act of 2014," all provisions.

Client expense: Not reported · Firm income: Not reported

Issues relating to general healthcare coverage and reimbursement. Issues relating to the implementation of P.L. 111-148 "Patient Protection and Affordable Care Act of 2010," all provisions. H.R. 460 "Patients Access to Treatment Act of 2013," all provisions. H.R. 4160 "The Keep the Promise to Seniors Act of 2014," all provisions. Issues relating to the Ways and Means Discussion Draft, Tax Reform Act of 2014, all provisions. H.R.4985 "Stop Corporate Expatriation and Invest in America's Infrastructure Act of 2014," all provisions. S.2360 "Stop Corporate Inversions Act of 2014," all provisions.

Client expense: Not reported · Firm income: Not reported

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557 / H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid ; Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data Act to Medicare/Medicaid

Client expense: $1,318,034 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. Issues related to the compounding of certain drugs. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act S.867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R. 4160, Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid ; Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data Act to Medicare/Medicaid

Client expense: $1,318,034 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

Support H.R. 351 and S.351 to repeal the Medicare Independent Payment Advisory Board mandated by the Affordable Care Act Oppose any reduction of Medicare Part B drug and biologic reimbursement payments that will harm patients. Support robust Part D formularies and continued coverage of the six protected classes. Support raising the Part D specialty tier cost-sharing threshold above the $600 minimum, and to at least index it to inflation.Support strong Part D oversight and improved transparency for consumers, as well as a better process for notice of non-coverage, for appeals, and exceptions to provide the best access to necessary, life-saving prescription medications. Support changes to the Part D Program that would address gaps in coverage, eliminate onerous cost-shifting through the use of specialty tiers and restrictive utilization management tools. Support any changes that improve the effectiveness of the program for those receiving low income subsidies. Support the most stringent safety requirements for any substitution of biosimilar drugs for any prescribed biologic, including notification of both the patient and the prescribing physician. Oppose any cuts to the Medicare Part D Program or any legislation requiring the Secretary of Health and Human Services to "negotiate" Part D prices or rebates that will forever limit access to the best drugs and biologics for Medicare beneficiaries. Support "Fight Fraud First" efforts (rather than Medicare benefit cuts or fee increases) to reduce overall Medicare spending. Oppose any changes to the Medicare Part D program that would shift additional costs to beneficiaries or create barriers to access, both of which actions would lead to cost increases in other parts of the Medicare program. Oppose all proposed cuts to Medicare reimbursements rates for critical home health services under the Home Health Prospective Payment System (HHPPS). Support the "Part D Beneficiary Appeals Fairness Act," H.R. 2827 and S. 1365. Opposed CMS efforts to institute a 700-page Medicare Part D Prescription Drug Plan "proposed rule" that included harmful changes to the critical "Six Protected Classes" of drugs and attempted to limit drug plan choices for patients. The proposed rule threatened destructive government interference in this successful program that could only result in fewer options and higher costs for beneficiaries. Support H.R. 4160, the Keep the Promise to Seniors Act. Support H.R. 3320, a measure to broaden coverage to include more Medicare beneficiaries who could benefit from the use of a ventricular assist device (VAD). Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Supported the nomination of Kirsten Axelsen to the position of Commissioner on the Medicare Payment Advisory Commission (MedPAC). Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Urged changes to the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 that would allow telehealth to reach its full potential, including relaxed reimbursement restrictions, increased coverage, and removal of other barriers to use such as state licensure barriers.

Client expense: $23,564 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., SENATE

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, Medicare Advantage Risk Delay Part D Cuts, See addendum on additional Medicare/Medicaid issues...Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program).

Client expense: $309,446 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 81, HR 105, HR.RES.17, HR 344, HR 544, HR 582, HR 607, HR 675, HR 762, HR 763, HR 903, HR 1076, HR 1200, HR 1205, HR 1239, HR 1248, HR 1254, HR 1342, HR 1549, HR 1558, HR 2328, HR 2527, HR 2575, HR 2577, HR 2667, HR 2995, HR 2988, HR 3362, HR 3367, HR 4244, HR 4128, HR 4144, HR 2453, HR 4160, HR 4302, HR 1179, S.CON. RES.8, S24, S351, S399, S.AMDT.409, S482, S603, S650, S701, S764, S1188, S1729, S2069, S2173, S2174, S2175, S2546

Client expense: $45,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, 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. 45, To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 523, Protect Medical Innovation Act of 2013 H.R. 581, First Responder Medical Device Tax Relief Act H.R. 582, Healthcare Tax Relief and Mandate Repeal Act H.R. 763, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 781, Medicare Identity Theft Prevention Act of 2013 H.R. 903 / S. 399, American Job Protection Act H.R. 1248 / S. 610, Family Health Care Flexibility Act H.R. 1254, Auto Enroll Repeal Act H.R. 1295, Medical Device Tax Elimination Act H.R. 1558 / S. 24, Small Business Health Relief Act of 2013 H.R. 1735, In It All Together Act H.R. 1780, To provide that the only health plans that the Federal Government may make available to the President, Vice President, Members of Congress, and Federal employees are those created under the Patient Protection and Affordable Care Act or offered through a health insurance exchange H.R. 2575, Save American Workers Act H.R. 2667, Authority for Mandate Delay Act H.R. 2668, Fairness for American Families Act H.R. 2674, Job Creation Act of 2013 H.R. 2835 / S. 1647, Restoring Access to Medication Act of 2013 H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 H.R. 2988 / S. 701 / S. 1188, Forty Hours Is Full Time Act of 2013 H.R. 3077, TELE-MED Act of 2013 H.R. 3121, American Health Care Reform Act of 2013 H.R. 3124, Investing in Permanency for Youth in Foster Care Act H.R. 3204, Drug Quality and Security Act H.R. 3367, To amend section 9010 of the Patient Protection and Affordable Care Act to delay the application of the health insurance provider annual fee until 2016 and to provide a process to return to consumers any amounts attributable to the expected application of the annual fee to 2014 or 2015 H.R. 3419, Small Business Fairness in Obamacare Act H.R. 3462 / S. 1735, Self-Insurance Protection Act H.R. 4118, SIMPLE Fairness Act H.R. 4160, Keep the Promise to Seniors Act of 2014 H.R. 4302, Protecting Access to Medicare Act of 2014 H.R. 4414, Expatriate Health Coverage Clarification Act of 2014 S. 232, Medical Device Access and Innovation Protection Act S. 603, Jobs and Premium Protection Act S. 612, Social Security Number Protection Act of 2011 S. 1031, Family and Retirement Health Investment Act of 2013 S. 1488, A bill to delay the application of the individual health insurance mandate, to delay the application of the employer health insurance mandate, and for other purposes S. 1647, Restoring Access to Medication Act Proposed Regulation on the Patient Protection and Affordable Care Act: standards related to Essential Health Benefits, Actuarial Value, and Accreditation (77 Fed. Reg. 70,644-70,676, November 26, 2012) (to be codified at 45 C.F.R. pts. 147, 155, 156) Proposed Regulation on the Health Insurance Market Rules: Rate Review (77 Fed. Reg. 70,584-70,617, November 26, 2012) (to be codified at 45 C.F.R. pts. 144, 147, 150) Proposed Regulation on the HHS Notice of Benefit and Payment Parameters for 2014 (77 Fed. Reg. 73,118-73,218, December 7, 2012) (to be codified at 45 C.F.R. pts. 153, 155, 156, 157, 158) Proposed Regulation on the Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation (77 Fed. Reg. 70,644-70,676, November 26, 2012) (to be codified at 45 C.F.R. pts. 147, 155, 156) Proposed Regulation on Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing (78 Fed. Reg. 4,594-4,724, January 22, 2013) (to be codified at 42 C.F.R. pts. 430, 431, 433, 435, 440, 447, 457) Proposed Regulation on Incentives for Nondiscriminatory Wellness Programs in Group Health Plans (77 Fed. Reg. 70,620-70,642, November 26, 2012) (to be codified at 26 C.F.R. pt. 54) Proposed Regulation on Shared Responsibility for Employers Regarding Health Coverage (78 Fed. Reg. 218-253, January 2, 2013) (to be codified at 26 C.F.R. pts. 1, 54, 301) Proposed Rule on Information Reporting of Minimum Essential Coverage (78 Fed. Reg. 54,986-54,996, September 9, 2013) (to be codified at 26 C.F.R. pts. 1, 301) Proposed Rule on Information Reporting by Applicable Large Employers on Health Insurance Coverage Offered Under Employer-Sponsored Plans (78 Fed. Reg. 54,996-55,013, September 9, 2013) (to be codified at 26 C.F.R. pt. 301) Proposed Rule regarding the Establishment of Exchanges and Qualified Health Plans: Small Business Health Options Program (78 Fed. Reg. 15,553-15,558, March 11, 2013) (to be codified at 45 C.F.R. pts. 155, 156) Interim Final Rule on Procedures for the Handling of Retaliation Complaints under Section 1558 of the Affordable Care Act (78 Fed. Reg. 13,222-13,236, February 27, 2013) (to be codified at 29 C.F.R. pt. 1984) Response to the Department of Labors document FAQs about Affordable Care Act Implementation Part XI issued on January 24, 2013, regarding the Patient Protection and Affordable Care Act, on the Legality of Employer Subsidies for Individual Health Insurance Proposed Rule on the Health Insurance Providers Fee (78 Fed. Reg. 14,034-14,046, March 4, 2013) (to be codified at 26 C.F.R. pt. 57) Proposed Rule on The $500,000 Deduction Limitation for Remuneration Provided by Certain Health Insurance Providers (78 Fed. Reg. 19,950-19,977, April 2, 2013) (to be codified at 26 C.F.R. pt. 1) Proposed Rule on Minimum Value of Eligible Employer-Sponsored Plans and Other Rules Regarding the Health Insurance Premium Tax Credit (78 Fed. Reg. 25,909-25,916, May 3, 2013) (to be codified at 26 C.F.R. pt. 1) Proposed Rule on Federal Employees Health Benefits Program: Members of Congress and Congressional Staff (78 Fed. Reg. 48,337-48,339, August 8, 2013) (to be codified at 5 C.F.R. pt. 890) Proposed Rule on HHS Notice of Benefit and Payment Parameters for 2015 (78 Fed. Reg. 72,322-72,392, December 2, 2013) (to be codified at 45 C.F.R. pts. 144, 147, 153, 155, 156) Proposed Rule on Amendments to Excepted Benefits (78 Fed. Reg. 77,632-77,642, December 24, 2013) (to be codified at 29 C.F.R. pt. 2590) Draft 2015 Letter to Issuers in the Federally-facilitated Marketplace (issued on February 4, 2014, from the Center for Consumer Information and Insurance Oversight, Centers for Medicare and Medicaid Services) Proposed Rule on Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Program (79 Fed. Reg. 1,918-2,073, January 10, 2014) (to be codified at 42 C.F.R. pts. 409, 417, 422 et. al.) Proposed Rule on Administrative Simplification: Certification of Compliance for Health Plans (79 Fed. Reg. 298-324, January 2, 2014) (to be codified at 45 C.F.R. pts. 160, 162) Proposed Rule on Exchange and Insurance Market Standards for 2015 and Beyond (79 Fed. Reg. 15,808-15,879, March 21, 2014) (to be codified at 45 C.F.R. pts. 146, 147, 148 et al.) Proposed Rule on Ninety-Day Waiting Period Limitation (79 Fed. Reg. 10,320-10,325, February 24, 2014) (to be codified at 29 C.F.R. pt. 2590; 45 C.F.R. pt. 147; and 26 C.F.R. pt. 54) Proposed Rule on Minimum Essential Coverage and Other Rules Regarding Shared Responsibility Payment for Individuals (79 Fed. Reg. 4,302-4,308, January 27, 2014) (to be codified at 26 C.F.R. pt. 1) Draft Guidance Notices on Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (79 Fed. Reg. 829-830, January 7, 2014) Statement for the Record in Response to a Notice of Meeting on Employee Welfare and Pension Benefit Plans (79 Fed. Reg. 28,555-28,556, May 16, 2014) Various issues relating to the Patient Protection and Affordable Care Act (P.L. 111-148), including implementation of regulatory process, legislative corrections, coverage, financing, delivery reform, 1099 reporting, Grandfathering, HSA and FSA changes, CMS claims database, IPAB, CLASS program, employer mandate, reporting requirements, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analyses, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits; the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including regulatory process and legislative corrections to the ERISA preemption, the impact on small business, the small business tax credit, insurance coverage, financing, delivery reform; changes to Medicare Advantage and Medicare Prescription Drug (Part D) programs including rebates and non-interference with prescription drug prices; entitlement reform; health information technology

Client expense: $21,610,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Trade Representative (USTR), White House Office