HHS Cybersecurity Modernization Act

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

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

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.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 Monitored HR 6 SUPPORT for Patients and Communities Act

Client expense: Not reported · Firm income: $130,000

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored 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. Monitored HR6 SUPPORT for Patients and Communities Act

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

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.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 Monitored HR 6 SUPPORT for Patients and Communities Act

Client expense: Not reported · Firm income: $130,000

S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, 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

Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored 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.

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

Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office

Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office

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

S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.

Client expense: $1,040,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.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

Client expense: Not reported · Firm income: $130,000

Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office

Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office

S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.

Client expense: $1,390,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored 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.

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

H.R. 394, Restoring Access to Medication Act of 2017, all provisions S. 85, Restoring Access to Medication Act of 2017, all provisions H.R. 1625, Consolidated Appropriations Act, 2018, provisions relating to Fix NICS Act, Dickey Amendment H.R. 3545, Overdose Prevention and Patient Safety Act, all provisions H.R. 5009, Jessie's Law, all provisions H.R. 5311, Comprehensive Addiction and Recovery Act (CARA) 2.0 Act of 2018, all provisions S. 2456, Comprehensive Addiction and Recovery Act (CARA) 2.0 Act of 2018, all provisions H.R. 1375, Prescriber Support Act of 2017, all provisions S. 2135, Fix NICS Act of 2017, all provisions H.R. 4909, Student, Teachers, and Officers Preventing (STOP) School Violence Act of 2018, all provisions H.R. 5002, Advancing Cutting-Edge (ACE) Research Act, all provisions S. 2406, Advancing Cutting-Edge (ACE) Research Act, all provisions H.R. 878, Right to Try Act of 2017, all provisions H.R. 2368, Right to Try Act, all provisions H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, all provisions S. 204, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, all provisions H.R. 4191, HHS Cybersecurity Modernization Act, all provisions H.R. 4163, Cyber Shield Act of 2017, all provisions S. 2020, Cyber Shield Act of 2017, all provisions H.R. 4613, Ensuring Patient Access to Healthcare Records Act of 2017 H.R. 2063, Opioid Preventing Abuse through Continuing Education (Opioid PACE) Act of 2017, all provisions S. 1803, Marijuana Effective Drug Studies Act of 2017, all provisions H.R. 1318, Preventing Maternal Deaths Act of 2017, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R. 5219, Opioid Prescription Verification Act of 2018, all provisions 42 CFR/Privacy of substance abuse records Opioid Abuse Cost-sharing reduction payments and ACA stabilization Health Savings Accounts - Prescription requirement for over-the-counter medications Telemedicine Electronic Health Records (EHR) Electronic prescribing of controlled substances Prescription Drug Monitoring Programs (PDMPs) Interoperability of EHRs and PDMPs Prior authorization and medically assisted therapy Continuing Medical Education (CME) requirements for DEA licensure Gun Violence Prescription drug pricing/transparency/value/prior authorization burdens Provider Price Transparency Continuing Medical Education (CME) and opioid/pain management prescribing Cybersecurity Laboratory Developed Tests (LDTs) Conscience Rights/Delegation of Authority Title X Funding Regulatory burdens FDA oversight of digital health tools/modernization options In-office Drug Compounding Virtual Diabetes Prevention Program/Telehealth Blood pressure device validation/accuracy

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

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored H.R.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

Client expense: Not reported · Firm income: $130,000

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

S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.

Client expense: $800,000 · Firm income: Not reported

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

Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE

Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE