JACK MANIKO

Issues related to pharmaceutical pricing. Issues related to drug shortages. Issues related to implementation of H.R. 1 (P.L. 119-21), One Big Beautiful Bill Act.

Issues relating to drug pricing, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. Issues related to artificial intelligence technology in healthcare; issues related to Hurricane Helene. Issues around emergency preparedness and critical medical supplies.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

None.

Issues related to pharmaceutical pricing. Issues related to drug shortages.

Issues relating to drug pricing, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. Issues related to artificial intelligence technology in healthcare; issues related to Hurricane Helene. Issues around emergency preparedness and critical medical supplies.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues related to pharmaceutical pricing. Issues related to drug shortages.

Issues relating to drug pricing, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. Issues related to artificial intelligence technology in healthcare; issues related to Hurricane Helene.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence technology in healthcare; issues related to Hurricane Helene, and HR 10445, Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act 2025.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence technology in healthcare.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence technology in healthcare.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence technology in healthcare.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic all-hazards preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence in healthcare.

Issues related to pharmaceutical pricing; Legislation to incentivize new technology for innovation in home dialysis (no current bill number).

Issues related to pharmaceutical pricing; Legislation to incentivize new technology for innovation in home dialysis (no current bill number).

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic all-hazards preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence in healthcare.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues related to pharmaceutical pricing; Legislation to incentivize new technology for innovation in home dialysis (no current bill number).

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization. Issues relating to safe mobility and issues relating to diabetic retinopathy. Issues relating to pandemic all-hazards preparedness act. H. Res. 550 and H.R. 4421. Issues related to artificial intelligence in healthcare.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues relating to CHIPs legislation, issues relating to access to semiconductors, Creating Helpful Incentives to Produce Semiconductors for the America Act or the CHIPS for AmericaAct.

Issues related to pharmaceutical pricing; Legislation to incentivize new technology for innovation in home dialysis (no current bill number).

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization. Issues relating to safe mobility and issues relating to diabetic retinopathy. H.R.7053/S.3792, the Hospital Inpatient Services Modernization Act and H.Res.1177.

HR3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions. HR19 / S. 2164, Lower Costs, More Cures Act of 2021, all provisions. Legislation to incentivize new technology for innovation in home dialysis (no current bill number). S.2025/H.R.5331, Patient Access to ESRD New Innovative Devices Act, all provisions. Issues relating to innovation in ventilators.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization. Issues relating to safe mobility and issues relating to diabetic retinopathy. H.R.7053/S.3792, the Hospital Inpatient Services Modernization Act and H.Res.1177.

Issues relating to CHIPs legislation, H.R.7178 Creating Helpful Incentives to Produce Semiconductors for the America Act or the CHIPS for America Act.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization. Issues relating to safe mobility and issues relating to diabetic retinopathy. H.R.7053/S.3792, the Hospital Inpatient Services Modernization Act and H.Res.1177.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues relating to CHIPs legislation, H.R.7178 Creating Helpful Incentives to Produce Semiconductors for the America Act or the CHIPS for America Act.

HR3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions. HR19 / S. 2164, Lower Costs, More Cures Act of 2021, all provisions. Legislation to incentivize new technology for innovation in home dialysis (no current bill number). S.2025, Patient Access to ESRD New Innovative Devices Act, all provisions. Issues relating to innovation in ventilators.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues related to increasing funding for Strategic National Stockpile. Labor, Health, and Human Services appropriations.

Issues related to increasing funding for Strategic National Stockpile.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

HR3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions. HR19 / S. 2164, Lower Costs, More Cures Act of 2021, all provisions. Legislation to incentivize new technology for innovation in home dialysis (no current bill number). S.2025, Patient Access to ESRD New Innovative Devices Act, all provisions.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization.

Issues related to increasing funding for Strategic National Stockpile.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

HR3, Elijah E. Cummings Lower Drug Costs Now Act, all provisions. HR19 / S. 2164, Lower Costs, More Cures Act of 2021, all provisions. Legislation to incentivize new technology for innovation in home dialysis (no current bill number). S.2025, Patient Access to ESRD New Innovative Devices Act, all provisions.

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization.

Legislation to incentivize new technology for innovation in home dialysis (no current bill number).

Issues relating to drug pricing, home dialysis expansion, ESRD reimbursement for Hemodialysis, 340B Drug pricing, device sterilization, MDUFA reauthorization.

Issues related to allocation and access to Baxter products during the COVID-19 emergency declaration.

Issues related to increasing funding for the Strategic National Stockpile

Issues related to allocation and access to Baxter product during the COVID-19 emergency declaration S734/HR1668, Internet of Things Cybersecurity Improvement Act of 2019, provisions relating to cybersecurity.

Issues related to drug pricing H.R. 547 Biological Implant Tracking and Vets safety Act of 2019 HR 447, Affordable and Safe Prescription Drug Importation Act Issues related to Home Dialysis Expansion Issues related to ESRD Reimbursement for Hemodialysis Implementation of 21st Century Cures regulations. Issues relating to 340B Drug Pricing Issues related to device sterilization Issues related to MDUFA reauthorization

Issues related to drug pricing H.R. 547 Biological Implant Tracking and Vets safety Act of 2019 HR 447, Affordable and Safe Prescription Drug Importation Act Issues related to Home Dialysis Expansion Issues related to ESRD Reimbursement for Hemodialysis Implementation of 21st Century Cures regulations. Issues relating to 340B Drug Pricing Issues related to device sterilization Issues related to MDUFA reauthorization

Issues related to allocation and access to Baxter product during the COVID-19 emergency declaration

HR 2710/S2751, Patient Access to ESRD New Innovative Devices Act, new tech innovation and increased access to home dialysis. CARES Act, P.L. 116-136, as it relates to home dialysis during public health emergency.

Issues related to allocation and access to Baxter product during the COVID-19 emergency declaration

Issues related to drug pricing H.R. 547 Biological Implant Tracking and Vets safety Act of 2019 HR 447, Affordable and Safe Prescription Drug Importation Act Issues related to Home Dialysis Expansion Issues related to ESRD Reimbursement for Hemodialysis Implementation of 21st Century Cures regulations. Issues relating to 340B Drug Pricing Issues related to device sterilization Issues related to MDUFA reauthorization

HR 2710/S2751, Patient Access to ESRD New Innovative Devices Act, new tech innovation and increased access to home dialysis. CARES Act, P.L. 116-136, as it relates to home dialysis during public health emergency.

Issues related to drug pricing H.R. 547 Biological Implant Tracking and Vets safety Act of 2019 HR 447, Affordable and Safe Prescription Drug Importation Act Issues related to Home Dialysis Expansion Issues related to ESRD Reimbursement for Hemodialysis Implementation of 21st Century Cures regulations. Issues relating to 340B Drug Pricing Issues related to device sterilization Issues related to MDUFA reauthorization

HR 2710/S2751, Patient Access to ESRD New Innovative Devices Act, new tech innovation and increased access to home dialysis. CARES Act, P.L. 116-136, as it relates to home dialysis during public health emergency.

Issues related to increasing funding for the Strategic National Stockpile

Issues related to corporate tax reform implementation

Issues related to allocation and access to Baxter product during the COVID-19 emergency declaration

Issues related to corporate tax reform. Issues related to Medical Device Tax.

ESRD new tech innovation and increased access home dialysis. HR 2710/S 2751, Patient Access to ESRD New Innovative Devices Act, regarding all provisions.

S. 650, CREATE Act of 2019, issues related to drug pricing. H.R. 547, Biological Implant Tracking and Veteran Safety Act of 2019, regarding all provisions. H.R. 447, Affordable and Safe Prescription Drug Importation Act, regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. Issues related to ESRD Reimbursement for Hemodialysis. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

S. 650, CREATE Act of 2019, issues related to drug pricing. H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, issues related to saline supply. H.R. 547, Biological Implant Tracking and Veteran Safety Act of 2019, regarding all provisions. H.R. 447, Affordable and Safe Prescription Drug Importation Act, regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. Issues related to ESRD Reimbursement for Hemodialysis. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

Issues related to corporate tax reform. Issues related to Medical Device Tax.

S. 650, CREATE Act of 2019, issues related to drug pricing. H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, issues related to saline supply. H.R. 547, Biological Implant Tracking and Veteran Safety Act of 2019, regarding all provisions. H.R. 447, Affordable and Safe Prescription Drug Importation Act, regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. Issues related to ESRD Reimbursement for Hemodialysis. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

Issues related to corporate tax reform. Issues related to Medical Device Tax.

ESRD new tech innovation and increased access home dialysis.

Issues related to corporate tax reform. Issues related to Medical Device Tax.

Issues related to Puerto Rico hurricane response and preparedness.

Issues related to Puerto Rico hurricane response and preparedness.

Issues related to corporate tax reform. Issues related to Medical Device Tax.

H.R. 2550, "Medicare Telehealth Parity Act of 2017", regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. H.R.1245/S. 469, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

H.R. 2550, "Medicare Telehealth Parity Act of 2017", regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. H.R.1245/S. 469, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

S. 870, "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017", regarding all provisions. H.R. 3178, "Medicare Part B Improvement Act of 2017", regarding all provisions. H.R. 2644/S. 1890, " "Chronic Kidney Disease Improvement Research & Treatment Act", regarding all provisions.

S. 598 / H.R. 1130, "Chronic Kidney Disease Improvement in Research and Treatment Act of 2015", regarding all provisions. S. 870, "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017", regarding all provisions. H.R. 3178, "Medicare Part B Improvement Act of 2017", regarding all provisions.

H.R. 2948, "Medicare Telehealth Parity Act" , regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. H.R.1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

H.R. 2948, "Medicare Telehealth Parity Act" , regarding all provisions. Issues relating to Home Dialysis Expansion Legislation. H.R.1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

Issues relating to Puerto Rico hurricane response.

S. 598 / H.R. 1130, "Chronic Kidney Disease Improvement in Research and Treatment Act of 2015", regarding all provisions. S. 870, "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017", regarding all provisions. H.R. 3178, "Medicare Part B Improvement Act of 2017", regarding all provisions.

Issues related to corporate tax reform, international tax reform and the taxation of U.S. multinational corporations and the medical device excise tax. Issues related to Medical Device Tax.

FY 2018 Labor HHS Appropriations bill. FY 2018 Department of Defense Appropriations bill.

Issues related to corporate tax reform, international tax reform and the taxation of U.S. multinational corporations and the medical device excise tax. Issues related to Medical Device Tax.

HR 3268, "Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018". HR 2998, "Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018". FY 2018 Labor HHS Appropriations bill. FY 2018 Department of Defense Appropriations bill.

H.R. 2948, "Medicare Telehealth Parity Act" , regarding all provisions. S.934, "FDA Reauthorization Act of 2017", regarding all provision. Issues relating to Home Dialysis Expansion Legislation. H.R.1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. H.R.1628, "American Health Care Act of 2017", regarding all provisions. H.R. 1628, "Better Care Reconciliation Act of 2017", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

S. 598 / H.R. 1130, "Chronic Kidney Disease Improvement in Research and Treatment Act of 2015", regarding all provisions. S. 3504, "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016", regarding all provisions.

HR 2948, "Medicare Telehealth Parity Act" , regarding all provisions. S.934, "FDA Reauthorization Act of 2017", regarding all provision. Issues relating to Home Dialysis Expansion Legislation. H.R.1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. H.R.1628, "American Health Care Act of 2017", regarding all provisions. H.R. 1628, "Better Care Reconciliation Act of 2017", regarding all provisions. S.1016, "CONNECT for Health Act of 2017", regarding all provisions. Issues related to ESRD Reimbursement for Hemodialysis. H.R.28, "Biological Implant Tracking and Veteran Safety Act of 2017", regarding all provisions. Implementation of the 21st Century Cures regulations. Issues relating to 340B Drug Pricing.

Issues related to corporate tax reform, international tax reform and the taxation of U.S. multinational corporations and the medical device excise tax.

Issues relating to 340B Drug Discount Program and FDA Regulatory Environment. Issues relating to CONNECT for Health Act of 2017 - Discussion Draft Issues relating to drug shortages. HR 1628, "American Health Care Act of 2017", regarding all provisions.

Issues relating to the report language for Labor HHS AG-FDA Annual Appropriations bills.

Issues relating to the report language for Labor HHS AG-FDA Annual Appropriations bills.

Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. S. 598 / H.R. 1130, "Chronic Kidney Disease Improvement in Research and Treatment Act of 2015", regarding all provisions. H.R. 2948, "Medicare Tele-health Parity Act of 2015", regarding all provisions. H.R. 5659, "ESRD Choice Act of 2016", regarding all provisions. S. 2484, "CONNECT for Health Act", regarding all provisions. S. 3504, "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016", regarding all provisions.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Drug Shortage 21st Century Cures Legislation-Healthier Americas Initiative

Issues related to corporate tax reform, international tax reform and the taxation of U.S. multinational corporations and the medical device excise tax. Proposed Treasury Section 385-Debt-Equity Regulations, as it relates to business cash pooling arrangements.

Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. The Chronic Kidney Disease Improvement in Research and Treatment Act is S.598 and H.R.1130 H.R.2948 Medicare Tele-health Parity Act of 2015 ESRD Choice Act HR 5659 CONNECT for Health Act S2484 Dialysis PATIENTS Act HR 5506

Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. The Chronic Kidney Disease Improvement in Research and Treatment Act is S.598 and H.R.1130 H.R.2948 Medicare Tele-health Parity Act of 2015

H.Con.Res. 25 S.Con. Res. Budget Resolutions Innovation Promotion Act of 2015 discussion draft International Tax Reform HR 880, the American Research and Competitiveness Act, and S. 537, the COMPETE Act, as they relate to the R&D tax credit. HR 2510, to make permanent bonus depreciation. HR 1430, to make permanent the CFC look through rule. S. 1946, the Tax Relief Extension Act, as it relates to the R&D credit, bonus depreciation, and the CFC look-through rule. HR 160, the Protect Medical Innovation Act, and S. 149, the Medical Device Access and Innovation Act, as they relate to repeal of the medical device excise tax. Budget reconciliation legislation, as it relates to the repeal of the medical device tax. Issues related to corporate tax reform and the taxation of U.S. multinational corporations. Proposed Treasury Section 385-Debt-Equity Regulations, as it relates to business cash pooling arrangements.

H.Con.Res. 25 S.Con. Res. Budget Resolutions Innovation Promotion Act of 2015 discussion draft International Tax Reform HR 880, the American Research and Competitiveness Act, and S. 537, the COMPETE Act, as they relate to the R&D tax credit. HR 2510, to make permanent bonus depreciation. HR 1430, to make permanent the CFC look through rule. S. 1946, the Tax Relief Extension Act, as it relates to the R&D credit, bonus depreciation, and the CFC look-through rule. HR 160, the Protect Medical Innovation Act, and S. 149, the Medical Device Access and Innovation Act, as they relate to repeal of the medical device excise tax. Budget reconciliation legislation, as it relates to the repeal of the medical device tax. Issues related to corporate tax reform and the taxation of U.S. multinational corporations.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Drug Shortage 21st Century Cures Legislation-Healthier Americas Initiative

Device Tax Legislation. H.Con.Res. 25 S.Con. Res. Budget Resolutions Innovation Promotion Act of 2015 discussion draft International Tax Reform HR 880, the American Research and Competitiveness Act, and S. 537, the COMPETE Act, as they relate to the R&D tax credit. HR 2510, to make permanent bonus depreciation. HR 1430, to make permanent the CFC look through rule. S. 1946, the Tax Relief Extension Act, as it relates to the R&D credit, bonus depreciation, and the CFC look-through rule. HR 160, the Protect Medical Innovation Act, and S. 149, the Medical Device Access and Innovation Act, as they relate to repeal of the medical device excise tax. Budget reconciliation legislation, as it relates to the repeal of the medical device tax. Issues related to corporate tax reform and the taxation of U.S. multinational corporations.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. Drug Shortage 21st Century Cures Legislation-Healthier Americas Initiative Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Telehealth Modernization Act of 2015- Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and consider adopting various conditions under which a health care professional delivering care through telehealth should perform such services

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. 21st Century Cures Legislation-Healthier Americas Initiative Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Telehealth Modernization Act of 2015- Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and consider adopting various conditions under which a health care professional delivering care through telehealth should perform such services

Device Tax Legislation. H.Con.Res. 25 S.Con. Res. Budget Resolutions Innovation Promotion Act of 2015 discussion draft International Tax Reform HR 880, the American Research and Competitiveness Act, and S. 537, the COMPETE Act, as they relate to the R&D tax credit. HR 2510, to make permanent bonus depreciation. HR 1430, to make permanent the CFC look through rule. S. 1946, the Tax Relief Extension Act, as it relates to the R&D credit, bonus depreciation, and the CFC look-through rule. HR 160, the Protect Medical Innovation Act, and S. 149, the Medical Device Access and Innovation Act, as they relate to repeal of the medical device excise tax. Budget reconciliation legislation, as it relates to the repeal of the medical device tax. Issues related to corporate tax reform and the taxation of U.S. multinational corporations.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. Orphan Drug Act; Biosimilars Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Telehealth Modernization Act of 2015- Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and consider adopting various conditions under which a health care professional delivering care through telehealth should perform such services

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit Device Tax Legislation. HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation. HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

Legislation to cut Medicare Part B Drug Reimbursement, Medicare Part B DME Competitive Bidding Program. Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD. HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act. HR 3306: Telehealth Enhancement Act of 2013. HR4814-The Chronic Kidney Disease Improvement in research and Treatment Act of 2014.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. Orphan Drug Act; Biosimilars Raise Awareness with legislators about survey and certification issues as it relates to home dialysis.

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation. HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill)S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation.HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. Orphan Drug Act; Biosimilars Raise Awareness with legislators about survey and certification issues as it relates to home dialysis.

Report language for Labor HHS Annual Appropriations BillHR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act. HR 3306: Telehealth Enhancement Act of 2013.

Legislation to cut Medicare Part B Drug Reimbursement, Medicare Part B DME Competitive Bidding Program. Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.H.R. 4814 Chronic Kidney Disease Improvement in Research and Treatment Act of 2014. To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes.

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation.HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

Legislation to cut Medicare Part B Drug Reimbursement, Medicare Part B DME Competitive Bidding Program. Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.

340B Drug Discount Program; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis. Disease registry for Mutifocal Motor Neuropathy at NIH. Orphan Drug Act; BiosimilarsRaise Awareness with legislators about survey and certification issues as it relates to home dialysis. Compounding : Traceability reforms HR. 3204. Drug Quality & Security Act

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation.HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act.

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation.HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. Pull through on Medicare demonstration to provide nursing services and supplies associated with home infusion of IVIG for patients with PIDD.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement. H.R. 8 American Taxpayer Relief Act of 2012 -- working to mitigate the impact to kidney patients of the payment reductions required by the Act.

Legislation to cut Medicare Part B Drug Reimbursement Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. Medicare Part B Drug Reimbursement.

HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; S. 232 Device Tax Legislation. Device Tax Legislation.HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act. H.Con.Res. 25 S.Con. Res. Budget Resolutions S.886, S. 1013, H.R.845, H.R. 2024 Intellectual Property

H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax LegislationHR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act.

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population.HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population. HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform. S. 3521, The Family and Business Tax Cut Certainty Act of 2012, HR 8, the American Taxpayer Relief Act.

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population. HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis.

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis. HR 3613: Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting access for home dialysis.

H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation S.2240/HR 4196, to extend bonus depreciation; and S. 2237, the Small Business Jobs and Tax Relief Act, as it relates to bonus depreciation. S. 1813/HR 4348, MAP-21, as it relates to pension funding relief. Issues related to the R&D tax credit, the taxation of U.S. multinational corporations and corporate tax reform.

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.Raise awareness with legislators about the barriers to and the importance of protecting reimbursement for home dialysis.

H.R. 2672/S. 1423, the Preserving Access to Orphan Drugs Act of 2011: Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.Device Tax Legislation HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation HR 3630, Middle Class Tax Relief and Job Creation Act (this is the payroll tax relief extension bill) S. 1813, MAP-21 Act (the Senate highway bill with pension relief) HR 4196 and S.2240, extension of bonus depreciation Issues related to taxation of U.S. multinational firms, corporate tax reform, and the R&D tax credit.

S515/S610/HR1260: Patent Reform Act 2009. All issues related to patent reform ; HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Legislation to expand the 340B drug discount program. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population.

