Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

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: $2,920,000 · 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)

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 Ebola supplemental funding. 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: $980,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Education, Dept of, 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)

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

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)

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

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)

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

Implementation issues related to the Pharmaceutical Quality, Security, and Accountability Act (P.L. 113-54); H.R.1416, Cancer Patient Protection Act of 2013; pharma supply chain issues; S.2007, Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (PROTECT Act); issues related to the 340B Program.

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

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: $375,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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, 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)

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)

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)

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

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

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

Implementation issues related to the Pharmaceutical Quality, Security, and Accountability Act (P.L. 113-54); H.R.1416, Cancer Patient Protection Act of 2013; pharma supply chain issues; S.2007, Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (PROTECT Act); issues related to the 340B Program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 112-25, the Budget Control Act of 2011 S. 2176, The Commonsense Reporting Act of 2014 H.R. 3635, The Safe and Secure Federal Websites Act S. 2694, The Ensuring Access to Primary Care for Women & Children Act S. 2461, The Childrens Health Insurance Program (CHIP) Extension Act of 2014 H.R. 5364, The CHIP Extension and Improvement Act of 2014 H.R. 4438, The American Research and Competitiveness Act of 2014 H.R. 4106, The Saving Lives, Saving Costs Act H.R. 4750, The Standard of Care Protection Act H.R. 3522, The Employee Health Care Protection Act S. 2578 The Protect Women's Health From Corporate Interference Act of 2014 H.R. 5051, The Protect Women's Health From Corporate Interference Act of 2014 H.R. 5539, To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. PL 113-128, Workforce Innovation and Opportunity Act H.R. 3303, Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act S.2007, Preventing Regulatory Overreach To Enhance Care Technology(PROTECT) Act of 2014

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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: $250,000 · 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

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

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).

Client expense: $430,000 · 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: $250,000 · 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 ActDraft Cybersecurity Information Sharing Act of 2014

Client expense: $1,690,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Treasury, Dept of, 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.H.R. 4015 - Sustainable Growth Rate (SGR) Repeal and Medicare Provider Payment Modernization Act of 2014 H.R. 4302 - Protecting Access to Medicare Act of 2014 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: $3,470,000 · Firm income: Not reported

Government targets: 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

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: $2,840,000 · 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)

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

H.R. 3303, the SOFTWARE Act, S. 2007, the PROTECT Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health IT, including H.R. 3303, SOFTWARE Act of 2013 and S. 2007, PROTECT Act of 2014 Medicare, including physician reimbursement SGR policy, S. 2000/H.R. 4012, SGR Repeal and Medicare Provider Payment Modernization Act of 2014 Long-term care, including Medicaid, beneficiaries dually eligible for Medicare and Medicaid, and private long-term care insurance Health care delivery and payment reform Prevention and nutrition and physical activity training in medical schools, including H.R. 4427, ENRICH Act

Client expense: $370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

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

Government targets: SENATE

S. 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation issues related to the Pharmaceutical Quality, Security, and Accountability Act (P.L. 113-54); H.R.1416, Cancer Patient Protection Act of 2013; pharma supply chain issues; S.2007, Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (PROTECT Act).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR3303 "SOFTWARE Act of 2013," all provisions. S2007 "Preventing Regulatory Overreach To Enhance Care Technology Act of 2014," all provisions. HR4015 "SGR Repeal and Medicare Provider Payment Modernization Act of 2014," all provisions relating to Accountable Care Organizations for small, independent practices. Issues relating to the role of health information technology in care coordination. Issues relating to Meaningful Use delays and "Hardship Exemption" for lack of vendor readiness.

Client expense: $230,000 · 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 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 diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the VA tracking of surgical implants Issues related to the VA credentialing system for health care industry representatives H.R. 3303 SOFTWARE Act of 2013 S. 2007 Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE