MODDERN Cures Act of 2011

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality.NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program.

Client expense: $560,000 · Firm income: Not reported

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

H.R. 1897 Alzheimer's Breakthrough Act of 2011, All sections H.R. 610 Making Investments Now for Dementia Act of 2011, All sections H.R. 3497 Modernizing our Drug & Diagnostics Evaluation and Regulator Network Cures Act", All sections S. 2113 Transforming the Regulatory Environment to Accelerate Access to Treatments Act, All sections H.Res 351/S.Res 176 Supporting a Semipostal Stamp to Support Medical Research Relating to Alzheimer's Disease, All sections. S.Res .434 / H. Res. 120 A resolution supporting the goal of preventing and effectively treating Alzheimer's disease by the year 2025, as articulated in the draft National Plan to Address Alzheimer's Disease from the Department of Health and Human Services, All sections. S.2069/H.R.3891 Spending Reductions through Innovations in Therapies Agenda Act of 2012, All sections S.2236 Advancing Breakthrough Therapies for Patients Act of 2012, All sections S.3187 Food and Drug Administration Safety and Innovation Act / H.R.5651 Food and Drug Administration Reform Act of 2012, All sections

Client expense: $150,000 · 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), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Public Law 111-148, The Patient Protection and Affordable Care Act Public Law 111-152, The Reconciliation Act of 2010 Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act H.R. 3497, MODDERN Cures Act of 2011 H.R.6446, To create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests Proposals to increase security of US drug distribution supply chain Proposals to improve viral hepatitis screening and testing Policies for FDA product approval reform

Client expense: $840,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Patient Protection and Affordable Health Care Act H.R. 3497 - Moddern Cures Act of 2011 H.R. 6446, To create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests

Client expense: Not reported · Firm income: $70,000

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

Implementation of Affordable Care Act -Essential Health Benefits -Comparative Effectiveness Research Implementation of Food and Drug Administration Safety and Innovation Act MODDERN Cures Act: HR 3497 Improving Diagnostic Innovations Act: HR 6446

Client expense: $8,000 · 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), Natl Institutes of Health (NIH), SENATE

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. NO BILL, Supply chain draft legislation - Lobbied for passage of legisaltion to increase security of the drug distribution supply chain.

Client expense: $1,280,000 · Firm income: Not reported

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

Issues related to medical device user fees including implementation of S.3187, The Food and Drug Administration Safety and Innovation Act. Issues relating to the role of medical devices and diagnostics including H.R.3497, the MODDERN Cures Act of 2011 and the sustainable growth rate. Issues relating to regulation of unique device identification system.

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - HR 6584, Verifying Authority and Legality In Drug Compounding Act of 2012, regarding all provisions.

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

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

Issues related to medical device user fees including implementation of S.3187, The Food and Drug Administration Safety and Innovation Act. Issues relating to the role of medical devices and diagnostics including H.R.3497, the MODDERN Cures Act of 2011 and the sustainable growth rate. Issues relating to regulation of unique device identification system.

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Issues related to oversight of implantable devices [Elizabeth Kegler, JC Scott] H.R. 675-- Strengthening Medicare Anti-Fraud Measures Act of 2011. [Elizabeth Kegler] Issues related to the implementation of Section 6002 (Transparency Reports and Reporting of Physician Ownership or Investment Interests) of the Patient Protection and Affordable Care Act (PL 111-148). [Elizabeth Kegler, Elizabeth Sharp] Issues related to physician owned distributors of devices [Elizabeth Kegler] S. 668/HR Health Care Bureaucrats Elimination Act (Repeal of IPAB). [Elizabeth Kegler, JC Scott] H.R. 452 Medicare Decisions Accountability Act of 2011(Repeal of IPAB). [Elizabeth Kegler, , JC Scott] H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 (Payment Reform) [Duane Wright, Elizabeth Sharp, Elizabeth Kegler, JC Scott] H.R. 6446 To create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests. [Duane Wright, Elizabeth Sharp, Elizabeth Kegler] Issues related to deficit reduction and Medicare [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to gainsharing [Elizabeth Kegler, Duane Wright]

Client expense: $453,093 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3497, the MODDERN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3497-The MODDERN Cures Act Drug shortage 340B drug discount program AIDS Dextromethorphan

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

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

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3497 - MODDERN Cures Act of 2011 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 S. 27 Preserve Access to Affordable Generics Act S. 373 Fair Prescription Drug Competition Act S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

Client expense: $486,262 · Firm income: Not reported

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

H.R.3497-The MODDERN Cures Act of 2011 340B Drug shortage Biologics; Childhood / Infant Nutrition S.3187-Food and Drug Administration Safety and Innovation Act; FARM Bill

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

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; HR 3267/S 1760: Healthy Start Reauthorization Act of 2007; HR 6111: Tax Relief and Health Care Act of 2006; 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; S 829/HR 1546: Medicare Access to Rehabilitation Services Act; HR 452: Medicare Decisions Accountability Act; HR 3765: Temporary Payroll Tax Cut Contribution Act of 2011; HR 3630: Middle Class Tax Relief & Job Creation Act of 2011; HR 5: Protecting Access to Health Care Act; HR 1700: Medicare Decision Accountability Act; HR 3497: MODDERN (Modernize Our Drug and Diagnostics Evaluation and Regulatory Network) Cures Act of 2011; HR 4378: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012; S 3289: Children's Mental Health Accessibility Act of 2012; HR 6079: Repeal of Obamacare Act; and H.R. 8: American Taxpayer Relief Act.

Client expense: $66,891 · Firm income: Not reported

Government targets: Access Board, Agriculture, Dept of (USDA), Defense, Dept of (DOD), 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

Intellectual property; HR 3497

Client expense: $2,055,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

MODDERN Cures Act (H.R. 3497) Awareness and education activities at CDC Patient-focused Drug Development at FDA

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · 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 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · 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 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · 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

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act HR6446, Improving Diagnostic Innovations Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act HR6446, Improving Diagnostic Innovations Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Marfan Syndrome Research activities at NIH Marfan Syndrome Education & Awareness activities at CDC H.R. 3497: MODDERN Cures Act of 2011

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues, standards development for diagnostics. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care; HR 1249, America Invents Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. No Bill#: Genomics and Personalized Medicine Act; No Bill#: Genomic Research and Accessibility Act; No Bill#: BETTER Patient Care Act; HR 1249, America Invents Act; HR 3207: Modernizing Laboratory Test Standards for Patients Act; HR 3497 MODDERN Cures Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Issues related to oversight of implantable devices and price transparency. [Elizabeth Kegler, JC Scott] Issues related to gainsharing. [Elizabeth Kegler, Duane Wright, JC Scott] Issues related to the implementation of Section 6002 (Transparency Reports and Reporting of Physician Ownership or Investment Interests) of the Patient Protection and Affordable Care Act (PL 111-148). [Elizabeth Kegler,] Issues related to physician owned distributors of devices [Elizabeth Kegler] H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 (Payment Reform) [Duane Wright, Elizabeth Sharp, Leah Kegler, JC Scott] Issues related to deficit reduction and Medicare [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]

Client expense: $366,862 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3497 - MODDERN Cures Act of 2011 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 S. 27 Preserve Access to Affordable Generics Act S. 373 Fair Prescription Drug Competition Act S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

Client expense: $487,850 · Firm income: Not reported

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

H.R. 1897 Alzheimer's Breakthrough Act of 2011, All sections H.R. 610 Making Investments Now for Dementia Act of 2011, All sections H.R. 3497 Modernizing our Drug & Diagnostics Evaluation and Regulator Network Cures Act", All sections S. 2113 Transforming the Regulatory Environment to Accelerate Access to Treatments Act, All sections H.Res 351/S.Res 176 Supporting a Semipostal Stamp to Support Medical Research Relating to Alzheimer's Disease, All sections. S.Res .434 / H. Res. 120 A resolution supporting the goal of preventing and effectively treating Alzheimer's disease by the year 2025, as articulated in the draft National Plan to Address Alzheimer's Disease from the Department of Health and Human Services, All sections. S.2069/H.R.3891 Spending Reductions through Innovations in Therapies Agenda Act of 2012, All sections S.2236 Advancing Breakthrough Therapies for Patients Act of 2012, All sections S.3187 Food and Drug Administration Safety and Innovation Act / H.R.5651 Food and Drug Administration Reform Act of 2012, All sections

Client expense: $145,000 · 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), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

H.R. 1897 Alzheimer's Breakthrough Act of 2011, All sections H.R. 610 Making Investments Now for Dementia Act of 2011, All sections H.R. 3497 Modernizing our Drug & Diagnostics Evaluation and Regulator Network Cures Act", All sections S. 2113 Transforming the Regulatory Environment to Accelerate Access to Treatments Act, All sections H.Res 351/S.Res 176 Supporting a Semipostal Stamp to Support Medical Research Relating to Alzheimer's Disease, All sections. S.Res .434 / H. Res. 120 A resolution supporting the goal of preventing and effectively treating Alzheimer's disease by the year 2025, as articulated in the draft National Plan to Address Alzheimer's Disease from the Department of Health and Human Services, All sections. S.2069/H.R.3891 Spending Reductions through Innovations in Therapies Agenda Act of 2012, All sections S.2236 Advancing Breakthrough Therapies for Patients Act of 2012, All sections S.3187 Food and Drug Administration Safety and Innovation Act / H.R.5651 Food and Drug Administration Reform Act of 2012, All sections

Client expense: $145,000 · 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), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act Implemenation of S.3187, The Food and Drug Administration Safety and Innovation Act of 2012 S.27 Preserve Access to Affordable Generics Act H.R. 3497, The MODDERN Cures Act of 2011 H.R.6446, a bill to create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests Proposals to establish a system to improve pharmaceutical traceability

Client expense: $1,790,000 · Firm income: Not reported

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

HR 2182, S1734, and S2187 (as passed in Pub. L. No. 112-144) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to 340B program amendments and implementation of statutory changes. HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to definition of essential health benefits and health insurance exchanges. HR 6160 - issues related to drug safety issues, including tamper resistent packaging HR 1513 - issues related to animal research HR 6502 - issues related to development of medicines for life-threatening illnesses HR 3497 - issues related to incentives for developing and improving diagnostic tests and related treatments HR 6272 - issues related to the expansion of clinical trial data banks and increase government reporting of same HR 6163 - issues related to incentives for increased research into pediatric treatments

Client expense: $980,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act Implemenation of S.3187, The Food and Drug Administration Safety and Innovation Act of 2012 S.27 Preserve Access to Affordable Generics Act H.R. 3497, The MODDERN Cures Act of 2011 H.R.6446, a bill to create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests Proposals to establish a system to improve pharmaceutical traceability

Client expense: $1,790,000 · Firm income: Not reported

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

Implementation of Affordable Care Act -Essential Health Benefits -Comparative Effectiveness Research MODDERN Cures Act: HR 3497 Food And Drug Administration Safety and Innovation Act: S. 3187; HR 5651 Improving Diagnostic Innovations Act: HR 6446

Client expense: $5,949 · 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), Natl Institutes of Health (NIH), SENATE

Issues related to oversight of implantable devices [Elizabeth Kegler, JC Scott] H.R. 675-- Strengthening Medicare Anti-Fraud Measures Act of 2011. [Elizabeth Kegler] Issues related to the implementation of Section 6002 (Transparency Reports and Reporting of Physician Ownership or Investment Interests) of the Patient Protection and Affordable Care Act (PL 111-148). [Elizabeth Kegler, Elizabeth Sharp] Issues related to physician owned distributors of devices [Elizabeth Kegler] S. 668/HR Health Care Bureaucrats Elimination Act (Repeal of IPAB). [Elizabeth Kegler, Elizabeth Sharp, JC Scott] H.R. 452 Medicare Decisions Accountability Act of 2011(Repeal of IPAB). [Elizabeth Kegler, Elizabeth Sharp, JC Scott] H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 (Payment Reform) [Duane Wright, Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to deficit reduction and Medicare [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to gainsharing [Elizabeth Kegler, Duane Wright]

Client expense: $267,490 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3497, MODDERN Cures Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Patient Protection and Affordable Health Care Act H.R. 3497 - Moddern Cures Act of 2011 H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 3187 Food and Drug Administration Safety and Innovation Act

Client expense: Not reported · Firm income: $70,000

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

H.R. 3497, the MODDERN Cures Act.

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

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; HR 3267/S 1760: Healthy Start Reauthorization Act of 2007; HR 6111: Tax Relief and Health Care Act of 2006; 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; S 829/HR 1546: Medicare Access to Rehabilitation Services Act; HR 452: Medicare Decisions Accountability Act; HR 3765: Temporary Payroll Tax Cut Contribution Act of 2011; HR 3630: Middle Class Tax Relief & Job Creation Act of 2011; HR 5: Protecting Access to Health Care Act; HR 1700: Medicare Decision Accountability Act; HR 3497: MODDERN (Modernize Our Drug and Diagnostics Evaluation and Regulatory Network) Cures Act of 2011; HR 4378: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012; S 3289: Children's Mental Health Accessibility Act of 2012; and HR 6079: Repeal of Obamacare Act.

Client expense: $74,200 · 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

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions.

Client expense: $1,420,000 · Firm income: Not reported

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

Personalized Medicine H.R.3497-The MODDERN Cures Act Drug shortage 340B drug discount program AIDS Dextromethorphan S.3187-Food and Drug Administration Safety and Innovation Act

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

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