John W. Walsh Alpha-1 Home Infusion Act of 2022

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

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