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Comments

​​This section contains comments that have been submitted to the government docket on issues of concern to the transfusion medicine and cellular therapies communities. Click on a link below to read current comments.

2020

Comments to Congress Regarding Pandemic Preparedness - 06/26/20

Comments to HHS in Response to the Request for Information on Maintaining an Adequate Blood Supply: Request for Data System - 06/18/20

Joint Comments to FDA on “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry” - 06/05/20

Joint Comments to FDA on “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry” - 03/18/20

2019

Joint Comments to CMS in Response to New Miscellaneous Code for Blood Components and Products – 12/02/19

Joint Comments to CMS in Response to the Proposed Rule Updating the Hospital Outpatient Payment System for 2020 – 9/26/19

Joint Comments to CMS in Response to the Proposed Rule Updating the Long-Term Care Hospital Payment System for 2020 - 6/24/19

Comments to CMS on the Proposed Rule Updating the Medicare Hospital Inpatient Payment System for 2020 - 6/24/19

Joint Comments to CMS on the Inpatient Rehabilitation Facility Prospective Payment System for Federal FY 2020 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program - 6/17/19

Joint Comments to CMS on the FY 2020 Hospice Wage Index and Payment Rule Update and Hospice Quality Reporting Requirements - 6/17/19

Joint Comments to CMS on the Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal FY 2020 - 6/17/19

Comments to CMS on Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers – 3/15/19 

Joint Comments to FDA on “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry” – 03/13/19 

2018

Joint Comments to FDA on “Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry” - 12/26/18

Joint Comments to FDA on “Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry” - 12/26/18

Comments to FDA on “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry” - 12/07/18

Joint Comments to FDA on “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry” - 09/28/18

Joint Comments to CMS on Proposed Changes to the Medicare Hospital Outpatient Prospective Payment System for 2019 - 09/24/18

Comments to CMS on Proposed Rule "Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates" - 06/25/18

Joint Comments to CMS on Medicare Payment Policy for Hematopoietic Stem Cell Transplants in Response to the Proposed Rule Entitled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates" - 06/14/18

Joint Comments to FDA on “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components Guidance for Industry” - 06/08/18

Joint Comments to FDA on “Amendment to ‘Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry’; Draft Guidance for Industry” - 04/06/18

Joint Comments to CMS on “Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)" - 03/12/18

2017

Comments to CMS on 2018 Preliminary Payment Rates Established Under the Medicare Clinical Laboratory Fee Schedule Private Payor Rate-Based Payment System - 10/23/17

Comments to CMS on Proposed Rule “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” - 09/08/17

Comments to CMS on Medicare Proposed Rule Related to 2018 Hospital Inpatient Payments and Long-Term Care Hospital Prospective Payment System - 06/09/17

Comments to the National Preparedness and Response Science Board (NPRSB) and National Advisory Committee on Children and Disasters (NACCD) - 04/13/17

Joint Comments to the FDA on “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion,” Draft Guidance for Industry - 04/12/17

Joint Comments to the FDA on “Labeling of Red Blood Cell Units with Historical Antigen Typing Results,” Draft Guidance for Industry - 03/30/17

Joint Comments to the FDA on “Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion Draft Guidance for Industry” - 02/08/17

2016

Joint Comments to the FDA on "Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products" - 11/23/16

Joint Comments to CMS on Proposed Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: HCPCS Codes for Blood Products - 9/6/16

Comments to CMS on Proposed Rule Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: Payment Rates - 9/2/16

Comments to CMS on Proposed Rule Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: HCPCS Codes for Blood Products - 9/2/16

Comments to CMS on Medicare Proposed Hospital Inpatient Rule for Fiscal Year 2017 - 6/17/16

Comments to FDA on “Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories” Proposed Rule - 5/31/16

​Joint Comments to FDA to on “Recommendations for Donor Screening, Deferral, and Product Management To Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry" - 5/26/16

Joint Comments to FDA on “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion” Draft Guidance - 5/16/16

Joint Comments to FDA on “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus” Draft Guidance - 3/2/16 

2015

Joint Comments to CMS on Proposed Rule “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” - 8/31/15

Comments to FDA to on the Draft Guidance for Revised Recommendations for Reducing the Risk of HIV by Blood Products - 7/14/15