Medicare IVIG Access Enhancement Act

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage and reimbursement of biologics and plasma therapies. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 3457 / H.R. 6218, Preserving Patient Access to Home Infusion Act, as it relates to access to drugs listed on the self-administered drug list. H.R. 7839, Continuing Access to In-Home IVIG Act. H.R. 133, the Consolidated Appropriations Act of 2021, including home infusion and DME self-administered therapies. Issues concerning the most favored nation rule as it relates to plasma-derived products.

Client expense: Not reported · Firm income: $50,000

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

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R. 4724 HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Awareness and education activities at CDC Patient-focused Drug Development at FDA 21st Century Cures Implementation Research programs at NIH Medicaid Cranial Prosthetics Legislation Healthcare Reform, Patient Protections HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B Home Infusion Services Temporary Transitional Payment Act, sections pertaining to payment of pharmacy fees. H.R.4724 - Medicare IVIG Access Enhancement Act - provisions relating to the development and funding for a IVIG demonstration project. HHS "American Patients First" request for information relating to Part B programs, essential health benefits, competitive acquisition programs and 340B discount programs. Part B to D issues. Issues and comments related to CMS-5528-ANPRM and HHS proposed rule, HR 2905, Medicare IVIG Enhancement Act relating to payment for immunoglobulin for home infusion, H.R. 3 - Lower Drug Costs Now Act of 2019, sections relating to drug reimbursement and pricing programs. Issues relating to access of plasma protein products by HHS and CMS, specifically home infusion of plasma protein products during the Covid-19 pandemic. Issues relating to availability of plasma donation center testing and plasma center donotions.

Client expense: $140,000 · Firm income: Not reported

HR 6218, S. 3587--Allowance of reimbursement for product and administration of durable medical equipment administered drugs (subcutaneous immune globulin specifically) that are listed on self administered drug lists by Medicare contractors. HR 2905--Medicare Intravenous Immune Globulin Enhancement Act--Legislation that would create a demonstration home infusion benefit under Medicare Part B for intravenous immune globulin when used in the treatment of chronic inflammatory dymyelinating polyneuropathy. HR 7839--Continuing Access to In-Home IVIG Act--Legislation that would extend the home infusion demonstration project under Medicare Part B for intravenous immune globulin when used in the treatment of primary immune deficiency. Raising awareness regarding COVID-19 and the potential for convalescent plasma to be used in the creation of a hyper-immune globulin therapy. S. 3129--Lower Costs, More Cures Act of 2019--Drug Pricing provisions included in presidential executive orders versus the policies put forward in legislation such as S. 3129 Raising general awareness about the need and importance of plasma donation - highlighting how there has been a downturn in plasma donation due to COVID and the importance of plasma for manufacturing rare disease therapies

Client expense: $320,000 · Firm income: Not reported

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020.

Client expense: Not reported · Firm income: $50,000

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage and reimbursement of biologics and plasma therapies. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 3457 / H.R. 6218, Preserving Patient Access to Home Infusion Act, as it relates to access to drugs listed on the self-administered drug list. Issues related to the Executive Order on Lowering Drug Prices by Putting America First. H.R. 7839, Continuing Access to In-Home IVIG Act.

Client expense: Not reported · Firm income: $50,000

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

Awareness and education activities at CDC Patient-focused Drug Development at FDA 21st Century Cures Implementation Research programs at NIH Medicaid Cranial Prosthetics Legislation Healthcare Reform, Patient Protections HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R. 4724 HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2905, "Medicare IVIG Access Enhancement Act" H.R. 3, "Lower Drug Costs Now Act of 2019" S. 2543, "Prescription Drug Pricing Reduction Act of 2019" H.R. 6218, S.3457 Preserving Patient Access to Home Infusion Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage and reimbursement of biologics and plasma therapies. Issues pertaining to drugs listed on the Self-Administered Drug list. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 3457 / H.R. 6218, Preserving Patient Access to Home Infusion Act, as it relates to access to drugs listed on the self-administered drug list. Monitored issues related to drug pricing. Issues related to the corona virus.

Client expense: Not reported · Firm income: $50,000

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

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B Home Infusion Services Temporary Transitional Payment Act, sections pertaining to payment of pharmacy fees. H.R.4724 - Medicare IVIG Access Enhancement Act - provisions relating to the development and funding for a IVIG demonstration project. HHS "American Patients First" request for information relating to Part B programs, essential health benefits, competitive acquisition programs and 340B discount programs. Part B to D issues. Issues and comments related to CMS-5528-ANPRM and HHS proposed rule, HR 2905, Medicare IVIG Enhancement Act relating to payment for immunoglobulin for home infusion, H.R. 3 - Lower Drug Costs Now Act of 2019, sections relating to drug reimbursement and pricing programs. Issues relating to access of plasma protein products by HHS and CMS, specifically home infusion of plasma protein products during the Covid-19 pandemic. Issues relating to availability of plasma donation center testing and plasma center donotions.

Client expense: $130,000 · Firm income: Not reported

H.R. 2905--Medicare IVIG Enhancement Act--Legislation that would create a home infusion benefit under Medicare Part B for intravenous immunoglobulin (IVIG) when used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). HR 6218, S. 3587--Preserving Patient Access to Home Infusion Act--Allowance of reimbursement for product and administration of durable medical equipment administered drugs (subcutaneous immune globulin specifically) that are listed on self administered drug lists by Medicare contractors. HR 6800--The Heroes Act--Seeking to amend the blood donation awareness program language within the CARES Act to include plasma. Sought provision seeking inclusion of temporary Medicare Part B home infusion during period of national healthy emergency Raising awareness regarding COVID-19 and the potential for convalescent plasma to be used in the creation of a hyper-immune therapy.

Client expense: $210,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act").

Client expense: Not reported · Firm income: $50,000

Awareness and education activities at CDC Patient-focused Drug Development at FDA 21st Century Cures Implementation Research programs at NIH Medicaid Cranial Prosthetics Legislation Healthcare Reform, Patient Protections HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R. 4724 HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B Home Infusion Services Temporary Transitional Payment Act, sections pertaining to payment of pharmacy fees. H.R.4724 - Medicare IVIG Access Enhancement Act - provisions relating to the development and funding for a IVIG demonstration project. HHS "American Patients First" request for information relating to Part B programs, essential health benefits, competitive acquisition programs and 340B discount programs. Part B to D issues. Issues and comments related to CMS-5528-ANPRM and HHS proposed rule :Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HR 2905, Medicare IVIG Enhancement Act relating to payment for immunoglobulin for home infusion, H.R. 3 - Lower Drug Costs Now Act of 2019, sections relating to drug reimbursement and pricing programs. Issues relating to access of plasma protein products by HHS and CMS, specifically home infusion of plasma protein products during the Covid-19 pandemic. Issues relating to availability of plasma donation center testing.

Client expense: $210,000 · Firm income: Not reported

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage and reimbursement of biologics and plasma therapies. Issues pertaining to drugs listed on the Self-Administered Drug list. H.R. 2296, the METRIC Act. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. H.R. 2113, Prescription Drug STAR Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. S. 3457 / H.R. 6218, Preserving Patient Access to Home Infusion Act, as it relates to access to drugs listed on the self-administered drug list. Monitored Coronavirus Aid, Relief and Economic Security "CARES Act," P.L. 116-136.

Client expense: Not reported · Firm income: $50,000

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

H.R. 2905, "Medicare IVIG Access Enhancement Act" H.R. 3, "Lower Drug Costs Now Act of 2019" S. 2543, "Prescription Drug Pricing Reduction Act of 2019" H.R. 6218, S.3457 Preserving Patient Access to Home Infusion Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

H.R. 3--Lower Drug Costs Now Act H.R. 19--Lower Costs, More Cures Act of 2019 S. 2543--Prescription Drug Pricing Reduction Act Administration Advance Notice of Proposed Rulemaking on International Pricing Index International Pricing Index, Inflation Cap Medicare Rebates H.R. 2905--Medicare IVIG Enhancement Act--Legislation that would create a home infusion benefit under Medicare Part B for intravenous immunoglobulin (IVIG) when used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). HR 6218, S. 3587--Preserving Patient Access to Home Infusion Act Allowance of reimbursement for product and administration of durable medical equipment administered drugs (subcutaneous immune globulin specifically) that are listed on self administered drug lists by Medicare contractors. HR 4712--Fairness in Orphan Drug Exclusivity Act--Clarifying the definition of orphan drug exclusivity HR 748--The "Coronavirus Aid, Relief, And Economic Security ('CARES') Act"--Sought provision seeking inclusion of temporary Medicare Part B home infusion during period of national healthy emergency; sought provision to include HR 6218 within CARES Act. Exploration of possibilities to assist with regard to vaccine development and immuno suppressive development specific to national coronavirus response.

Client expense: $200,000 · Firm income: Not reported

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Supply of intravenous immunoglobulin. S.3548/H.R. 748, Coronavirus Aid, Relief, and Economic Security Act; H.R. 6201, Families First Coronavirus Response Act; and H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020.

Client expense: Not reported · Firm income: $50,000

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R. 4724 HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Awareness and education activities at CDC Patient-focused Drug Development at FDA 21st Century Cures Implementation Research programs at NIH Medicaid Cranial Prosthetics Legislation Healthcare Reform, Patient Protections HR 2905 S.2633 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R. 4724 HR 2905 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Awareness and education activities at CDC Patient-focused Drug Development at FDA 21st Century Cures Implementation Research programs at NIH Medicaid Cranial Prosthetics Legislation Healthcare Reform, Patient Protections HR 2905 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage reimbursement of biologics and plasma therapies. Issues pertaining to drugs listed on the Self-Administered Drug list. H.R. 2296, the METRIC Act. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. H.R. 2113, Prescription Drug STAR Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act.

Client expense: Not reported · Firm income: $50,000

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

H.R. 2905, Medicare IVIG Access Enhancement Act H.R. 3, Lower Drug Costs Now Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3--Lower Drug Costs Now Act H.R. 19--Lower Costs, More Cures Act of 2019 S. 2543--Prescription Drug Pricing Reduction Act Administration Advance Notice of Proposed Rulemaking on International Pricing Index International Pricing Index, Inflation Cap Medicare Rebates H.R. 2905--Medicare IVIG Enhancement Act--Legislation that would create a home infusion benefit under Medicare Part B for intravenous immunoglobulin (IVIG) when used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Allowance of reimbursement for product and administration of durable medical equipment administered drugs (subcutaneous immune globulin specifically) that are listed on self administered drug lists by Medicare contractors. HR 4712--Fairness in Orphan Drug Exclusivity Act--Clarifying the definition of orphan drug exclusivity

Client expense: $280,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B Home Infusion Services Temporary Transitional Payment Act, sections pertaining to payment of pharmacy fees. H.R.4724 - Medicare IVIG Access Enhancement Act - provisions relating to the development and funding for a IVIG demonstration project. HHS "American Patients First" request for information relating to Part B programs, essential health benefits, competitive acquisition programs and 340B discount programs. Part B to D issues. Issues and comments related to CMS-5528-ANPRM and HHS proposed rule :Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HR 2905, Medicare IVIG Enhancement Act relating to payment for immunoglobulin for home infusion, H.R. 3 - Lower Drug Costs Now Act of 2019, sections relating to drug reimbursement and pricing programs. Issues relating to access of plasma protein products by HHS and CMS.

Client expense: $140,000 · Firm income: Not reported

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Supply of intravenous immunoglobulin.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2905, Medicare IVIG Access Enhancement Act H.R. 3, Lower Drug Costs Now Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3/S. 2543--Lower Drug Costs Now Act; Prescription Drug Pricing Reduction Act; Administration Advance Notice of Proposed Rulemaking on International Pricing Index; International Pricing Index, Inflation Cap Medicare Rebates H.R. 2905--Medicare IVIG Enhancement Act--Legislation that would create a home infusion benefit under Medicare Part B for intravenous immunoglobulin (IVIG) when used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Allowance of reimbursement for product and administration of durable medical equipment administered drugs (subcutaneous immune globulin specifically) that are listed on self administered drug lists by Medicare contractors. H.R. 2296--METRIC Act--Drug Price transparency reporting requirements

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B Home Infusion Services Temporary Transitional Payment Act, sections pertaining to payment of pharmacy fees. H.R.4724 - Medicare IVIG Access Enhancement Act - provisions relating to the development and funding for a IVIG demonstration project. HHS "American Patients First" request for information relating to Part B programs, essential health benefits, competitive acquisition programs and 340B discount programs. Part B to D issues. Issues and comments related to CMS-5528-ANPRM and HHS proposed rule :Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HR 2905, Medicare IVIG Enhancement Act relating to payment for immunoglobulin for home infusion, H.R. 3 - Lower Drug Costs Now Act of 2019, sections relating to drug reimbursement and pricing programs.

Client expense: $150,000 · Firm income: Not reported

Issues related to home infusion and DME self-administered therapies. Issues regarding coverage reimbursement of biologics and plasma therapies. Issues pertaining to drugs listed on the Self-Administered Drug list. H.R. 2296, the METRIC Act. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. H.R. 2113, Prescription Drug STAR Act. Monitored S. 2543, Prescription Drug Pricing Reduction Act of 2019.

Client expense: Not reported · Firm income: $50,000

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

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Supply of intravenous immunoglobulin.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to home infusion and DME self-administered therapies. Issues regarding reimbursement of drugs, biologics and plasma therapies. Issues pertaining to drugs listed on the Self-Administered Drug list. H.R. 2296, FAIR Drug Pricing Act of 2019. Monitored issues related to H.R. 2905, Medicare IVIG Access Enhancement Act. H.R. 2113, Prescription Drug STAR Act.

Client expense: Not reported · Firm income: $50,000

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

HR 2905--Medicare IVIG Enhancement Act--Legislation that would create a home infusion benefit under Medicare Part B for intravenous immunoglobulin (IVIG) when used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Allowance of reimbursement for administration of durable medical equipment administered drugs that are listed on self administered drug lists by Medicare contractors. Advanced Notice of Proposed Rulemaking on International Pricing Index S. 474 (Senate SPIKE Act), HR 2113 (House STAR Act), HR 2296 (House FAIR Act)--Drug Pricing Transparency reporting requirements Allowance of reimbursement for administration of durable medical equipment administered drugs that are listed on self-administered drug lists by Medicare contractors.

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE