CYNTHIA SENSIBAUGH

Public Law 115-271 The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment Act. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. H.R. 6102 VALID (Verifying Accurate Leading-edge IVCT Development) Act of 2020. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs). Proposals to advance policies related to effective pain management. Proposals related to the advancement of testing and detection of TBI (Traumatic Brain Injuries). Issues related to medical device cybersecurity.

Proposals to prohibit the VA from changing their current system of selecting and contracting for diabetes monitoring supplies and equipment.

Proposed Hospital Inpatient Prospective Payment System Rule. Proposals to ensure Medicare coverage for emerging medical device technology.

Public Law 115-97 The Tax Cuts and Jobs Act of 2017. Public Law 115-120 Making Further Continuing Appropriations for Fiscal Year 2018. Proposals to suspend or repeal the Medical Device Tax. Proposals to reform domestic and international tax structures.

Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposed Hospital Inpatient Prospective Payment System Rule. Proposals for Medicare reimbursement for diagnostic patient self-testing.

Public Law 115-271 The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment Act. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs). Proposals to ensure Department of Defense coverage for emerging medical device technology. Proposals to advance policies related to effective pain management. Issues related to medical device cybersecurity.

Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

Issues related to data privacy.

Issues related to the purchasing of medical supplies and equipment by the VA. Proposals to ensure VA Coverage for emerging medical device technology. Proposals to ensure Department of Defense coverage for emerging medical device technology.

Public Law 115-97 The Tax Cuts and Jobs Act of 2017. Public Law 115-120 Making Further Continuing Appropriations for Fiscal Year 2018. Proposals to suspend or repeal the Medical Device Tax. Proposals related to the delay of the Affordable Care Act Excise Tax on High-Value Health Plans. Proposals to reform domestic and international tax structures.

Proposals to prohibit the VA from changing their current system of selecting and contracting for diabetes monitoring supplies and equipment. Proposals to ensure VA Coverage for emerging medical device technology. Proposals to ensure Department of Defense coverage for emerging medical device technology.

Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs). Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals to introduce policies to prevent the spread of Anti-Microbial Resistant Bacteria.

Issues related to the purchasing of medical supplies and equipment by the VA.

H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

H.R. 1892 Bipartisan Budget Act of 2018. Title IV Section 50414 - Strengthening Rules in Case of Competition for Diabetes Testing Strips. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals to introduce policies to prevent the spread of Anti-Microbial Resistant Bacteria.

Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare/DOD/VA coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

Public Law 115-97: The Tax Cuts and Jobs Act of 2017 Proposals to suspend or repeal the Medical Device Tax. Proposals to reform domestic and international tax structures.

H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

Issues related to the purchasing of medical supplies and equipment by the VA.

Issues related to the purchasing of medical supplies and equipment by the VA.

H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

H.R. 1892 Bipartisan Budget Act of 2018. Title IV Section 50414 - Strengthening Rules in Case of Competition for Diabetes Testing Strips. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals to introduce policies to prevent the spread of Anti-Microbial Resistant Bacteria.

Public Law 115-97: The Tax Cuts and Jobs Act of 2017 Proposals to reform domestic and international tax structures. Proposals to suspend or repeal the Medical Device Tax.

S. 1557 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018. H.R. 2998 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018, Section 223. H.R. 3219 Make America Secure Appropriations Act, 2018.

H.R. 3271 Protecting Access to Diabetes Supplies Act of 2017. Proposals to improve the DME competitive bidding program for diabetes products. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs). Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals to introduce policies to prevent the spread of Anti-Microbial Resistant Bacteria.

Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals related to the use of the Unique Device Identification Code. Proposals to reform the regulation of diagnostics including Laboratory Developed Tests (LDTs). Proposals to support appropriate Medicare coverage for heart failure technology.

H.R.2998 - Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018, Sec. 223.

H.R.2474 - Medical Product Review Harmonization Act of 2017. Proposals related to Affordable Care Act improvements/repeal and replace. Issues related to medical device cybersecurity.

Proposals related to Affordable Care Act improvements/repeal and replace. Issues related to medical device cybersecurity.

Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals related to the use of the Unique Device Identification Code. Proposals regarding FDA Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). Proposals regarding re-authorization of the Medical Device User Fee Act (MDUFA). Proposals to support appropriate Medicare coverage for heart failure technology.

Initiatives related to NFP and GMO labeling harmonization. Proposals to reduce adult malnutrition and hospital readmissions.

H.R. 3271 Protecting Access to Diabetes Supplies Act of 2017. Proposals to improve the DME competitive bidding program for diabetes products. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule under PAMA. Proposals related to the use of the Unique Device Identification Code. Proposals to support appropriate Medicare coverage for heart failure technology. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).

S. 1557 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018. H.R. 2998 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018, Section 223. H.R. 3219 Make America Secure Appropriations Act, 2018.

Proposals regarding infant nutrition marketing. Proposals regarding modernization of the North American Free Trade Agreement (NAFTA). Issues related to international price controls on drugs and devices. Issues related to WHO Prequalification of medical products.

Public Law 114-216 National Bioengineered Food Disclosure Standard S. 2621 Biotechnology Food Labeling Uniformity Act H.R. 1599 Safe and Accurate Food Labeling Act of 2015 Initiatives related to NFP and GMO labeling harmonization. Proposals to reduce adult malnutrition and hospital readmissions.

H.R.2474 - Medical Product Review Harmonization Act of 2017. Proposals related to Affordable Care Act improvements/repeal and replace. Issues related to medical device cybersecurity.

H.R.2998 - Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018, Sec. 223.

Proposals regarding infant nutrition marketing. Proposals regarding modernization of the North American Free Trade Agreement (NAFTA). Issues related to international price controls on drugs and devices. Issues related to WHO Prequalification of medical products.

Proposals regarding infant nutrition marketing. Issues related to international price controls on drugs and devices. Issues related to a US Export Certificate. Issues related to WHO Prequalification of medical products.

Initiatives related to NFP and GMO labeling harmonization. Proposals to reduce adult malnutrition and hospital readmissions.

Proposals related to Affordable Care Act improvements/repeal and replace. Issues related to medical device cybersecurity.

Proposals to reduce adult malnutrition and hospital re-admissions.

S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals related to Affordable Care Act improvements/repeal and replace. Proposals to modify requirements for diabetes testing supplies. Proposals regarding payments across healthcare sites of service.

S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals related to Affordable Care Act improvements/repeal and replace. Proposals to modify requirements for diabetes testing supplies. Proposals regarding payments across healthcare sites of service.

Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals related to the use of the Unique Device Identification Code. Proposals regarding FDA Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).

S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding payments across healthcare sites of service.

Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals related to the use of the Unique Device Identification Code. Proposals regarding FDA Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).

Proposals regarding infant nutrition marketing. Issues related to importation of diagnostics devices. Issues related to suppliers of TSRA-licensed and other humanitarian goods. Issues related to international regulatory review of drugs and devices. Issues related to international price controls on drugs and devices.

H.R. 4432 Safe and Accurate Food Labeling Act of 2015. Initiatives to support patient access to therapeutic nutrition. Proposals to reduce adult malnutrition and hospital re-admissions.

S. 1622 FDA Device Accountability Act of 2015. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. H.R. 771 Protecting Access to Diabetes Supplies Act of 2015. Proposals regarding payments across healthcare sites of service. Proposals to provide Diagnostic Regulatory Reform.

H.R. 3422 VA Vendor Verification Act. Proposals to prohibit VA blood glucose strips sole source contracting.

H.R. 4432 Safe and Accurate Food Labeling Act of 2015. Initiatives regarding Trade Implications of International Food Labeling Requirements. Proposals to reduce adult malnutrition and hospital re-admissions.

S. 1622 FDA Device Accountability Act of 2015. H.R. 6 - The 21st Century CURES Act, Sec. 2228. H.R. 771 Protecting Access to Diabetes Supplies Act of 2015. Proposals regarding HHS proposed rule to require informed consent for de-identified clinical specimens. Proposals regarding payments across healthcare sites of service. Proposals to provide Diagnostic Regulatory Reform.

H.R. 6 - The 21st Century CURES Act, Sec. 2228. H.R. 771 Protecting Access to Diabetes Supplies Act of 2015. Proposals regarding payments across healthcare sites of service. Proposals to provide Diagnostic Regulatory Reform.

Proposals regarding the 2015 Child Nutrition and WIC Reauthorization Act. Proposals regarding infant nutrition marketing.

H.R. 2029 Consolidated Appropriations Act of 2016, proposals related to food labeling. H.R. 4432 Safe and Accurate Food Labeling Act of 2015. Initiatives regarding Trade Implications of International Food Labeling Requirements. Proposals to reduce adult malnutrition and hospital re-admissions.

H.R. 2029 Consolidated Appropriations Act of 2016, proposals related to food labeling. H.R. 4432 Safe and Accurate Food Labeling Act of 2015. Initiatives regarding Trade Implications of International Food Labeling Requirements. Proposals to reduce adult malnutrition and hospital re-admissions.

H.R. 3422 VA Vendor Verification Act.

H.R. 6 - The 21st Century CURES Act, Sec. 2228. H.R. 771 Protecting Access to Diabetes Supplies Act of 2015. Proposals regarding payments across healthcare sites of service. Proposals to provide Diagnostic Regulatory Reform.

S. 1622 - FDA Device Accountability Act of 2015. H.R. 771 - Protecting Access to Diabetes Supplies Act of 2015. H.R. 6 - The 21st Century CURES Act. Proposals regarding improvements to Public Law 111-148 The Patient Protection and Affordable Care Act.

H.R. 1427/S. 804 - Medicare CGM Access Act of 2015.

S. 2689 - Medicare CGM Access Act of 2014. H.R. 1427 - Medicare CGM Access Act of 2015. Proposals to reform the Medicare new technology add-on payment provision for inpatient services. Proposals regarding changes to modernize and update the Medicare Physician Fee Schedule.

H.R. 771 - Protecting Access to Diabetes Supplies Act of 2015. H.R. 6 - The 21st Century CURES Act. Proposals regarding improvements to Public Law 111-148 The Patient Protection and Affordable Care Act. Proposals related to FDA Guidances for Lab Developed Tests. Proposals regarding CLIA-Waiver Reform for diagnostic testing.

S. 2689 - Medicare CGM Access Act of 2014. H.R. 1427 - Medicare CGM Access Act of 2015. Proposals to reform the Medicare New Technology add-on payment provision for inpatient services.

H.R. 1295, Medical Device Tax Elimination Act. Proposals to reform domestic and international tax structures.

S. 662 Trade Facilitation and Trade Enforcement Reauthorization Act of 2013. Proposals regarding Country of Origin Labeling and marketing restrictions. Initiatives regarding Trade Trans-Pacific Partnership (TPP). Initiatives regarding issues related to international price controls on drugs and devices.

21st Century CURES Initiative Proposals regarding the President's Emergency Plan for AIDS Relief (PEPFAR) Proposals to modify requirements for diabetes testing supplies Proposals related to FDA Guidances for Lab Developed Tests Proposals regarding CLIA-Waiver Reform for diagnostic testing

S. 2260 EXPIRE Act H.R. 1295, Medical Device Tax Elimination Act H.R. 523 Protect Medical Innovation Act H.R. 4438 American Research & Competitiveness Act of 2013 Proposals to reform domestic and international tax structures.

H.R. 4920 - Medicare DMEPOS Competitive Bidding Improvement Act of 2014. Proposals to reform the Medicare New Technology add-on payment provision for inpatient services.

Proposals to modify requirements for diabetes testing supplies. 21st Century CURES initiative Proposals related to FDA guidances for diagnostic tests

Proposals to modify inpatient and outpatient prospective payment system.

Initiatives regarding Trade Trans-Pacific Partnership (TPP). International trade policies regarding pharmaceuticals and medical devices. International trade policies regarding nutrition.

Proposals to modify requirements for diabetes testing supplies. Initiatives regarding the Illinois Center for Nutrition, Learning and Memory. 21st Century CURES initiative. Lab Developed Tests FDA Guidance.

H.R. 4486, Military Construction, VA and Related Agencies Appropriations Act of 2014, Section 427.

PL-110-275 Implementation of Medicare DMEPOS Competitive Acquisition Program. H.R. 2810: Medicare Patient Access and Quality Improvement Act of 2013. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule.

Initiatives regarding Trade Promotion Authority (TPA).

H.R. 3309: Innovation Act

H.R. 2810: Medicare Patient Access and Quality Improvement Act of 2013 Proposals relating to implementation of competitive bidding for diabetes strips. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule.

H.R. 3309: Innovation Act

H.R. 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013.

S. 1562 Older Americans Act Reauthorization of 2013. Proposals to Modify Labeling Requirements. Initiatives to reduce patient malnutrition. Initiatives to support patient access to therapeutic nutrition.

H.R. 2810: Medicare Patient Access and Quality Improvement Act of 2013 Proposals to modify DMEPOS reimbursement in Medicare. Proposals regarding changes to modernize and update the Clinical Laboratory Fee Schedule.

H.R. 3497 The MODDERN Cures Act of 2011 H.R. 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 S. 957 Drug Supply Chain Security Act

Initiatives regarding Infant Nutrition. H.R. 1947 Federal Agriculture Reform and Risk Managment Act of 2013. S. 954 Agriculture Reform, Food and Jobs Act of 2013. Initiatives regarding implementation of Public Law 111-296 Health, Hunger-Free Kids Act of 2011

Proposals to reform domestic and international tax structures. H.R. 1295, Medical Device Tax Elimination Act, H.R. 523 Protect Medical Innovation Act, S. Con. Res 8, Amendment 297.

H.R. 3497 The MODDERN Cures Act of 2011 H.R. 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 S. 957 Drug Supply Chain Security Act

Initiatives regarding Infant Nutrition. H.R. 1947 Federal Agriculture Reform and Risk Managment Act of 2013. S. 954 Agriculture Reform, Food and Jobs Act of 2013. Initiatives regarding implementation of Public Law 111-296 Health, Hunger-Free Kids Act of 2011

Proposals to reform domestic and international tax structures. H.R. 1295, Medical Device Tax Elimination Act, H.R. 523 Protect Medical Innovation Act, S. Con. Res 8, Amendment 297.

H.R. 3497, The MODDERN Cures Act of 2011

Proposals to modify DMEPOS reimbursement in Medicare

Proposals to reform domestic and international tax structures. H.R. 1295, Medical Device Elimination Act, H.R. 523 Protect Medical Innovation Act, S. Con. Res 8, Amendment 297.

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

Proposals to reform domestic and international tax structures R & D Tax Credit, Controlled Foreign Corporation look-through

Proposals to modify DMEPOS reimbursement in Medicare Medicare payment proposals

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

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

Proposals to modify DMEPOS reimbursement in Medicare Medicare payment proposals

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act S.3187, the Food and Drug Administration Safety and Innovation Act of 2012 H.R. 3497, The MODDERN Cures Act of 2011 Funding for State AIDS Drug Assistance programs under Ryan White Care Act

Implementation of Public Law 110-275, Medicare DMEPOS Competitive Acquistion Program Proposals to expand competitive bidding for DMEPOS Policies to enhance patient access to medicines in Medicare Medicare payment proposals

Implementation of Public Law 110-275, Medicare DMEPOS Competitive Acquistion Program Proposals to expand competitive bidding for DMEPOS Policies to enhance patient access to medicines in Medicare Medciare payment proposals

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act H.R. 2245 / S. 296, Preserving Access to Life-Saving Medications Act of 2011 H.R. 5, Protecting Access to Healthcare Act of 2012 H.R. 3497, The MODDERN Cures Act of 2011 H.R. 3207, Modernizing Laboratory Test Standards for Patients Act of 2011 Reauthorization of The Prescription Drug User Fee Act Reauthorization of the Medical Device User Fee Act Policies for FDA product approval reform Proposals to improve viral hepatitis screening and testing

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 H.R. 2245 / S. 296, Preserving Access to Life-Saving Medications Act of 2011 S. 27, Preserve Access to Affordable Generics Act H.R. 3026, Safeguarding Americas Pharmaceuticals Act of 2011 H.R. 2112, Consolidated and Further Continuing Appropriations Act, 2012, Amendment #769 Reauthorization of The Prescription Drug User Fee Act Reauthorization of the Medical Device User Fee Act Policies for FDA product approval reform FDA proposals to enhance imported product safety

Proposals to clarify employee labor status

Proposals to reform domestic and international tax structures R&D Tax Credit, Controlled Foreign Corporation look-through

Implementation of Public Law 110-275 Medicare DMEPOS Competitive Acquistion Program Proposals to expand competitive bidding for DMEPOS S.17, Medical Device Access and Innovation Protection Act H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011 Proposals to give Center for Medicare and Medicaid Services authority to use the least costly alternative reimbursement policy Policies to enhance patient access to medicines in Medicare Reimbursement protocols for HIV diagnostics Medicare payment proposals

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.2245, Preserving Access to Life-Saving Medications Act of 2011 S.296, Preserving Access to Life-Saving Medications Act of 2011 Reauthorization of The Prescription Drug User Fee Act Reauthorization of The Medical Device User Fee Act Proposals to expand debt ceiling, various proposals related to health care Proposals to advance personalized medicine Proposals to improve viral hepatitis screening and testing Policies for FDA product approval reform Briefings on medical device technology

Trade issues regarding the Trans-Pacific Partnership H.R.2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, amendment 36.

Implementation of Public Law 110-275 Medicare DMEPOS Competative Acquistion Program Proposals to expand competitive bidding for DMEPOS S.17, Medical Device Access and Innovation Protection Act H.R.675 Strengthening Medicare Anti-Fraud Measures Act of 2011 Medicare Part D program

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 110-293, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act S.319, The Pharmaceutical Market Access and Drug Safety Act of 2011 Reauthorization of The Prescription Drug User Fee Act Reauthorization of The Medical Device User Fee Act H.R.5440, Genomics and Personalized Medicine Act of 2010 H.R. 1483, Drug Safety Enhancement Act of 2011 Proposals to reduce health disparities Policies for FDA product approval reform FDA proposals to enhance imported product safety Briefings on medical device techonology

PL-110-275 Implementation of Medicare DMEPOS Competitive Acquisition Program H.R. 3790 To amend title XVIII of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS) in a budget neutral manner H.R.1321, S. 2404 Medicare Advanced Laboratory Diagnostics Act of 2007

H.R. 6331/S. 3101 Medicare Improvements for Patients and Providers Act of 2008, implementation of sections 153, 154

Health Care Reform H.R. 3590 Patient Protection and Affordable Care Act H.R. 4872 Health Care and Education Reconciliation Act of 2010 H.R. 1548 Pathway for Biosimilars Act HR 3200: America's Affordable Health Choices Act S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009

H.R. 6331/S.3101 Medicare Improvements for Patients and Providers Act of 2008, implementation of sections 153, 154 PL-110-275 Implementation of Medicare DMEPOS Competitive Acquisition Program

H.R. 6331/S. 3101 Medicare Improvements for Patients and Providers Act of 2008, implementation of sections 153, 154

Health Care Reform H.R. 3590 Patient Protection and Affordable Care Act H.R. 4872 Health Care and Education Reconciliation Act of 2010 H.R. 1548 Pathway for Biosimilars Act HR 3200: America's Affordable Health Choices Act S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009

Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009

H.R.1427/S.726 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act S. 1695 Biologics Price Competition and Innovation Act of 2007 Health Care Reform H.R.1346/S.540 Medical Device Safety Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 S.882 Drug and Device Accountability Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1679 Affordable Health Choices Act H.R 3200 America's Affordable Health Choices Act of 2009 S. 1796 the Americas Healthy Future Act

Health Care Reform S 1679: Affordable Health Choices Act S 1796: America's Healthy Future Act HR 3200: America's Affordable Health Choices Act H.R. 3962 Affordable Health Care for America Act H.R. 1548 Pathway for Biosimilars Act H.R.1346/S.540 Medical Device Safety Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009

Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009 H.R. 3790 To amend title XVIII of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS).

Health Care Reform S 1679: Affordable Health Choices Act S 1796: America's Healthy Future Act HR 3200: America's Affordable Health Choices Act H.R. 3962 Affordable Health Care for America Act H.R. 1548 Pathway for Biosimilars Act H.R.1346/S.540 Medical Device Safety Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009

Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009 H.R. 3790 To amend title XVIII of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS).

Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009

H.R.1427/S.726 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act S. 1695 Biologics Price Competition and Innovation Act of 2007 Health Care Reform H.R.1346/S.540 Medical Device Safety Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 S.882 Drug and Device Accountability Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1679 Affordable Health Choices Act H.R 3200 America's Affordable Health Choices Act of 2009 S. 1796 the Americas Healthy Future Act

Standards for regulation of consumer products

Implementation of Medicare Improvements for Patients and Providers Act of 2008, sections 152-154 Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009

H.R.1427/S.726 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act S. 1695 Biologics Price Competition and Innovation Act of 2007 Health Care Reform H.R. 1616 Early Treatment for HIV Act of 2009 H.R.1346/S.540 Medical Device Safety Act of 2009 Topics related to the safety of medical products Creating a federal program to strengthen awareness, education and treatment of chronic kidney disease H.R.759 Food and Drug Administration Globalization Act of 2009 S.882 Drug and Device Accountability Act of 2009 S.1213/H.R.2502 Patient-Centered Outcomes Research Act of 2009 S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009

Standards for regulation of consumer products

Implementation of Medicare Improvements for Patients and Providers Act of 2008, sections 152-154 Implementation of DMEPOS Competitive Acquistion Program H.R. 684/S. 330 Medicare Prescription Drug Savings and Choice Act of 2009

H.R.1321/S.2404 Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, implementation of sections 153, 154 Medicaid Implementation and Rebates

Intellectual Property Protection World Health Organization Initiatives

H.R.6381/S.3398 - Medical Device Safety Act of 2008 H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008 S.3385 - FDA Food Safety Modernization Act Health Care Reform S.2221 Transparency in Medical Device Pricing Act of 2007 S. 1695 Biologics Price Competition and Innovation Act of 2007 S. 623/H.R. 1038 Access to Life-Saving Medicine Act H.R.5629 Pathway for Biosimlars Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 S 2029 Physician Payments Sunshine Act of 2007 Topics relates to the safety of medical products H.R. 3610, the Food and Drug Import Safety Act S.2731/H.R. 5501 - Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reuthorization Act of 2008

H.R. 6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, Section 153, 154 S.3118 - Preserving Access to Medicare Act of 2008, Section 152 H.R. 6252/S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 Protection of private sector delivery H.R. 1321 - Medicare Advanced Laboratory Diagnostics Act of 2007 Proposal to repeal CMS's Least Costly Alternative reimbursement policy for selected medicines H.R. 638/S. 3398 - Medicaid Device Safety Act of 2008 H.R.3162 - Children's Health and Medicare Protection Act of 2007 H.R.4854 - False Claims Act Correction Act of 2007 HR 3326 - Early Treatment for HIV Act of 2007

H.R. 6381- Medical Device Safety Act of 2008 H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008 S.3385 - FDA Food Safety Modernization Act Health Care Reform S.2731/H.R. 5501 Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 H.R. 3580, the Food and Drug Administration Amendments Act of 2007 - issues related to implementation of the Prescription Drug User Fee Act. S.1695, Biologics Price Competition and Innovation Act of 2007 S.623/H.R. 1038 Access to Life-Saving Medicine Act H.R.5629 Pathway for Biosimilars Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007

H.R. 6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, Section 154 S.3118 - Preserving Access to Medicare Act of 2008, Section 152 H.R. 6252/S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 S. 1951/H.R. 3700: Fair Medicaid Drug Payment Act of 2007 H.R. 1321 - Medicare Advanced Laboratory Diagnostics Act of 2007 Proposal to repeal CMS's Least Costly Alternative reimbursement policy for selected medicines

H.R. 6381- Medical Device Safety Act of 2008 H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008 Issues related to potential FDA globalization legislation S.2731/H.R. 5501 Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 H.R. 3580, the Food and Drug Administration Amendments Act of 2007 - issues related to implementation of the Prescription Drug User Fee Act. H.R. 4986, the National Defense Authorization Act - Section 703 - TriCare Retail Pharmacy S.1695, Biologics Price Competition and Innovation Act of 2007 S.623/H.R. 1038 Access to Life-Saving Medicine Act H.R.5629 Pathway for Biosimilars Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 S.334/H.R.3163, Healthy Americans Act

H.R. 3161, The Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2008, Title IV, WIC Implementation issues for WIC reauthorization (legislative and regulatory) H.R. 2419 Farm, Nutrition, and Bioenergy Act of 2007

S. 2221 - Transparency in Medical Device Pricing Act of 2007 H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007 Implementation of Section 641 of public law 108-173, Medicare Prescription Drug Improvement and Modernization Act of 2003 HR 1321/S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007 Implementation of Section 302 of Public Law 108-173, Medicare Prescription Drug Improvement and Modernization Act of 2003

H.R.2419, Farm , Nutrition, and Bioenergy Act of 2007, Sections 11316 and 11317 H.R.1280, S. 714: Pet Safety and Protection Act of 2007

International Intellectual Property Protection World Health Organization initiatives

H.R. 1712: Research and Development Tax Credit Act of 2007 S. 41: Research Competitiveness Act of 2007

Implementation of Public Law 108-265, Child Nutrition Improvement And Integrity Act

S. 736, Laboratory Test Improvement Act S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 1038, S. 623, Access to Life-Saving Medicine Act H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007 S. 1505, Affordable Biologics for Consumers Act H.R. 2900, S.1082, Food and Drug Administration Revitalization Act S. 976, Genomics and Personalized Medicine Act of 2007

H.R. 1908, S.1145, Patent Reform Act H.R. 1432, Preserve Access to Affordable Generics Act