Medicare IVIG Access Enhancement Act

HR 3808--Medicare IVIG Enhancement Act--Coverage for Intravenous immune globulin and its administration in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. HR 7346--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases. HR 5376--Build Back Better Act/Budget Reconciliation--Medicare Part D restructure, direct negotiation of Medicare pricing, Medicare inflation caps, restriction on use of orphan drug tax credit. Highlighting issues that could arise if these measures are included in the Senate version of BBBA. HR 7389--MVP Act--Codify the CMS Medicaid Value Based Payment rule allowing for multiple best prices, modify the Average Manufacturers Price to accommodate value based arrangements, update anti-kickback regulations to ensure value based arrangements are compliant. S.4348/HR 7667--FDA Safety and Landmark Advancements Act/The FDA Food and Drug Amendments of 2022--Reauthorization of PDUFA (Prescription Drug User Fee Act) VII specific to FDA user fees. Advocating for language that would not hinder the accelerated approval pathway.

Client expense: $390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B provisions relating to home infusion of IVIG, particularly in CIPD and H.R. 3808. CMS programs relating to proposed rules, including most favored nation and international pricing index. HR 3 Lowering Drug Costs Now Act provisions relating to drug reimbursement in Medicare and HR 5376, Build Back Better Act provisions related to drug pricing. Issues relating to COVID and plasma protein products. Activity relating to cross border donation of plasma.

Client expense: $120,000 · Firm income: Not reported

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

Education visits to House and Senate offices relating to plasma protein therapies and the rare disease patients that use them and the economic value as well as the need for continued Source plasma donations. The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B provisions relating to home infusion of IVIG, particularly in CIPD and HR 3808. CMS programs relating to proposed rules, including most favored nation and international pricing index and use of foreign reference pricing. HCR that moves U.S. towards single decisionmakers and government negotiations. HR 3 Lowering Drug Costs Now Act provisions relating to drug reimbursement in Medicare and the Build Back Better Act provisions related to drug pricing. . Issues relating to COVID and plasma protein products. Activity related to cross border donation of plasma and impact on patients.

Client expense: $120,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS)

GBS/CIDP research at NIH FDA, Patient Focused Drug Development Initiative CIDP, MMN Home Infusion Healthcare Reform, Patient Protections H.R.3808 CDC Chronic Disease Education and Awareness COVID-19 Relief Packages

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3808--Medicare IVIG Enhancement Act--Coverage for Intravenous immune globulin and its administration in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. HR 7346--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases. HR 5376--Build Back Better Act/Budget Reconciliation--Medicare Part D restructure, direct negotiation of Medicare pricing, Medicare inflation caps, restriction on use of orphan drug tax credit. Highlighting issues that could arise if these measures are included in the Senate version of BBBA. HR 7389--MVP Act--Codify the CMS Medicaid Value Based Payment rule allowing for multiple best prices, modify the Average Manufacturers Price to accommodate value based arrangements, update anti-kickback regulations to ensure value based arrangements are compliant. S.4348/HR 7667--FDA Safety and Landmark Advancements Act/The FDA Food and Drug Amendments of 2022--Reauthorization of PDUFA (Prescription Drug User Fee Act) VII specific to FDA user fees. Advocating for language that would not hinder the accelerated approval pathway.

Client expense: $350,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B provisions relating to home infusion of IVIG, particularly in CIPD and H.R. 3808. CMS programs relating to proposed rules, including most favored nation and international pricing index. HR 3 Lowering Drug Costs Now Act provisions relating to drug reimbursement in Medicare and HR 5376, Build Back Better Act provisions related to drug pricing. Issues relating to COVID and plasma protein products. Activity relating to cross border donation of plasma.

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

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

Education visits to House and Senate offices relating to plasma protein therapies and the rare disease patients that use them and the economic value as well as the need for continued Source plasma donations. The Affordable Care Act, provisions relating to essential health benefits and patient protections. Medicare Part B provisions relating to home infusion of IVIG, particularly in CIPD and HR 3808. CMS programs relating to proposed rules, including most favored nation and international pricing index and use of foreign reference pricing. HCR that moves U.S. towards single decisionmakers and government negotiations. HR 3 Lowering Drug Costs Now Act provisions relating to drug reimbursement in Medicare and the Build Back Better Act provisions related to drug pricing. . Issues relating to COVID and plasma protein products. Activity related to cross border donation of plasma and impact on patients.

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

H.R. 5376- "Build Back Better Act"; H.R. 3808- "Medicare IVIG Access Enhancement Act"

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3808--Medicare IVIG Enhancement Act--Coverage for Intravenous immune globulin and its administration in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. HR 7346--To amend title XVIII of the Social Security Act to provide for coverage and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under part B of such title, and for other purposes. Coverage for alpha 1 proteinase inhibitor and its administration in the home under Medicare Part B. S 1281, HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases. HR 5376--Build Back Better Act--Medicare Part D restructure, direct negotiation of Medicare pricing, restriction on use of orphan drug tax credit. Highlighting issues that could arise if these measures are included in a scaled back version of BBBA.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376- "Build Back Better Act"; H.R. 3808- "Medicare IVIG Access Enhancement Act"

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5376--Build Back Better Act--Medicare Part D restructure, direct negotiation of Medicare pricing, restriction on use of orphan drug tax credit HR 3808--Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S. 1281, HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3--Elijah E. Cummings Lower Drug Costs Now Act--Medicare Part D restructure, reference pricing, direct negotiation of Medicare pricing HR 3808--The Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S 1281; HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

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

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

HR 3--Elijah E. Cummings Lower Drug Costs Now Act--Medicare Part D restructure, reference pricing, direct negotiation of Medicare pricing HR 3808--The Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S 1281; HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Customs & Border Protection

HR 1319: American Rescue Plan Act; HR 3808: Medicare IVIG Access Enhancement Act; Medicare home infusion coverage and reimbursement; Perscription Drug Pricing and Transparency Issues

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE