Patient-Centered Outcomes Research Act of 2009

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

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

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S.1213 - Patient Centered Outcomes Research Act (all provisions); S.1142 - Informed Health Care Decision Making Act (all provisions); Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act - issues related to comparative effectiveness and physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related to comparative effectiveness and physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009" - issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010 - issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general; H. Res. 1438 - Promoting Increased Awarness and Diagnosis of Peripheral Arterial Disease (all provisions); General issues related to BPA.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform, and the FDA device approval process; S.1213 - Patient Centered Outcomes Research Act (all provisions); S.1142 - Informed Health Care Decision Making Act (all provisions); Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act - issues related to comparative effectiveness and physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related to comparative effectiveness and physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009" - issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010 - issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general, H. Res. 1438 - Promoting increased Awareness and Diagnosis of Peripheral Arterial Disease (all provisions).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S.1213 - Patient Centered Outcomes Research Act (all provisions); S.1142 - Informed Health Care Decision Making Act (all provisions); Issues related to FDA 510(K) legislative changes. S.1679 - Affordable Health Choice Act - provisions related to comparative effectiveness and physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - provisions related to comparative effectiveness and physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009" - provisions related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010 - provisions related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general.

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act (all provisions); H.R. 2502 - Comparative Effective Research Act of 2009 (all provisions); S. 1142 - Informed Health Care Decision Making Act (all provisions). S. 1679 - Affordable Health Choice Act (all provisions); H.R. 3590 - Patient Protection and Affordable Care Act of 2009 (all provisions); H.R. 3962 - Affordable Healthcare for American Act (all provisions); S. 1796 - "The Americas Healthy Future Act of 2009" (all provisions); Issues relating to the medical device tax/fee; Senate Finance Committee Healthcare Reform Bill; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010 (all provisions).

Client expense: $490,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Rx drug importation into the US, other than by drug manufacturer (no specific bill); requiring safety and cost savings certification by HHS Sec'y in any Rx drug importation legislation (no specific bill); promote public/private partnerships for comparative effectiveness assessments (S. 1213); Physician Payments Sunshine Act of 2009 (S. 301); health care reform; increasing coverage of uninsured; coverage of preventative services; including immunizations; expansion of the 340B pricing program to include additional covered entities and inpatient prescription drug utilization; maintaining market-based, private sector health care delivery system (H.R. 3200; S. 1679; S. 1796; H.R. 3590; H.R. 4872)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Health care reform and issues in both health care reform and independent legislation. See following page. See also Medicare and Medicaid. Support implementation of comprehensive health care reform legislation (Patient Protection and Affordable Care Act, HR 3590 and Health Care & Education Reconciliation Act of 201, HR 4872) and the related goals of reducing costs, improving quality and expanding health care coverage for Americans with disabilities and chronic conditions and all Americans (including those who lack health insurance). Issues with asterisks * indicate legislation pursued both as part of health care reform and independently. Issues include: Provide for health coverage that adequately meets the needs of people with disabilities and chronic conditions including -- Covering durable medical equipment, prosthetics and orthotics (DMEPOS) including but not limited to power wheelchairs that meet the individual needs of people with disabilities and chronic conditions, enable them to be as independent as possible, to live in their homes and participate in their communities, and enable them to be employed without fear of losing health care/services and supports they need. This includes retaining the first month purchase option for people who have permanent or long-term need for power wheelchairs and including DMEPOS as covered in essential health insurance benefits; delaying CMS competitive bidding program; and having DMEPOS included as essential benefits in health insurance coverage. Providing insurance market reforms, such as those included in House and/or Senate bills, that could greatly improve the lives of people with disabilities and chronic conditions by allowing increased access to health care, such as: --Requiring health insurers to provide the same coverage, charge the same premiums and renew policies to people no matter what their disability or other pre-existing or newly acquired conditions. Currently, unless they have employer-sponsored plans, people with disabilities are often denied coverage altogether, the policies exclude needed services or the premiums are way too costly. --Prohibiting annual and lifetime caps on coverage. People with serious injuries or conditions often quickly exceed these caps due to lengthy hospital stays and/or extensive rehabilitation -- Requiring health insurance to cover rehabilitation and habilitative services. -- Providing for a temporary high risk pool through which people with disabilities and other pre-existing conditions may obtain health insurance pending full implementation of health insurance market reforms. Concerns about the proposed excise tax on medical devices -- that an excise tax on manufacturers would increase their costs which are likely to be passed on to consumers, resulting in increased costs for medical equipment for people with disabilities and chronic conditions who depend on them. Providing for prevention and wellness including --Developing standards for accessible medical equipment; --Authorizing funds to establish a Prevention and Public Health Investment Fund; --Providing for community Transformation Grants that include focus on the needs of people with disabilities; -- Including disability status within data collection on health disparities; -- Proving training programs for primary care providers and dentistry professionals on how to treat individuals with disabilities; Concerns about well-intended wellness provisions that reward people for meeting health standards set by employers and insurance companies with potentially serious unintended onsequences that people with disabilities or other chronic conditions will be unable to meet the health or participation standards because of a limitation, and consequently they would have to pay more for their health coverage, including but not limited to higher deductibles, than people without disabilities or chronic conditions. Providing for comparative effectiveness research and using the resulting information in a way that respects that what works for many people will not work for all; Providing for home and community-based services and supports for people with disabilities and chronic conditions such as Community Living Assistance and Supports (CLASS) provisions* and the Community First ChoiceOption in health care reform. Support increasing Medicaid elibility to a nationwide standard for those whose incomes are up to 133% of the Federal Poverty Level. Since many people with disabilities have low incomes, this would extend Medicaid coverage to many people with disabilities, including childless adults. - Support elimination of Medicare Part D coverage gap (Part D "donut hole") and immediate $250 rebate for beneficiaries who fall into donut hole in 2010. continued next page Note -- Asterisk * indicates issue pursued both independently and as part of health care reform. CLASS Act* -- S. 697/H.R. 1721 included in HR 3590 (Senate health care reform bill) and HR 3962 (House health care reform bill) . Support legislation to establish a voluntary payroll deduction insurance plan so that people with disabilities will be able to pay for assistance with activities of daily living. This would enable them to remain in their homes and off of the Medicaid program. CBO estimates that the CLASS provisions will save Medicaid $2.5 billion in the first 10 years alone. Community Choice Act* (S. 683/H.R. 1670). Support legislation to make services in the home and community the norm under Medicaid - enabling people to stay in their homes and remain part of their communities rather than having to go into nursing homes or other institutions to receive needed services. Became Community First Choice Option in health care reform bills. End Medicares 24-month waiting period* - S 700/HR 1708. Support legislation to end the waiting period for Medicare for people who qualify for Title II Social Security disability benefits and people with life-threatening conditions. Comparative Effectiveness Research HR 2502/S 1213* Support legislation to create non-government independent entities to study the comparative effectiveness of treatments in health care. Mental Illness Chronic Care Improvement (MICCI) Act, S 1136* Support legislation to facilitate access to needed medical services. Amend the Medicare Savings Programs and the Low Income Subsidy* to align, simplify and increase income eligibility, eliminate or substantially increase asset limits, stabilize the programs and make administrative simplifications. First month purchase option* Advocated to maintain the current ability for Medicare beneficiaries to purchase their power wheelchair in the first month of use. Both the House and Senate included language in health reform that would require a beneficiary to rent a power wheelchair for 13 months before purchase. Supported inclusion in HR 3590 and HR 3962 of provisions to exempt Class III and higher power wheel chairs from the rental period and to retain the first-month purchase option under existing law. Community First Choice Option* would allow states to create Medicaid plans that would reverse the institutional bias in Medicaid. The option would provide a 6% increase in FMAP matching funds to states. Supported H.R.2575 to provide parity under group health plans and group health insurance coverage in the provision of benefits for prosthetic devices and orthotics devices, components and benefits for other medical and surgical services. Met with senior HHS officials to talk about implementation of health reform. See also Medicare and Medicaid.

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

Government targets: AMTRAK - Natl Railroad Passenger Corporation, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

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

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Medicare issues; payment policies for prescription drugs; implementation of H.R.1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patient Protection and Affordable Care Act; H.R.4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S726/H.R. 1427 Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Compartiveffectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act; American Health Future Act of 2009; Pharmaceutical Import Safety legislation.

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 - Informed Health Care Decision Making Act H.R. 3276 - Nuclear Medicine and Research Legislation Medical Device Tax H.R. 3590 - Patient Protection and Affordable Care Act implementation H.R. 4872 - Health Care and Education Reconciliation Act of 2010 implementation H.R. 4956 - Stop Oxy Abuse Act of 2010 Issues related to 510(k) changes

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138, Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations 510(k) REform Patient Safety Organizations S 3737, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1451, FAA Air Transportation Modernization and Safety Improvement Act HR 4994, Medicare and Medicaid Extenders Act of 2010

Client expense: $7,240,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R.3590, Patient Protection and Affordable Care Act - Lobbied in support of and on implementation of health care legislation that would reform the health care system to provide affordable quality health care and expand access to long-term services and supports. Provided information on the need for nursing education capacity and the retention of newer and older nurses in the workplace (no bill). S.1569/H.R.3185, Medicare Graduate Nursing Education Act - Advocated for modernizing Medicare funding so that nursing education funds are directed to advanced nurse practice programs to help produce more highly-skilled nurses to care for the Medicare population. S. 623/HR 1558, Pre-existing Condition Patient Protection Act of 2009 - Lobbied in support of bill that would prohibit insurers from denying health insurance or delaying coverage for people with pre-existing conditions. H.R. 2778, Health Equity and Accountability through Research Act of 2009 - Lobbied in support of bill that would address racial and ethnic disparities in care. S. 979/HR 2360, Small Business Health Options Programs Act - Lobbied in support of bill that would establish a nationwide health insurance purchasing pool for small businesses and the self-employed that would offer a choice of private health plans and make health coverage more affordable, predictable and accessible. S.1213, Patient-Centered Outcomes Research Act - Lobbied in support of bill that would create a public-private partnership to conduct and disseminate comparative effectiveness research. S. 726/H.R. 1427, Promoting Innovation and Access to Life Saving Medicines - Discussed legislation which would create a pathway for approval of safe, effective biosimilar and generic biologic drugs. H.R. 3090, Health Equity and Accountability Act - Discussed need to end racial and ethnic disparities in care. S. 3686, Labor, HHS, Education and Related Agencies Appropriations Act FY 2011 - Lobbied for funding for healthcare services, research and training involving NIH, AHRQ, CMS, HRSA, HHS and AOA. H.R. 3082, H.R. 3081, H.J. Res.101, H.J. Res. 105, Continuing Appropriations and Surface Transportation Extensions Act, 2011 - Lobbied for funding for various federal programs serving Older Americans, most notably SSA Administrative expenses, LIHEAP, aging services, HECM reverse mortgage subsidy and Section 202, Housing for the Elderly. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care law which makes improvements such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act and implementation of some provisions. H.R. 5364, Special Care Dentistry Act - Discussed bill that would require states to provide oral health coverage for aged, blind,or disabled individuals through a separate state adult dental program, with 100% federal match. H.R. 4213, American Workers, State and Business Relief Act/American Jobs and Closing Tax Loopholes Act - Lobbied for extension of UI, COBRA, FMAP, and SGR. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for SSA, various health care, employment, aging services and nutrition programs. H.R. 4224, Together We Care Act - Bill creates a three-year pilot program to train public housing residents to provide covered home-based health services. H.R. 5853, Fiscal Responsibility and Retirement Security Act - Bill requires review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes. S. 2814, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare. H.R. 4993, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare.

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R.3590, Patient Protection and Affordable Care Act - Lobbied in support of and on implementation of health care legislation that would reform the health care system to provide affordable quality health care and expand access to long-term services and supports. Provided information on the need for nursing education capacity and the retention of newer and older nurses in the workplace (no bill). S.1569/H.R.3185, Medicare Graduate Nursing Education Act - Advocated for modernizing Medicare funding so that nursing education funds are directed to advanced nurse practice programs to help produce more highly-skilled nurses to care for the Medicare population. S. 623/HR 1558, Pre-existing Condition Patient Protection Act of 2009 - Lobbied in support of bill that would prohibit insurers from denying health insurance or delaying coverage for people with pre-existing conditions. H.R. 2778, Health Equity and Accountability through Research Act of 2009 - Lobbied in support of bill that would address racial and ethnic disparities in care. S. 979/HR 2360, Small Business Health Options Programs Act - Lobbied in support of bill that would establish a nationwide health insurance purchasing pool for small businesses and the self-employed that would offer a choice of private health plans and make health coverage more affordable, predictable and accessible. S.1213, Patient-Centered Outcomes Research Act - Lobbied in support of bill that would create a public-private partnership to conduct and disseminate comparative effectiveness research. S. 726/H.R. 1427, Promoting Innovation and Access to Life Saving Medicines - Discussed legislation which would create a pathway for approval of safe, effective biosimilar and generic biologic drugs. H.R. 3090, Health Equity and Accountability Act - Discussed need to end racial and ethnic disparities in care. S. 3686, Labor, HHS, Education and Related Agencies Appropriations Act FY 2011 - Lobbied for funding for healthcare services, research and training involving NIH, AHRQ, CMS, HRSA, HHS and AOA. H.R. 3082, H.R. 3081, H.J. Res.101, H.J. Res. 105, Continuing Appropriations and Surface Transportation Extensions Act, 2011 - Lobbied for funding for various federal programs serving Older Americans, most notably SSA Administrative expenses, LIHEAP, aging services, HECM reverse mortgage subsidy and Section 202, Housing for the Elderly. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care law which makes improvements such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act and implementation of some provisions. H.R. 5364, Special Care Dentistry Act - Discussed bill that would require states to provide oral health coverage for aged, blind,or disabled individuals through a separate state adult dental program, with 100% federal match. H.R. 4213, American Workers, State and Business Relief Act/American Jobs and Closing Tax Loopholes Act - Lobbied for extension of UI, COBRA, FMAP, and SGR. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for SSA, various health care, employment, aging services and nutrition programs. H.R. 4224, Together We Care Act - Bill creates a three-year pilot program to train public housing residents to provide covered home-based health services. H.R. 5853, Fiscal Responsibility and Retirement Security Act - Bill requires review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes. S. 2814, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare. H.R. 4993, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare.

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues

Client expense: $4,900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Physician payment disclosure including S. 301; Physician Payments Sunshine Act of 2009; H.R. 3962, Affordable Health Care for Americans Act; H.R. 3590, Patient Protection and Affordable Care Act; H.R. 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R. 1427, Promoting Innovation and Access to Life Savings Medicines Act; H.R. 3962, Affordable Health Care for America Act; Comparative effectiveness legislation including S. 1213; Patient-Centered Outcomes Research Act of 2009; H.R. 3200, America's Health Future Act; H.R. 1548- Pathway for Dissimilar Act; Legislative changes in the health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act."; S. 1679, Affordable Health Choice Act; S. 1796, America's Healthy Future Act of 2009; Pharmaceutical import safety legislation.

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Community Pharmacy Fairness Act of 2009 H.R. 1204 Healthy Americans Act H.R. 1321 Emergency Retiree Health Benefits Protection Act H.R. 1322 Family Leave Insurance Act of 2009 H.R. 1723 Long-Term Care Affordability and Security Act of 2009 H.R. 2096 Healthy Families Act H.R. 2460 The Patients Choice Act H.R. 2520 Tax Equity for Health Plan Beneficiaries Act of 2009 H.R. 2625 Prevent application of ERISA preemption to state law causes of action - H.R. 3925 Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 -H.R. 3962/Public Law No: 111-192 Common Sense Health Care Reform and Affordability Act H.R. 4038 American Workers, State, and Business Relief Act H.R. 4213, Unemployment Compensation Extension Act of 2010 Public Law No: 111-205 Medicare and Medicaid Extenders Act H.R. 4994 Health Care Reform regulatory implementation and compliance issues from the Patient Protection and Affordable Care Act (PPACA) Public Law No: 111-148 & the Health Care and Education Reconciliation Act of 2010 (HCERA) Public Law No: 111-152 National Commission on Fiscal Responsibility and Reform implications for benefits Senate Healthy Americans Act - S. 391 Long-Term Care Affordability and Security Act of 2009 S. 702 The Patients Choice Act S. 1099 Healthy Families Act S. 1152 Tax Equity for Health Plan Beneficiaries Act of 2009 S. 1153 Confidence in Long-Term Care Insurance Act S. 1177 Patient Centered Outcomes Research Act S. 1213 American Jobs Protection Act S. 3501 American Workers, State, and Business Relief Act H.R. 4213 & substitute amendment Small Business Paperwork Relief Act S. 3946 Empowering States to Innovate Act S. 3958 Medicare and Medicaid Extenders Act H.R. 4994 Health Care Reform regulatory implementation and compliance issues from the Patient Protection and Affordable Care Act (PPACA) Public Law No: 111-148 & the Health Care and Education Reconciliation Act of 2010 (HCERA) Public Law 111-152 National Commission on Fiscal Responsibility and Reform implications for benefits Regulatory Proposed rule on application of ERISA to state/local health reform efforts COBRA premium subsidy assistance extension American Recovery and Reinvestment Act of 2009 (ARRA) included in the Department of Defense Appropriations Act of 2010 Guidance for and implementation of the Patient Protection and Affordable Care Act (PPACA) & the Health Care and Education Reconciliation Act of 2010 (HCERA) employer responsibility provisions, tax treatment of certain plans, transition period and good faith compliance standard, CLASS Act provisions, Early Retiree Reinsurance Program (ERRP), retiree only plans, grandfathered plans, grandfathering rules as applied to collectively bargained health plans, coverage of adult children, medical loss ratios (MLRs), limited benefit plans, quality improvement initiatives, meaningful use rules, preventive care, preexisting conditions, annual & lifetime limits, patient protections, claims and appeals procedures, external review, health information technology & electronic health records, health literacy and insurance exchanges, wellness, tax reporting issues, non-discrimination requirements Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 comments on Interim Final Regulations. Health Information Technology for Economic and Clinical Health (HITECH) Act

Client expense: $272,633 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

- HR 109, "To provide for the offering of Health Benefit Plans to individuals, to increase funding for State high risk health insurance pools, and to promote best practice protocols for State high risk pools" a/k/a "America's Affordable Health Care Act", regarding all provisions. - S 391/HR 1321, "A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away" a/k/a "Healthy Americans Act", regarding all provisions. - HR 1, "Making supplemental appropriations for job preservation and creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for fiscal year ending September 30, 2009, and for other purposes" a/k/a "American Recovery and Reinvestment Act of 2009", regarding COBRA Benefits Section 3002 and Comparative Effectiveness Council Section 9201. - HR 2096/S 702, "To amend the Internal Revenue Code of 1986 to allow long-term care insurance to be offered under cafeteria plans and flexible spending arrangements and to provide additional consumer protections for long-term care insurance", a/k/a "The Long-Term Care Affordability and Security Act of 2009", regarding all provisions. - S 1177, "A bill to improve consumer protections for purchasers of long-term care insurance, and for other purposes", a/k/a "Long-Term Care Insurance Act of 2009", regarding all provisions. - HR 2520, "To provide comprehensive solutions for the health care system of the United States, and for other purposes", a/k/a "Patients Choice Act", regarding all provisions. - S 1099, "A bill to provide comprehensive solutions for the health care system of the United States, and for other purposes", a/k/a "Patients Choice Act", regarding all provisions. - S 1213, "A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Patient-Centered Outcomes Research Trust Fund, and for other purposes", a/k/a "Patient-Centered Outcome Research Act of 2009", regarding all provisions. - HR 1721/S 697, "A bill to amend the Public Health Service Act to help individuals with functional impairments and their families pay for services and supports that they need to maximize their functionality and independence and have choices about community participation, education, and employment, and for other purposes", a/k/a "Community Living Assistance Services and Supports Act", regarding all provisions. - S 1679, "An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce", a/k/a "Affordable Health Choices Act", regarding all provisions. - S 1730, "A bill to provide for minimum loss ratios for health insurance coverage", a/k/a "Fairness in Health Insurance Act of 2009", regarding all provisions. - HR 3200, "To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes", a/k/a "America's Affordable Health Choices Act of 2009" regarding all provisions. - HR 3962, "To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes", a/k/a, "Affordable Health Care for America Act", regarding all provisions. - HR 3590, "Patient Protection & Affordable Care Act", regarding all provisions. - S 1636, "A bill to develop a model disclosure form to assist consumers in purchasing long-term care insurance", a/k/a "Long-Term Care Insurance Consumer Right-to-Know Act", regarding all provisions. - HR 4372, "Health Care and Education Affordability Reconciliation Act", regarding all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

H.R. 43/S.46 - Medicare Access to Rehabilitation Services Act of 2009 H.R. 1137 - Athletic Trainers' Equal Access to Medicare Act of 2009 H.R. 1829/ S. 950 - Medicare Patient Access to Physical Therapists Act of 2009 H.R. 1430 - The Medicare Oral Health Rehabilitative Enhancement Act Revisions to the home health assessment instrument OASIS National Quality Forum home health quality measures Cardiac and Pulmonary Rehab national coverage policies AHRQ technical assessment of negative pressure wound therapy devices Comprehensive assessment regarding the development of HCPCS codes for negative pressure wound therapy (sign on) Analysis of the Inpatient Rehabilitation Condition of Participation (COP) on rehab agencies Importance of support personnel and related services under IDEA and ESEA. Development of a Plan to Transition to a Medicare Value-Based Purchasing (VBP) Program for Physician and Other Professional Services Issues Paper (comments) Changes to Medicare payment policies (STATS workgroup), development of short-term alternatives Section 427 of Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) Quality Measures Medically Unbelievable Edits (comments) DMEPOS Accreditation AMA Physician Consortium for Performance Improvement EMG performance Physical Medicine and Rehabilitation LCD (comments) Physician Quality Reporting Initiative Provider Enrollment Post Acute Care Issues-HHPPS Proposed Rule 2011, SNF Updates 2011 Post Acute Care Payment Reform Demonstration, including development and testing of CARE tool Development of long term alternatives to the therapy cap - "Developing Outpatient Therapy Alternatives Project" (DOTPA) Medicare Orthotics and Prosthetics Physician Fee Schedule Update Sustainable Growth Rate (SGR) Inpatient Rehab Issues Medicaid Rules H.R. 1094- The Medicare Home Health Flexibility Act Inclusion of Physical Therapists in the Medicare & Medicaid Health Information Technology incentives S. 1213- Patient Centered Outcomes Research Act of 2009 H.R. 2068- Medicare Telehealth Enhancement Act of 2009 H.R. 1094- Medicare Home Health Flexibility Act The Addition of a program to the Center for Medicare Services Innovation Center to research direct access models for expanding access to physical therapy for Medicare beneficiaries. Medicare SNF PPS FY 2010 Medicare IRF PPS FY 2010 Medicare Home Health PPS CY 2010 H.R. 3590 Patient Protection and Affordable Care Act Physician Practice Information Survey (PPIS) H.R. 4371- To amend title XVIII of the Social Security Act to continue using 2009 Medicare practice expense relative value units for certain cardiology services. H.R. 4872- Health Care & Education Affordability Reconciliation Act H.R. 4851-Continuing Extension Act of 2010 H.R. 4154- American Workers State and Business Relief Act of 2010 H.R. 4662- Lymphedema Diagnosis and Treatment Cost Saving Act of 2010 H.R. 3962- Preservation of Access to Care for Medicare Beneficiaries & Pension Relief Act H.R. 4213- American Jobs, Closing Loopholes and Preventing Outsourcing Act 2011 Medicare Physician Fee Schedule Proposed Rule Health Care Truth and Transparency Legislative Recommendations for Medicaid & CHIP- RFI June 2010 MedPAC Report to Congress-Aligning Incentives in Medicare H.R. 2575/S.3220 -Prosthetic and Custom Orthotic Parity Act of 2009 H.R. 2479- Medicare Orthotics and Prosthetics Improvement Act of 2009 HIT Rules- Meaningful Use Health Exchanges Proposed Rule Multiple Procedure Payment Reduction In Office Ancillary Services/Self Referral Annual Wellness Visit Rule Extension of Federal Medical Assistance Percentages H.R. 4994- the Medicare and Medicaid Extenders Act H.R. 5712- the Physician Payment and Therapy Relief Act of 2010 Comments on Physician Compare Federal External Review Process Comments

Client expense: $240,000 · 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), Defense, Dept of (DOD), Education, Dept of, Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

Medicare and Medicaid reform; Medicare competitive bidding; PL 108-173: Medicare Prescription Drug and Modernization Act of 2003; Federal Medical Assistance Percentage legislation; budget resolutions; Community Choice Act; Economic Recovery in Health Care Act; S 1213: Patient Centered Outcomes Research Act; HR 2502: Comparative Effectiveness Research Act; PL 111-148: Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; HR 4872: Health Care and Education Reconciliation Act of 2010.

Client expense: $51,583 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office

HR 3248/ S 1283: Lifespan Respite Care Act of 2005; HR 4281: Small Business Health Fairness Act; PL 109-365: Older Americans Act Amendments of 2006; Older Americans Act Reauthorization; Healthcare reform policy; HR 3267/S 1760: Healthy Start Reauthorization Act of 2007; HR 1017/S 578: Protecting Children's Health in Schools Act; HR 6111: Tax Relief and Health Care Act of 2006; Combating Autism Act; Expanding the Promise for Individuals with Autism Act; FY 2009 and FY 2010 Labor-HHS-Education Appropriations; PL 110-343: Paul Wellstone and Pete Domenici Mental Health Parity Act; HR 2502: Comparative Effectiveness Research Act of 2009; S 1213: Patient Centered Outcomes Research Act of 2009; HR 3200/S 1679: America's Affordable Health Choices Act of 2009; HR 1708/S 700: Ending the Medicare Disability Waiting Period Act of 2009; S 1630: Affordable Access to Prescription Medications Act of 2009; PL 111-148: The Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; HR 4872: Health Care and Education Reconciliation Act of 2010; HR 4213 American Jobs and Closing Tax Loopholes Act; PL 111-192: Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act; and H R 4994: Medicare and Medicaid Extenders Act of 2010.

Client expense: $51,583 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office

General Issues related to healthcare, healthcare reimbursement, healthcare reform, and the FDA device approval process; S.1213 Patient Centered Outcomes Rresearch Act- issues regarding all provisions; S. 1142 - Informed Health Care Decision Making Act- issues regarding all provision; Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act- issues related comparative effectiveness & physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related comparative effectiveness & physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009"- issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010- issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general; House Resolutions 1438, Promoting Increased Awareness and Diagnosis of Peripheral Arterial Disease - Generally; General issues related to BPA.

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare issues; payment policies for prescription drugs; implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patitient Protection and Affordable Care Act; H.R> 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R.1427, Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Comparativ effectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act;, American Health Future Act of 2009; Pharmaceutical Import safety legislation.

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page S. 1213 - Patient-Centered Outcomes Research Act of 2009, comparative effectiveness PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page S. 301/H.R. 3138 Physician Payments Sunshine Act of 2009, disclosure H.R. 759 Food and Drug Administration Globalization Act S. 510 - FDA Food Safety Modernization Act S. 1213 - Patient-Centered Outcomes Research Act of 2009, comparative effectiveness PL 111-148 - The Patient Protection and Affordable Care Act, implementation ***, no specific bill(s), 510k reform, imaging policy

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

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

**see addendum page S. 1213 - Patient-Centered Outcomes Research Act of 2009, comparative effectiveness Biosimilars S. 726/H.R. 1427 Access to Life-Saving Medicine Act, Follow-on Biologics H.R. 1548 The Pathway for Biosimilars Act Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation

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

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

**see addendum page H.R. 756 - National Pain Care Policy Act, pain management S. 1213 Patient-Centered Outcomes Research Act of 2009, comparative effectiveness S. 301/H.R. 3138 Physician Payments Sunshine Act of 2009, disclosure H.R. 1346/S. 540 Medical Device Safety Act of 2009, preemption PL 111-148 - The Patient Protection and Affordable Care Act, implementation Import Safety H.R. 759 - Food and Drug Administration Globalization Act of 2009 S. 510 - FDA Food Safety Modernization Act ***, no specific bill(s), import safety, price transparency, health care reform, 510k reform

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

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

Omnibus health Care Reform legislation to be introduced. S. 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Patient-Centered Outcomes Research Trust Fund, and for other purposes. S. 1259 - A bill to protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in personalized medicine and differences in patient treatment response. H.R. 2520 - To provide comprehensive solutions for the health care system of the United States, and for other purposes. H.R. 3200 - To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 1796 - An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 1679 - An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R. 3962 - To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590 - An act entitled The Patient Protection and Affordable Care Act. H.R. 4872 - Health Care and Education Reconciliation Act of 2010.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

EPA memorandum of Understanding (MOU) with EPA to help reduce amalgam in the environment; H.R. 2400, Strategies to Address Anti-microbial Resistance Act; STATE, Internation Agreement on Mercury Emissions; EPA - Proposed rule to protect waterways by reducing mercury from dental offices. S. 1259, Preserving Access to Targeted, Individualized, and Effective new Treatments and Service (PATIENTS) Act of 2009; H.R. 3856, Bone Health Promotion and Research Act of 2009; H.R. 4731, Lead in Dental Crowns issue; H.R. 2824, Doctor-Patient Relationship and Research Protection Act; S. 1213, Patient-Centered Outcomes Research Act of 2009; H.Res. 648, Expressing the need for enhanced public awareness of potential health effects posed by mercury; H.R. 4615, Consumers Have Options for Molar Protection Act of 2009; H.R. 4731, Medicaid Options for Dental Fillings Act of 2010. H.R. 5116/S. 3605, America COMPETES Reauthorization Act of 2010; Agency for Healthcare Research and Quality (AHRQ) reauthorization; AHRQ, U.S. Preventative Services Taskforce; AHRQ, National Advisory Council for Healthcare Research and Quality; FDA Dental Products Panel of the Medical Devices Advisory Committeee; NIH, National Advisory on Dental & Craniofacial Research Council; NIH, National Advisory Committee to the NIH DIrector; NIH, Working Group of the NIH Advisory Committee to the Director; Patient-Centered Outcomes Research Institute.

Client expense: $590,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Air Force, Dept of, Army, Dept of (Other), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Natl Institutes of Health (NIH), Navy, Dept of, Occupational Safety & Health Administration (OSHA), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

H.R. 1427, Promoting Innovations and Lifesaving Medicines Act; H.R. 3590, Patient Protection and Affordable Care Act; H.R. 4872, The Health Care and Education Reconciliation Act of 2010. S. 525, S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009. Issues pertaining to: prescription drug importation, comparative effectiveness, follow-on biologics, Medicare prescription drug coverage, Medicaid rebates. H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues. H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation. H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness. H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness. H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring. H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances. S. 1203, Grow Research Opportunities with Taxcredits' Help Act: R&D tax credit provisions. S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness. S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues. S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

See page three HR 1 American Recovery and Reinvestment Act of 2009 HR 805 / S 1028 Strengthening America's Public Health System Act H.R. 1105 FY 2009 Omnibus Appropriations Act HR 1321 Healthy Americans Act HR 1452 Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2009 HR 1699 / S 1220 Patient Access to Critical Lab Tests Act HR 2400 Strategies to Address Antimicrobial Resistance Act HR 2502 Comparative Effectiveness Research Act of 2009 HR 2824 Doctor-Patient Relationship and Research Protection Act HR 2937/ S 1305 MRSA Infection Prevention and Patient Protection Act HR 3104 Healthy Hospitals Act of 2009 HR 3002 / S 1259 PATIENTS Act of 2009 HR 3200 America's Affordable Health Choices Act of 2009 HR 3590 Patient Protection and Affordable Care Act HR 3962 Affordable Health Care for America Act HR 6331 Generating Antibiotic Incentives Now Act S 1208 Strengthening America's Public Health System Act S 1213 Patient-Centered Outcomes Research Act of 2009 S 1220 Patient Access to Critical Lab Tests Act S 1299 Worker Infection Protection Act S. 1679 Affordable Health Choices Act S. 1796 America's Healthy Future Act of 2009

Client expense: $30,000 · 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page five HR 1 American Recovery and Reinvestment Act of 2009 HR 805 / S 1028 Strengthening America's Public Health System Act H.R. 1105 FY 2009 Omnibus Appropriations Act HR 1321 Healthy Americans Act HR 1452 Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2009 HR 1699 / S 1220 Patient Access to Critical Lab Tests Act HR 2400 Strategies to Address Antimicrobial Resistance Act HR 2502 Comparative Effectiveness Research Act of 2009 HR 2824 Doctor-Patient Relationship and Research Protection Act HR 2937/ S 1305 MRSA Infection Prevention and Patient Protection Act HR 3104 Healthy Hospitals Act of 2009 HR 3002 / S 1259 PATIENTS Act of 2009 HR 3200 America's Affordable Health Choices Act of 2009 HR 3590 Patient Protection and Affordable Care Act HR 3962 Affordable Health Care for America Act HR 6331 Generating Antibiotic Incentives Now Act S 1208 Strengthening America's Public Health System Act S 1213 Patient-Centered Outcomes Research Act of 2009 S 1220 Patient Access to Critical Lab Tests Act S 1299 Worker Infection Protection Act S. 1679 Affordable Health Choices Act S. 1796 America's Healthy Future Act of 2009

Client expense: $30,000 · 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

Omnibus health Care Reform legislation to be introduced. S. 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Patient-Centered Outcomes Research Trust Fund, and for other purposes. S. 1259 - A bill to protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in personalized medicine and differences in patient treatment response. H.R. 2520 - To provide comprehensive solutions for the health care system of the United States, and for other purposes. H.R. 3200 - To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 1796 - An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 1679 - An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R. 3962 - To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590 - An act entitled The Patient Protection and Affordable Care Act. H.R. 4872 - Health Care and Education Reconciliation Act of 2010.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care reform and issues in both health care reform and independent legislation. See following page. See also Medicare and Medicaid. Support implementation of comprehensive health care reform legislation (Patient Protection and Affordable Care Act, HR 3590 and Health Care & Education Reconciliation Act of 201, HR 4872) and the related goals of reducing costs, improving quality and expanding health care coverage for Americans with disabilities and chronic conditions and all Americans (including those who lack health insurance). Issues with asterisks * indicate legislation pursued both as part of health care reform and independently. Issues include: Provide for health coverage that adequately meets the needs of people with disabilities and chronic conditions including -- Covering durable medical equipment, prosthetics and orthotics (DMEPOS) including but not limited to power wheelchairs that meet the individual needs of people with disabilities and chronic conditions, enable them to be as independent as possible, to live in their homes and participate in their communities, and enable them to be employed without fear of losing health care/services and supports they need. This includes retaining the first month purchase option for people who have permanent or long-term need for power wheelchairs and including DMEPOS as covered in essential health insurance benefits; delaying CMS competitive bidding program; and having DMEPOS included as essential benefits in health insurance coverage. Providing insurance market reforms, such as those included in House and/or Senate bills, that could greatly improve the lives of people with disabilities and chronic conditions by allowing increased access to health care, such as: --Requiring health insurers to provide the same coverage, charge the same premiums and renew policies to people no matter what their disability or other pre-existing or newly acquired conditions. Currently, unless they have employer-sponsored plans, people with disabilities are often denied coverage altogether, the policies exclude needed services or the premiums are way too costly. --Prohibiting annual and lifetime caps on coverage. People with serious injuries or conditions often quickly exceed these caps due to lengthy hospital stays and/or extensive rehabilitation -- Requiring health insurance to cover rehabilitation and habilitative services. -- Providing for a temporary high risk pool through which people with disabilities and other pre-existing conditions may obtain health insurance pending full implementation of health insurance market reforms. Concerns about the proposed excise tax on medical devices -- that an excise tax on manufacturers would increase their costs which are likely to be passed on to consumers, resulting in increased costs for medical equipment for people with disabilities and chronic conditions who depend on them. Providing for prevention and wellness including --Developing standards for accessible medical equipment; --Authorizing funds to establish a Prevention and Public Health Investment Fund; --Providing for community Transformation Grants that include focus on the needs of people with disabilities; -- Including disability status within data collection on health disparities; -- Proving training programs for primary care providers and dentistry professionals on how to treat individuals with disabilities; Concerns about well-intended wellness provisions that reward people for meeting health standards set by employers and insurance companies with potentially serious unintended onsequences that people with disabilities or other chronic conditions will be unable to meet the health or participation standards because of a limitation, and consequently they would have to pay more for their health coverage, including but not limited to higher deductibles, than people without disabilities or chronic conditions. Providing for comparative effectiveness research and using the resulting information in a way that respects that what works for many people will not work for all; Providing for home and community-based services and supports for people with disabilities and chronic conditions such as Community Living Assistance and Supports (CLASS) provisions* and the Community First ChoiceOption in health care reform. Support increasing Medicaid elibility to a nationwide standard for those whose incomes are up to 133% of the Federal Poverty Level. Since many people with disabilities have low incomes, this would extend Medicaid coverage to many people with disabilities, including childless adults. - Support elimination of Medicare Part D coverage gap (Part D "donut hole") and immediate $250 rebate for beneficiaries who fall into donut hole in 2010. continued next page Note -- Asterisk * indicates issue pursued both independently and as part of health care reform. CLASS Act* -- S. 697/H.R. 1721 included in HR 3590 (Senate health care reform bill) and HR 3962 (House health care reform bill) . Support legislation to establish a voluntary payroll deduction insurance plan so that people with disabilities will be able to pay for assistance with activities of daily living. This would enable them to remain in their homes and off of the Medicaid program. CBO estimates that the CLASS provisions will save Medicaid $2.5 billion in the first 10 years alone. Community Choice Act* (S. 683/H.R. 1670). Support legislation to make services in the home and community the norm under Medicaid - enabling people to stay in their homes and remain part of their communities rather than having to go into nursing homes or other institutions to receive needed services. Became Community First Choice Option in health care reform bills. End Medicares 24-month waiting period* - S 700/HR 1708. Support legislation to end the waiting period for Medicare for people who qualify for Title II Social Security disability benefits and people with life-threatening conditions. Comparative Effectiveness Research HR 2502/S 1213* Support legislation to create non-government independent entities to study the comparative effectiveness of treatments in health care. Mental Illness Chronic Care Improvement (MICCI) Act, S 1136* Support legislation to facilitate access to needed medical services. Amend the Medicare Savings Programs and the Low Income Subsidy* to align, simplify and increase income eligibility, eliminate or substantially increase asset limits, stabilize the programs and make administrative simplifications. First month purchase option* Advocated to maintain the current ability for Medicare beneficiaries to purchase their power wheelchair in the first month of use. Both the House and Senate included language in health reform that would require a beneficiary to rent a power wheelchair for 13 months before purchase. Supported inclusion in HR 3590 and HR 3962 of provisions to exempt Class III and higher power wheel chairs from the rental period and to retain the first-month purchase option under existing law. Community First Choice Option* would allow states to create Medicaid plans that would reverse the institutional bias in Medicaid. The option would provide a 6% increase in FMAP matching funds to states. Supported H.R.2575 to provide parity under group health plans and group health insurance coverage in the provision of benefits for prosthetic devices and orthotics devices, components and benefits for other medical and surgical services. Met with senior HHS officials to talk about implementation of health reform. See also Medicare and Medicaid.

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

Government targets: AMTRAK - Natl Railroad Passenger Corporation, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations 510(k) REform Patient Safety Organizations S 3737, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1451, FAA Air Transportation Modernization and Safety Improvement Act

Client expense: $9,280,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations

Client expense: $15,460,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act AAA Screening Legislation HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Medicare Coverage of CT Colonography Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency

Client expense: $7,310,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Physician payment disclosure including S. 301; Physician Payments Sunshine Act of 2009; H.R. 3962, Affordable Health Care for Americans Act; H.R. 3590, Patient Protection and Affordable Care Act; H.R. 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R. 1427, Promoting Innovation and Access to Life Savings Medicines Act; H.R. 3962, Affordable Health Care for America Act; Comparative effectiveness legislation including S. 1213; Patient-Centered Outcomes Research Act of 2009; H.R. 3200, America's Health Future Act; H.R. 1548- Pathway for Dissimilar Act; Legislative changes in the health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act."; S. 1679, Affordable Health Choice Act; S. 1796, America's Healthy Future Act of 2009; Pharmaceutical import safety legislation.

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy

Client expense: $5,180,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

EPA memorandum of Understanding (MOU): MOU with EPA to help reduce amalgam in the environment; H.R. 2400, Strategies to Address Anti-microbial Resistance Act; STATE, Internation Agreement on Mercury Emissions; EPA - Proposed rule to protect waterways by reducing mercury from dental offices. S. 1259, Preserving Access to Targeted, Individualized, and Effective new Treatments and Service (PATIENTS) Act of 2009; H.R. 3856, Bone Health Promotion and Research Act of 2009; H.R. 4731, Lead in Dental Crowns issue; H.R. 2824, Doctor-Patient Relationship and Research Protection Act; S. 1213, Patient-Centered Outcomes Research Act of 2009; H.Res. 648, Expressing the need for enhanced public awareness of potential health effects posed by mercury; H.R. 4615, Consumers Have Options for Molar Protection Act of 2009; H.R. 4731, Medicaid Options for Dental Fillings Act of 2010. H.R. 5116/S. 3605, America COMPETES Reauthorization Act of 2010; Agency for Healthcare Research and Quality reauthorization; Agency for Healthcare Research and Quality , U.S. Preventative Services Taskforce; FDA Amalgam Classification; NIH, National Advisory on Dental & Craniofacial Research Council.

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

Government targets: Agriculture, Dept of (USDA), Air Force, Dept of, Army, Dept of (Other), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Natl Institutes of Health (NIH), Navy, Dept of, Occupational Safety & Health Administration (OSHA), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

H.R.3590, Patient Protection and Affordable Care Act - Lobbied in support of and on implementation of health care legislation that would reform the health care system to provide affordable quality health care and expand access to long-term services and supports. Provided information on the need for nursing education capacity and the retention of newer and older nurses in the workplace (no bill). S.1569/H.R.3185, Medicare Graduate Nursing Education Act - Advocated for modernizing Medicare funding so that nursing education funds are directed to advanced nurse practice programs to help produce more highly-skilled nurses to care for the Medicare population. S. 623/HR 1558, Pre-existing Condition Patient Protection Act of 2009 - Lobbied in support of bill that would prohibit insurers from denying health insurance or delaying coverage for people with pre-existing conditions. H.R. 2778, Health Equity and Accountability through Research Act of 2009 - Lobbied in support of bill that would address racial and ethnic disparities in care. S. 979/HR 2360, Small Business Health Options Programs Act - Lobbied in support of bill that would establish a nationwide health insurance purchasing pool for small businesses and the self-employed that would offer a choice of private health plans and make health coverage more affordable, predictable and accessible. S.1213, Patient-Centered Outcomes Research Act - Lobbied in support of bill that would create a public-private partnership to conduct and disseminate comparative effectiveness research. S. 726/H.R. 1427, Promoting Innovation and Access to Life Saving Medicines - Discussed legislation which would create a pathway for approval of safe, effective biosimilar and generic biologic drugs. H.R. 3090, Health Equity and Accountability Act - Discussed need to end racial and ethnic disparities in care. S. 3686, Labor, HHS, Education and Related Agencies Appropriations Act FY 2011 - Lobbied for funding for healthcare services, research and training involving NIH, AHRQ, CMS, HRSA, HHS and AOA. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care law which makes improvements such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act and implementation of some provisions. H.R. 5364, Special Care Dentistry Act - Discussed bill that would require states to provide oral health coverage for aged, blind, or disabled individuals through a separate state adult dental program, with 100% federal match. H.R. 4213, American Workers, State and Business Relief Act/American Jobs and Closing Tax Loopholes Act - Lobbied for extension of UI, COBRA, FMAP, and SGR. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for SSA, various health care, employment, aging services and nutrition programs. H.R. 5795, Personalize Your Care Act - Bill gives Americans the opportunity to make advance care plans should he or she become unable to direct their own care. S. 1177, Confidence in Long-Term Care Insurance Act - Bill provides options to help Americans pay for the long-term services and supports they may need, including to help them live in their homes and communities. H.R. 5890, Long-Term Care Insurance Reform Act - Bill provides options to help Americans pay for the long-term services and supports they may need, including to help them live in their homes and communities. S. 776, Promoting Small House Nursing Homes Act - Provides incentives for new, affordable models of long-term services and supports. H.R. 4224, Together We Care Act - Bill creates a three-year pilot program to train public housing residents to provide covered home-based health services. H.R. 5853, Fiscal Responsibility and Retirement Security Act - Bill requires review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes. S. 2814, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare. H.R. 4993, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare.

Client expense: $4,710,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

General Issues related to healthcare, healthcare reimbursement, healthcare reform, and the FDA device approval process; S.1213 Patient Centered Outcomes research Act- issues regarding all provisions; S. 1142 - Informed health care Decision Making Act- issues regarding all provision; Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act- issues related comparative effectiveness & physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related comparative effectiveness & physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009"- issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010- issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general; House Resolutions 1438, Promoting Increased Awareness and Diagnosis of Peripheral Arterial Disease - Generally

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3248/ S 1283: Lifespan Respite Care Act of 2005; HR 4281: Small Business Health Fairness Act; PL 109-365: Older Americans Act Amendments of 2006; Older Americans Act Reauthorization; Healthcare reform policy; HR 2/PL 111-3: CHIP Reauthorization; HR 3267/S 1760: Healthy Start Reauthorization Act of 2007; HR 1017/S 578: Protecting Children's Health in Schools Act; HR 6111: Tax Relief and Health Care Act of 2006; Combating Autism Act; Expanding the Promise for Individuals with Autism Act; FY 2009 and FY 2010 Labor-HHS-Education Appropriations; PL 110-343: Paul Wellstone and Pete Domenici Mental Health Parity Act; HR 2502: Comparative Effectiveness Research Act of 2009; S 1213: Patient Centered Outcomes Research Act of 2009; HR 3200/S 1679: America's Affordable Health Choices Act of 2009; HR 1708/S 700: Ending the Medicare Disability Waiting Period Act of 2009; S 1630: Affordable Access to Prescription Medications Act of 2009; PL 111-148: The Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; HR 4872: Health Care and Education Reconciliation Act of 2010; HR 4213 American Jobs and Closing Tax Loopholes Act; HR 1347: Concussion Treatment and Care Tools Act of 2010; and PL 111-192: Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act.

Client expense: $57,615 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office

Medicare and Medicaid reform; Medicare competitive bidding; PL 108-173: Medicare Prescription Drug and Modernization Act of 2003; Federal Medical Assistance Percentage legislation; budget resolutions; Community Choice Act; Economic Recovery in Health Care Act; S 1213: Patient Centered Outcomes Research Act; HR 2502: Comparative Effectiveness Research Act; PL 111-148: Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; HR 4872: Health Care and Education Reconciliation Act of 2010.

Client expense: $57,615 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office