Medical Device Servicing Safety and Accountability Act

Medical Device User Fee Act - S.692 Medical Device Access and Innovation Protection Act - section 710 requiring FDA to report on third-party servicing of medical devices. H.R. 1362, Medical Innovation Never Stops Act - All provisions Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act (115th Congress) Cybersecurity Artificial Intelligence issues relating to medical devices PL 115-271: SUPPORT for Patients and Communities Act - Implementation of various provisions, including opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues Upcoming FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medical Device User Fee Act - S.692 Medical Device Access and Innovation Protection Act and companion legislation in House (to be introduced) H.R. 1362, Medical Innovation Never Stops Act Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act Cybersecurity Artificial Intelligence issues relating to medical devices Possible legislation to incentivize/require AEDs in schools H.R.6 - Opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues Upcoming FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes

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), Internal Revenue Service (IRS), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues related to post-market surveillance of medical devices and unique device identifiers. Issues related to third-party servicing of medical devices, H.R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to implementation of Title VII (device inspection and regulatory improvements) of the FDA Reauthorization Act (P.L. 115-52). Section 6111 of H.R. 6, the SUPPORT for Patients and Communities Act, issues related to CMS Open Payments System.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

Medical Device User Fee Act Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act Cybersecurity Artificial Intelligence issues relating to medical devices Possible legislation to incentivize/require AEDs in schools H.R.6 - Opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 Medical imaging reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Hospital outpatient reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018 HR 6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Ultrasound Reimbursement Cyber Security

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2118 related to third party servicing of medical devices Issues related to diagnostics regulation Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies H.R. 5418 related to improving the Medical-Surgical Prime Vendor procurement program at the VA S. 1691 related to cybersecurity and government procurement Issues related to medical technology and the opioid crisis H.R. 6 related to the opioid crisis

Client expense: $530,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

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

Government targets: Bureau of Land Management (BLM), HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

340B Program; Medicare Shared Savings Program; 2019 Home Health Rule; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; Stark Law Reform/Modernization; Value-based purchasing/payments; H.R. 2118 Medical Device Servicing and Safety Accountability Act; Post acute care payment; Drug pricing; Medicare regulatory reform; Oppose site neutral cuts and 340B cuts in OPPS rule; 2019 OPPS Rule; Medicaid funding; Anti-kickback reform; Healthcare innovation; Digital health; Regulatory relief/waivers.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

340B Program; Medicare Shared Savings Program; 2019 Home Health Rule; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; Stark Law Reform/Modernization; Value-based purchasing/payments; HR 2118 Medical Device Servicing Safety and Accountability Act; Post acute care payment; Drug pricing; Medicare regulatory reform; Oppose site neutral cuts and 340B cuts in OPPS rule; 2019 OPPS Rule; Medicaid funding; Anti-kickback reform; Healthcare innovation; Digital health; Regulatory relief/waivers.

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

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 VA medical equipment acquisition Medical imaging reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Nuclear medicine reimbursement Hospital outpatient reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues related to post-market surveillance of medical devices and unique device identifiers. Issues related to third-party servicing of medical devices, H.R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to implementation of Title VII (device inspection and regulatory improvements) of the FDA Reauthorization Act (P.L. 115-52). Section 6111 of H.R. 6, the SUPPORT for Patients and Communities Act, issues related to CMS Open Payments System.

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 VA medical equipment acquisition Medical imaging reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Nuclear medicine reimbursement Hospital outpatient reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018

Client expense: $1,020,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 VA Medical Equipment Acquisition Medical Imaging Reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 - Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Nuclear Medicine Reimbursement Hospital Outpatient Reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018

Client expense: $1,100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

340B Program; Medicare Three Day Stay Rule; Medicare Shared Savings Program; Medicare Conditions of Participation; 2019 Home Health Rule; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; IMPACT Act implementation; HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes; Stark Law Reform/Modernization; Value-based purchasing/payments; HR 2118 Medical Device Servicing Safety and Accountability Act; Inpatient prospective payment system rule; Post acute care payment; Drug pricing; Medicare regulatory reform; Oppose OPPS site neutral cuts; MSSP digital signature change; MACRA; 2019 Physician fee schedule; 2019 OPPS Rule; Medicaid funding; Anti-kickback reform.

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

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2118 related to third party servicing of medical devices Issues related to diagnostics regulation Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies H.R. 5418 related to improving the Medical-Surgical Prime Vendor procurement program at the VA S. 1691 related to cybersecurity and government procurement Issues related to medical technology and the opioid crisis H.R. 6 related to the opioid crisis

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

Medical Device User Fee Act - H.R.2430 / S.934 - FDA Reauthorization Act (FDARA) - P.L. 115-52 and related amendments. Potential for BARDA to exercise purchase option under a 2014 contract with Philips Respironics. Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Cybersecurity Artificial Intelligence issues relating to medical devices Possible legislation to incentivize/require AEDs in schools H.R.6 - Opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, Veterans Affairs, Dept of (VA)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

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

Government targets: Bureau of Land Management (BLM), HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

340B Program; Medicare Three Day Stay Rule; Medicare Shared Savings Program; Medicare Conditions of Participation; 2019 Home Health Rule; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; IMPACT Act implementation; HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes; Stark Law Reform/Modernization; Value-based purchasing/payments; HR 2118 Medical Device Servicing Safety and Accountability Act; Inpatient prospective payment system rule; Post acute care payment; Drug pricing; Medicare regulatory reform; Oppose OPPS site neutral cuts; MSSP digital signature change; MACRA; 2019 Physician fee schedule; 2019 OPPS Rule; Medicaid funding; Anti-kickback reform.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to post-market surveillance of medical devices and unique device identifiers. Issues related to third-party servicing of medical devices, H.R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to implementation of Title VII (device inspection and regulatory improvements) of the FDA Reauthorization Act (P.L. 115-52).

Client expense: $530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 VA medical equipment acquisition Medical imaging reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Nuclear medicine reimbursement Hospital outpatient reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications Issues related to diagnostics regulation Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies H.R. 5418 related to improving the Medical-Surgical Prime Vendor procurement program at the VA S. 1691 related to cybersecurity and government procurement Issues related to medical technology and the opioid crisis H.R. 6 related to the opioid crisis

Client expense: $740,386 · Firm income: Not reported

340B Program; Medicare Three Day Stay Rule; Medicare Shared Savings Program; Medicaid Provider Tax; Medicare Conditions of Participation; Home Health; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; Bundled Payment for Care Improvement - Advanced Model; IMPACT Act Implementation; HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B discount drug program shall have no force or effect, and for other purposes; Stark Law Reform/Modernization; Value based-purchasing/payments; HR 2118 Medical Device Servicing Safety Accountability Act; Inpatient prospective payment system rule; CHIP rescission cuts.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program; Medicare Three Day Stay Rule; Medicare Shared Savings Program; Medicaid Provider Tax; Medicare Conditions of Participation; Home Health; Medicare Advantage; Graduate Medical Education; Center for Medicare and Medicaid Innovation; Bundled Payment for Care Improvement - Advanced Model; IMPACT Act implementation; HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes; Stark Law Reform/Modernization; Value-based purchasing/payments; HR 2118 Medical Device Servicing Safety and Accountability Act; Inpatient prospective payment system rule; CHIP recission cuts.

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

Government targets: HOUSE OF REPRESENTATIVES

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

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

Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 VA medical equipment acquisition Medical imaging reimbursement H.R. 2118 - Medical Device Servicing Safety and Accountability Act HR 2479 Protecting Business Opportunities for Veterans Act Wireless Medical Telemetry Nuclear medicine reimbursement Hospital outpatient reimbursement H.R. 1301 - Continuing Appropriations Amendments Act, 2018

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications Issues related to diagnostics regulation Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies

Client expense: $1,050,000 · Firm income: Not reported

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017. H. R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes. H. R. 1892, the Bipartisan Budget Act of 2018. H. R. 1625, the Consolidated Appropriations Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA)

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $520,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $510,000 · Firm income: Not reported

Government targets: Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administration action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications H.R. 878 the Right to Try Act of 2017 Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to cybersecurity for medical technology S. 1691 Internet of Things (IoT) Cybersecurity Improvement Act of 2017 H.R. 3985 Internet of Medical Things Resilience Partnership Act of 2017 H.R. 4163 and S. 2020 Cyber Shield Act of 2017 H.R. 4191 HHS Cybersecurity Modernization Act Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies

Client expense: $1,010,000 · Firm income: Not reported

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

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

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)