Meaningful Access to Federal Health Plan Claims Data Act of 2021

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 Support H.R. 8437, the Improving Seniors Timely Access to Care Act of 2022 Support H.R. 4122/S. 3645, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Advocate for legislative solution to access problems to iPLEDGE/REMS program for isotretinoin (H.R. 7667, Food and Drug Amendments of 2022/S. 4348 FDASLA Act of 2022, H.R. 2617, Consolidated Appropriations Act). Support H.R. 7649, a bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes. Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act Support H.R. 7995, GOLD CARD Act of 2022 Advocate to provide relief from the 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, eliminate the nearly 4.5% conversion factor cut in the CMS proposed rule for the 2023 Medicare Physician Fee Schedule (MPFS) associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2 (H.R. 2617, Consolidated Appropriations Act). Support H.R. 8800, Supporting Medicare Providers Act of 2022 Advocate against H.R 6708, Improving Access to Workers Compensation for Injured Federal Workers Act, which expands the role of nurse practitioners and physician assistants in providing services to injured federal workers under the federal workers' compensation program. Oppose H.R. 8812, the Improving Care & Access to Nurses Act (I CAN Act)

Client expense: $410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- establishes Biomedical Innovation Fund H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries HR 3773/S 1357- PACT Act of 2021- requires the NIH to support early career pediatric researchers

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Passage of HR 5394 Federal Health Plans Claims Data Act Passage of parts of HR 6000 Cures 2.0 Act

Client expense: Not reported · Firm income: Not reported

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; Sect. 1557 Nondiscrimination in Health Programs and Activities; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act S. 1260

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

Advocate for adequate and accurate network coverage for dermatologic care within Medicare Advantage. Advocate for increased funding and reforms to Graduate Medical Education. Lobby members of Congress regarding improvements to Health Information Technology implementation. Advocate for expansion of telemedicine services under Medicare and increased reimbursement for such services. Advocate for improving disease management and care coordination for patients with chronic diseases. Support preservation of the In-Offices Ancillary Services Exemption (IOASE) under Stark Law regarding physician self-referral and oppose repeal of the in-office ancillary and physician services exception. Advocate for relief from Medicare regulations under Medicare Access and CHIP Reauthorization Act (MACRA P.L. 114-110), including the Quality Payment Program (QPP) and specifically the development of advanced alternative payment models (APMs) and implementation of the Merit-Based Incentive Payment System (MIPS). Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Lobby Congress to urge CMS to strengthen Qualified Clinical Data Registries (QCDRs) by removing barriers that restrict access to data from EHRs. (H.R. 6000) Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act (H.R. 1677/S. 620). Support H.R.8437, the Improving Seniors Timely Access to Care Act of 2022 Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, eliminate the nearly 4.5% conversion factor cut in the CMS proposed rule for the 2023 Medicare Physician Fee Schedule (MPFS) associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 8800, the Supporting Medicare Providers Act of 2022 Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Support H.R. 7995, GOLD CARD Act of 2022

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislation. (S. 610) Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 Support H.R. 8437, the Improving Seniors Timely Access to Care Act of 2022 Support H.R. 4122/S. 3645, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Advocate for legislative solution to access problems to iPLEDGE/REMS program for isotretinoin (H.R. 7667, Food and Drug Amendments of 2022/S. 4348 FDASLA Act of 2022). Support H.R. 7649, a bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes. Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act Support H.R. 7995, GOLD CARD Act of 2022 Advocate to support extension of moratorium on 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, eliminate the nearly 4.5% conversion factor cut in the CMS proposed rule for the 2023 Medicare Physician Fee Schedule (MPFS) associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 8800, Supporting Medicare Providers Act of 2022 Advocate against H.R 6708, Improving Access to Workers Compensation for Injured Federal Workers Act, which expands the role of nurse practitioners and physician assistants in providing services to injured federal workers under the federal workers' compensation program.