S515/S610/HR1260: Patent Reform Act 2009. All issues related to patent reform ; HR4213 -The tax Extenders Act of 2009; HR5297; The Small Business Jobs and Credit Act and HR 4853: The tax relief, unemployment Insurance Reauthorization and job Creation Act of 2010, as they related to the R&D tax credit ; Device Tax Legislation

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to cut Medicare Part B Drug Reimbursement.

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Legislation to expand the 340B drug discount program.

HR 1845/S 960: Provide supplies and nursing services necessary for home infusion of IVIG to Medicare beneficiaries with Primary Immunodeficiency Diseases; Legislation to expand the orphan drug exemption from the drug fee (PPACA) to include drugs that only treat rare diseases; Legislation that would expand the 340b drug discount program

S. 296, H.R. 2245 Preserving Access to Life-Saving Medications Act; 340B Drug Discount; H.R. 1483, Drug Safety Enhancement Act; Device Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment

Issues related to the taxation of foreign earnings of US Multinational Corporations. HR 4213-The Tax Extenders Act of 2009; HR5297-The Small Business Jobs and Credit Act and HR 4853-The Tax Relief, Unemployment Insurance Reauthorization and Job Creation Act of 2010, as they relate to the R&D tax credit; HR 1586-Jobs and Medicaid funding bill; HR 5792-Close Foreign Tax Loopholes Act; HR 5893-Investing in American Jobs Act as it relates to the taxation of foreign earnings of US multinationals; S 3578 and HR 5141-The Small Business Paperwork Mandate Elimination Act; S 510-The Food Safety Modernization Act as it relates to the 1099 Reporting Requirements of PPACA; Device tax legislation

Drat legislation to establish Medicare patient IVIG access demonstration project

HR 1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intraveneous immune globulin (IVIG) in a patient's home for the treatment of primary immunde deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. HR 5597: To establish a Medicare patient IVIG access demonstration project HR 4994-Medicare and Medicaid Extenders Act of 2010: To establish a Medicare patient IVIG access demonstration project S 701-Medicare Patient IVIG Access Act of 2009 HR 1586-Education, Jobs and Medicaid funding bill as it relates to Medicaid AMP

Issues related to the taxation of foreign earnings of U.S. multinational corporations. HR 4213-The Tax Extenders Act of 2009; HR 5297-The Small Business Jobs & Credit Act and HR. 4853- The Tax Relief, Unemployment Insurance Reauthorization and Job Creation Act of 2010, as they relate to the R&D tax credit, CFC lookthrough rules and limittaions on foreign tax credits under Section 956 of the Internal Revenue Code; HR 1586-Education, Jobs and Medicaid funding bill; HR 5792-Close Foreign Tax loopholes act; HR 5893-Investing in American Jobs Act as they relate to the taxation of foreign earnings of US multinationals; S 3578 & HR 5141-The Small Business Paperwork Mandate Elimination Act; S 510-The Food Safety Modernization Act as it relates to the 1099 reporting requirements of PPACA

H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010, provisions relating to 340B 340B drug discount program 510(k) approval for medical devicesDrug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.5982: Small Business Tax Relief Act of 2010 H.R.5793: Close Foreign Tax Loopholes: Make it in America Act of 2010 H.R. 5893: Investing in American Jobs Act H.R. 5297: Small Business Jobs and Credit Act H.R. 1586: Education, Jobs and Medicaid funding bill H.R. 5141/S. 3578: The Small Business Paperwork Mandate Elimination S. 3793: Job Creation and Tax Cuts Act S. 3816: Creating Jobs and Ending Offshoring Act

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 4872: The Health Care and Education Reconciliation Act. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R. 5597: To establish a Medicare patient IVIG access demonstration project H.R. 4899: Small Business and Infrastructure Jobs Tax Act of 2010, specific focus on Average Manufacturer Price (AMP) calculation for Medicaid drugs. H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010, specific focus on Average Manufacturer Price (AMP) calculation for Medicaid drugs, changes to 340B drug discount program and international tax provisions and research and development tax credits. H.R. 4846: Bleeding Disorder Screening, Awareness, and Further Education (SAFE) Act of 2010 S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). S. 1796/H.R. 3200: America's Healthy Future Act, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices.

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. H.R.2502 : To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues