PHILIPS HOLDING USA, INC. for PHILIPS HOLDING USA INC.

Financial Institutions/Investments/Securities FIN

PL 115-232, Title XVII: The Foreign Investment Risk Review Modernization Act (FIRRMA) - implementation of various provisions Modernizing the Committee on Foreign Investment in the U.S. (CFIUS)

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); White House Office; HOUSE OF REPRESENTATIVES; Treasury, Dept of; SENATE; Internal Revenue Service (IRS); Veterans Affairs, Dept of (VA); Office of the Vice President of the United States; Justice, Dept of (DOJ)

Disaster Planning/Emergencies DIS

Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Food & Drug Administration (FDA); Treasury, Dept of; U.S. Trade Representative (USTR); Office of the Vice President of the United States; Centers For Medicare and Medicaid Services (CMS); Veterans Affairs, Dept of (VA); SENATE; Internal Revenue Service (IRS); Justice, Dept of (DOJ); HOUSE OF REPRESENTATIVES; White House Office; Health & Human Services, Dept of (HHS)

Health Issues HCR

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 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 HR 2669 - Medical Device Safety Act (all provisions) Possibility of establishing Congressional Sleep Health Caucus Healthcare Data Privacy NPRM on Anti-Kickback Safe Harbor Provision 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

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Veterans Affairs, Dept of (VA); White House Office; Justice, Dept of (DOJ); U.S. Trade Representative (USTR); Office of the Vice President of the United States; Health & Human Services, Dept of (HHS); Internal Revenue Service (IRS); Treasury, Dept of; Food & Drug Administration (FDA)

Bills named: H.R. 2118 (116th), H.R. 1362 (116th), H.R. 2669 (116th), S. 692 (116th)

Foreign Relations FOR

H.R.1- For the People Act of 2019 - issues around campaign finance reform and FARA Foreign Agents Disclosure and Registration Enhancement Act of 2019 (S.1762)/Disclosing Foreign Influence Act (S.2039, 115th Congress) - all provisions Issues related to effective foreign assistance Private sector engagement in international development funding Buy America proposals (no bills)

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Justice, Dept of (DOJ); HOUSE OF REPRESENTATIVES; Internal Revenue Service (IRS); Food & Drug Administration (FDA); Office of the Vice President of the United States; Treasury, Dept of; White House Office; SENATE; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Veterans Affairs, Dept of (VA); U.S. Trade Representative (USTR)

Bills named: S. 1762 (116th), H.R. 1 (116th), S. 2039 (116th)

Medicare/Medicaid MMM

PL 111-148: Patient Protection and Affordable Care Act (ACA) - implementation of various provisions including: various reimbursement cuts and policy proposals for medical imaging, remote monitoring technology in the context of accountable care organizations, medical homes and post acute bundling, transparency. PL. 111-152: Healthcare Education and Reconciliation Act: implementation of provisions related to imaging cuts, device tax transparency, and remote monitoring. The Medicare DMEPOS Competitive Bidding Program - inclusion of noninvasive ventilators in competitive bidding program Medicare Reimbursement of drug-coated balloons for PAD angioplasty Potential legislation to address the problem of falls in the frail/elderly population Medication adherence among Medicare beneficiaries Barriers to further telehealth adoption in Medicare - eliminating originating site requirements; parity for telehealth and in-person visits H.R.2508 - the Better Respiration through Expansion Access to TeleHealth Act (BREATH Act) - all provisions Percutaneous coronary intervention procedures in ambulatory surgical centers (ACS) and related Medicare reimbursement issues in the proposed CY20 rule CARES Act H.R.748 - provisions dealing with DME and telehealth Issues related to COVID-19 pandemic response

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: White House Office; Health & Human Services, Dept of (HHS); Office of the Vice President of the United States; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); SENATE; Internal Revenue Service (IRS); Veterans Affairs, Dept of (VA); Justice, Dept of (DOJ); HOUSE OF REPRESENTATIVES; Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 2508 (116th), H.R. 748 (116th)

Medical/Disease Research/Clinical Labs MED

Capabilities related to COVID-19 pandemic and disaster response and planning

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Internal Revenue Service (IRS); Office of the Vice President of the United States; White House Office; Justice, Dept of (DOJ); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Veterans Affairs, Dept of (VA); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Treasury, Dept of; SENATE; HOUSE OF REPRESENTATIVES

Budget/Appropriations BUD

FY 2021 Veterans Affairs Appropriations FY20 Labor, Health and Human Services, and Education Appropriations report language - NIVS in competitive bidding

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Treasury, Dept of; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Internal Revenue Service (IRS); Justice, Dept of (DOJ); White House Office; HOUSE OF REPRESENTATIVES; Office of the Vice President of the United States; Veterans Affairs, Dept of (VA); SENATE; Centers For Medicare and Medicaid Services (CMS)

Trade (domestic/foreign) TRD

Discussions regarding medical device provisions in the US-EU trade talks Withdrawal from the WTO/GPA

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: SENATE; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Justice, Dept of (DOJ); Office of the Vice President of the United States; HOUSE OF REPRESENTATIVES; Internal Revenue Service (IRS); White House Office; Treasury, Dept of; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Veterans Affairs, Dept of (VA)

Manufacturing MAN

Issues related to COVID-19 pandemic response Issues related to manufacturing supply chain and capacity. Issues related to production and procurement of ventilators.

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Internal Revenue Service (IRS); Office of the Vice President of the United States; White House Office; Veterans Affairs, Dept of (VA); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Justice, Dept of (DOJ); U.S. Trade Representative (USTR); SENATE

Defense DEF

Telehealth in DOD Issues related to COVID-19 pandemic response Defense Production Act implementation

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Veterans Affairs, Dept of (VA); Internal Revenue Service (IRS); Health & Human Services, Dept of (HHS); Justice, Dept of (DOJ); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Office of the Vice President of the United States; SENATE; Centers For Medicare and Medicaid Services (CMS); White House Office; Treasury, Dept of

Veterans VET

U.S. Department of Veteran Affairs' acquisition process Telehealth for veterans

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Internal Revenue Service (IRS); Justice, Dept of (DOJ); Health & Human Services, Dept of (HHS); Veterans Affairs, Dept of (VA); HOUSE OF REPRESENTATIVES; SENATE; White House Office; Centers For Medicare and Medicaid Services (CMS); Office of the Vice President of the United States; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Treasury, Dept of

Taxation/Internal Revenue Code TAX

Issues related to the implementation of BEAT Tax/NOL (net operating loss) CARES Act HR 748 - provisions related to business tax

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Centers For Medicare and Medicaid Services (CMS); Internal Revenue Service (IRS); Justice, Dept of (DOJ); SENATE; U.S. Trade Representative (USTR); White House Office; Treasury, Dept of; Veterans Affairs, Dept of (VA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Office of the Vice President of the United States; Health & Human Services, Dept of (HHS)

Bills named: H.R. 748 (116th)

Telecommunications TEC

Connectivity and security of internet of things issues

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: White House Office; Veterans Affairs, Dept of (VA); Treasury, Dept of; Justice, Dept of (DOJ); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Internal Revenue Service (IRS); SENATE; Health & Human Services, Dept of (HHS); Office of the Vice President of the United States

Tariff (miscellaneous tariff bills) TAR

Section 301 tariffs on component parts and medical devices from China China tariff exclusion requests

Foreign entity interest: The interests of Philips Holdings USA Inc. are those of its parent corporation, Koninklijke Philips Electronics, N.V.

Contacted: Treasury, Dept of; Health & Human Services, Dept of (HHS); White House Office; Veterans Affairs, Dept of (VA); Internal Revenue Service (IRS); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); SENATE; Office of the Vice President of the United States; Food & Drug Administration (FDA); Justice, Dept of (DOJ)