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HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

HR 1199/S 1544: Facilitating Innovative Nuclear Diagnostics Act of 2023

Meetings with CMS regarding 2024 and 2025 OPPS payment for radiopharmaceuticals. Meetings with House and Senate members and staff on HR 1199/S 1544, the Facilitating Innovative Nuclear Diagnostics Act which provides more appropriate reimbursement for radiopharmaceuticals.

Meetings with the Center for Medicare and Medicaid Services to seek more appropriate federal coverage, coding and reimbursement for PET diagnostic procedures. House and Senate staff regarding HR 1199 / S 1544 Facilitating Innovative Nuclear Diagnostics Act of 2023 to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system.

Meetings with House and Senate Congressional staff on H.R. 1199, Facilitating Innovative Nuclear Diagnostics Act of 2023, to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system. Developed educational materials for CMS and Capitol Hill meetings on coverage and reimbursement issues for Alzheimer's positron emission tomography imaging diagnostics.

Meetings with the Center for Medicare and Medicaid Services to seek more appropriate federal coverage, coding and reimbursement for PET diagnostic procedures. House and Senate staff regarding HR 1199 / S 1544 Facilitating Innovative Nuclear Diagnostics Act of 2023 to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system.

Meetings with CMS regarding 2024 and 2025 OPPS payment for radiopharmaceuticals. Meetings with House and Senate members and staff on HR 1199/S 1544, the Facilitating Innovative Nuclear Diagnostics Act which provides more appropriate reimbursement for radiopharmaceuticals.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Supported inclusion of regulating Contrast and Diagnostic Radiopharmaceuticals as drugs in the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) Met with House and Senate Appropriations staff regarding Defense Production Act funding, H.R. 2471 - Consolidated Appropriations Act of 2022, for domestic transformer production opportunities under the appropriations bill. Meeting with House, Senate and White House staff on the Defense Production Act, and FY 2023 Omnibus Appropriations Act.

Meetings with House staff and Senate Members and staff on H.R. 7677, the Food and Drug Amendments of 2022 and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 to promote passage of user fees and issues related to medical device cybersecurity. Meetings with House staff on H.R. 4006, the Fair Repair Act, to educate on medical device right to repair. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022. Meetings with House and Senate staff on focused ultrasound policies to improve access in the VA Healthcare System. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022.

Advocated in the House, Senate and CMS for passage of the Facilitating Innovative Nuclear Diagnostics (FIND) Act (HR 4479/S 2609). Encouraged the Centers for Medicare and Medicaid to fully open its reconsideration and remove the national non-coverage for amyloid PET diagnostics.

Meetings with House and Senate members/staff including House Ways and Means, Energy and Commerce and Senate Finance Committee staff regarding the Facilitating Innovative Nuclear Diagnostics Act (S 2609/HR 4479). Internal legislative strategy meetings; FIND Act Coalition legislative strategy meetings; physician and patient outreach; LTE campaign. Strategy, advocacy, and outreach activities with regard to CMS request for comment on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R) partial retirement of amyloid PET NCD. Strategy, advocacy, and outreach activities with regard to CMS request for comment on AHRQ's proposal seeking comments on Topic Refinement Regarding Draft Analysis of Requirements for Coverage with Evidence Development.

Advocacy on HR 4479/S 2609, The FIND Act, seeking separate reimbursement for radiopharmaceuticals in the Medicare hospital outpatient setting. Advocacy on the CMS Final Decision regarding appropriate coverage for Monoclonal Antibody therapies and PET diagnostics.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Advocacy on PDUFA and GDUFA user fee legislation/regulation seeking to maintain certain exemptions for positron emission tomography imaging drugs Advocacy on H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act, seeking clarification the definition of remanufacturing, education and inspections; advocacy on cybersecurity vulnerabilities of legacy medical imaging devices; advocacy on artificial intelligence and need for reimbursement pathway; advocacy on focused ultrasound and need for improved coverage pathways and research funding; advocacy on medical device user fees

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Meetings with House staff and Senate Members and staff on H.R. 7677, the Food and Drug Amendments of 2022 and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 to promote passage of user fees and issues related to medical device cybersecurity. Meetings with House staff on H.R. 4006, the Fair Repair Act, to educate on medical device right to repair. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022. Meetings with House and Senate staff on focused ultrasound policies to improve access in the VA Healthcare System. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022.

Meetings with House staff and Senate Members and staff on H.R. 7677, the Food and Drug Amendments of 2022 and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 to promote passage of user fees and issues related to medical device cybersecurity. Meetings with House staff on H.R. 4006, the Fair Repair Act, to educate on medical device right to repair. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022. Meetings with House and Senate staff on focused ultrasound policies to improve access in the VA Healthcare System. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Advocated in the House, Senate and CMS for passage of the Facilitating Innovative Nuclear Diagnostics (FIND) Act (HR 4479/S 2609). Encouraged the Centers for Medicare and Medicaid to fully open its reconsideration and remove the national non-coverage for amyloid PET diagnostics.

Advocacy on HR 4479/S 2609, The FIND Act, seeking separate reimbursement for radiopharmaceuticals in the Medicare hospital outpatient setting. Advocacy on the CMS Final Decision regarding appropriate coverage for Monoclonal Antibody therapies and PET diagnostics.

Meetings with House and Senate members/staff including House Ways and Means, Energy and Commerce and Senate Finance Committee staff regarding the Facilitating Innovative Nuclear Diagnostics Act (S 2609/HR 4479). Internal legislative strategy meetings; FIND Act Coalition legislative strategy meetings; physician and patient outreach; LTE campaign. Strategy, advocacy, and outreach activities with regard to CMS request for comment on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R) partial retirement of amyloid PET NCD. Strategy, advocacy, and outreach activities with regard to CMS request for comment on AHRQ's proposal seeking comments on Topic Refinement Regarding Draft Analysis of Requirements for Coverage with Evidence Development.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Meetings with House staff and Senate Members and staff on H.R. 7677, the Food and Drug Amendments of 2022 and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 to promote passage of user fees and issues related to medical device cybersecurity. Meetings with House staff on H.R. 4006, the Fair Repair Act, to educate on medical device right to repair. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022. Meetings with House and Senate staff on focused ultrasound policies to improve access in the VA Healthcare System. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022.

Meetings with House staff and Senate Members and staff on H.R. 7677, the Food and Drug Amendments of 2022 and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 to promote passage of user fees and issues related to medical device cybersecurity. Meetings with House staff on H.R. 4006, the Fair Repair Act, to educate on medical device right to repair. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022. Meetings with House and Senate staff on focused ultrasound policies to improve access in the VA Healthcare System. Strategy and outreach activities with regard to FDA request for comment on conducting remote regulatory assessments (Docket No. FDA-2022-D-0810: Conducting Remote Regulatory Assessments - Questions and Answers; Draft Guidance for Industry). Strategy and outreach activities for the continued regulation of contrast and diagnostic radiopharmaceuticals as drugs in S. 4535, the Food and Drug Administration Simple Reauthorization Act, and H.R. 7667, Food and Drug Amendments of 2022.

Urging Secretary of State to urge Mexican officials to broaden Mexico vaccine availability; to urge sponsors of Nicholas and Zachary Burt Memorial Carbon Monoxide Poisoning Prevention Act (S.351/HR1460) to support the bills but to correct language in the bills with regard to alarm/detector compliance with UL standards. Advocacy on all aspects of the FIND Act and CMS/OPPS to ensure that Medicare appropriately pays for certain diagnostic radiopharmaceuticals approved after 2008 with a cost per day of $500 or more. Additional advocacy on the Medicare Physician Fee Schedule, in which we encouraged CMS to remove its automatic non-coverage for non-oncologic PET. NEMA also requested that FDA grant an extension on timeline for comments to the proposed notice and comment on a court decision that requires the FDA to review whether a product should be reviewed as a drug or a device. Advocacy to ensure medical imaging device servicing is performed safely by qualified repair technicians with FDA oversight. Advocacy to increase federal coverage for focused ultrasound therapy under HR 4043. Developing advocacy for cybersecurity protections for legacy medical imaging devices.

Urging Secretary of State to urge Mexican officials to broaden Mexico vaccine availability; to urge sponsors of Nicholas and Zachary Burt Memorial Carbon Monoxide Poisoning Prevention Act (S.351/HR1460) to support the bills but to correct language in the bills with regard to alarm/detector compliance with UL standards. Advocacy on all aspects of the FIND Act and CMS/OPPS to ensure that Medicare appropriately pays for certain diagnostic radiopharmaceuticals approved after 2008 with a cost per day of $500 or more. Additional advocacy on the Medicare Physician Fee Schedule, in which we encouraged CMS to remove its automatic non-coverage for non-oncologic PET. NEMA also requested that FDA grant an extension on timeline for comments to the proposed notice and comment on a court decision that requires the FDA to review whether a product should be reviewed as a drug or a device. Advocacy to ensure medical imaging device servicing is performed safely by qualified repair technicians with FDA oversight. Advocacy to increase federal coverage for focused ultrasound therapy under HR 4043. Developing advocacy for cybersecurity protections for legacy medical imaging devices.

Promoting the use of nuclear medicine through the Facilitating Innovative Nuclear Diagnostics Act (HR 4479/ S 2609). Advocacy to increase coverage for Positron Emission Tomography. Advocacy to promote appropriate medical device servicing, use of artificial intelligence in medical imaging devices, focused ultrasound, and reasonable medical device user fees.

Promoting the use of nuclear medicine through the Facilitating Innovative Nuclear Diagnostics Act (HR 4479/ S 2609). Advocacy to increase coverage for Positron Emission Tomography. Advocacy to promote appropriate medical device servicing, use of artificial intelligence in medical imaging devices, focused ultrasound, and reasonable medical device user fees.

Urging Secretary of State to urge Mexican officials to broaden Mexico vaccine availability; to urge sponsors of Nicholas and Zachary Burt Memorial Carbon Monoxide Poisoning Prevention Act (S.351/HR1460) to support the bills but to correct language in the bills with regard to alarm/detector compliance with UL standards. Advocacy on all aspects of the FIND Act and CMS/OPPS to ensure that Medicare appropriately pays for certain diagnostic radiopharmaceuticals approved after 2008 with a cost per day of $500 or more. Additional advocacy on the Medicare Physician Fee Schedule, in which we encouraged CMS to remove its automatic non-coverage for non-oncologic PET. NEMA also requested that FDA grant an extension on timeline for comments to the proposed notice and comment on a court decision that requires the FDA to review whether a product should be reviewed as a drug or a device. Advocacy to ensure medical imaging device servicing is performed safely by qualified repair technicians with FDA oversight. Advocacy to increase federal coverage for focused ultrasound therapy under HR 4043. Developing advocacy for cybersecurity protections for legacy medical imaging devices.

Coverage and Payment for Nuclear Medicine generally; HR 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 specifically. Medical Device Servicing, MDUFA, DLA Procurement Policies; Focused Ultrasound, Provider E/M Policies; The Critical Medical Infrastructure Right-to-Repair Act of 2020; Meet with Defense Logistics Agency to discuss progress relating to government contracts for Members involving medical device contracts Planning for meeting with Defense Health Agency and the National Acquisitions Center/ Veterans' Affairs regarding medical device government contracts Questions on the implementation at the Defense Health Agency of the Cybersecurity maturity model certification and general agenda setting for Defense Health Agency and the VA/National Acquisition Center

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET; GDUFA, PDUFA COVID Relief, Medical Device Servicing; Medical Device Servicing, Focused Ultrasound; Medical Device Servicing

Coverage and Payment for Nuclear Medicine generally; HR 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 specifically. Meet with Defense Logistics Agency to discuss progress relating to government contracts for Members involving medical device contracts Planning for meeting with Defense Health Agency and the National Acquisitions Center/ Veterans' Affairs regarding medical device government contracts Questions on the implementation at the Defense Health Agency of the Cybersecurity maturity model certification and general agenda setting for Defense Health Agency and the VA/National Acquisition Center

Coverage and Payment for Nuclear Medicine generally; HR 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 specifically. Medical Device Servicing, MDUFA, DLA Procurement Policies; Focused Ultrasound, Provider E/M Policies; The Critical Medical Infrastructure Right-to-Repair Act of 2020; Meet with Defense Logistics Agency to discuss progress relating to government contracts for Members involving medical device contracts Planning for meeting with Defense Health Agency and the National Acquisitions Center/ Veterans' Affairs regarding medical device government contracts Questions on the implementation at the Defense Health Agency of the Cybersecurity maturity model certification and general agenda setting for Defense Health Agency and the VA/National Acquisition Center

3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET Provider relief; Provider relief; Provider relief, TRICARE DBT coverage

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET; GDUFA, PDUFA COVID Relief, Medical Device Servicing; Medical Device Servicing, Focused Ultrasound; Medical Device Servicing

3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET Provider relief; Provider relief; Provider relief, TRICARE DBT coverage

3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET Provider relief; Provider relief; Provider relief, TRICARE DBT coverage

HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET; GDUFA, PDUFA COVID Relief, Medical Device Servicing; Medical Device Servicing, Focused Ultrasound; Medical Device Servicing

3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of non-oncologic PET.; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET; HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019; Coverage of Non-oncologic PET Provider relief; Provider relief; Provider relief, TRICARE DBT coverage

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Radiopharmaceutical Payment Equity Act of 2019; HR 3772 - Medicare Diagnostic

Medical Device tax repeal, servicing of medical devices, cybersecurity and medical devices Device Tax, DBT Coverage; HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emission Tomography, Drug Waste legislation

Medical Device tax repeal, servicing of medical devices, cybersecurity and medical devices Device Tax, DBT Coverage; HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emission Tomography, Drug Waste legislation

HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emmission Tomography.

HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emmission Tomography.

HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emmission Tomography.

HR 3772, Payment Equity for Radiopharmaceuticals; Medicare Coverage for Positron Emmission Tomography.

Medical device tax repeal, servicing of medical imaging equipment, cybersecurity; servicing of medical devices, cybersecurity; Medical device tax repeal (S. 692) Equitable Payment for Radiopharmaceuticals in the Medicare Outpatient Setting, Medicare National Coverage Determinations; Device tax, focused ultrasound;

Medical device tax repeal, servicing of medical imaging equipment, cybersecurity; servicing of medical devices, cybersecurity; Medical device tax repeal (S. 692) Equitable Payment for Radiopharmaceuticals in the Medicare Outpatient Setting, Medicare National Coverage Determinations; Device tax, focused ultrasound;

Tariffs on medical devices, medical device tax repeal, servicing of medical devices HR 6948, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018

Tariffs on medical devices, medical device tax repeal, servicing of medical device HR 6948, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 VA; Focused Ultrasound; medical device tax

Tariffs on medical devices, medical device tax repeal, servicing of medical device HR 6948, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 VA; Focused Ultrasound; medical device tax

Tariffs on medical devices, medical device tax repeal, servicing of medical devices HR 6948, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018