SOFTWARE Act of 2013

H.R. 973, to exempt employers from any excise tax and certain suits and penalties in the case of a failure of a group health plan to provide coverage to which an employer objects on the basis of religious belief or moral conviction. H.R. 1274, to amend title XVIII of the Social Security Act to improve access to diabetes self-management training by authorizing certified diabetes educators to provide diabetes self-management training services. H.R. 2415, to amend title XVIII of the Social Security Act to include information on the coverage of intensive behavioral therapy for obesity in the Medicare and You Handbook and to provide for the coordination of programs to prevent and treat obesity. H.R. 2752, to amend the Internal Revenue Code of 1986 to exclude seasonal workers from the applicable large employer determination for purposes of employer shared responsibility regarding health coverage; to Ways & Means. H.R. 2820, to amend the IRC of 1986 to provide for equity relating to medical costs. H.R. 3303, to amend the Federal Food, Drug, and Cosmetic Act to provide for regulating medical software, and for other purposes. H.R. 3591, to amend the Public Health Service Act to authorize grants to provide treatment for diabetes in minority communities. HR 4765, the Fit for Life Act of 2014, to address childhood obesity, and for other purposes. H.R.5790 -- Health Prizes Rewarding Innovation, Savings, and Effectiveness Act of 2014 H.R.5823 -- Incentivizing Healthcare Quality Outcomes Act of 2014 S. 1422, to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. S. 2007, to amend the Federal Food, Drug and Cosmetic Act to provide for regulating clinical and health software, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2375 -Transparency and Accountability in Medicare Bidding Act of 2013 - provisions related to Round One recompete and implications for diabetes products. HR 2810 - The Medicare Patient Access and Quality Improvement Act of 2013 - issues related to reform of the physician fee schedule and the SGR formula.Provided continuing support for Medtronic acquisition of Covidien, which included attention to potential legislation on federal contracting limitations and various tax policy proposals. H.R. 2725 - FDA Safety Over Sequestration Act of 2013, and S. 1413 FDA User Fee Protection Act - provisions related to protecting industry paid user fees from sequestration H.R. 2663 & S. 1422 - The Preventative Health Savings Act - provisions that will permit leaders in Congress to request that CBO estimate the long-term health savings that are possible from preventative health initiatives like abdominal aortic aneurysm, hypertension screenings. H.R. 3077 The TELE-MED Act of 2013 provisions related to telemedicine and remote monitoring that increase access to health care and enhance patient outcomes H.R. 3303 Software Act of 2013 - provisions related to FDA regulation of health information technology and mobile medical applications S. 1932 - Better Care, Lower Cost Act - provisions related to management of chronic disease H.R. - 3890 - Better Care, Lower Cost Act - provisions related to management of chronic disease Issues related to neuroscience research Issues related to the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

Client expense: $950,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Incentives for health information technology, Affordable Care Act implementation, and other healthcare policy issues. Proposed regulation of medical software. H.R. 3303 "SOFTWARE Act of 2013". S. 2007 "PROTECT Act of 2014". S.2977 "MEDTECH Act"

Client expense: $338,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Incentives for health information technology, Affordable Care Act implementation, and other healthcare policy issues. Proposed regulation of medical software. H.R. 3303 "SOFTWARE Act of 2013". S. 2007 "PROTECT Act of 2014". S.2977 "MEDTECH Act"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocated for inclusion of language supporting an open standards reference architecture for Military and VA electronic health records (H.R. 4486 Fiscal Year 2015 Military Construction, Veterans Affairs Appropriations Bill, Information Technology Funding; H.R. 4870 Fiscal Year 2015 Defense Appropriations Bill). Advocated for Medical Devices bills (H.R. 3303 SOFTWARE Act of 2013; S. 2007 Senate Protect Act of 2014). Advocated for Telehealth bills (H.R. 3306 Telehealth Enhancement Act; H.R. 5830 Medicare Telehealth Parity Act) and the House Energy and Commerce 21st Century Cures Initiative.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES

Data privacy and security, policies pertaining to "Big Data" and privacy; Department of Commerce Multistakeholder process to develop privacy best practices; Federal Trade Commission review of privacy and big data; Cross-border data flows and international server localization requirements; Legislation to amend the Electronic Communications Privacy Act, Electronic Communications Privacy Act Amendments Act of 2013 (S. 607 and H.R. 1852); Cybersecurity, cyber threat information sharing, including the Cyber Intelligence Sharing and Protection Act (H.R. 624); Internet Governance, including details regarding the proposed transition the Internet Assigned Numbers Authority (IANA) function per the March 14, 2014 National Telecommunications and Information Agency (NTIA) announcement; Health IT, FDA regulation of software, including the Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 (H.R. 3303), the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (S. 2007) and the Medical Electronic Data Technology Enhancement for Consumers Health Act (S. 2977); NIST Privacy Engineering Initiative; Federal Information Security Modernization Act(S. 2521), issues pertaining to federal IT procurement and data breach notification.

Client expense: $330,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Implementation of Public Law 112-144: The Food and Drug Administration Safety and Improvement Act H.R. 3303, the Software Act - FDA regulation of health information technology, mobile medical applications and software Telehealth legislation Energy & Commerce Committee 21st Century Cures Initiative

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

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

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

Client expense: $167,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3303: SOFTWARE Act of 2013. Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES

HR 3303 "SOFTWARE Act," all provisions pertaining to a framework for oversight of patient safety in health information technology. S 2977 "MEDTECH Act," all provisions pertaining to a framework for oversight of patient safety in health information technology. HR 4015 "SGR Repeal and Medicare Provider Payment Modernization Act of 2014," all provisions related to a proposed alternative to Accountable Care Organizations for small, independent practices. Issues relating to the role of health information technology in care coordination. Issues relating to opposition to the current trajectory of the Meaningful Use program.

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3077 - TEL-Med Act of 2013 (regarding Medicare providers; cross-state licensing) H.R. 3303 - SOFTWARE Act of 2013 (regulation of medical software) H.R. 3489 - To amend section 1341 of the Patient Protection and Affordable Care Act to repeal the funding mechanism for the transitional reinsurance program in the individual market, and for other purposes.S. 2007 - Preventing Regulatory Overreach to Enhance Care Technology Act of 2014 (PROTECT Act) Implementation of the Patient Protection and Affordable Care Act Healthcare information technology including potential regulation

Client expense: $2,970,000 · Firm income: Not reported

Government targets: Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Office of the Comptroller of the Currency (OCC), SENATE, Treasury, Dept of, White House Office

Regulation of Health IT, including the SOFTWARE Act (H.R. 3303), PROTECT Act (S. 2007), and MEDTECH Act (S. 2977) Health care data, input on improving accessibility and utility of data to improve care while maintaining and protecting patient privacy Medicare, including physician reimbursement SGR policy, S. 2000/H.R. 4012, SGR Repeal and Medicare Provider Payment Modernization Act of 2014 Beneficiaries dually eligible for Medicare and Medicaid Health care delivery and payment reform

Client expense: $301,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries, including H.R. 5214, legislation to improve the use of clinical data registries Issues related to unique device identifier Issues related to FDA regulation of blood glucose meters Issues related to the competitiveness of the medical technology industry and the impact of Federal policies Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the VA credentialing system for health care industry representatives Issues related to the regulation of mobile medical technology, including H.R. 3303 SOFTWARE Act of 2013 S. 2007 Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S. 2977 Medical Electronic Data Technology Enhancement for Consumers Health Act or the MEDTECH Act Issues related to VA contracts with medical device companies and direct shipment to consumers

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5481 - Flexibility in Health IT Reporting Act of 2014, HR 3303 - SOFTWARE Act/MEDTECH Act Electronic Health Records, Patient Safety, Regulation of Health IT, ICD-10, Health Software Regulation, Quality Measurement, Patient Data Matching, Interoperability

Client expense: $10,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), SENATE

HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013/ Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, Cybersecurity, Health Software Regulation, Electronic Health Records, Patient Safety

Client expense: $10,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), SENATE

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $3,540,000 · 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 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, 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. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", 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. - 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/ S 2902, "The Microbead Free Waters Act of 2014", regarding all provisions. - Issues related to the expanded use of unapproved drugs. - Issues related to combination products. - Issues related to the PROTECT Act (bill number pending), specifically medical mobile applications. - Issues related to Government Health Care Exclusion/ Debarment (bill number pending) - S 2977, "MEDTECH Act", regarding provisions related to medical mobile applications. - S 2917, "Adding Ebola to the FDA Priority Review Voucher Program Act", regarding all provisions.

Client expense: $1,400,000 · Firm income: Not reported

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

Implementation of PL-111-148, Patient Protection and Affordable Care Act Implementation of PL-112-144, Food and Drug Administration Safety and Innovation Act Medical Device Postmarket Surveillance H.R. 3303, "SOFTWARE Act of 2013: Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 Enhanced Surgical Recovery Protocols 21st Century Cures and other Device Innovation Initiatives

Client expense: $200,000 · Firm income: Not reported

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

H.R. 3303: SOFTWARE Act of 2013. Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussion of differences between laparoscopic and hysteroscopic morcellation procedures. "Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013" (H.R. 3303). "Preventing Regulatory Overreach To Enhance Care Technology Act of 2014" (S. 2007). Custom Device Exemption: Draft Guidance for Industry and Food and Drug Administration Staff (FDA-2013-D-1601).Final Rule - Unique Device Identification System: September 24, 2013

Client expense: $415,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative & Regulatory Issues Related to Technology Policy, including R&D, Cybersecurity, Privacy, Health IT & Technology Procurement: H.R. 2495/S. 733 American Super Computing Leadership Act. H.R. 3303 Software Act; S. 2007 Protect Act. S. 2588 Cybersecurity Information Sharing Act of 2014; S. 1353 Cybersecurity Enhancement Act of 2014; S. 2521 Federal Information Security Modernization Act of 2014. Section 508 Accessibility Guidelines. S. 2871 Law Enforcement Access to Data Stored Abroad (LEADS) Act.

Client expense: $1,150,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Education, Dept of, Energy, Dept of, Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), U.S. Trade Representative (USTR), White House Office

Healthcare IT funding issues; Health IT regulatory issues; H.R. 3303 Software Act; Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014; H.R. 1 American Recovery and Reinvestment Act: implementation of health IT funding and privacy and security issues; VA Health System, Medical Equipment Procurement Reform; S. 2450 and H.R. 4841 Veterans' Access to Care through Choice, Accountability and Transparency Act of 2014.Regulation of diagnostic laboratory testing (no bills introduced). FDA related legislation, user fees; Personalized MediLink (Modern Cures Act); Device Tax.

Client expense: $1,121,762 · 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

Monitor Medicare issues: medical device tax; HR 3303, Software Act of 2013

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES

Patent reform legislation impacting universities; H.R. 3303 Innovation Act: concerns about impact on developing the patent approval process; Patent Transparency and Improvements Act (S.1720).

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

Government targets: Agriculture, Dept of (USDA), Education, Dept of, HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Discussion of differences between laparoscopic and hysteroscopic morcellation procedures. "Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013" (H.R. 3303). "Preventing Regulatory Overreach To Enhance Care Technology Act of 2014" (S. 2007). Custom Device Exemption: Draft Guidance for Industry and Food and Drug Administration Staff (FDA-2013-D-1601).Final Rule - Unique Device Identification System: September 24, 2013

Client expense: $375,000 · Firm income: Not reported

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

HR 2375 -Transparency and Accountability in Medicare Bidding Act of 2013 - provisions related to Round One recompete and implications for diabetes products. HR 2810 - The Medicare Patient Access and Quality Improvement Act of 2013 - issues related to reform of the physician fee schedule and the SGR formula.H.R. 2725 - FDA Safety Over Sequestration Act of 2013, and S. 1413 FDA User Fee Protection Act - provisions related to protecting industry paid user fees from sequestration H.R. 2663 & S. 1422 - The Preventative Health Savings Act - provisions that will permit leaders in Congress to request that CBO estimate the long-term health savings that are possible from preventative health initiatives like abdominal aortic aneurysm, hypertension screenings. H.R. 3077 The TELE-MED Act of 2013 provisions related to telemedicine and remote monitoring that increase access to health care and enhance patient outcomes H.R. 3303 Software Act of 2013 - provisions related to FDA regulation of health information technology and mobile medical applications S. 1932 - Better Care, Lower Cost Act - provisions related to management of chronic disease H.R. - 3890 - Better Care, Lower Cost Act - provisions related to management of chronic disease Issues related to neuroscience research Issues related to the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulation of Health IT, including H.R. 3303, SOFTWARE Act of 2013 and S. 2007, PROTECT Act of 2014 Health care data, input on improving accessibility and utility of data to improve care while maintaining and protecting patient privacy Medicare, including physician reimbursement SGR policy, S. 2000/H.R. 4012, SGR Repeal and Medicare Provider Payment Modernization Act of 2014Beneficiaries dually eligible for Medicare and Medicaid Health care delivery and payment reform

Client expense: $330,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Incentives for health information technology, Affordable Care Act implementation, and other healthcare policy issues. Proposed regulation of medical software. H.R. 3303 "SOFTWARE Act of 2013". S. 2007 "PROTECT Act of 2014".

Client expense: $240,000 · 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), SENATE

Legislative & Regulatory Issues Related to Technology Policy, including R&D, Cybersecurity, Privacy, Health IT & Technology Procurement: H.R. 2495/S. 733 American Super Computing Leadership Act. H.R. 3303 Software Act; S. 2007 Protect Act.H.R. 3696 National Cybersecurity and Critical Infrastructure Protection Act of 2014; S. 2577 Cybersecurity Information Sharing Act of 2014.

Client expense: $850,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Education, Dept of, Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Labor, Dept of (DOL), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Incentives for health information technology, Affordable Care Act implementation, and other healthcare policy issues. Proposed regulation of medical software. H.R. 3303 "SOFTWARE Act of 2013". S. 2007 "PROTECT Act of 2014".

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Advocated for inclusion of language supporting an open standards reference architecture for Military and VA electronic health records (H.R. 4486 Fiscal Year 2015 Military Construction and Veteran Affairs Appropriations Bill, Information Technology Funding; H.R. 4870 Fiscal Year 2015 Defense Appropriations Bill). Advocated for Medical Devices bills (H.R. 3303 SOFTWARE Act of 2013)Advocated for Telehealth bills (H.R. 3306 Telehealth Enhancement Act; H.R. 5830 Medicare Telehealth Parity Act) and the House Energy amd Commerce 21st Century Cures Initiative.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES

Advocated for inclusion of language supporting an open standards reference architecture for Military and VA electronic health records (H.R. 4486 Fiscal Year 2015 Military Construction, Veterans Affairs Appropriations Bill, Information Technology Funding; H.R. 4870 Fiscal Year 2015 Defense Appropriations Bill). Advocated for Medical Devices bills (H.R. 3303 SOFTWARE Act of 2013; S. 2007 Senate Protect Act of 2014).Advocated for Telehealth bills (H.R. 3306 Telehealth Enhancement Act; H.R. 5830 Medicare Telehealth Parity Act) and the House Energy and Commerce 21st Century Cures Initiative.

Client expense: $810,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Telecommunications & Information Administration (NTIA), SENATE, Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies ActHR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $5,320,000 · 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 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, 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 Public Law 112-144: The Food and Drug Administration Safety and Improvement Act, HR 3303, the Software Act - FDA regulation of health information technology and mobile medical applications

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

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

H.R. 973, to exempt employers from any excise tax and certain suits and penalties in the case of a failure of a group health plan to provide coverage to which an employer objects on the basis of religious belief or moral conviction. H.R. 1274, to amend title XVIII of the Social Security Act to improve access to diabetes self-management training by authorizing certified diabetes educators to provide diabetes self-management training services. H.R. 2415, to amend title XVIII of the Social Security Act to include information on the coverage of intensive behavioral therapy for obesity in the Medicare and You Handbook and to provide for the coordination of programs to prevent and treat obesity. H.R. 2752, to amend the Internal Revenue Code of 1986 to exclude seasonal workers from the applicable large employer determination for purposes of employer shared responsibility regarding health coverage; to Ways & Means. H.R. 3303, to amend the Federal Food, Drug, and Cosmetic Act to provide for regulating medical software, and for other purposes. H.R. 3591, to amend the Public Health Service Act to authorize grants to provide treatment for diabetes in minority communities. HR 4765, the Fit for Life Act of 2014, to address childhood obesity, and for other purposes. S. 1422, to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. S. 2007, to amend the Federal Food, Drug and Cosmetic Act to provide for regulating clinical and health software, and for other purposes.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Data privacy and security, policies pertaining to "Big Data" and privacy; Department of Commerce Multistakeholder process to develop privacy best practices; Federal Trade Commission review of privacy and big data; Obama Administration request for informtion on the consumer privacy bill of rights, cross-border data flows and international server localization requirements.Legislation to amend the Electronic Communications Privacy Act, including Electronic Communications Privacy Act Amendments Act of 2013 (S. 607 and H.R. 1852); and cybersecurity. Internet Governance, including details regarding the proposed transition the Internet Assigned Numbers Authority (IANA) function per the March 14, 2014 National Telecommunications and Information Agency (NTIA) announcement. Health IT, FDA regulation of software, including the Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 (H.R. 3303) and Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (S. 2007).

Client expense: $350,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. International Trade Commission (ITC), U.S. Postal Service (USPS), U.S. Trade Representative (USTR)

H.R. 3077 - TEL-Med Act of 2013 (regarding Medicare providers; cross-state licensing) H.R. 3303 - SOFTWARE Act of 2013 (regulation of medical software) H.R. 3489 - To amend section 1341 of the Patient Protection and Affordable Care Act to repeal the funding mechanism for the transitional reinsurance program in the individual market, and for other purposes.S. 2007 - Preventing Regulatory Overreach to Enhance Care Technology Act of 2014 (PROTECT Act) Implementation of the Patient Protection and Affordable Care Act

Client expense: $2,910,000 · Firm income: Not reported

Government targets: Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Office of the Comptroller of the Currency (OCC), SENATE, Treasury, Dept of, White House Office

H.R. 3303: SOFTWARE Act of 2013. Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars. H.R. 1281: Newborn Screening Saves Lives Reauthorization Act of 2013. H.R. 3303: SOFTWARE Act of 2013. Education about the value of innovative new medicines.Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3303: SOFTWARE Act of 2013. Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3303 / S 2007 "SOFTWARE Act," all provisions pertaining to a framework for oversight of patient safety in health information technology. HR 4015 "SGR Repeal and Medicare Provider Payment Modernization Act of 2014," all provisions related to a proposed alternative to Accountable Care Organizations for small, independent practices. Issues relating to the role of health information technology in care coordination. Issues relating to opposition to the current trajectory of the Meaningful Use program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare IT funding issues; Health IT regulatory issues; H.R. 3303 Software Act; Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014; H.R. 1 American Recovery and Reinvestment Act: implementation of health IT funding and privacy and security issues; VA Health System, Medical Equipment Procurement Reform; S. 2450 and H.R. 4841 Veterans' Access to Care through Choice, Accountability and Transparency Act of 2014.Regulation of diagnostic laboratory testing (no bills introduced). FDA related legislation, user fees; Personalized MediLink (Modern Cures Act); Device Tax.

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 implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries, including H.R. 5214, legislation to improve the use of clinical data registries Issues related to unique device identifier Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to FDA regulation of blood glucose meters Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the VA credentialing system for health care industry representatives Issues related to the regulation of mobile medical technology, including H.R. 3303 SOFTWARE Act of 2013 S. 2007 Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

Client expense: $510,000 · 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. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", 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. - 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/ S 2902, "The Microbead Free Waters Act of 2014", regarding all provisions. - Issues related to the expanded use of unapproved drugs. - Issues related to combination products. - Issues related to the PROTECT Act (bill number pending), specifically medical mobile applications. - Issues related to Government Health Care Exclusion/ Debarment (bill number pending)

Client expense: $1,350,000 · Firm income: Not reported

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

Implementation of PL-111-148, Patient Protection and Affordable Care Act; Implementation of PL-112-144, "Food and Drug Administration Safety and Innovation Act"; Medical Device Postmarket Surveillance; H.R. 3303, "SOFTWARE Act of 2013: Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013"; Enhanced Surgical Recovery Protocols; 21st Century Cures and other Device Innovation Initiatives;

Client expense: $210,000 · Firm income: Not reported

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