JOHN MCMANUS

Patient access and reimbursement of ophthalmic medical devices. Issues related to patient access to glaucoma treatment in 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (CMS-1850-P).

Education on ophthalmic medical devices.

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). Issues related to skin substitute payment in 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P) Advanced Wound Care and Regenerative Medicine Access and Reform Act (H.R. 6852)

H.R.5269/2761 - RESULTS Act Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169- Inflation Reduction Act of 2022. Support for EPIC Act - S. 832, and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Policies related to the Most Favored Nation Drug Pricing Model

Issues related to infant monitoring in H.R.9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027

H.R. 2168/S.3712, Baby Observation (BO's) Act

Education and advocacy regarding emergency services and Medicare reimbursement of freestanding emergency centers, including H.R. 3134, the Emergency Care Improvement Act.

Issues relating to the implementation of provisions included in Subtitle BB of PL.116-260- No Surprises Act, including the No Surprises Act Enforcement Act (H.R. 4710/S. 2420). Issues relating to the Federal Independent Dispute Resolution Operations proposed rule

Issues related to Transitional Coverage for Emerging Technologies (TCET)(CMS-3421-NC), including H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Access to and reimbursement of medical devices in Medicare program.

Issues related to global trade and tariffs.

Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Issues related to access and physician reimbursement under Medicare Part B, including H.R. 879 - Medicare Patient Access and Practice Stabilization Act; H.R. 2474 - Strengthening Medicare for Patients and Providers Act; S. 1640 - Medicare Patient Access and Practice Stabilization Act of 2025 Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 2484- Seniors' Access to Critical Medications Act of 2025. Issues related to prior authorization. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Issues related to stark regulation of in office dispensing of Part D drugs. Issues related to the Provider Reimbursement Stability Act of 2026 (H.R.8163). Issues related to the Patients First Act of 2026 (H.R.9693)

Advocating for access to and reimbursement for biosimilars. Issues related to vertical integration and white bagging. Issues related to patient access to products for asthma and allergies.

Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act

Medicare issues as they relate to oncology and multi-cancer early detection, including diagnostics and screening.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Support for H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to patient access for HIV prevention.

Issues related to tax exempt hospitals and charity care. Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to the SECURE 340B Act (H.R.9599).

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Policies related to the Most Favored Nation Drug Pricing Model.

Access to autologous cellular immunotherapies in Medicare Part B. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022.

Issues related to the Department of Veterans Affairs National Oncology Program's Prostate Cancer Oncology Clinical Pathway.

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). Issues related to skin substitute payment in 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P) Advanced Wound Care and Regenerative Medicine Access and Reform Act (H.R. 6852)

Issues related to site neutrality. Issues related to provider and insurer payment transparency. S.1629 - Same Care, Lower Cost Act. Issues related to Patients Deserve Price Tags Act (S.2355/H.R.5582). Issues related to Lower Costs, More Transparency Act of 2026 (H.R.9393). Issues related to Health Care Price Certainty for All Americans Act (H.R.9645).

Advocacy for increased patient access and reimbursement to ambulatory surgical centers. Issues related to Medicare payment and beneficiary patients to ASCs. Medicare Beneficiary Co-Pay Fairness Act of 2025 (H.R. 3006/S. 1776) Outpatient Surgery Access Act of 2026 (H.R. 8091) Promoting Fairness for Medicare Providers Act of 2026 (H.R. 7863)

Issues related to telehealth services, H.R. 1614- To amend title XVIII of the Social Security Act to expand practitioners eligible to furnish telehealth services under the Medicare program. H.R. 2013- Medicare Home Health Accessibility Act. CONNECT for Health Act of 2025 (H.R. 4206/S. 1261) H.R. 4037/S. 2847- Occupational Therapy Mental Health Parity Act

Issues related to the 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-105-F), specifically the inclusion of oral-only drugs in the ESRD PPS Bundled Payment. Issues related to Most Favored Nation Drug Pricing Reform

Access and reimbursement for Part B and Part D drugs. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement under Medicare Part B drugs, including H.R. 4299 -Protecting Patient Access to Cancer and Complex Therapies Act Policies related to the Most Favored Nation Drug Pricing Model

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). Issues related to skin substitute payment in 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P) Advanced Wound Care and Regenerative Medicine Access and Reform Act (H.R. 6852)

Issues related to Artificial Intelligences approval in Medical Devices. Issues related to The SECURE Data Act (H.R. 8413).

Access and reimbursement of medical devices in Medicare program. Issues related to capping beneficiary copayments for Medicare beneficiaries in ambulatory surgery centers, included in Medicare Beneficiary Co-Pay Fairness Act of 2025(H.R. 3006/S. 1776) The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717)

Issues related to tax-advantaged savings accounts for Medicare beneficiaries, including the creation and regulation of Medicare Flex Fund Accounts to cover qualified medical expenses

Issues related to making Health Savings Accounts and Health Reimbursement Arrangements more accessible and ubiquitous, including H.R. 548- HSA Modernization Act, H.R.919 - Chronic Disease Flexible Coverage Act, S. 2875 - Custom Health Option and Individual Care Expense (CHOICE) Act, H.R. 5463 - Choice Arrangement Act, S.2875 - CHOICE Act H.R.1157 - ACCESS Act

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Issues related to coverage, including VIA Disc local coverage determination. LCD ID: L39962 - Coverage Indications, Limitations and/or Medical Necessity section to include non-coverage for all intervertebral disc injections for management of chronic low back pain. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program.

Education on FDA regulation of Human Cellular Tissue Products (HCTPs).

Education on ophthalmic medical devices.

Patient access and reimbursement of ophthalmic medical devices.

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F).

H.R.5269/2761 - RESULTS Act Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Issues related to global trade and tariffs.

Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169- Inflation Reduction Act of 2022. Support for EPIC Act - S. 832, and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Policies related to the Most Favored Nation Drug Pricing Model

H.R. 2168/S.3712, Baby Observation (BO's) Act

Issues related to infant monitoring in H.R.9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027

Education and advocacy regarding emergency services and Medicare reimbursement of freestanding emergency centers, including H.R. 3134, the Emergency Care Improvement Act.

Issues relating to the implementation of provisions included in Subtitle BB of PL.116-260- No Surprises Act, including the No Surprises Act Enforcement Act (H.R. 4710/S. 2420). Issues relating to the Federal Independent Dispute Resolution Operations proposed rule

Issues related to global trade and tariffs.

Issues related to Transitional Coverage for Emerging Technologies (TCET)(CMS-3421-NC), including H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Access to and reimbursement of medical devices in Medicare program.

Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Issues related to access and physician reimbursement under Medicare Part B, including H.R. 879 - Medicare Patient Access and Practice Stabilization Act; H.R. 2474 - Strengthening Medicare for Patients and Providers Act; S. 1640 - Medicare Patient Access and Practice Stabilization Act of 2025 Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 2484- Seniors' Access to Critical Medications Act of 2025. Issues related to prior authorization. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Issues related to stark regulation of in office dispensing of Part D drugs. Issues Related to the Provider Reimbursement Stability Act of 2026 (H.R.8163).

Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act

Advocating for access to and reimbursement for biosimilars. Issues related to vertical integration and white bagging. Issues related to patient access to products for asthma and allergies.

Medicare issues as they relate to oncology and multi-cancer early detection, including diagnostics and screening.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to patient access for HIV prevention.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Support for H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to tax exempt hospitals and charity care. Issues related to the Tax Exempt Hospital Transparency Act (H.R. 9504).

Education and advocacy regarding sickle cell disease, including H.R. 1796/S. 735- Sickle Cell Disease and Other Heritable Blood Disorders, Research, Surveillance, Prevention, and Treatment Act of 2025.

Access to autologous cellular immunotherapies in Medicare Part B. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022.

Issues related to the Department of Veterans Affairs National Oncology Program's Prostate Cancer Oncology Clinical Pathway.

Policies related to the Most Favored Nation Drug Pricing Model Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R.4299 - Protecting Patient Access to Cancer and Complex Therapies Act Issues related to Center for Medicare and Medicaid Innovation (CMMI) guardrails

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Advocacy for increased patient access and reimbursement to ambulatory surgical centers. Issues related to Medicare beneficiary patients to ASCs. Medicare Beneficiary Co-Pay Fairness Act of 2025 (H.R. 3006/S. 1776) Outpatient Surgery Access Act of 2026 (H.R. 8091)

Issues related to site neutrality. Issues related to provider and insurer payment transparency. S.1629 - Same Care, Lower Cost Act. S.2355/H.R.5582 - Patients Deserve Price Tags Act. Issues related to Lower Costs, More Transparency Act of 2026 (H.R.9393)

Issues related to telehealth services, H.R. 1614- To amend title XVIII of the Social Security Act to expand practitioners eligible to furnish telehealth services under the Medicare program. H.R. 2013- Medicare Home Health Accessibility Act. CONNECT for Health Act of 2025 (H.R. 4206/S. 1261) H.R. 4037/S. 2847- Occupational Therapy Mental Health Parity Act

Issues related to the 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-105-F), specifically the inclusion of oral-only drugs in the ESRD PPS Bundled Payment. Issues related to Most Favored Nation Drug Pricing Reform

Access and reimbursement for Part B and Part D drugs. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement under Medicare Part B drugs. Policies related to the Most Favored Nation Drug Pricing Model

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F).

Education on ophthalmic medical devices.

H.R. 2168/S.3712, Baby Observation (BO's) Act

H.R. 2168/S.3712, Baby Observation (BO's) Act

Issues related to the 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-105-F), specifically the inclusion of oral-only drugs in the ESRD PPS Bundled Payment. H.R.6214 - Kidney Care Access Protection Act Issues related to Most Favored Nation Drug Pricing Reform

Access and reimbursement of medical devices in Medicare program. Issues related to capping beneficiary copayments for Medicare beneficiaries in ambulatory surgery centers, included in Medicare Beneficiary Co-Pay Fairness Act of 2025(H.R. 3006/S. 1776) The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717)

Issues related to Artificial Intelligences approval in Medical Devices.

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Issues related to coverage, including VIA Disc local coverage determination. LCD ID: L39962 - Coverage Indications, Limitations and/or Medical Necessity section to include non-coverage for all intervertebral disc injections for management of chronic low back pain. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program.

Education on FDA regulation of Human Cellular Tissue Products (HCTPs).

Issues related to tax-advantaged savings accounts for Medicare beneficiaries, including the creation and regulation of Medicare Flex Fund Accounts to cover qualified medical expenses

Issues related to making Health Savings Accounts and Health Reimbursement Arrangements more accessible and ubiquitous, including H.R. 548- HSA Modernization Act, H.R.919 - Chronic Disease Flexible Coverage Act, S. 2875 - Custom Health Option and Individual Care Expense (CHOICE) Act, H.R. 5463 - Choice Arrangement Act. H.R.1157 - ACCESS Act

Education and advocacy regarding emergency services and Medicare reimbursement of freestanding emergency centers, including H.R. 3134, the Emergency Care Improvement Act.

Issues relating to the implementation of provisions included in Subtitle BB of PL.116-260- No Surprises Act, including the No Surprises Act Enforcement Act (H.R. 4710/S. 2420). Issues relating to the Federal Independent Dispute Resolution Operations proposed rule

Issues related to global trade and tariffs.

Issues related to Transitional Coverage for Emerging Technologies (TCET)(CMS-3421-NC), including H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Access to and reimbursement of medical devices in Medicare program.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Issues related to access and physician reimbursement under Medicare Part B, including H.R. 879 - Medicare Patient Access and Practice Stabilization Act; H.R. 2474 - Strengthening Medicare for Patients and Providers Act; S. 1640 - Medicare Patient Access and Practice Stabilization Act of 2025 Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 2484- Seniors' Access to Critical Medications Act of 2025. Issues related to prior authorization. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act

Medicare issues as they relate to oncology and multi-cancer early detection, including diagnostics and screening, H.R.842/S. 339- Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to federal funding for HIV prevention.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Support for H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to tax exempt hospitals and charity care.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Support for H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to the Department of Veterans Affairs National Oncology Program's Prostate Cancer Oncology Clinical Pathway.

Access to autologous cellular immunotherapies in Medicare Part B. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022.

Education and advocacy regarding sickle cell disease, including H.R. 1796/S. 735- Sickle Cell Disease and Other Heritable Blood Disorders, Research, Surveillance, Prevention, and Treatment Act of 2025. Priority review vouchers: Give Kids a Chance Act of 2025 (H.R. 1262/S.932) Issues related to FDA Accelerated Approval Pathways

Issues related to global trade and tariffs.

H.R.5269/2761 - RESULTS Act Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169- Inflation Reduction Act of 2022. Support for EPIC Act - S. 832, and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Policies related to the Most Favored Nation Drug Pricing Model S.3345 - PBM Price Transparency and Accountability Act

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act

Advocating for access to and reimbursement for biosimilars. Issues related to vertical integration and white bagging.

Advocacy for increased patient access and reimbursement to ambulatory surgical centers. Issues related to Medicare beneficiary patients to ASCs. Medicare Beneficiary Co-Pay Fairness Act of 2025 (H.R. 3006/S. 1776) Outpatient Surgery Access Act of 2026 (H.R. 8091)

Issues related to site neutrality. Issues related to provider and insurer payment transparency. S.1629 - Same Care, Lower Cost Act. S.2355 - Patients Deserve Price Tags Act.

Issues related to the 2026 Medicare Physician Fee Schedule Proposed Rule (CMS-1832-P). Issues related to telehealth services, H.R. 1614- To amend title XVIII of the Social Security Act to expand practitioners eligible to furnish telehealth services under the Medicare program. H.R. 2013- Medicare Home Health Accessibility Act. CONNECT for Health Act of 2025 (H.R. 4206/S. 1261) H.R. 4037/S. 2847- Occupational Therapy Mental Health Parity Act

Access and reimbursement for Part B and Part D drugs. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement under Medicare Part B drugs. Policies related to the Most Favored Nation Drug Pricing Model

Improve beneficiary access with altered cost sharing

Issues related to coverage of and reimbursement for Human Cell & Tissue products, including Local Coverage Determination L39764- Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program.

Issues related to modernizing payment policy for comprehensive minimally invasive glaucoma surgery procedures.

Policies related to the Most Favored Nation Drug Pricing Model Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R.4299 - Protecting Patient Access to Cancer and Complex Therapies Act

Issues related to coverage of and reimbursement for Human Cell & Tissue products. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F).

Improve beneficiary access with altered cost sharing

Access to autologous cellular immunotherapies in Medicare Part B. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022.

Issues related to the Department of Veterans Affairs National Oncology Program's Prostate Cancer Oncology Clinical Pathway.

Issues related to modernizing payment policy for comprehensive minimally invasive glaucoma surgery procedures.

Education on ophthalmic patient access.

General pharmaceutical coverage and reimbursement issues, issues and activities affecting oncology, neurodegenerative and fertility products. Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to IVF treatments, including the Infertility Treatment Affordability Act (H.R. 4639).

Support for S. 839, EPIC Act and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program Medicare and Medicaid pharmaceutical coverage and reimbursement issues, particularly regarding neurodegenerative products. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Policies related to the Most Favored Nation Drug Pricing Model.

Access and reimbursement of medical devices in Medicare program. Issues related to capping beneficiary copayments for Medicare beneficiaries in ambulatory surgery centers, included in Medicare Beneficiary Co-Pay Fairness Act of 2025(H.R. 3006/S. 1776) The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717)

Issues related to Artificial Intelligences approval in Medical Devices.

Issues related to coverage of and reimbursement for Human Cell & Tissue products, including Local Coverage Determination L39764- Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to the 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-105-F), specifically the inclusion of oral-only drugs in the ESRD PPS Bundled Payment. H.R.6214 - Kidney Care Access Protection Act Issues related to Most Favored Nation Drug Pricing Reform

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Issues related to access and physician reimbursement under Medicare Part B, including H.R. 879 - Medicare Patient Access and Practice Stabilization Act; H.R. 2474 - Strengthening Medicare for Patients and Providers Act; S. 1640 - Medicare Patient Access and Practice Stabilization Act of 2025 Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R. 2484- Seniors' Access to Critical Medications Act of 2025. Issues related to prior authorization. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Issues related to the 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to coverage of and reimbursement for Human Cell & Tissue products, including Local Coverage Determination L39764- Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program.

Education on Human Cellular Tissue Products (HCTPs).

Issues related to coverage of and reimbursement for Human Cell & Tissue products, including Local Coverage Determination L39764- Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Issues related to coverage, including VIA Disc local coverage determination. LCD ID: L39962 - Coverage Indications, Limitations and/or Medical Necessity section to include non-coverage for all intervertebral disc injections for management of chronic low back pain. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program.

Issues related to coverage of and reimbursement for Human Cell & Tissue products, including Local Coverage Determination L39764- Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Skin Substitute Access and Payment Reform Act of 2025 (H.R. 5768/S. 2561). H.R.6852 - To amend title XVIII of the Social Security Act to adjust payment for skin substitute products under the Medicare program. Issues related to skin substitute payment in 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to the 2026 Medicare Physician Fee Schedule Proposed Rule (CMS-1832-P). Issues related to telehealth services, H.R. 1614- To amend title XVIII of the Social Security Act to expand practitioners eligible to furnish telehealth services under the Medicare program. H.R. 2013- Medicare Home Health Accessibility Act. CONNECT for Health Act of 2025 (H.R. 4206/S. 1261)

Advocacy for increased patient access and reimbursement to ambulatory surgical centers. Issues related to Medicare beneficiary patients to ASCs. Medicare Beneficiary Co-Pay Fairness Act of 2025 (H.R. 3006/S. 1776)

Issues related to site neutrality. Issues related to provider and insurer payment transparency. S.1629 - Same Care, Lower Cost Act. S.2355 - Patients Deserve Price Tags Act.

Advocating for access to and reimbursement for biosimilars.

Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to virtual supervision of infusion drugs. H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Issues related to the 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)

Issues related to making Health Savings Accounts and Health Reimbursement Arrangements more accessible and ubiquitous, including H.R. 548- HSA Modernization Act, H.R.919 - Chronic Disease Flexible Coverage Act, S. 2875 - Custom Health Option and Individual Care Expense (CHOICE) Act, H.R. 5463 - Choice Arrangement Act. H.R.1157 - ACCESS Act

Issues related to tax-advantaged savings accounts for Medicare beneficiaries, including the creation and regulation of Medicare Flex Fund Accounts to cover qualified medical expenses

Education and advocacy regarding emergency services and Medicare reimbursement of freestanding emergency centers, including H.R. 3134, the Emergency Care Improvement Act.

Issues relating to the implementation of provisions included in Subtitle BB of PL.116-260- No Surprises Act, including the No Surprises Act Enforcement Act (H.R. 4710/S. 2420).

H.R. 2168, Baby Observation (BO's) Act

Policies related to the Most Favored Nation Drug Pricing Model Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. H.R.4299 - Protecting Patient Access to Cancer and Complex Therapies Act

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169- Inflation Reduction Act of 2022. Support for EPIC Act - S. 832, and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act Policies related to the Most Favored Nation Drug Pricing Model S.3345 - PBM Price Transparency and Accountability Act

H.R.5269/2761 - RESULTS Act Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Access and reimbursement in Medicare Parts B and D. Implementation of provisions included in Subtitle B of PL.117-169-Inflation Reduction Act of 2022. Issues related to physician reimbursement for Part B drugs, including Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299). Support for H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program.

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program. Issues related to federal funding for HIV prevention.

Support for EPIC Act - S. 832, and H.R. 1492, To equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. Policies related to the Most Favored Nation Drug Pricing Model.

Education and advocacy regarding sickle cell disease, including H.R. 1796/S. 735- Sickle Cell Disease and Other Heritable Blood Disorders, Research, Surveillance, Prevention, and Treatment Act of 2025. Priority review vouchers: Give Kids a Chance Act of 2025 (H.R. 1262/S.932)

Issues related to Transitional Coverage for Emerging Technologies (TCET)(CMS-3421-NC), including H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Access to and reimbursement of medical devices in Medicare program.