New Era of Preventing End-Stage Kidney Disease Act

Reported lobbying issue

Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act; end-stage renal disease policy and rare kidney disease Pharmacy: HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act; HR 4709, the Newborn Screening Saves Lives Reauthorization Act; PDUFA/regulatory review process; H.R. 9102, Biotech Investment National Security Act (BINSA) Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Medicare and Medicaid related provisions in H.R.1, One Big Beautiful Bill Act.H.R. 9509, the Kidney Disease Education Expansion Act Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes; proposals regarding patent thickets. S. 2658, Medication Affordability and Patent Integrity Act Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%; R&D tax credit; related implementation provisions in H.R.1, One Big Beautiful Bill Act; pharmaceutical tariffs, specifically related to orphan drugs

Reported lobbying issue

Health Issues: -Expanding Support for Living Donors Act (H.R. 7868) Legislation to expand how much living donors can be reimbursed and to increase the threshold for income-based qualification -Living Donor Protection Act (H.R. 4583) and related FMLA bill (H.R. 4582 and S. 1552). Clarifies and strengthens protections for Americans who donate an organ. -Concurrent Care for Comfort Act (HR 8367) and related policy concepts regarding helping patients on dialysis nearing end of life also access hospice care -Home Dialysis Improvement Act (HR 8875) and related policy concepts helping more patients consider electing home dialysis -Kidney Disease Education Expansion Act of 2026 (H.R. 9509) and related policy concepts to increase earlier upstream intervention to slow the progression of kidney disease, including screening and diagnosis -$77M in appropriations for HRSA Organ Transplant work in FY27 (funding to modernize the US transplant system and support living donors through reimbursement for living kidney donation-related costs) -$25M in appropriations for HHS in FY27 to support KidneyX (public-private partnership to catalyze innovation in kidney disease prevention, diagnosis, and treatment through a series of prize competitions) -Called for continued focus on modernizing the U.S. transplant system, including implementing the 2023 Securing the U.S. OPTN Act -Called for the creation of an Officer of Kidney Health and Transplantation within the immediate office of the secretary of HHS (to coordinate kidney health care, research, and data-related efforts across the numerous HHS agencies with a role in kidney health) -Urged HHS to ensure kidney health data remains accessible and complete, including advancing data-sharing, data standards, and interoperability -Encouraged CMMI to develop a subsequent kidney care focused model, building on the successes and lessons of the CKCC model -Asked questions about the adequacy of kidney patient access to specialized kidney and transplant care in MA plans -Endorsed the following bills: -Keeping Individuals with Dialysis Needs Equipped through Year-round (KIDNEY) Remote Monitoring Act (HR 8319) Provider Reimbursement Stability Act (HR 8163) -The Diabetes Foot Health Access and Modernization Act of 2026 (HR 7905/S 4070) -H-1Bs for Physicians and Healthcare Workforce Act (HR 7961) Living Organ Volunteer Engagement (LOVE) Act (HR 7581) -New Era of Preventing ESRD Act (HR 1518) -PKD Cures Act (HR 9169) Science/Technology: -$51.303B in appropriations for NIH in FY27 (to support investments in basic, clinical, translational, and other health-related research activities) -$1 billion in appropriations for kidney research at NIDDK within the overall NIDDK FY27 appropriation, implementing the recommendations of the Transforming Kidney Health Research report -$25M in appropriations for HHS in FY27 to support KidneyX (public-private partnership to catalyze innovation in kidney disease prevention, diagnosis, and treatment through a series of prize competitions) -Called for significant revision or recision of the proposed Regulation for Federal Financial Assistance

Reported lobbying issue

Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes; proposals regarding patent thickets Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act; end-stage renal disease policy and rare kidney disease Pharmacy: HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act; HR 4709, the Newborn Screening Reauthorization Act; PDUFA/regulatory review process Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Medicare and Medicaid related provisions in H.R.1, One Big Beautiful Bill Act. Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%; R&D tax credit; related implementation provisions in H.R.1, One Big Beautiful Bill Act; tariffs

Reported lobbying issue

Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act Pharmacy: HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act; HR 4709, the Newborn Screening Reauthorization Act Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Medicare and Medicaid related provisions in H.R.1, One Big Beautiful Bill Act. Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes; proposals regarding patent thickets Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%; R&D tax credit; related provisions in H.R.1, One Big Beautiful Bill Act; tariffs

Reported lobbying issue

Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act Pharmacy: HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act; HR 4709, the Newborn Screening Reauthorization Act Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Medicare and Medicaid related provisions in H.R.1, One Big Beautiful Bill Act. Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%; R&D tax credit; related provisions in H.R.1, One Big Beautiful Bill Act; tariffs

Reported lobbying issue

Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act Pharmacy: HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Medicare and Medicaid related provisions in H.R.1, One Big Beautiful Bill Act. Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%; R&D tax credit; related provisions in H.R.1, One Big Beautiful Bill Act; tariffs

Reported lobbying issue

Health Issues: Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 1518, the New Era of Preventing End-Stage Kidney Disease Act Pharmacy: HR 946, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act) Medical/Disease Research/Clinical Labs: HR 1262, S 932 Give Kids a Chance Act to renew PRV program Medicare/Medicaid: Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Copyright/Patent/Trademark: S.1040, to prohibit product hopping and for other purposes Taxation/Internal Revenue Code: H.R. 1414, Cameron's Law to increase Orphan Drug Tax Credit to 50%

Reported lobbying issue

Health Issues: Access to Genetic Counselor Services Act: H.R. 6280, S. 3607 Living Donor Protection Act: H.R. 4582, H.R 4583, S. 1552 Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2025: H.R. 1518. Restore Protections for Dialysis Patients Act: H.R. 2199; S. 1173. Permanent OPTN Fee Authority Act: H.R.5259; S. 2751. Kidney Care Access Protection Act: S.2730. H.R. 6214 Expanding Support for Living Donors Act: H.R. 7868 Improving Home Dialysis Act: H.R. 8875 Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (CMS-4212-P) Request for Information: Opportunities, Challenges, and Emerging Areas in Statistical Data, Analysis, and Research

Reported lobbying issue

Health Issues: Issues related to drug pricing; Issues related to H.R. 1227/S. 475 - Alternatives to PAIN Act; Issues related to H.R. 1518 - New Era of Preventing End-Stage Kidney Disease Act. Defense: Issues related to coverage of opioid alternatives.

Reported lobbying issue

Health Issues: Federal policies impacting pharmaceutical development, approval, and reimbursement; Copay accumulators and maximizers, H.R. 6423/S. 864 - HELP Copays Act; Alternative Funding Programs; Unmet medical need in acute pain; Barriers to patient access of non-opioid pain medicines; General education about kidney disease, including APOL-1 and H.R. 1518 - New Era of Preventing End-Stage Kidney Disease; Cystic Fibrosis; Sickle cell disease; Innovations in Type 1 diabetes treatments. Medicare/Medicaid: Unmet medical need in acute pain; H.R. 1227/S. 475 - The Alternatives to PAIN Act; Implementation of Public Law No: 117-328 sec. 4135 NO PAIN Act; Medically necessary fertility treatments for patients undergoing fully myeloablative conditioning; CMMI demo focusing on sickle cell disease; Drug Pricing Policies including Most Favored Nation policy proposals. Taxation/Internal Revenue Code: Corporate tax reform; H.R. 1414 - Cameron's Law, Preservation of Orphan Drug Tax Credit. Budget/Appropriations: Education about non-opioid pain therapies and patient access to non-opioid medicines, updates on coverage progress at the VHA and CMS. Veterans: Issues related to veteran's access to non-opioid alternatives and implementation of report language in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (PL 119-37). Defense: Issues related to the Defense Health Agency and service member access to non-opioid alternatives, including reinstating the DHA Benefits Advisory Panel and the structured formulary management process. District of Columbia: Issues related to Sec. 232 pharmaceutical tariffs, onshoring active pharmaceutical ingredients (API), and supply chain disruptions for products related to the opioid public health emergency.

Reported lobbying issue

Budget/Appropriations: Appropriations for the Department of Health & Human Services and the Department of Veterans Affairs, and Department of Defense. Veterans: Health care policies relating to mental health and PTSD, including authorizations and appropriations for the Department of Veterans Affairs related to mental health and PTSD. Medicare/Medicaid: Implementation of the Inflation Reduction Act. Issues related to Medicare Part D redesign's impact on low-income subsidy beneficiaries. Issues related to prior authorization, open access, and medication step therapy; The Safe Step Act (HR 5509/S. 2903) Health Issues: Issues relating to early detection of PTSD, mental health parity and coordinated care and mental health equity. PBM reform. Issues related to rare nephrology/kidney diseases, 340B reform, psychedelics treatments for PTSD and mental health. H.R. 1518, the New Era of Preventing End-Stage Kidney Disease Act. Issues related to drug pricing, foreign reference pricing, biomedical research, and pharmaceutical supply chain. Tariff (miscellaneous tariff bills): Issues related to tariffs on pharmaceuticals and pharmaceutical supply chain.

Reported lobbying issue

Budget/Appropriations: FY 2027 Appropriations for organ donation and transplantation activities (HRSA). FY 2027 Appropriations for CDC, including the Chronic Kidney Disease Initiative. FY 2027 Appropriations for kidney research at the National Institute of Diabetes and Digestive and Kidney Diseases. FY 2027 Appropriations for Dept. of Defense Congressionally Directed Medical Research Program. FY 2027 Appropriations for Indian Health Service. Health Issues: Activities to facilitate organ donation and transplantation, including the Honor our Living Donors Act (H.R. 628, S. 957); the Living Donor Protection Act (S.1552 and H.R. 4583); and legislation to clarify that organ donation surgery qualifies as a serious health condition for FMLA coverage (S. 1552, H.R. 4582). Implementation of P.L. 118-14, "Securing the U.S. Organ Procurement and Transplantation Network Act." Comments to FDA re: Proposal to Withdraw Approval of New Drug Application for TAVNEOS (Avacopan). Support for xenotransplantation. Initiatives to improve chronic kidney disease early detection and management. Implementation of the Advancing American Kidney Health Initiative. Support for telemedicine and telehealth access. The New Era of Preventing End-Stage Kidney Disease Act (H.R. 1518). Support for access to affordable, accessible health care, including Affordable Care Act enhanced premium tax credits. Medicare/Medicaid: Initiatives to expand access to home dialysis. H.R. 9509, the "Kidney Disease Education Access Expansion Act of 2026," to expand eligibility and utilization of the Medicare kidney disease education benefit and improve kidney disease detection. S.1973 and H.R. 4231, "Treat and Reduce Obesity Act," to provide Medicare coverage of anti-obesity medications and obesity treatment. Support for Medicare GLP-1 Bridge Program. Support for telemedicine and telehealth access, including the CONNECT for Health Act (S.1261, H.R. 4206) for Medicare beneficiaries. Medicaid eligibility and affordability of coverage under the One Big Beautiful Bill. Activities to address detection and management of chronic kidney disease. Support for Medicare Part D Protected Classes. Implementation of the Advancing American Kidney Health Initiative.

Reported lobbying issue

Health Issues: Access to Genetic Counselor Services Act Living Donor Protection Act: H.R. 4582; H.R 4583; S. 1552 Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2025: H.R. 1518. Restore Protections for Dialysis Patients Act: H.R. 2199; S. 1173. Enhanced Advance Premium Tax Credits (eAPTCs) Permanent OPTN Fee Authority Act: H.R.5259; S. 2751. Kidney Care Access Protection Act: S.2730. H.R. 1 CMS-1830-P: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40060 Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40058

Reported lobbying issue

Health Issues: Issues related to drug pricing; Issues related to H.R. 1227/S. 475 - Alternatives to PAIN Act; Issues related to H.R. 1518 - New Era of Preventing End-Stage Kidney Disease Act. Defense: Issues related to coverage of opioid alternatives.

Reported lobbying issue

Medicare/Medicaid: Implementation of the Inflation Reduction Act. Issues related to Medicare Part D redesign's impact on low-income subsidy beneficiaries. Health Issues: Issues relating to early detection of PTSD, mental health parity and coordinated care and mental health equity. PBM reform. Issues related to rare nephrology/kidney diseases, 340B reform, psychedelics treatments for PTSD and mental health. H.R. 1518, the New Era of Preventing End-Stage Kidney Disease Act. Issues related to drug pricing, foreign reference pricing, biomedical research, and pharmaceutical supply chain. Budget/Appropriations: Appropriations for the Department of Health & Human Services, the Department of Veterans Affairs, and the Department of Defense. Veterans: Health care policies relating to mental health and PTSD, including authorizations and appropriations for the Department of Veterans Affairs related to mental health and PTSD. Tariff (miscellaneous tariff bills): Issues related to tariffs on pharmaceuticals and pharmaceutical supply chain.

Reported lobbying issue

Health Issues: Federal policies impacting pharmaceutical development, approval, and reimbursement; Copay accumulators and maximizers, H.R. 6423/S. 864 - HELP Copays Act; Alternative Funding Programs; Unmet medical need in acute pain; Barriers to patient access of non-opioid pain medicines; General education about kidney disease, including APOL-1 and H.R. 1518 - New Era of Preventing End-Stage Kidney Disease; Cystic Fibrosis; Sickle cell disease; Innovations in Type 1 diabetes treatments. Medicare/Medicaid: Unmet medical need in acute pain; H.R. 1227/S. 475 - The Alternatives to PAIN Act; Implementation of Public Law No: 117-328 sec. 4135 NO PAIN Act; Medically necessary fertility treatments for patients undergoing fully myeloablative conditioning; CMMI demo focusing on sickle cell disease; Drug Pricing Policies including Most Favored Nation policy proposals. Taxation/Internal Revenue Code: Corporate tax reform; H.R. 1414 - Cameron's Law, Preservation of Orphan Drug Tax Credit. Budget/Appropriations: Education about non-opioid pain therapies and patient access to non-opioid medicines, updates on coverage progress at the VHA and CMS. Trade (domestic/foreign): Intellectual property reforms to address unfair trade practices in Argentina and Russia. Veterans: Issues related to veteran's access to non-opioid alternatives and implementation of report language in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (PL 119-37). Defense: Issues related to the Defense Health Agency and service member access to non-opioid alternatives, including reinstating the DHA Benefits Advisory Panel and the structured formulary management process.

Reported lobbying issue

Budget/Appropriations: FY 2026 and FY 2027 Appropriations for organ donation and transplantation activities (HRSA). FY 2026 and FY 2027 Appropriations for CDC, including the Chronic Kidney Disease Initiative. FY 2026 and FY 2027 Appropriations for kidney research at the National Institute of Diabetes and Digestive and Kidney Diseases. FY 2026 and FY 2027 Appropriations for Dept. of Defense Congressionally Directed Medical Research Program. FY 2026 and FY 2027 Appropriations for Indian Health Service. Health Issues: Activities to facilitate organ donation and transplantation, including the Honor our Living Donors Act (H.R. 628, S. 957); the Living Donor Protection Act (S.1552 and H.R. 4583); and legislation to clarify that organ donation surgery qualifies as a serious health condition for FMLA coverage (S. 1552, H.R. 4582). Implementation of P.L. 118-14, "Securing the U.S. Organ Procurement and Transplantation Network Act." Support for xenotransplantation. Comment letter in support for FDA approval of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). Implementation of the Advancing American Kidney Health Initiative. Support for telemedicine and telehealth access. The New Era of Preventing End-Stage Kidney Disease Act (H.R. 1518). Activities in support of access to affordable, accessible health care, including Affordable Care Act enhanced premium tax credits. Medicare/Medicaid: Initiatives to expand access to home dialysis. Initiatives to expand eligibility and utilization of the Medicare kidney disease education benefit. S.1973 and H.R. 4231, "Treat and Reduce Obesity Act," to provide Medicare coverage of anti-obesity medications and obesity treatment. Support for telemedicine and telehealth access, including the CONNECT for Health Act (S.1261, H.R. 4206) for Medicare beneficiaries. Comments on the Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program. Comments on Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model. Comments on Organ Procurement Organizations (OPO) Conditions for Coverage Revision. Medicaid eligibility and affordability of coverage under the One Big Beautiful Bill. Activities to address detection and management of chronic kidney disease. Support for Medicare Part D Protected Classes. Implementation of the Advancing American Kidney Health Initiative.

Reported lobbying issue

Budget/Appropriations: FY 2026 Appropriations for organ donation and transplantation activities (HRSA). FY 2026 Appropriations for CDC, including the Chronic Kidney Disease Initiative. FY 2026 Appropriations for kidney research at the National Institute of Diabetes and Digestive and Kidney Diseases. FY 2026 Appropriations for Dept. of Defense Congressionally Directed Medical Research Program. FY 2026 Appropriations for Indian Health Service. Health Issues: Activities to facilitate organ donation and transplantation, including the Honor our Living Donors Act (H.R. 628, S. 957); the Living Donor Protection Act (S.1552 and H.R. 4583); and legislation to clarify that organ donation surgery qualifies as a serious health condition for FMLA coverage (S. 1552, H.R. 4582). Request to require inclusion of phosphorus on nutrition labels. Implementation of P.L. 118-14, "Securing the U.S. Organ Procurement and Transplantation Network Act." Support for xenotransplantation. Implementation of the Advancing American Kidney Health Initiative. Support for telemedicine and telehealth access. The New Era of Preventing End-Stage Kidney Disease Act (H.R. 1518). Activities in support of access to affordable, accessible health care, including Affordable Care Act enhanced premium tax credits. Medicare/Medicaid: Initiatives to expand access to home dialysis. Request to Reinstate Race & Ethnicity Data Collection in the ESRD Quality Reporting System. S.1973 and H.R. 4231, "Treat and Reduce Obesity Act," to provide Medicare coverage of anti-obesity medications and obesity treatment. Support for telemedicine and telehealth access, including the CONNECT for Health Act (S.1261, H.R. 4206) for Medicare beneficiaries. Medicaid eligibility and affordability of coverage under the One Big Beautiful Bill. Activities to address detection and management of chronic kidney disease. Support for Medicare Part D Protected Classes. Implementation of the Advancing American Kidney Health Initiative.

Reported lobbying issue

Health Issues: Access to Genetic Counselor Services Act Living Donor Protection Act: H.R. 4582; H.R 4583; S. 1552 Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2025: H.R. 1518. Restore Protections for Dialysis Patients Act: H.R. 2199; S. 1173. Enhanced Advance Premium Tax Credits (eAPTCs) Permanent OPTN Fee Authority Act: H.R.5259; S. 2751. Kidney Care Access Protection Act: S.2730. H.R. 1 CMS-1830-P: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40060 Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40058

Reported lobbying issue

Health Issues: Access to Genetic Counselor Services Act Living Donor Protection Act: H.R. 4582; H.R 4583; S. 1552 Appropriations-NIH, NIDDK, Kidney Research The New Era for Preventing End-Stage Kidney Disease Act of 2025: H.R. 1518. Restore Protections for Dialysis Patients Act: H.R. 2199; S. 1173. Enhanced Advance Premium Tax Credits (eAPTCs) Permanent OPTN Fee Authority Act: H.R.5259; S. 2751. Kidney Care Access Protection Act: S.2730. H.R. 1 CMS-1830-P: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40060 Proposed Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft Rejection Proposed LCD ID: DL40058

Reported lobbying issue

Health Issues: Activities to facilitate organ donation and transplantation, including the Honor our Living Donors Act (H.R. 628, S. 957); the Living Donor Protection Act (S.1552 and H.R. 4583); and legislation to clarify that organ donation surgery qualifies as a serious health condition for FMLA coverage (S. 1552, H.R. 4582). Implementation of P.L. 118-14, "Securing the U.S. Organ Procurement and Transplantation Network Act." Implementation of the Advancing American Kidney Health Initiative. Support for telemedicine and telehealth access. The New Era of Preventing End-Stage Kidney Disease Act (H.R. 1518). Activities in support of access to affordable, accessible health care. Opposed changes to Affordable Care Act eligibility, access and affordability under the One Big Beautiful Bill (H.R. 1). Medicare/Medicaid: Initiatives to expand access to home dialysis (bill introduction pending). S.1973 and H.R. 4231, "Treat and Reduce Obesity Act," to provide Medicare coverage of anti-obesity medications and obesity treatment. Support for telemedicine and telehealth access, including the CONNECT for Health Act (S.1261, H.R. 4206) for Medicare beneficiaries. Opposed changes to Medicaid eligibility, access and affordability of coverage under the One Big Beautiful Bill (H.R. 1). Activities to address detection and management of chronic kidney disease. Support for Medicare Part D Protected Classes. Implementation of the Advancing American Kidney Health Initiative. Outreach to CMS to request restoration of the collection of race and ethnicity data collection on Medicare beneficiaries with end stage renal disease. Comments on the Calendar Year Proposed Rules for the Medicare Physician Fee Schedule and Medicare Prospective Payment System. Budget/Appropriations: FY 2026 Appropriations for organ donation and transplantation activities (HRSA). FY 2026 Appropriations for CDC, including the Chronic Kidney Disease Initiative. FY 2026 Appropriations for kidney research at the National Institute of Diabetes and Digestive and Kidney Diseases. FY 2026 Appropriations for Dept. of Defense Congressionally Directed Medical Research Program. FY 2026 Appropriations for Indian Health Service.

Reported lobbying issue

Health Issues: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Medicare/Medicaid: H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs, Medicare and Medicaid. Pharmacy: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. PDUFA/regulatory review process. Medical/Disease Research/Clinical Labs: The Newborn Screening Reauthorization Act, and improving funding of newborn screening implementation; Importance of patient voice in rare kidney disease. Taxation/Internal Revenue Code: H.R.1414, Camerons Law, to restore the amount of the Orphan Drug Tax Credit.

Reported lobbying issue

Pharmacy: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. PDUFA/regulatory review process. Health Issues: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Medicare/Medicaid: H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs, Medicare and Medicaid. Medical/Disease Research/Clinical Labs: Legislation regarding clinical research for rare diseases and orphan drug development, and the Accelerated Approval pathway. H.R.1262/S.932, Give Kids a Chance Act to renew PRV program. Related provisions in Pub. L. No. 119-21, One Big Beautiful Bill Act. The Newborn Screening Reauthorization Act. Importance of patient voice in rare kidney disease. Taxation/Internal Revenue Code: H.R.1414, Camerons Law, to restore the amount of the Orphan Drug Tax Credit. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs.

Reported lobbying issue

Health Issues: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Policies regarding copay accumulators and impact on rare disease patients. Support of reauthorization of priority review voucher program. H.R.1968, Full-Year Continuing Appropriations and Extensions Act, 2025. Medicare/Medicaid: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation impacting products approved under the Accelerated Approval pathway. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Policies regarding copay accumulators and impact on rare disease patients. Pharmacy: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding orphan drug pricing, value, and reimbursement, relative to the Inflation Reduction Act of 2022 (Pub. L. No. 117-169, 136 Stat. 1818 (2022)). Policies regarding copay accumulators and impact on rare disease patients. Support of reauthorization of priority review voucher program. H.R.1968, Full-Year Continuing Appropriations and Extensions Act, 2025. Medical/Disease Research/Clinical Labs: Legislation regarding clinical research for rare diseases and orphan drug development, and the Accelerated Approval pathway. Support of reauthorization of priority review voucher program. Taxation/Internal Revenue Code: H.R.1414, Camerons Law, to restore the amount of the Orphan Drug Tax Credit. Legislation to improve education and care pathways for patients with rare kidney disease.

Reported lobbying issue

Taxation/Internal Revenue Code: H.R.1414, Camerons Law, to restore the amount of the Orphan Drug Tax Credit. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Medicare/Medicaid: H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs, Medicare and Medicaid. Pharmacy: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. Health Issues: Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Medical/Disease Research/Clinical Labs: Legislation regarding clinical research for rare diseases and orphan drug development, and the Accelerated Approval pathway. H.R.1262/S.932, Give Kids a Chance Act to renew PRV program. Related provisions in Pub. L. No. 119-21, One Big Beautiful Bill Act. The Newborn Screening Reauthorization Act.