Diagnostic Innovation Testing and Knowledge Advancement Act of 2013

Bioterrorism and Medical Countermeasures DNA Identification Health IT regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4302 - Protecting Access to Medicare Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 Veterans Health Care

Client expense: $3,470,000 · Firm income: Not reported

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

Diagnostic Imaging Payments; CT PETAmyloid, Lung Cancer Coverage; Budget Control Act Implementation; Medicare Reform Legislation; H.R. 2085, The Diagnostic Innovation Testing and Laboratory Services Payment Issues; Knowledge Advancement Act of 2013; H.R. 4302 Protecting Access to Medicare Act of 2014; CT Dose Policy; 21st Century Cures Act

Client expense: $1,332,576 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Energy Regulatory Commission (FERC), Federal Railroad Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issues related to creating incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests; H.R. 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013; Issues related to Medicare program integrity and device procedure registries;Issues related to price transparency for medical devices

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1309, Health Information Technology Reform Act HR 2085, Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 HR 4302, Protecting Access to Medicare Act of 2014

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

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

Implementation of FDA Safety and Innovation Act -Patient-Focused Drug Development HR 3116: MODDERN Cures Act HR 2085: Diagnostics Innovation Testing and Knowledge Advancement Act HR 4302: Protecting Access to Medicare Act Affordable Care Act implementation -Out of pocket costs -Anti-discrimination oversight -Enrollment -Patient assistance programs -Physician Payment Sunshine Act

Client expense: $6,408 · 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), SENATE, White House Office

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to Physician Payment Sunshine provisions. - Issues related to regulation and reimbursement of diagnostics.- Issues related to health care reform, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 1074, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 539, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 452, "Medicare Diabetes Prevention Act of 2013", regarding all provisions. - Issues related to personalized medicine incentives and regulation. - Issues related to Moddern Cures initiative. - Issues related to modernizing laboratory test standards. - Issues related to diagnostic payments. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to vision care coverage. - PL 112-144, "Food and Drug Administration Safety and Innovation Act", regarding Medical Device User Fee Act provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - Issues related to hepatitis C testing and treatment guidelines. - PL 101-381, "Ryan White Comprehensive AIDS Resources Emergency (CARE) Act" and issues related to state ADAP funding. - Issues related to drug resistant tuberculosis. - Issues related to legislation that would establish drug importation. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to medical device reprocessing. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", regarding all provisions. - HR 2085, "Diagnostic Payment Reform", regarding all provisions. - Issues related to health care associated inflation policy. - HR 2663/ S 1422, "Preventative Health Savings Act", regarding all provisions. - HR 3204, "Drug Quality and Security Act", regarding all provisions. - Issues related to neglected tropical diseases. - Issues related to transferable market exclusivity. - HR 4015, "SGR Repeal and Medicare Provider Payment Modernization Act of 2014", regarding all provisions. - Issues related to health care associated infections. - S 959, "Pharmaceutical Quality Security and Accountability Act", regarding all provisions. - Issues related to FDA regulation of custom medical devices. - Issues related to Tricare coverage of Total Disc Arthroplasty. - Issues related to VA requirements for vendor access and credentialing. - Issues related to 21st Century Cures. - Issues related to Medicare beneficiary access. - Issues related to mobile medical applications and digital healthcare. - Issues related to FDA draft guidances on blood glucose meters. - HR 4895, "The Microbead Free Waters Act of 2014", regarding all provisions. - Issues related to the expanded use of unapproved drugs.

Client expense: $1,060,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Diagnostic Imaging Payments, CT PETAmyloid, Lung Cancer Budget Control Act implementation Coverage; Medicare Reform Healthcare Reform Legislation H.R. 2085, The Diagnostic Innovation Testing and Laboratory Services Payment Issues Knowledge Advancement Act of 2013 H.R. 4302 Protecting Access to Medicare Act of 2014 CT Dose Policy

Client expense: $1,313,679 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Energy Regulatory Commission (FERC), Federal Railroad Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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 (PL111-148) Issues related to physician owned distributors of devices Issues related to creating incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests HR 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 Issues related to deficit reduction and Medicare Issues related to Medicare program integrity and device procedure registries Issues relating to payment reform, ACOs and Bundling HR 2925 Strengthening Medicare Anti-Fraud Measures of 2013 Issues related to price transparency for medical devices

Client expense: $640,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1309, Health Information Technology Reform Act HR 2085, Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 HR 4302, Protecting Access to Medicare Act of 2014

Client expense: Not reported · Firm income: $40,000

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

Product safety issues Childhood / Infant Nutrition Diagnostic reimbursement H.R.2085-Diagnostic Innovation Testing and Knowledge Advancement Act of 2013Competitive bidding

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

H.R. 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013. Proposals for blood glucose monitoring test systems. Proposals regarding Public-Private Partnership for HIV Testing in Africa.

Client expense: $410,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

Product safety issues Childhood / Infant Nutrition Diagnostic reimbursement H.R.2085-Diagnostic Innovation Testing and Knowledge Advancement Act of 2013Competitive bidding

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

Bioterrorism and Medical Countermeasures DNA Identification Health IT regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4302 - Protecting Access to Medicare Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 Veterans Health Care

Client expense: $3,360,000 · Firm income: Not reported

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

Implementation of FDA Safety and Innovation Act -Patient-Focused Drug Development HR 3116: MODDERN Cures Act HR 2085: Diagnostics Innovation Testing and Knowledge Advacement ActHR 4302: Protecting Access to Medicare Act Affordable Care Act implementation -Out-of-pocket limits -Anti-discrimination oversight -Enrollment -Patient assistance programs -Physician Payment Sunshine Act

Client expense: $5,018 · 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), SENATE, White House Office

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"

Client expense: $131,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to Physician Payment Sunshine provisions. - Issues related to regulation and reimbursement of diagnostics.- Issues related to health care reform, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 1074, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 539, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 452, "Medicare Diabetes Prevention Act of 2013", regarding all provisions. - Issues related to personalized medicine incentives and regulation. - Issues related to Moddern Cures initiative. - Issues related to modernizing laboratory test standards. - Issues related to diagnostic payments. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to vision care coverage. - PL 112-144, "Food and Drug Administration Safety and Innovation Act", regarding Medical Device User Fee Act provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - Issues related to hepatitis C testing and treatment guidelines. - PL 101-381, "Ryan White Comprehensive AIDS Resources Emergency (CARE) Act" and issues related to state ADAP funding. - Issues related to drug resistant tuberculosis. - Issues related to legislation that would establish drug importation. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to medical device reprocessing. - HR 2375, "Competitive Bidding for DME Delay", regarding all provisions. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", regarding all provisions. - HR 2085, "Diagnostic Payment Reform", regarding all provisions. - Issues related to health care associated inflation policy. - HR 2663/ S 1422, "Preventative Health Savings Act", regarding all provisions. - HR 3204, "Drug Quality and Security Act", regarding all provisions. - Issues related to neglected tropical diseases. - Issues related to transferable market exclusivity. - HR 4015, "SGR Repeal and Medicare Provider Payment Modernization Act of 2014", regarding all provisions. - Issues related to health care associated infections. - S 959, "Pharmaceutical Quality Security and Accountability Act", regarding all provisions. - Issues related to FDA regulation of custom medical devices. - Issues related to Tricare coverage of Total Disc Arthroplasty. - Issues related to VA requirements for vendor access and credentialing.

Client expense: $2,110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 (PL111-148) Issues related to physician owned distributors of devicesIssues related to creating incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests HR 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 Issues related to deficit reduction and Medicare Issues relating to payment reform, ACOs and Bundling HR 2925 Strengthening Medicare Anti-Fraud Measures of 2013 Issues related to the CMS program for durable medical equipment

Client expense: $660,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013. Education with respect to implementation issues in the Medicare Competitive Bidding program, specifically as it relates to access to brand name diabetes test strips. H.R. 4302: Protecting Access to Medicare Act of 2014, specifically as it relates to clinical lab fee schedule reforms.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. HR 1309: Health Information Technology Reform Act HR 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013HR 4302 Protecting Access to Medicare Act of 2014

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), 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. HR 1309: Health Information Technology Reform Act HR 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013

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

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

Diagnostic Imaging Payments, CT PETAmyloid, Lung Cancer Budget Control Act implementation Coverage; Medicare Reform Healthcare Reform Legislation H.R. 2085, The Diagnostic Innovation Testing and Laboratory Services Payment Issues Knowledge Advancement Act of 2013 H.R. 4302 Protecting Access to Medicare Act of 2014 CT Dose Policy

Client expense: $1,347,244 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Energy Regulatory Commission (FERC), Federal Railroad Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

DNA Identification Health IT Regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013HR 523 - Protect Medical Innovation Act of 2013 HR 527 - Responsible Helium Administration and Stewardship Act of 2013 Medicare Reimbursement for Imaging Services Medicare Reimbursement for Lab Services S 1871 - SGR Repeal and Medicare Beneficiaries Access Act of 2013 S 232 - Medical Device Access and Innovation Act of 2013 S 783 - Helium Stewardship Act of 2013 Veterans Health Care

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

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

H.R. 3005: Medical Testing Availablity Act of 2013; Provisions regarding FDA regulations of certain diagnostics and lab developed tests. Draft and final guidance regarding commercially distributed in vitro diagnostic products labeled "For Research Only" or "Investigational Use Only"; Provisions regarding FDA regulation of certain diagnostics.H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013; Provisions regarding value based payment for advanced diagnostics.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

DNA Identification Health IT Regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013HR 523 - Protect Medical Innovation Act of 2013 HR 527 - Responsible Helium Administration and Stewardship Act of 2013 Medicare Reimbursement for Imaging Services Medicare Reimbursement for Lab Services S 1871 - SGR Repeal and Medicare Beneficiaries Access Act of 2013 S 232 - Medical Device Access and Innovation Act of 2013 S 783 - Helium Stewardship Act of 2013 Veterans Health Care

Client expense: $3,890,000 · Firm income: Not reported

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

Implementation of FDA Safety and Innovation Act -Patient-Focused Drug Development HR 3116: MODDERN Cures Act HR 2085: Diagnostics Innovation Testing and Knowledge Advancement ActAffordable Care Act implementation -Out-of-pocket limits -Formulary oversight and methodology -Patient Assistance Programs -Physician Payment Sunshine Act

Client expense: $9,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE

Product safety issues Childhood / Infant Nutrition Diagnostic reimbursement H.R.2085-Diagnostic Innovation Testing and Knowledge Advancement Act of 2013Competitive bidding

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to Physician Payment Sunshine provisions. - Issues related to regulation and reimbursement of diagnostics.- Issues related to health care reform, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 1074, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 539, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 452, "Medicare Diabetes Prevention Act of 2013", regarding all provisions. - Issues related to personalized medicine incentives and regulation. - Issues related to Moddern Cures initiative. - Issues related to modernizing laboratory test standards. - Issues related to diagnostic payments. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to vision care coverage. - PL 112-144, "Food and Drug Administration Safety and Innovation Act", regarding Medical Device User Fee Act provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - Issues related to hepatitis C testing and treatment guidelines. - PL 101-381, "Ryan White Comprehensive AIDS Resources Emergency (CARE) Act" and issues related to state ADAP funding. - Issues related to drug resistant tuberculosis. - Issues related to legislation that would establish drug importation. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to medical device reprocessing. - HR 2375, "Competitive Bidding for DME Delay", regarding all provisions. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", regarding all provisions. - HR 2085, "Diagnostic Payment Reform", regarding all provisions. - Issues related to health care associated inflation policy. - HR 2663/ S 1422, "Preventative Health Savings Act", regarding all provisions. - HR 3204, "Drug Quality and Security Act", regarding all provisions. - Issues related to neglected tropical diseases. - Issues related to transferable market exclusivity. - S. 1871, "SGR Repeal and Medicare Beneficiary Access Act of 2013", regarding all provisions. - Issues related to health care associated infections. - S. 959, "Pharmaceutical Quality Security and Accountability Act", regarding all provisions.

Client expense: $860,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013. Education with respect to implementation issues in the Medicare Competitive Bidding program, specifically as it relates to access to brand name diabetes test strips.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $700,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Diagnostic Imaging Payments, CT PETAmyloid, Lung Cancer Budget Control Act implementation Coverage; Medicare Reform Healthcare Reform Legislation H.R. 2085, The Diagnostic Innovation Testing and Laboratory Services Payment Issues Knowledge Advancement Act of 2013

Client expense: $1,238,210 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Energy Regulatory Commission (FERC), Federal Railroad Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 (PL111-148) Issues related to physician owned distributors of devicesS. 351 Protecting Seniors' Access to Medicare Act of 2013 (Repeal of IPAB). H.R. 351 Protecting Seniors' Access to Medicare Act of 2013 (Repeal of IPAB). Issues related to creating incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests. HR 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013. Issues related to deficit reduction and Medicare. Issues relating to payment reform, ACOs and Bundling. HR 2925 Strengthening Medicare Anti-Fraud Measures of 2013.

Client expense: $550,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3005: Medical Testing Availablity Act of 2013; Provisions regarding FDA regulations of certain diagnostics and lab developed tests. Draft and final guidance regarding commercially distributed in vitro diagnostic products labeled "For Research Only" or "Investigational Use Only"; Provisions regarding FDA regulation of certain diagnostics.H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013; Provisions regarding value based payment for advanced diagnostics.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues impacting the legislative and regulatory oversight of laboratory developed tests, reimbursement of diagnostic tests, DNA patents, workforce issues. HR 1309: Health Information Technology Reform Act HR 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), 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. HR 1309: Health Information Technology Reform Act HR 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013

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

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

Affordable Care Act implementation -Essential Health Benefits -Exchange implementation -Out-of-pocket limitsImplementation of FDA Safety and Innovation Act HR 3116: MODDERN Cures Act HR 2085: Diagnostics Innovation Testing and Knowledge Advancement Act

Client expense: $11,777 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE

Diagnostic Imaging Payments, CT PETAmyloid, Lung Cancer Budget Control Act implementation Coverage; Medicare Reform Healthcare Reform Legislation H.R. 2085, The Diagnostic Innovation Testing and Laboratory Services Payment Issues Knowledge Advancement Act of 2013

Client expense: $1,323,332 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Energy Regulatory Commission (FERC), Federal Railroad Administration, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

DNA Identification Health IT regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 HR 523 - Protect Medical Innovation Act of 2013HR 527 - Responsible Helium Administration and Stewardship Act of 2013 Medicare Reimbursement for Imaging Services Medicare Reimbursement for Lab Services S 232 - Medical Device Access and Innovation Act of 2013 S 783 - Helium Stewardship Act of 2013 Veterans Health Care

Client expense: $3,420,000 · Firm income: Not reported

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

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to Physician Payment Sunshine provisions. - Issues related to regulation and reimbursement of diagnostics.- Issues related to health care reform, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 1074, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 539, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 452, "Medicare Diabetes Prevention Act of 2013", regarding all provisions. - Issues related to personalized medicine incentives and regulation. - Issues related to Moddern Cures initiative. - Issues related to modernizing laboratory test standards. - Issues related to diagnostic payments. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to vision care coverage. - PL 112-144, "Food and Drug Administration Safety and Innovation Act", regarding Medical Device User Fee Act provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - Issues related to hepatitis C testing and treatment guidelines. - PL 101-381, "Ryan White Comprehensive AIDS Resources Emergency (CARE) Act" and issues related to state ADAP funding. - Issues related to drug resistant tuberculosis. - Issues related to legislation that would establish drug importation. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to medical device reprocessing. - HR 2375, "Competitive Bidding for DME Delay", regarding all provisions. - Issues related to health care pricing transparency. - Issues related to Mobile Medical Application draft legislation. - HR 2085, "Diagnostic Payment Reform", regarding all provisions. - Issues related to health care associated inflation policy. - HR 2663/ S 1422, "Preventative Health Savings Act", regarding all provisions. - HR 3204, "Drug Quality and Security Act", regarding all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013. Education with respect to implementation issues in the Medicare Competitive Bidding program, specifically as it relates to access to brand name diabetes test strips.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 (PL111-148) Issues related to physician owned distributors of devicesS. 351 Protecting Seniors' Access to Medicare Act of 2013 (Repeal of IPAB). H.R. 351 Protecting Seniors' Access to Medicare Act of 2013 (Repeal of IPAB). Issues related to creating incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests HR 2085 Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 Issues related to deficit reduction and Medicare Issues relating to payment reform, ACOs and Bundling HR 2925 Strengthening Medicare Anti-Fraud Measures of 2013

Client expense: $590,033 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1701, Cutting Costly Codes Act of 2013, all provisions S. 972, Cutting Costly Codes Act of 2013, all provisions H.R. 2085, Diagnostic Innovation Testing and Knowledge Advancement Act of 2013, all provisions H.R. 2835, Restoring Access to Medication Act of 2013, all provisionsS. 1323, Protecting Our Youth from Dangerous Synthetic Drugs Act of 2013, all provisions H.R. 3204, Drug Quality and Security Act, provisions relating to drug compounding S. 959, Pharmaceutical Quality, Security, and Accountability Act, all provisions H.R. 3089, Compounding Clarity Act of 2013, all provisions H.R. 2094, School Access to Emergency Epinephrine Act, all provisions H.R. 2073, Pulmonary Hypertension Research and Diagnosis Act of 2013, all provisions Affordable Care Act - repeal of Section 9003 - HSA/FSA OTC drugs prescription requirement Affordable Care Act Section 2607(a) - Provider Non-discrimination Genetic Information Nondiscrimination Act Personalized Medicine Electronic Health Records - Meaningful Use Regulations Health Information Technology In-office Ancillary Services Exception Prescription Drug Diversion and Abuse Regulation of laboratory developed tests Prescriber education and mandatory/voluntary CME training Pay-for-delay Physician Coding Rogue Online/Internet Pharmacies Telehealth/Telemedicine Prescription Drug Compounding Drug Shortages ICD-10 Repeal HIPAA Privacy/Security issues and accounting for disclosures Physician Compare Redesign Opioid Analgesics Shared Savings/Accountable Care Organization program Delivery Reform Health Insurance Reform Marketing of high stimulant/caffeine drinks to children Sunshine Act Supplemental Nutrition Assistance Program (SNAP)

Client expense: $4,270,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 3005: Medical Testing Availablity Act of 2013; Provisions regarding FDA regulations of certain diagnostics and lab developed tests. Draft guidance regarding commercially distributed in vitro diagnostic products labeled "For Research Only or Investigational Use Only:" Frequently Asked Questions; Provisions regarding regulation of certain diagnostics.H.R. 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013; Provisions regarding value based payment for advanced diagnostics.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, 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; HR 1309: Health Information Technology Reform Act HR 2085: Diagnostic Innovation Testing and Knowledge Advancement Act of 2013

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