# Presentation: 010464

## Progress Report of Recommendations made by the  Advisory Committee on Blood Safety and AvailabilityPeriod 2001-2006

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan  2006 | Subj: Potential Pandemic     Influenza  
Recognize blood and plasma systems as a key element of the critical infrastructure of HHS Plan
Assure full funding of research to resolve key scientific questions regarding impact of pandemic influenza on blood, organs, and tissue safety and availability .
 | 
Blood/plasma recognized as critical element of health care infrastructure
Funding for research studies being considered

 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan
2006 | Subj: Potential Pandemic     Influenza (con’t) 
Target federal support to enhance global and domestic surveillance for seasonal and pandemic influenza. | 

Global and Domestic surveillance through CDC |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan  2006 | Subj: Potential Pandemic Influenza (con’t) 
Recognize the central role of the AABB Task Force on Domestic Disasters and Acts of Terrorisms in the development and implementation of a national strategy to address potentially missive blood and blood product shortages during a pandemic:
Assure input into key federal policy making and communication
Promote communication and cooperation amongst state and local public health authorities and appropriate blood collection organizations, hospitals, medical professional organizations and patient advocacy organizations. | 

HHS Agencies actively participating with AABB Task Force 
Blood Safety and Availability part of communication working group
Coordination of local and state messaging coordinated through RHA |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan  2006 | Subj: Potential Pandemic     Influenza  (con’t) 
Develop national principles under which state and local public health authorities and health care providers can prioritize allocation of and minimize disparities in blood and blood products availability and use during critical shortages. | 

To be determined |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept
2005 | Subj: Immune Globulin Intravenous (IGIV)
Increase reimbursement for non-hospital IGIV therapy to a level consistent with current market pricing
Consider reclassifying  as a biological response modifier (BRM).
Consider a public health emergency to address short-term problem
Modify the current plan to change hospital reimbursement to ASP +8% in January 2006
 | 

IGIV access and availability is complex. 
Reimbursement reported monthly and readjusted quarterly.  
Manufacturers have raised prices
BRM is dependent on recommendation of AMA |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept 2005 | Subj: IGIV (con’t) 

Reexamine whether the current IGIV supplies are meeting patient needs
Work with Congress to establish a long term stable and sustainable reimbursement structure | 
Manufacturers have increased distribution 16% since August 2004.
Secondary and grey/black market activities
CMS claims increased from 2003 to 2004 in both hospital and physician offices.  Do claims equal utilization?
Ways and Means Committee
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept 2005 | Subj: Strategic Plan  
Structured process for policy and decision-making
Integration of blood system into the public Health infrastructure
Surveillance of adverse events related to blood donations and transfusions
Risk communication
Error prevention in blood collection centers, transfusion services and clinical transfusion settings
Donor recruitment and retention | 
To be discussed at the ACBSA meeting in May 2006  |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept 2005 | Subj: Strategic Plan  (con’t) 

Donor recruitment and retention
Clinical practice standards for transfusion 
Strategic research agena
Disaster planning
Stable and sustainable reimbursement 
Funding for promising new technologies | 
To be discussed at the ACBSA meeting in May 2006 |

| Date | Recommendation | Response |
| --- | --- | --- |
| May 2005 | Subj: Reimbursement  
Declare a public health emergency so as to enable CMS to apply alternative mechanisms for determination of the reimbursement schedule for IGIV products
Assist CMS to identify effective short and long term solutions to the problem of unavailability of access to IGIV product in all settings | 
Product availability but in different channels
Office of the Inspector General report due out at the end of Summer 2006
Jan 2006 CMS included a temporary add-on fee
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2005 | Subj: Bacterial Blood Safety Initiative
Monitor residual bacterial contamination risk and generate summary reports
Provide resources for surveillance of transfusion-associated sepsis
Make additional recommendations as may be needed to maintain recipient safety
 | 

Strategic plan to be discussed May 2006 ACBSA meeting |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2005 | Subj: Reimbursement of Plasma Derive Products and their recombinant analogues
Adopted principles to guide reimbursement
Urged the Secretary to support any proposed policy and /or legislation to address the extraordinary financial burden for these patients
 | 

CMS included add-on fee for coagulations factors at $0.14 per unit |

| Date | Recommendation | Response |
| --- | --- | --- |
| Aug 2004 | Subj: Transfusion Related Acute Lung Injury 
The expeditious development of a standardized definition
Implementation of clinical education and effective surveillance
Modeling the impact of deferral  or screening intervention
Research into the etiology, diagnostic testing, epidemiology, treatment and prevention  | 

Professional groups in Canada and US developed standardized criteria

Research added to NHLBI grants already funded |

| Date | Recommendation | Response |
| --- | --- | --- |
| Aug 2004 | Subj: Access to Treatment for Individuals with Rare Blood Disorders 
Promote obtaining additional licensed indications for already licensed products
Promote approval of  products and their indications in the US for European licensed products 
Promote developing new products | 

Workshops supported in May 2005

Researchers and clinicians discussed with FDA pathways for licensing during May 2005 meeting.   |

| Date | Recommendation | Response |
| --- | --- | --- |
| Aug 2004 | Subj: Bacterial Detection in Platelet Concentrates and Seven Day Platelets 
Urge DHHS to adopt strategies to expedite licensure of a pre-storage pooled WBDP component for transfusion based on a critical review of the available information | 
FDA is currently working with blood centers and manufactures on pre-storage pooled platelets and apheresis platelets for 7 day approval. |

| Date | Recommendation | Response |
| --- | --- | --- |
| Aug 2004 | Subj: Public Health Impact of Implementing HBV Mini-pool NAT for Blood Donor Testing 
Committee does not support the mini-pool HBV NAT for blood donation (as currently conceived);  health dollars would best be spent to expand the hepatitis B immunization program 
Encourages the development of multiplex direct pathogen testing on individual donations. | 

FDA approved mini-pooled HBV NAT but did not mandate for donor testing. 
Department encourages broader HBV immunization programs especially of the younger generation
Support ID multiplex testing |

| Date | Recommendation | Response |
| --- | --- | --- |
| April 2004 | Subj: Reimbursement  
Reiterates recommendation of January 2004 meeting.
Endorses the MMA Conference report statement that the Secretary is directed  to compile and clarify the procedures and policies for billing of blood and blood cost in the hospital inpatient and outpatient setting as well as the operation of the collection of the blood deductible.
Timely response on the above | 
Secretary Thompson directed Dr Beato and Dr. McClellan to discuss issue presented by the Committee.
CMS Transmittal  Publication 100-04 for Medicare Claims Processing of March 2005 clarified blood terminology and charges |

| Date | Recommendation | Response |
| --- | --- | --- |
| April 2004 | Subj: Reimbursement (con’t) 
Secretary to exclude blood clotting factors from competitive acquisition under the Exclusion Authority granted in the MMA of 2003.
Secretary should use his authority contained in the MMA to exclude all blood products and transfusion medicine services from the establishment of quality standard and competitive acquisition provisions of the MMA. | 
Secretary Thompson directed Dr Beato and Dr. McClellan to discuss issue presented by the Committee. Response in May 2005 by Dr. McClellan
Blood not part of competitive acquisition provision of the MMA
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| April 2004 | Subj: Bacterial Contamination of Platelet Products 
Committee encourages dialog between HHS agencies, blood programs and manufacturers to ensure strategies for: 
Prompt development of technologies
Design and completion of feasible studies
Satisfaction of licensing requirements to permit both the pre-storage pooling of whole blood derived platelets and extension of platelet dating. | 
DHHS agencies have joined the AABB Task Force on Bacterial Contamination of Platelet Products to accomplish additional guidance to the user community, design of clinical studies and  clarification of regulatory requirements of platelet pooling/extension.
Blood establishments are proceeding to 7-day platelets
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2004 | Subj: National Blood Policy 
Committee finds goals of supply, quality, accessibility and efficiency as stated in the 1974 National Blood Policy as applicable today.
Recommends development of a 5-7 day inventory
Recommends full funding of DHHS Blood Action Plan in the area of private and government supply monitoring and increasing blood supply.
Funding of National Blood Reserve | 
Awareness programs are being coordinated in the private sector (AABB, ABC, and ARC).
BASIS monitoring program launched Spring 2006; recruitment of participants 
Funding remains an issue
Office continues to work issue.   |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2004 | Subj: Reimbursement 
Committee urges the Secretary to address funding needs at all levels of the blood system to support product safety, quality, availability and access through targeting of additive resources and appropriate reform of the CMS reimbursement system for blood and blood products including plasma derived therapeutics and their recombinant analogs.  | 
Secretary Thompson directed Dr Beato and Dr. McClellan to discuss issue presented by the Committee.
Transmittal of March 2005 Publication 100-04 clarified blood charges.
Coagulation factor add-on $0.14 per unit
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Aug 2003 | Subj: Reimbursement (con’t) 
Committee recommends the Secretary direct CMS to reexamine its framework for cost reimbursement in the product area and, in the interim, provide reimbursement based on actual cost of acquiring and providing the products. 
Committee recommends that CMS utilize validated cost data available from product manufacturers and distributors. | 
Secretary Thompson directed Dr Beato and Dr. McClellan to discuss issue presented by the Committee. Response received May 2005
APC recommended CMS use blood community data  (August 2003 and Feb 2004)
Community data obtained in national survey
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| May
2003 | Subj: Reimbursement (con’t) 
CMS to identify specific cost of blood products and services within the “market basket”
CMS to consolidate, simplify, and review reimbursement policy of all blood and blood derived products.
CMS to develop timely and adequate reimbursement mechanisms within and without the CMS appropriation system to assure the improvement in blood safety can be concurrently implemented. | 
Secretary Thompson directed Dr Beato and Dr. McClellan to discuss issue presented by the Committee. Response received May 2005
APC recommended CMS use blood community data  (August 2003 and Feb 2004)
Community data obtained in national survey |

| Date | Recommendation | Response |
| --- | --- | --- |
| May
2003 | Subj: Reimbursement (con’t) 
Identify contingency funding for unanticipated blood safety initiatives that require immediate implementation.
CMS amend the definition of blood and blood products to include all plasma derived products for which there is a need to provide continuing access for therapies used to treat chronic diseases and life threatening conditions, specifically including IGIV.
CMS establish parity of payment rates across different billing dosage
 | 
MMA corrected some issues as well as correction made to the MMA on January 1, 2004.
Transmittal of March 2005 Publication 100-04 clarified blood charges. |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2003 | Subj: Recognition of current leading causes of Transfusion Related Fatalities (con’t) 
Secretary should take steps to encourage and facilitate implementation of available measures to
Reduce risk of bacterial contamination
Prevent errors 
Research that may improve safety and extend the shelf-life of platelets
Research in technologies/practices that could reduce the incidence of TRALI | 
AABB Task Force on Bacterial Contamination in place May 2004 with HHS agencies participating.
Bar Code Ruling to include common data identifiers for blood products.
NHLBI initiated working group on TRALI in Summer 2003. |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2003 | Subj: Subcommittee formation 
Committee tasked itself to develop a process to identify and evaluate residual, known and unknown risks affecting blood safety and secondarily availability, both in relation to etiological agents and the processes used in transfusion medicine.  Tasked to use the process as one tool, combined with other relevant data to propose prioritization of efforts by government, industry and the health care system to address these risks for further consideration by the committee. | 
Committee action |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2003 | Subj: Reimbursement 
Committee reaffirms its previous recommendations regarding recombinant clotting factors, and further recommends that the Secretary direct CMS to promptly revise the Carrier Manual provisions regarding reimbursement for hemophilia clotting factor to remove all insurance barriers to recombinant technology. 

 | 
CMS Transmittal  Publication 100-04 for Medicare Claims Processing of March 2005 clarified blood terminology and charges

 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept  2002 | Subj: Reimbursement 

Secretary  direct CMS to establish 2003 Medicare HOPPS rates for blood/blood components, transfusion services, and transfusion laboratory procedures based on current year acquisition and actual total cost of providing such products and services, rather than on hospital outpatient claims form previous years. 
 | 

No action noted |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept  2002 | Subj: Reimbursement (con’t) 

Secretary  direct CMS that payment for plasma derived therapies and their recombinant analogs be based on current year acquisition and actual total cost of providing such products and services both within hospitals and in non-inpatient settings (including physician offices) to ensure patient access to care. 
 | 

No action noted |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept  2002 | Subj: Public Awareness
Secretary  should promote public awareness of the ongoing need for routine blood donation by healthy persons via:
PSA’s and visible blood donations by top officials and paid advertising campaigns.
Funding of demonstration projects
Support specific initiatives to encourage routine donations by young persons and minorities 
Play a lead role in increasing participation of federal employee | 

“Give Life, give twice campaign”
Secretary Thompson donations and Press Releases
Donation Nation
Private sector Public Service Announcements |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept  2002 | Subj: Monitoring
Secretary  should fund and support blood supply monitoring to address:
Long term trends in blood collection and use
Data on daily nationally distributed blood inventories;
Indications of blood shortages and excesses
Predictive models to identify trigger points for coordinated national donation campaign;
Coordination of governmental and non-government initiatives | 

Analysis of improved monitoring system initiated in 2003
Supported by Secretary’s Operation Center
BASIS implemented and facilities recruited Spring 2006 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Sept  2002 | Subj: Inventory Management
Secretary  should support initiatives to improve management of blood inventories including:
Defining the role(s) of liquid and/or frozen reserves
To moderate fluctuations in supply, and 
To improve disaster response preparedness
Integration of supply forecasting into intervention strategies directed to correct imbalances in supply and need, and; 
Strategies to facilitate movement of blood from are of surplus to areas of shortage. | 
Some of the principles of the National Blood Reserve
Blood Community has changed impression of worthiness of National Blood Reserve
ASH would like Committee to readdress the frozen reserves with rationale on recommendations  |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2002 | Subj: Response to Disasters
Secretary should act to promote and coordinate a single, consistent public message on blood issues.
ESF #8 of the Federal Response Plan should be reviewed to incorporate the recommendations and organizational member of the AABB Task Force.
AABB Task Force should coordinate the national response of the blood community.
Fund the evaluation and potential development of a National Blood Reserve. | 
ASH is responsible for the nation’s blood supply.  In time of disaster,  a coordinated message will be prepared through the ASH office.
ESF#8 has been rewritten for coordination with the AABB Task Force.
Evaluation of the NBR is currently underway.
AABB TF SCC 
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan 2002 | Subj: Donor Awareness
Secretary should  recognize and incorporate the FDA’s Office of Blood Research and Review strategic plan into the DHHS response plan for counter terrorism and disaster preparedness. | 
FDA strategic plan has been incorporated into the Department’s plan.
 |

| Date | Recommendation | Response |
| --- | --- | --- |
| April 2001 | Subj: Global Blood Safety
Secretary should  foster research, training, and standard setting activities in international blood safety, including development and transfer of appropriate technologies for the developing world. 
Support the establishment of a mechanism to identify priorities and coordinate the exchange of information and activities among government and non-government agencies in the US and International community. | 
ASH Senior Advisor for Blood Policy involved with GCBS. 
PEPFAR
Professional organizations
AABB
PPTA
WHF |

| Date | Recommendation | Response |
| --- | --- | --- |
| April 2001 | Subj: Blood Monitoring and Data Collection
Secretary should  establish an office that has  responsibility to facilitate the gathering and dissemination of national blood collection, distribution and utilization data, and the development of analytic models to predict shortages.  
Federal dollars should be provided to support collection, analysis and distribution of these critical public heath data. 
Support programs for public and physician education.  | 
Blood Monitor with statistical modeling
Blood participation in the Secretary’s Operation Center
National blood data survey completed Spring 2006 to validate blood monitoring system 
Education program not developed or funded |

| Date | Recommendation | Response |
| --- | --- | --- |
| Jan  2001 | Subj: Universal Leukocyte Reduction
Secretary should  strive to minimize the impact on supply, assure adequate funding for ULR, issue a regulation to implement ULR that addresses these concerns.
Support research to investigate unresolved scientific issues in are of ULR.
Secretary should appoint a non-voting member from CMS. | 

No formal decision on ULR made.

Research on-going

CMS appointed a member to the ACBSA in August 2003.  |