ms KATHLEEN CLAESSENS

H.R.771-"Protecting Access to Diabetes Supplies Act of 2015 H.R.6-"21st Century Cures Initiative" un-introduced proposal to change FDA regulations of labs developed and In-vitro diagnostic tests H.R.160-"Protect Medical Innovation Act of 2015"

H.R.771-"Protecting Access to Diabetes Supplies Act of 2015 H.R.6-"21st Century Cures Initiative" un-introduced proposal to change FDA regulations of labs developed and In-vitro diagnostic tests H.R.160-"Protect Medical Innovation Act of 2015"

H.R.771-"Protecting Access to Diabetes Supplies Act of 2015" un-introduced Senate version of H.R.771 H.R.6-"21st Century Cures Initiative" un-introduced proposal to change FDA regulations of labs developed and In-vitro diagnostic tests

H.R.771-"Protecting Access to Diabetes Supplies Act of 2015" un-introduced Senate version of H.R.771 H.R.6-"21st Century Cures Initiative" un-introduced proposal to change FDA regulations of labs developed and In-vitro diagnostic tests

21st Century Cure Initiative (legislation was not introduced) Medical Electronic Data Technology Enhancement for Consumers' Health Act (not yet introduced) H.R.771-on reforming the competitive bidding program Department of Defense Appropriations Act of 2015

H.R.771-"Protecting Access to Diabetes Supplies Act of 2015 H.R.6-"21st Century Cures Initiative" un-introduced proposal to change FDA regulations of labs developed and In-vitro diagnostic tests H.R.160-"Protect Medical Innovation Act of 2015"

H.R. 4015, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013" Draft legislation to reform the Clinical Lab Fee Schedule H.R.523-"Protect Medical Innovation Act of 2013" S.232-"Medical Device Access and Innovation Protection Act"

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

H.R. 4015, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013" Draft legislation to reform the Clinical Lab Fee Schedule H.R.523-"Protect Medical Innovation Act of 2013" S.232-"Medical Device Access and Innovation Protection Act"

21st Century Cure Initiative (no legislation introduced yet); Reform to Medicare competitive bidding program (no legislation introduced yet); H.R.523 - Protecting Medicare Innovation Act of 2013

) HPV primary screening application before the FDA (no bill) 2) H.R.523-"Protect Medical Innovation Act of 2013" 3) S.232-"Medical Device Access and Innovation Protection Act"

H.R. 4015, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013" Draft legislation to reform the Clinical Lab Fee Schedule H.R.523-"Protect Medical Innovation Act of 2013" S.232-"Medical Device Access and Innovation Protection Act"

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

H.R. 4015, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013" Draft legislation to reform the Clinical Lab Fee Schedule H.R.523-"Protect Medical Innovation Act of 2013" S.232-"Medical Device Access and Innovation Protection Act"

) HPV primary screening application before the FDA (no bill) 2) H.R.523-"Protect Medical Innovation Act of 2013" 3) S.232-"Medical Device Access and Innovation Protection Act"

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

21st Century Cure Initiative (legislation was not introduced) S.2977-Medical Electronic Data Technology Enhancement for Consumers' Health Act H.R.3303-Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 H.R.4870-Department of Defense Appropriations Act of 2014 S.1429-Department of Defense Appropriations Act of 2014

H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013"; CY 2014 Medicare Physician Fee Schedule Rule (CMS/HHS); Draft legislation to reform the Clinical Lab Fee Schedule; H.R.523-"Protect Medical Innovation Act of 2013"; S.232-"Medical Device Access and Innovation Protection Act"; The Diabetes Access to Care Coalition; The CLFS Reform Coalition; and The PFS Pathology Payment Coalition.

CMS competitive bidding program modification; Regulation of IVDs and LDTs; Protect Medical Innovation Act of 2013-HR 523; H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013"; CY 2014 Medicare Physician Fee Schedule Rule Proposal legislation (not yet introduced) to direct OIG study on the impact of DTS competitive bidding program on patient care

CMS competitive bidding program modification; Regulation of IVDs and LDTs; Protect Medical Innovation Act of 2013-HR 523; H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013"; CY 2014 Medicare Physician Fee Schedule Rule Proposal legislation (not yet introduced) to direct OIG study on the impact of DTS competitive bidding program on patient care

H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013"; CY 2014 Medicare Physician Fee Schedule Rule (CMS/HHS); Draft legislation to reform the Clinical Lab Fee Schedule; H.R.523-"Protect Medical Innovation Act of 2013"; S.232-"Medical Device Access and Innovation Protection Act"; The Diabetes Access to Care Coalition; The CLFS Reform Coalition; and The PFS Pathology Payment Coalition.

H.R.2085-"Diagnostic Innovation Testing and Knowledge Advancement Act of 2013"; CY 2014 Medicare Physician Fee Schedule Rule (CMS/HHS); Draft legislation to reform the Clinical Lab Fee Schedule; H.R.523-"Protect Medical Innovation Act of 2013"; S.232-"Medical Device Access and Innovation Protection Act"; The Diabetes Access to Care Coalition; The CLFS Reform Coalition; and The PFS Pathology Payment Coalition.

