Critical Medical Infrastructure Right-to-Repair Act of 2020

S. 3548/H.R. 748 CARES Act S. 4473/H.R. 7956 Critical Medical Infrastructure Right-to-Repair Act H.R. 925 Heroes Act 21st Century Cures Act implementation

Client expense: $353,750 · Firm income: Not reported

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

3rd Party Service regulation - Critical Medical Infrastructure Right-to-Repair Act of2020 (S. 4473 - Wyden/H.R. 7956), in whole. Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval- 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring Healthcare Data Privacy Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators Issues related to upcoming MDUFA V legislation COVID related government procurement contracts H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions Value-based care issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S. 3548/H.R. 748 CARES Act S. 4473/H.R. 7956 Critical Medical Infrastructure Right-to-Repair Act H.R. 925 Heroes Act 21st Century Cures Act implementation

Client expense: $376,875 · Firm income: Not reported

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

Issues related to value-based healthcare and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. H.R. 5663, Safeguarding Therapeutics Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Issues related to opioid induced respiratory compromise patient monitoring. Support for the Amputation Reduction and Compassion Act. Issues related to the coverage and payment of preventative screenings. Issues related to disparities of care.

Client expense: $930,000 · Firm income: Not reported

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity

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

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity

Client expense: $940,000 · Firm income: Not reported

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity

Client expense: $940,000 · Firm income: Not reported

3rd Party Service regulation - Critical Medical Infrastructure Right-to-Repair Act of 2020 (S. 4473 - Wyden/H.R. 7956), in whole Cybersecurity Artificial Intelligence issues relating to medical devices Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring Healthcare Data Privacy Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators Issues related to upcoming MDUFA V legislation H.R.6142: Momnibus Act of 2020, all provisions. COVID related government procurement contracts

Client expense: $450,000 · Firm income: Not reported

S.734, Internet of Things Cybersecurity Improvement Act of 2019, creates national standards for cybersecurity for products purchased by the federal government; S.142, American Data Dissemination Act of 2019 - creates data privacy rules; S.189, Social Media Privacy Protection and Consumer Rights Act of 2019; draft legislation and HHS proposed rules to create new value base care arrangement safe harbors under Stark and Anti-Kickback Statutes and educate key staff on FDA regulation of device service; S.3404, H.R.6102, the Verifying Accurate Leading-edge IVCT Development Act 2020 - legislation to modernize regulation of lab tests; S. 3548 CARES Act regarding enhanced provider funding and medical device shortage provisions. COVID-19 Testing - PCR molecular, serology testing coverage, payment, and funding; S.4473 and H.R.7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S.734, Internet of Things Cybersecurity Improvement Act of 2019, creates national standards for cybersecurity for products purchased by the federal government; S.142, American Data Dissemination Act of 2019 - creates data privacy rules; S.189, Social Media Privacy Protection and Consumer Rights Act of 2019; draft legislation and HHS proposed rules to create new value base care arrangement safe harbors under Stark and Anti-Kickback Statutes and educate key staff on FDA regulation of device service; S.3404, H.R.6102, the Verifying Accurate Leading-edge IVCT Development Act 2020 - legislation to modernize regulation of lab tests; S. 3548 CARES Act regarding enhanced provider funding and medical device shortage provisions. COVID-19 Testing - PCR molecular, serology testing coverage, payment, and funding; S.4473 and H.R.7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization.

S. 3952, the Protecting American Intellectual Property Act of 2020 H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring including the H.R. 7885, The RPM Access Act. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.

Client expense: $771,000 · Firm income: Not reported

3rd Party Service regulation - Critical Medical Infrastructure Right-to-Repair Act of 2020 (S. 4473 - Wyden/H.R. 7956), in whole Cybersecurity Artificial Intelligence issues relating to medical devices Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring Healthcare Data Privacy Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators Issues related to upcoming MDUFA V legislation H.R.6142: Momnibus Act of 2020, all provisions.

Client expense: $440,000 · Firm income: Not reported

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity

Client expense: $940,000 · Firm income: Not reported

S. 3548/H.R. 748 CARES Act S. 4473/H.R. 7956 Critical Medical Infrastructure Right-to-Repair Act H.R. 925 Heroes Act S. 2543 the Prescription Drug Pricing Reduction Act 21st Century Cures Act implementation

Client expense: $329,375 · Firm income: Not reported

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

Issues related to third party servicing of medical devices, cybersecurity, AI, focused ultrasound, the healthcare supply chain, and provider assistance. H.R. 5238 and S.2944, legislation to revise coverage of services to women under the TRICARE program to include the use of digital breast tomosynthesis in breast cancer screening and S. 4397, Uterine Fibroid Research and Education Act. Patient safety issues related to S.4473 and H.R. 7956, the Critical Medical Infrastructure Right-to-Repair Act of 2020. Issues related to PL 116-136, Coronavirus Aid, Relief and Economic Security Act (CARES Act). Discussions related to medical device user fees.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.734, Internet of Things Cybersecurity Improvement Act of 2019, creates national standards for cybersecurity for products purchased by the federal government; S.142, American Data Dissemination Act of 2019 - creates data privacy rules; S.189, Social Media Privacy Protection and Consumer Rights Act of 2019; draft legislation and HHS proposed rules to create new value base care arrangement safe harbors under Stark and Anti-Kickback Statutes and educate key staff on FDA regulation of device service; S.3404, H.R.6102, the Verifying Accurate Leading-edge IVCT Development Act 2020 - legislation to modernize regulation of lab tests; S. 3548 CARES Act regarding enhanced provider funding and medical device shortage provisions. COVID-19 Testing - PCR molecular, serology testing coverage, payment, and funding; S.4473 and H.R.7956, Critical Medical Infrastructure Right-to-Repair Act of 2020.

Client expense: $1,060,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

3rd Party Service regulation - Critical Medical Infrastructure Right-to-Repair Act of 2020 (S. 4473 - Wyden/H.R. 7956), in whole Cybersecurity Artificial Intelligence issues relating to medical devices Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring Healthcare Data Privacy Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators

Client expense: $540,000 · 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), Justice, Dept of (DOJ), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.

Client expense: $1,867,000 · Firm income: Not reported

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020

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

Support Critical Medical Infrastructure Right-to-Repair Act (S.4473 and H.R.7956).

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

Government targets: Commerce, Dept of (DOC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Marshals Service

Issues related to third party servicing of medical devices, cybersecurity, AI, focused ultrasound, the healthcare supply chain, and provider assistance. H.R. 5238 and S.2944, legislation to revise coverage of services to women under the TRICARE program to include the use of digital breast tomosynthesis in breast cancer screening and S. 4397, Uterine Fibroid Research and Education Act. Patient safety issues related to S.4473 and H.R. 7956, the Critical Medical Infrastructure Right-to-Repair Act of 2020. Issues related to PL 116-136, Coronavirus Aid, Relief and Economic Security Act (CARES Act).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.4473.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE