MARY REUTHER

Education efforts surrounding hemophilia B and CSL Behring's new gene therapy treatment HR 2666--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.

Education regarding H.R.6465-Preserving Life-saving Access to Specialty Medicines in America Act (PLASMA Act) Issues related to the Medicaid Drug Rebate Program proposed rule, gene therapies, and value-based payment arrangements. Education on issues related to plasma derived products and inflation penalties related to drug shortages.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA, which has been licensed. 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. HR 2617--Consolidated Appropriations Act 2023--Discussion of health policy riders within the legislation, including language surrounding the accelerated approval pathway and clinical trial diversity.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA for licensure HR 5376--Inflation Reduction Act--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 Build Back Better Act. 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 Prescription Drug User Fee Act VII specific to FDA user fees.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA for licensure HR 5376--Inflation Reduction Act--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 Build Back Better Act. 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 Prescription Drug User Fee Act VII specific to FDA user fees.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA, which has been licensed. 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. HR 2617--Consolidated Appropriations Act 2023--Discussion of health policy riders within the legislation, including language surrounding the accelerated approval pathway and clinical trial diversity.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA for licensure HR 5376--Inflation Reduction Act--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 Build Back Better Act. 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 Prescription Drug User Fee Act VII specific to FDA user fees.

Education efforts surrounding hemophilia B and a new gene therapy treatment that CSL Behring submitted to FDA for licensure HR 5376--Inflation Reduction Act--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 Build Back Better Act. 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 Prescription Drug User Fee Act VII specific to FDA user fees.

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.

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.

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.

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.