The Secretary’s The Secretary’s Advisory Committee on Blood Advisory Committee on Blood

Safety and AvailabilitySafety and AvailabilityUpdateUpdate

September 19 & 20, 2005September 19 & 20, 2005

www.hhs.gov/bloodsafety

Issues DiscussedIssues Discussed

Varicella Zoster Immune Globulin (VZIG)Varicella Zoster Immune Globulin (VZIG)– Potential shortfallPotential shortfall– ACIP recommendationsACIP recommendations

Immune Globulin Intravenous (IGIV)Immune Globulin Intravenous (IGIV)

Strategic Plan for Improving Blood Safety Strategic Plan for Improving Blood Safety Against Known and Unknown Transfusion Against Known and Unknown Transfusion Transmitted Complications in the 21Transmitted Complications in the 21stst CenturyCentury

Varicella Zoster Immune Globulin Varicella Zoster Immune Globulin (VZIG)(VZIG)

Potential shortfallPotential shortfall

Use rate of 200 vials/month Use rate of 200 vials/month

ACIP recommendations may lead to the ACIP recommendations may lead to the use of IGIV as an alternate product until use of IGIV as an alternate product until VZIGVZIG

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

Manufacturers

Distributors

• Primary

• Secondary

Hospitals

Physician Offices

Hospital OutpatientWholesale and Sales prices reported to CMS

MMA: ASP + 6%, $56/g

AWP + 83%, $80/g

Distributors are not part of calculation for reimbursement

DistributorsLabeled Use

Evidenced Based Use

Non -Evidenced Based Use

Manufacturers

MMA: Reimbursement

Change in Service

Part BOct 28 ASP for Q4 05

Lyophilized 45.57/ gLiquid 56.30/ g

Findings on Immune Globulin Findings on Immune Globulin Intravenous(IGIV) AvailabilityIntravenous(IGIV) Availability

Increase in off-label use of IGIVIncrease in off-label use of IGIVIndustry Industry

– Consolidation Consolidation – Changes in business practiceChanges in business practice– Market correctionMarket correction– Reduction in inventoryReduction in inventory– Smaller number of distributorsSmaller number of distributors

Medicare Modernization Act effective January 2005 Medicare Modernization Act effective January 2005 changed the Medicare Part B to 106 percent of the changed the Medicare Part B to 106 percent of the manufacturers’ average sales pricemanufacturers’ average sales price..

– Medicare payment rate is updated quarterlyMedicare payment rate is updated quarterly– Increased 9% for lyophilized IGIV as of July 2005Increased 9% for lyophilized IGIV as of July 2005

Findings on Immune Globulin Findings on Immune Globulin Intravenous (IGIV) AvailabilityIntravenous (IGIV) Availability

Sufficient supply of IGIV for patients who need Sufficient supply of IGIV for patients who need treatmenttreatment

Suggest that under the allocation process, Suggest that under the allocation process, physicians might best serve patients by physicians might best serve patients by communicating their supply needs directly to communicating their supply needs directly to manufacturers.manufacturers.

Ensure that IGIV treatment is prioritized toward Ensure that IGIV treatment is prioritized toward FDA labeled use and those diseases or clinical FDA labeled use and those diseases or clinical conditions that have been shown to benefit from conditions that have been shown to benefit from IGIV based on evidence of safety and efficacy.IGIV based on evidence of safety and efficacy.

Action PlanAction PlanWeb Posting – Web Posting – www.hhs.gov/bloodsafetywww.hhs.gov/bloodsafety

– Report denial of treatment, delay of treatment, forced reduction in dosageReport denial of treatment, delay of treatment, forced reduction in dosage– FDA FDA

CBER Product Shortage Number 800-835-4709CBER Product Shortage Number 800-835-4709

CBERProductshortages@cber.fda.govCBERProductshortages@cber.fda.gov

– CMSCMS1-800-MEDICARE1-800-MEDICARE

Supply Channel and Emergency ReserveSupply Channel and Emergency Reserve– Discussions with PPTA and manufacturersDiscussions with PPTA and manufacturers– Hotline establishedHotline established

Evidence Based Medicine Study -TBDEvidence Based Medicine Study -TBD

CMS ReimbursementCMS Reimbursement– Monitor costMonitor cost– IG assistance IG assistance

ACBSA RecommendationACBSA Recommendation

We therefore recommend that the Secretary take immediate steps to:We therefore recommend that the Secretary take immediate steps to:Increase reimbursement for non-hospital IGIV therapy to a level Increase reimbursement for non-hospital IGIV therapy to a level consistent with current market pricing.consistent with current market pricing.– Consider reclassifying IGIV as a biological response modifier.Consider reclassifying IGIV as a biological response modifier.– Consider declaring a public health emergency to address the short-Consider declaring a public health emergency to address the short-

term problem.term problem.Modify the current plan to change hospital outpatient Modify the current plan to change hospital outpatient reimbursement to ASP + 8% in January 2006 in such a way as to reimbursement to ASP + 8% in January 2006 in such a way as to prevent any sudden and large decrease in reimbursement.prevent any sudden and large decrease in reimbursement.Reexamine whether the current IGIV supplies are meeting patient Reexamine whether the current IGIV supplies are meeting patient needs.needs.Work with Congress to establish a long term stable and Work with Congress to establish a long term stable and sustainable reimbursement structure.sustainable reimbursement structure.

Strategic Plan for Improving Blood Strategic Plan for Improving Blood Safety Against Known and Safety Against Known and

Unknown Transfusion Transmitted Unknown Transfusion Transmitted Complications in the 21Complications in the 21stst Century Century

Committee finds that there are compelling needs for Committee finds that there are compelling needs for improvement in some areas:improvement in some areas:

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

Reassessing policies and their related interventions Reassessing policies and their related interventions based on evaluation of their impacts, based on evaluation of their impacts,

Intensifying efforts to influence clinical practices Intensifying efforts to influence clinical practices related to blood transfusion and alternative related to blood transfusion and alternative therapies, based on scientific evidence,therapies, based on scientific evidence,

Accelerating responses to threats (e.g., patient Accelerating responses to threats (e.g., patient /specimen/unit misidentification) for which there are /specimen/unit misidentification) for which there are available interventions,available interventions,

Utilizing formal risk communication strategies Utilizing formal risk communication strategies targeted to blood donors, patients, and care targeted to blood donors, patients, and care providers to enhance scientific comprehension and providers to enhance scientific comprehension and public trust, public trust,

Pursuing opportunities to enhance public health in Pursuing opportunities to enhance public health in the management of blood donors, the management of blood donors,

Promoting comprehensive disaster planning Promoting comprehensive disaster planning including sustaining the inventories necessary for including sustaining the inventories necessary for an effective crisis response, an effective crisis response,

Establishing a proactive, prioritized, and goal- Establishing a proactive, prioritized, and goal- oriented research agenda,oriented research agenda,

Utilizing formal assessment tools more routinely in Utilizing formal assessment tools more routinely in policy development and decision making,policy development and decision making,

Further clarifying the respective roles of Further clarifying the respective roles of government agencies and the private sector in government agencies and the private sector in management and oversight of the blood system,management and oversight of the blood system,

Such a plan should encompass:Such a plan should encompass:– Structured process for policy and decision-Structured process for policy and decision-

makingmaking– Integration of blood system within the PH Integration of blood system within the PH

InfrastructureInfrastructure– Surveillance of adverse events related to blood Surveillance of adverse events related to blood

donations and transfusionsdonations and transfusions– Risk communicationRisk communication– Error prevention in blood collection centers, Error prevention in blood collection centers,

transfusion services and clinical transfusion transfusion services and clinical transfusion settingssettings

– Donor recruitment and retentionDonor recruitment and retention– Clinical practice standards for transfusionClinical practice standards for transfusion– Strategic research agendaStrategic research agenda– Disaster planningDisaster planning– Stable and sustainable reimbursement Stable and sustainable reimbursement – Funding for promising new technologiesFunding for promising new technologies

Blood Response in DisastersBlood Response in Disasters

Katrina Wilm

a

Rita

Ophelia

AssessmentAssessment

Pre-planningPre-planning– Storage at hospitalsStorage at hospitals– Infrastructure protectionInfrastructure protection

Generators Generators FuelFuel

Hurricane aftermathHurricane aftermath– Patient evacuationPatient evacuation– Blood needs – unified public messageBlood needs – unified public message– Hemophilia Treatment Center relocatedHemophilia Treatment Center relocated– Tracking blood needsTracking blood needs– Tracking availability of anti-venom, HBIG, tetanus Tracking availability of anti-venom, HBIG, tetanus

vaccine, Hepatitis A vaccine and tetanus vaccine vaccine, Hepatitis A vaccine and tetanus vaccine

Katrina and RitaKatrina and Rita

Louisiana/MississippiLouisiana/Mississippi– Blood Bank of New OrleansBlood Bank of New Orleans

Serves 44 hospitalsServes 44 hospitals

– AABB TF coordinated resupply through various blood AABB TF coordinated resupply through various blood organization networksorganization networks

TexasTexas– HoustonHouston

Good patient evacuationGood patient evacuation Resupply from days of closed blood centersResupply from days of closed blood centers

– Approximately 2000 units of RBC Approximately 2000 units of RBC – Approximately 1000 units of WB derived plateletsApproximately 1000 units of WB derived platelets– Approximately 250 apheresis plateletsApproximately 250 apheresis platelets

Lessons LearnedLessons LearnedAwareness of local and state governmentAwareness of local and state government– Plan in placePlan in place– Early evacuationEarly evacuation– Patient evacuation if hospital can not sustain anticipated Patient evacuation if hospital can not sustain anticipated

stormstorm

Patient tracking Patient tracking Educate State EOC regarding blood Educate State EOC regarding blood Push supplies, don’t wait Push supplies, don’t wait Priorities may not be local priority (i.e., fuel)Priorities may not be local priority (i.e., fuel)Increase awareness of HTC and Tissue/Organ Increase awareness of HTC and Tissue/Organ Procurement OrganizationsProcurement Organizations

National Response PlanNational Response Plan

Secretary Ridge signed, December 2004Secretary Ridge signed, December 2004– Base PlanBase Plan – Support AnnexesSupport Annexes

Emergency Support FunctionsEmergency Support Functions

ESF #8 ESF #8 Public Health and Medical ServicesPublic Health and Medical Services

– Incident AnnexesIncident Annexes– AppendixesAppendixes

ESF #8 Public Health and Medical ESF #8 Public Health and Medical Services AnnexServices Annex

ESF Coordinator: DHHSESF Coordinator: DHHSPrimary Agency: DHHS Primary Agency: DHHS Support Agency: Support Agency: – Dept of AgricultureDept of Agriculture– Dept of DefenseDept of Defense– Dept of EnergyDept of Energy– Dept of Homeland SecurityDept of Homeland Security– Dept of the InteriorDept of the Interior– Dept of JusticeDept of Justice– Dept of Labor Dept of Labor – Dept of TransportationDept of Transportation– Dept of Veterans AffairsDept of Veterans Affairs

– US Agency for International US Agency for International Development Development

– Environmental Protection AgencyEnvironmental Protection Agency– General Services AdministrationGeneral Services Administration– US Postal ServiceUS Postal Service– American Red CrossAmerican Red Cross

ESF #8 ESF #8

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

Blood and Blood Products

““HHS monitors blood availability and maintains HHS monitors blood availability and maintains contact with the American Association of Blood contact with the American Association of Blood Banks Inter-organizational Task Force on Banks Inter-organizational Task Force on Domestic Disasters and Acts of Terrorism and, Domestic Disasters and Acts of Terrorism and, as necessary, its individual members to as necessary, its individual members to determine:determine:– The need for blood, blood products, and the supplies The need for blood, blood products, and the supplies

used in their manufacture, testing, and storage.used in their manufacture, testing, and storage.– The ability of existing supply chain resources to meet The ability of existing supply chain resources to meet

these needs; and these needs; and – Any emergency measures needed to augment or Any emergency measures needed to augment or

replenish existing supplies.replenish existing supplies.

RECOVERYCRISIS

HHS AABB TF

EVENT

AuthorityAuthority ResponsibilityResponsibility

HHSHHS 100%, varies 100%, varies over timeover time

100%, varies over 100%, varies over timetime

TFTF Varies over Varies over timetime

Varies over timeVaries over time

SOC contact points: Primary: Office of Blood Safety and

Availability

Event

Hospital

Hospital

Hospital

Affected Blood

Collector

HHS’ Blood Issues handled by the ASH’s Office of Blood Safety and Availability

through Secretary’s Operation

CenterData

Activate Critical Infrastructure Protection Plans

SuppliesElectricity

CommunicationWater

Local EMA

State EOC

ASBPO

CDCFDA

HRSACMS

Level I Task Force

Event

Hospital

Hospital

Hospital

Affected Blood

Collector

AssistAffected Blood

Collector

Level 2 Task Force

A A B B

AABB TF

SOC contact points: Primary: Office of Blood Safety and

Availability Secondary: AABB Staff

Level I Task Force

Event

Hospital

Hospital

Hospital

Affected Blood

Collector

AssistAffected Blood

Collector

Level 2 Task Force

HHS Messag

e to PublicMessage

To Blood

Community

HHS’ Blood Issues handled by the ASH’s Office of Blood Safety and Availability

through Secretary’s Operation

Center

A A B B

Data

Activate Critical Infrastructure Protection Plans

SuppliesElectricity

CommunicationWater

Local EMA

State EOC

FDA CDC

ASBPO

HRSACMS