Improving Diagnostic Innovations Act of 2012

H.R. 6446: To create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests. H.R. 8: American Taxpayer Relief Act of 2012 as it relates to sequestration and Medicare, including updates to the Medicare Sustainable Growth rate formula for physicians and related issues.

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Drug safety; Drug importation; authorized generics; drug company settlements; Preserve Access to Affordable Generics Act; H.R. 6446; childhood nutrition issues; Federal preemption for drugs and devices; Medical device safety; Prescription drug advertising; Congressional oversight issues; General health care reform (Patient Protection and Affordable Care Act).

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

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

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

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

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

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

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

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

See attached sheet Iroquois Healthcare Alliance Extension of key Medicare provisions No additional funding cuts to Medicaid Also, we have been publicly supportive of NYS 1115 Medicaid Waiver proposal H.R.6446 /S .3473 Sequestration Prevention Act of 2012 creates incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests. S.2620/H.R. 5943 Rural Hospital Access Act provides an extension of the enhanced low-volume Medicare adjustment for PPS hospitals through Sept 30, 2013

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

Government targets: HOUSE OF REPRESENTATIVES, 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. 5651, the Food and Drug Administration Reform Act of 2012 HR 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 S. 3187, the Food and Drug Administration Safety and Innovation Act

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. 5651, the Food and Drug Administration Reform Act of 2012 HR 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 S. 3187, the Food and Drug Administration Safety and Innovation Act

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. 5651, the Food and Drug Administration Reform Act of 2012 HR 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 S. 3187, the Food and Drug Administration Safety and Innovation Act

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: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety; Drug importation; authorized generics; drug company settlements; Preserve Access to Affordable Generics Act; H.R. 6446; childhood nutrition issues; Federal preemption for drugs and devices; Medical device safety; Prescription drug advertising; Congressional oversight issues; General health care reform (Patient Protection and Affordable Care Act).

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