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)

Client expense: $310,000 · Firm income: Not reported

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

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- establishes Biomedical Innovation Fund H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries HR 3773/S 1357- PACT Act of 2021- requires the NIH to support early career pediatric researchers

Client expense: $125,406 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Emergency funding for COVID therapeutics Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394) Health Equity and Accountability Act (H.R. 7585) Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348)

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

Issues related to Medicare physician payment reform, Medicare Payment Advisory Commission (MEDPAC), surgical global payments, Centers for Medicare & Medicaid Innovation (CMMI), registry access to Medicare claims data, Medicare Coverage of Innovative Technology (MCIT), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC); general provisions related to: Meaningful Access to Federal Health Plan Claims Data Act (H.R.5394)

Client expense: $180,837 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: health care reform, health care quality improvement, lung cancer screenings, congenital heart disease, unique device identifiers, medical liability reform, price transparency, extracorporeal membrane oxygenation (ECMO), surprise billing, prior authorization, Transcatheter aortic valve replacement (TAVR), surprise billing, transplant programs, organ procurement organizations; general provisions related to: Access to Federal Health Plan Claims Data Act (H.R.5394), Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667), Cures 2.0 Act (H.R. 6000), H.Res.909 - Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors

Client expense: $180,837 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate for adequate and accurate network coverage for dermatologic care within Medicare Advantage. Advocate for increased funding and reforms to Graduate Medical Education. Lobby members of Congress regarding improvements to Health Information Technology implementation. Advocate for expansion of telemedicine services under Medicare and increased reimbursement for such services. Advocate for improving disease management and care coordination for patients with chronic diseases. Support preservation of the In-Offices Ancillary Services Exemption (IOASE) under Stark Law regarding physician self-referral and oppose repeal of the in-office ancillary and physician services exception. Advocate for relief from Medicare regulations under Medicare Access and CHIP Reauthorization Act (MACRA P.L. 114-110), including the Quality Payment Program (QPP) and specifically the development of advanced alternative payment models (APMs) and implementation of the Merit-Based Incentive Payment System (MIPS). Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Lobby Congress to urge CMS to strengthen Qualified Clinical Data Registries (QCDRs) by removing barriers that restrict access to data from EHRs. (H.R. 6000) Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act (H.R. 1677/S. 620). Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, extend the congressionally-enacted 3% temporary increase in the Medicare Physician Fee Schedule (MPFS) conversion factor to avoid cuts associated with budget neutrality adjustments tied to Evalution & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Support H.R. 7995, GOLD CARD Act of 2022

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislation. (S. 610) Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act Support H.R. 4122/S. 3645, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Advocate for legislative solution to access problems to iPLEDGE/REMS program for isotretinoin (H.R. 7667, Food and Drug Amendments of 2022/S. 4348 FDASLA Act of 2022). Support H.R. 7649, a bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes. Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act Support H.R. 7995, GOLD CARD Act of 2022 Advocate to support extension of moratorium on 2% Medicare sequester, replace scheduled and anticipated cuts in payments with positive, inflationary-based updates, extend the congressionally-enacted 3% temporary increase in the Medicare Physician Fee Schedule (MPFS) conversion factor to avoid cuts associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes, and waive the 4% PAYGO sequester to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Advocate against H.R 6708, Improving Access to Workers Compensation for Injured Federal Workers Act, which expands the role of nurse practitioners and physician assistants in providing services to injured federal workers under the federal workers' compensation program.

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act S. 1260

Client expense: $410,000 · Firm income: Not reported

Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Emergency funding for COVID therapeutics Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394) Health Equity and Accountability Act (H.R. 7585) Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348)

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

Issues related to Medicare physician payment reform, Medicare Payment Advisory Commission (MEDPAC), surgical global payments, Centers for Medicare & Medicaid Innovation (CMMI), registry access to Medicare claims data, Medicare Coverage of Innovative Technology (MCIT), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC); general provisions related to: Meaningful Access to Federal Health Plan Claims Data Act (H.R.5394)

Client expense: $79,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: health care reform, health care quality improvement, lung cancer screenings, congenital heart disease, unique device identifiers, medical liability reform, price transparency, extracorporeal membrane oxygenation (ECMO), surprise billing, prior authorization, Transcatheter aortic valve replacement (TAVR), surprise billing, transplant programs, organ procurement organizations; general provisions related to: Access to Federal Health Plan Claims Data Act (H.R.5394), Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667), Cures 2.0 Act (H.R. 6000), H.Res.909 - Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors

Client expense: $79,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)

Client expense: $330,000 · Firm income: Not reported

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

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- establishes Biomedical Innovation Fund H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries HR 3773/S 1357- PACT Act of 2021- requires the NIH to support early career pediatric researchers

Client expense: $155,610 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare physician payment reform, Medicare Payment Advisory Commission (MEDPAC), surgical global payments, Centers for Medicare & Medicaid Innovation (CMMI), registry access to Medicare claims data, Medicare Coverage of Innovative Technology (MCIT), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC); general provisions related to: Meaningful Access to Federal Health Plan Claims Data Act (H.R.5394)

Client expense: $75,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: health care reform, health care quality improvement, lung cancer screenings, congenital heart disease, unique device identifiers, medical liability reform, price transparency, extracorporeal membrane oxygenation (ECMO), surprise billing, prior authorization, Transcatheter aortic valve replacement (TAVR), surprise billing, transplant programs, organ procurement organizations; general provisions related to: Access to Federal Health Plan Claims Data Act (H.R.5394), Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667), Cures 2.0 Act (H.R. 6000), H.Res.909 - Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors

Client expense: $75,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Emergency funding for coronavirus-related research disruptions/research recovery Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394)

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

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Transcatheter Mitral Valve National Coverage Decision Coronavirus Preparedness and Response Provisions Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)

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

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

Advocate for adequate and accurate network coverage for dermatologic care within Medicare Advantage. Advocate for increased funding and reforms to Graduate Medical Education. Lobby members of Congress regarding improvements to Health Information Technology implementation. Advocate for expansion of telemedicine services under Medicare and increased reimbursement for such services. Advocate for improving disease management and care coordination for patients with chronic diseases. Support preservation of the In-Offices Ancillary Services Exemption (IOASE) under Stark Law regarding physician self-referral and oppose repeal of the in-office ancillary and physician services exception. Advocate for relief from Medicare regulations under Medicare Access and CHIP Reauthorization Act (MACRA P.L. 114-110), including the Quality Payment Program (QPP) and specifically the development of advanced alternative payment models (APMs) and implementation of the Merit-Based Incentive Payment System (MIPS). Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Lobby Congress to urge CMS to strengthen Qualified Clinical Data Registries (QCDRs) by removing barriers that restrict access to data from EHRs. (H.R. 6000) Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act (H.R. 1677/S. 620). Support H.R. 3173, Improving Seniors Timely Access to Care Act Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislation. (S. 610) Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173, Improving Seniors Timely Access to Care Act Support H.R. 4122/S. 3645, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for a study on skin cancer in minority populations and communities to be included in the FY2022 Labor, Health and Human Services, Education and Related Agencies Appropriations bill and FY2022 Omnibus (H.R. 4502/H.R. 2471) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Advocate for legislative solution to access problems to iPLEDGE/REMS program for isotretinoin. Support H.R. 5030/S. 2706, the Diversifying Investigations and Equitable Research Studies for Everyone (DIVERSE) Trials Act

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries

Client expense: $213,980 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act S. 1260

Client expense: $420,000 · Firm income: Not reported

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries

Client expense: $95,038 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health care reform, health care quality improvement, lung cancer screenings, congenital heart disease, unique device identifiers, medical liability reform, price transparency, extracorporeal membrane oxygenation (ECMO), surprise billing, prior authorization, Transcatheter aortic valve replacement (TAVR), surprise billing, and Food and Drug Administration nominations; provisions related to cardiothoracic surgeons and healthcare providers in the following legislation Access to Federal Health Plan Claims Data Act (H.R.5394), Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act (S.4760), Good Samaritan Health Professional Act of 2021 (H.R. 5239), Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667), Cures 2.0 Act (H.R. 6000)

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare physician payment reform, Medicare Payment Advisory Commission (MEDPAC), surgical global payments, Centers for Medicare & Medicaid Innovation (CMMI), registry access to Medicare claims data, Medicare Coverage of Innovative Technology (MCIT), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC); provisions related to cardiothoracic surgeons and healthcare providers in the following legislation: Meaningful Access to Federal Health Plan Claims Data Act (H.R.5394), Supporting Medicare Providers Act of 2021 (H.R. 6020)

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S. 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification

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

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries

Client expense: $92,330 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H. Res 436, sense of the House supporting state, local and community initiatives to curb incidences of skin cancer beginning with childhood skin cancer. Support H. Res 718, designating October 17, 2021 as National Vitiligo Awareness Day Support H.R. 2163/S. 464, Safe Step Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 153, Protecting Consumer Access to Generic Drugs Act Support S. 898, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 3662, Patient Access to Urgent-Use Pharmacy Compounding Act Support H.R. 1916/S. 754, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislation. (S. 610) Support H.R. 1677/S. 620, the KEEP Telehealth Options Act. Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support the Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667). Support H.R. 3173, Improving Seniors Timely Access to Care Act Support H.R. 1554, Resident Education Deferred Interest Act or the REDI Act Support the Resident Physician Shortage Reduction Act (S. 834/H.R. 2256) Advocate for a study on skin cancer in minority populations and communities to be included in the FY2022 Labor, Health and Human Services, Education and Related Agencies Appropriations bill (H.R. 4502) Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act Lobby regarding access problems to iPLEDGE/REMS program for isotretinoin.

Advocate for adequate and accurate network coverage for dermatologic care within Medicare Advantage. Advocate for increased funding and reforms to Graduate Medical Education. Lobby members of Congress regarding improvements to Health Information Technology implementation. Advocate for expansion of telemedicine services under Medicare and increased reimbursement for such services. Advocate for improving disease management and care coordination for patients with chronic diseases. Support preservation of the In-Offices Ancillary Services Exemption (IOASE) under Stark Law regarding physician self-referral and oppose repeal of the in-office ancillary and physician services exception. Advocate for relief from Medicare regulations under Medicare Access and CHIP Reauthorization Act (MACRA P.L. 114-110), including the Quality Payment Program (QPP) and specifically the development of advanced alternative payment models (APMs) and implementation of the Merit-Based Incentive Payment System (MIPS). Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Lobby Congress to urge CMS to strengthen Qualified Clinical Data Registries (QCDRs) by removing barriers that restrict access to data from EHRs. (H.R. 6000) Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act (H.R. 1677/S. 620). Support H.R. 3173, Improving Seniors Timely Access to Care Act Support H.R. 2903/S. 1512 the CONNECT for Health Act of 2021 Support H.R. 5054, Keep Physicians Serving Patients Act Advocate to support extension of moratorium on 2% Medicare sequester as well as waiving PAYGO and mitigating anticipated additional 4% cuts to Medicare physician payment reimbursement due to enactment of H.R. 1319, American Recovery Act, P.L. 117-2. Support H.R. 6020, the Supporting Medicare Providers Act Support H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act.

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Transcatheter Mitral Valve National Coverage Decision Coronavirus Preparedness and Response Provisions Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)

Client expense: $340,000 · 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), SENATE, Treasury, Dept of

Implementation of PL 114-255, 21st Century Cures Act Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) Medicare Coverage for Innovative Technologies (MCIT) rule Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 FDA Reauthorization for 2022/FDA User Fees Coronavirus Preparedness and Response Provisions Health Equity Issues Cures 2.0 Draft HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 1193, The Cardiovascular Advances in Research and Opportunities Legacy Act CAROL Act Coverage with Evidence Development

Client expense: $340,000 · 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), SENATE, Treasury, Dept of

Sickle cell disease/trait issues Hematology/oncology treatment issues Hematology/oncology drug research and approval issues General hematology public health and research issues Fetal tissues research Emergency funding for coronavirus-related research disruptions/research recovery Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289) Open access policy for peer reviewed research journals Issues impacting blood supply shortages/safety Issues related to convalescent plasma Issues impacting delivery of bone marrow, peripheral blood, and cord blood Issues related to implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) Issues related to health equity/disproportionate impact of COVID-19 on minority populations COVID-19 vaccination policies/prioritization Clinical trials regulations and coverage Issues related to diversity, equity, and inclusion (DEI) in hematology research, practice, and training Cures 2.0 Act (H.R. 6000) Advanced Research Projects Agency for Health (ARPA-H) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706 / H.R. 5030) Meaningful Access to Federal Health Plan Claims Data Act (H.R. 5394)

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

FY 2022 Appropriations for the National Institutes of Health (NIH), National Cancer Institute (NCI), and the Food & Drug Administration (FDA) S 289/HR 869 RISE Act - emergency funding for the NIH S 2187 - National Biomedical Research Act- H.R. 5394- Meaningful Access to Federal Health Plan Claims Data Act of 2021 -ensures meaningful access to claims data by clinician-led clinical data registries

Client expense: $73,240 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of PL 114-255, 21st Century Cures Act Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) Medicare Coverage for Innovative Technologies (MCIT) rule Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 FDA Reauthorization for 2022/FDA User Fees Coronavirus Preparedness and Response Provisions Health Equity Issues Cures 2.0 Draft HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 1193, The Cardiovascular Advances in Research and Opportunities Legacy Act CAROL Act Coverage with Evidence Development

Client expense: $290,000 · 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), SENATE, Treasury, Dept of

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) (includes MCIT Proposed Rule) Heart Valve Disease Awareness Transcatheter Mitral Valve National Coverage Decision Coronavirus Preparedness and Response Provisions Health Equity Issues Coverage with Evidence Development HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 6, SUPPORT For Patients and Communities Act (Sunshine)

Client expense: $290,000 · 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), SENATE, Treasury, Dept of

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S. 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification

Client expense: $420,000 · Firm income: Not reported