The Secretary’s Advisory Committee on Blood Safety and Availability Update September 19 & 20, 2005

1. The Secretary’s Advisory Committee on Blood Safety and AvailabilityUpdateSeptember 19 & 20, 2005 www.hhs.gov/bloodsafety

2. Issues Discussed • Varicella Zoster Immune Globulin (VZIG) • Potential shortfall • ACIP recommendations • Immune Globulin Intravenous (IGIV) • Strategic Plan for Improving Blood Safety Against Known and Unknown Transfusion Transmitted Complications in the 21st Century

3. Varicella Zoster Immune Globulin (VZIG) • Potential shortfall • Use rate of 200 vials/month • ACIP recommendations may lead to the use of IGIV as an alternate product until VZIG

4. IGIV: A Perfect Storm or Market Adjustment to the MMA?

5. Manufacturers • Distributors • Primary • Secondary Distributors are not part of calculation for reimbursement Hospitals Physician Offices Hospital Outpatient MMA: ASP + 6%, $56/g AWP + 83%, $80/g Wholesale and Sales prices reported to CMS

6. Change in Service Distributors Non -Evidenced Based Use Labeled Use Manufacturers Evidenced Based Use Part B Oct 28 ASP for Q4 05 Lyophilized 45.57/ g Liquid 56.30/ g MMA: Reimbursement

7. Findings on Immune Globulin Intravenous(IGIV) Availability • Increase in off-label use of IGIV • Industry • Consolidation • Changes in business practice • Market correction • Reduction in inventory • Smaller number of distributors • Medicare Modernization Act effective January 2005 changed the Medicare Part B to 106 percent of the manufacturers’ average sales price. • Medicare payment rate is updated quarterly • Increased 9% for lyophilized IGIV as of July 2005

8. Findings on Immune Globulin Intravenous (IGIV) Availability • Sufficient supply of IGIV for patients who need treatment • Suggest that under the allocation process, physicians might best serve patients by communicating their supply needs directly to manufacturers. • Ensure that IGIV treatment is prioritized toward FDA labeled use and those diseases or clinical conditions that have been shown to benefit from IGIV based on evidence of safety and efficacy.

9. Action Plan • Web Posting – www.hhs.gov/bloodsafety • Report denial of treatment, delay of treatment, forced reduction in dosage • FDA • CBER Product Shortage Number 800-835-4709 • CBERProductshortages@cber.fda.gov • CMS • 1-800-MEDICARE • Supply Channel and Emergency Reserve • Discussions with PPTA and manufacturers • Hotline established • Evidence Based Medicine Study -TBD • CMS Reimbursement • Monitor cost • IG assistance

10. ACBSA Recommendation We therefore recommend that the Secretary take immediate steps to: • Increase reimbursement for non-hospital IGIV therapy to a level consistent with current market pricing. • Consider reclassifying IGIV as a biological response modifier. • Consider declaring a public health emergency to address the short-term problem. • Modify the current plan to change hospital outpatient reimbursement to ASP + 8% in January 2006 in such a way as to prevent any sudden and large decrease in reimbursement. • Reexamine whether the current IGIV supplies are meeting patient needs. • Work with Congress to establish a long term stable and sustainable reimbursement structure.

11. Strategic Plan for Improving Blood Safety Against Known and Unknown Transfusion Transmitted Complications in the 21st Century

12. Committee finds that there are compelling needs for improvement in some areas: • Minimizing disruptions in the supply of and access to blood products and their analogues, • Meeting the product development needs for patients with rare disorders, • Timely funding to ensure appropriate utilization of new technologies, • Integrating presently fragmented systems for monitoring blood safety and availability, • Aligning reimbursement and funding policies with product approvals and other decisions intended to optimize blood safety and availability, • Modifying reimbursement policies as needed to sustain access to blood products and their analogues for all patient groups (e.g. IGIV),

13. Reassessing policies and their related interventions based on evaluation of their impacts, • Intensifying efforts to influence clinical practices related to blood transfusion and alternative therapies, based on scientific evidence, • Accelerating responses to threats (e.g., patient /specimen/unit misidentification) for which there are available interventions, • Utilizing formal risk communication strategies targeted to blood donors, patients, and care providers to enhance scientific comprehension and public trust,

14. Pursuing opportunities to enhance public health in the management of blood donors, • Promoting comprehensive disaster planning including sustaining the inventories necessary for an effective crisis response, • Establishing a proactive, prioritized, and goal- oriented research agenda, • Utilizing formal assessment tools more routinely in policy development and decision making, • Further clarifying the respective roles of government agencies and the private sector in management and oversight of the blood system,

15. Such a plan should encompass: • Structured process for policy and decision-making • Integration of blood system within the PH 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 • Clinical practice standards for transfusion • Strategic research agenda • Disaster planning • Stable and sustainable reimbursement • Funding for promising new technologies

16. Blood Response in Disasters Wilma Katrina Rita Ophelia

17. Assessment • Pre-planning • Storage at hospitals • Infrastructure protection • Generators • Fuel • Hurricane aftermath • Patient evacuation • Blood needs – unified public message • Hemophilia Treatment Center relocated • Tracking blood needs • Tracking availability of anti-venom, HBIG, tetanus vaccine, Hepatitis A vaccine and tetanus vaccine

18. Katrina and Rita • Louisiana/Mississippi • Blood Bank of New Orleans • Serves 44 hospitals • AABB TF coordinated resupply through various blood organization networks • Texas • Houston • Good patient evacuation • Resupply from days of closed blood centers • Approximately 2000 units of RBC • Approximately 1000 units of WB derived platelets • Approximately 250 apheresis platelets

19. Lessons Learned • Awareness of local and state government • Plan in place • Early evacuation • Patient evacuation if hospital can not sustain anticipated storm • Patient tracking • Educate State EOC regarding blood • Push supplies, don’t wait • Priorities may not be local priority (i.e., fuel) • Increase awareness of HTC and Tissue/Organ Procurement Organizations

20. National Response Plan • Secretary Ridge signed, December 2004 • Base Plan • Support Annexes • Emergency Support Functions • ESF #8 Public Health and Medical Services • Incident Annexes • Appendixes

21. ESF #8 Public Health and Medical Services Annex • ESF Coordinator: DHHS • Primary Agency: DHHS Support Agency: • Dept of Agriculture • Dept of Defense • Dept of Energy • Dept of Homeland Security • Dept of the Interior • Dept of Justice • Dept of Labor • Dept of Transportation • Dept of Veterans Affairs • US Agency for International Development • Environmental Protection Agency • General Services Administration • US Postal Service • American Red Cross

22. ESF #8 • ESF #8, when activated, is coordinated by the Assistant Secretary for Public Health Emergency Preparedness. Once activate, ESF #8 is coordinated by HHS through the Secretary’s Operation Center

23. Blood and Blood Products “HHS monitors blood availability and maintains contact with the American Association of Blood Banks Inter-organizational Task Force on Domestic Disasters and Acts of Terrorism and, as necessary, its individual members to determine: • The need for blood, blood products, and the supplies used in their manufacture, testing, and storage. • The ability of existing supply chain resources to meet these needs; and • Any emergency measures needed to augment or replenish existing supplies.

24. CRISIS RECOVERY EVENT AABB TF HHS

25. Event HHS’ Blood Issues handled by the ASH’s Office of Blood Safety and Availability through Secretary’s Operation Center Local EMA State EOC Hospital Affected Blood Collector Data Hospital Hospital FDA CDC CMS HRSA Activate Critical Infrastructure Protection Plans Supplies Electricity Communication Water ASBPO SOC contact points: Primary: Office of Blood Safety and Availability

26. Event Hospital Affected Blood Collector AABB TF Hospital Hospital A A B B Level I Task Force Level 2 Task Force Assist Affected Blood Collector

27. Event HHS’ Blood Issues handled by the ASH’s Office of Blood Safety and Availability through Secretary’s Operation Center Local EMA State EOC Hospital Affected Blood Collector Data Hospital Hospital FDA CDC A A B B CMS HRSA HHS Message to Public Activate Critical Infrastructure Protection Plans Supplies Electricity Communication Water Message To Blood Community Level I Task Force SOC contact points: Primary: Office of Blood Safety and Availability Secondary: AABB Staff Level 2 Task Force Assist Affected Blood Collector ASBPO