Medicare, Durable Equipment, Prosthetics, Orthotics and Supplies-Competitive Bidding Program Issues, H.R. 3590 Patient Protection and Affordable Care Act-, H.R. 616 Pharmacists Exemption to CMS DME Requirements, H.R. 3790 Repeal of Medicare Competitive Acquisition Program for DMEPOS

Medicare, Durable Equipment, Prosthetics, Orthotics and Supplies-Competitive Bidding Program Issues, H.R. 3590 Patient Protection and Affordable Care Act-, H.R. 616 Pharmacists Exemption to CMS DME Requirements, H.R. 3790 Repeal of Medicare Competitive Acquisition Program for DMEPOS

Medicare, Durable Equipment, Prosthetics, Orthotics and Supplies-Competitive Bidding Program Issues, H.R. 3590 Patient Protection and Affordable Care Act-, H.R. 616 Pharmacists Exemption to CMS DME Requirements, H.R. 3790 Repeal of Medicare Competitive Acquisition Program for DMEPOS

Pandemic preparedness; accutane safety; general diabetes and pharmaceutical issues; health care reform legislation; H.R. 3200, America Affordable Health Choices Act; and the America's Health Future Act of 2009; Community Relations and Outreach to develop and maintain relationships with minority groups and health organizations to promote diabetes awareness. Developing strategies on the most effective approaches to address and try to resolve health disparities affecting minority communities General healthcare issues - biosimilars.

Advocate on legislative changes regarding biosimilars; pandemic preparedness, health reform, health care reform legislation, including safety and data exclusivity issues regarding follow-on biologics; policy analysis; address concerns regarding the federal government's purchase and stockpiling of Tamiflu; HR 3200 America's Affordable Health Choices Act: and the America's Healthy Future Act of 2009; H.R. 1 - Pandemic influenza funding; H.R. 1105 Omnibus Appropriations Act; Pandemic funding issues; FY10 Labor HHS Appropriations legislation: H.R. 2346 Supplemental Appropriations Act of 2009 Congress and Federal Agencies; community relations and outreach to develop and maintain relationships with minority groups and health organizations; Public policy such as developming strategies on the most effective approaches to tell the story of Roche's efforts to address and try to resolve health disparities affecting minority communities.

Advocate on legislative changes regarding biosimilars; pandemic preparedness, health reform, health care reform legislation, including safety and data exclusivity issues regarding follow-on biologics; policy analysis; address concerns regarding the federal government's purchase and stockpiling of Tamiflu; HR 3200 America's Affordable Health Choices Act: and the America's Healthy Future Act of 2009; H.R. 1 - Pandemic influenza funding; H.R. 1105 Omnibus Appropriations Act; Pandemic funding issues; FY10 Labor HHS Appropriations legislation: H.R. 2346 Supplemental Appropriations Act of 2009 Congress and Federal Agencies; community relations and outreach to develop and maintain relationships with minority groups and health organizations; Public policy such as developming strategies on the most effective approaches to tell the story of Roche's efforts to address and try to resolve health disparities affecting minority communities.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis adn ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Diagnostics Act of 2007; H.R> 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R.3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Congress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Reimbursement and other issues related to anemia and arthritis drugs. Planning treatment protocols for patients requiring cancer drugs; Medicare coding policies for Part B drugs; H.R. 6331/S.3101, Medicare Improvement for Patients and Providers Act, as it pertains to the physicians quality reporting initiative; S. 3118, Preserving Access to Medicare Access to Medicare Act, as it pertains to the physicians quality reporting initiative; S.2499 Medicare, Medicaid and SCHIP Extension Act of 2007; Issues related to Medicare coverage policy for blood glucose monitors and test strips. Issues related to dynamic scoring.; HR6331 - Medicare improvements for patients and partners Act of 2008 related to competitive building of diabetes equipment.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis adn ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Diagnostics Act of 2007; H.R> 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R.3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Congress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis adn ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Diagnostics Act of 2007; H.R> 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R.3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Congress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Reimbursement and other issues related to anemia and arthritis drugs. Planning treatment protocols for patients requiring cancer drugs; Medicare coding policies for Part B drugs; H.R. 6331/S.3101, Medicare Improvement for Patients and Providers Act, as it pertains to the physicians quality reporting initiative; S. 3118, Preserving Access to Medicare Access to Medicare Act, as it pertains to the physicians quality reporting initiative; S.2499 Medicare, Medicaid and SCHIP Extension Act of 2007; Issues related to Medicare coverage policy for blood glucose monitors and test strips. Issues related to dynamic scoring.; HR6331 - Medicare improvements for patients and partners Act of 2008 related to competitive building of diabetes equipment.

Reimbursement and other issues related to anemia and arthritis drugs. Planning treatment requiring cancer drugs; Medicare coding policies for Part B drugs; S.2499 Medicare, Medicaid and SCHIP Extension Act of 2007 - Issues related to Medicare coverage policy for blood glucose monitors and test strips; issues related to dynamic scoring.

Reimbursement and other issues related to anemia and arthritis drugs. Planning treatment protocols for patients requiring cancer drugs; Medicare coding policies for Part B drugs; H.R. 6331/S.3101, Medicare Improvement for Patients and Providers Act, as it pertains to the physicians quality reporting initiative; S. 3118, Preserving Access to Medicare Access to Medicare Act, as it pertains to the physicians quality reporting initiative; S.2499 Medicare, Medicaid and SCHIP Extension Act of 2007; Issues related to Medicare coverage policy for blood glucose monitors and test strips. Issues related to dynamic scoring.; HR6331 - Medicare improvements for patients and partners Act of 2008 related to competitive building of diabetes equipment.

Reimbursement and other issues related to anemia and arthritis drugs. Planning treatment protocols for patients requiring cancer drugs; Medicare coding policies for Part B drugs; H.R. 6331/S.3101, Medicare Improvement for Patients and Providers Act, as it pertains to the physicians quality reporting initiative; S. 3118, Preserving Access to Medicare Access to Medicare Act, as it pertains to the physicians quality reporting initiative; S.2499 Medicare, Medicaid and SCHIP Extension Act of 2007; Issues related to Medicare coverage policy for blood glucose monitors and test strips. Issues related to dynamic scoring.; HR6331 - Medicare improvements for patients and partners Act of 2008 related to competitive building of diabetes equipment.