MEDTECH Act

- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - S. 1622, "The FDA Devise Accountablility Act", regarding all provisions. - S. 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions.

Client expense: $1,260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act (prev S.2977) H.R. 6 - 21st Century Cures Act Oversight of EHR Incentive Program

Client expense: $190,000 · Firm income: Not reported

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

Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act (prev S.2977) H.R. 6 - 21st Century Cures Act Oversight of EHR Incentive Program

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

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

- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - S. 1622, "The FDA Devise Accountablility Act", regarding all provisions. - S. 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions.

Client expense: $780,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Sensible Oversight for Technology Which Advances Regulatory Efficiently (SOFTWARE) (prev. H.R. 3303) Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act (prev S.2977) 21st Century Cures Initiative

Client expense: $190,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

Sensible Oversight for Technology Which Advances Regulatory Efficiently (SOFTWARE) (prev. H.R. 3303) Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act (prev S.2977) 21st Century Cures Initiative

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

Government targets: Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

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

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

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)

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

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

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

- 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)

FCC National Broadband Plan; S.609 Electronic Communications Privacy Act Amendments of 2013; S.21 Cybersecurity & American Cyber Competitiveness Act; implementation of Title VI of Middle Class Tax Reform & Job Creation Act of 2011; HR 2454, Aaron's Law Act of 2013; S.517 Unlocking Consumer Choices & Wireless Competition Act; S.987, Free Flow of Information Act of 2013; S.1353, Cybersecurity Act of 2013; S.1215, FISA Accountability & Privacy Protection Act of 2013; Allocation ofUnlicensed Spectrum; FCC Process Reform; Preserving Open Internet/Broadband Industry Practices; S.2454, Satellite Television Access Reauthorization Act of 2014; S.2977, Satellite Television Access & Viewer Rights Act; S.2536, Stop Advertising Victims of Exploitation Act of 2014; S.2505, Wi-Fi Innovation Act.

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

Government targets: Federal Communications Commission (FCC), Justice, Dept of (DOJ), SENATE, White House Office

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FCC National Broadband Plan; S.609 Electronic Communications Privacy Act Amendments of 2013; S.21 Cybersecurity & American Cyber Competitiveness Act; implementation of Title VI of Middle Class Tax Reform & Job Creation Act of 2011; HR 2454, Aaron's Law Act of 2013; S.517 Unlocking Consumer Choices & Wireless Competition Act; S.987, Free Flow of Information Act of 2013; S.1353, Cybersecurity Act of 2013; S.1215, FISA Accountability & Privacy Protection Act of 2013; Allocation ofUnlicensed Spectrum; FCC Process Reform; Preserving Open Internet/Broadband Industry Practices; S.2454, Satellite Television Access Reauthorization Act of 2014; S.2977, Satellite Television Access & Viewer Rights Act; S.2536, Stop Advertising Victims of Exploitation Act of 2014; S.2505, Wi-Fi Innovation Act.

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

Government targets: Federal Communications Commission (FCC), Justice, Dept of (DOJ), SENATE, White House Office

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

To extend or suspend the duty on various chemicals introduced in the 112th Congress: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

To extend or suspend the duty on various chemicals: HR 4851-66, HR 4977 S. 2977-81, S. 2985-6, S 2989, S 2991-95, S 3003-4, S 3006-7

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE