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Blood Safety Summary - August 1999

DATE: September 3, 1999

TO: Interested Parties

FROM: Stephen D. Nightingale, M. D., Executive Secretary Advisory Committee on Blood Safety and Availability

SUBJECT: Summary of August 26 and 27, 1999 Meeting


The Advisory Committee on Blood Safety and Availability met for the ninth time on August 26 and 27, 1999 at the Hyatt Regency Capitol Hill Hotel, 400 New Jersey Ave., N. W., Washington, D. C. 20001. Voting members present were Dr. Caplan; Dr. Albrecht; Mr. Allen; Drs. AuBuchon, Gilcher, Gomperts, Guerra, Haas, and Hoots; Ms. Jones; Dr. Kuhn; Ms. O'Connor; Drs. Piliavin; and Mr. Walsh. Ex officio members present were Dr. Chamberland; COL Fitzpatrick; and Drs. McCurdy and Snyder. Also present were Dr. Davey, Dr. Nightingale, CAPT McMurtry, and approximately 50 members of the public. Drs. Busch, Epstein, Goosby, Penner, Secundy, and Schiff were unable to attend. Dr. Jesse Goodman represented FDA at the meeting.

The meeting began at 9:08 AM with roll call, announcements regarding conflict of interest, and welcoming from Dr. Caplan. Next, Dr. David Satcher, Assistant Secretary for Health and Surgeon General, addressed the Committee. Dr. Satcher reviewed the scientific evidence on which the recent FDA Guidance to Industry on variant Creutzfeldt-Jakob disease (vCJD) was based, and the scientific questions that remain about how vCJD might be transmitted. Dr. Satcher outlined steps the Department of Health and Human Services (DHHS) was taking to insure the adequacy as well as the safety of the blood supply. Dr. Satcher expressed concern about the current availability of plasma derivatives, and he expressed support for the Department's hepatitis C lookback initiatives. He concluded by emphasizing the persistent vigilance that will be necessary to maintain the safety of the blood supply in the future. Dr. Satcher then invited questions from the Committee. The text of his speech is appended at TAB A.

Dr. AuBuchon asked Dr. Satcher why the decision ob British donor deferrals had been made without input from the Committee. Dr. Satcher responded that the Committee had previously spoken on general issues of safety and specific issues of availability that related to this issue, and he felt that the Department's decision was in the spirit of these recommendations. Mr. Allen asked Dr. Satcher about the availability of funding for the general notification component of the hepatitis C lookback. Dr. Satcher responded that funds for all purposes were limited, but that the Department feels it will be able to carry out the program it has proposed. Dr. Gilcher expressed his hope that British donors now deferred might be acceptable in the future, and Dr. Satcher reiterated his commitment to revisit this issue regularly and whenever new information became available. Dr. Caplan commented on the importance, in the face of potential shortages, of having good measures of blood availability. Dr. Satcher responded that the National Heart, Lung, and Blood Institute (NHLBI) of the NIH had committed funds to address this issue. Dr. Guerra asked Dr. Satcher to comment on how best to communicate risks, particularly potential ones, to the public and at the same time maintain public trust in important public health programs. In response, Dr. Satcher discussed how the Department was handling the issue of vaccines that contain thiomersal as a preservative.

Dr. Nightingale read the Secretary's letter of July 15, 1999 to Dr. Caplan into the record. The Secretary directed the Committee to monitor closely current trends in blood donation and demand. She concurred with the Committee's recommendation regarding blood donation by individuals with hemochromatosis. The text of her letter is appended at TAB B.

DEFERRAL OF BLOOD DONORS WHO HAVE RESIDED OR TRAVELED IN THE UNITED KINGDOM FOR A CUMULATIVE SIX MONTHS OR MORE BETWEEN JANUARY 1, 1980 AND DECEMBER 31, 1996.

Dr. Dorothy Scott of FDA reviewed the August 17, 1999 FDA Guidance to Industry on this issue. Dr. Scott noted that the Guidance also recommends deferral if an individual had used injectable products, such as bovine insulin, from Bovine Spongiform Encephalopathy (BSE)-endemic countries, and she discussed labeling of non-implicated blood products for the theoretical risk of CJD and viral transmission. Dr. Scott noted that comments on the Guidance would be discussed at the next Blood Products Advisory Committee (BPAC) meeting.

Dr. Davey expressed concern that diabetic donors would not know if some of their insulin had come from a BSE-endemic country. Dr. Gilcher commented that his blood center defers diabetics who are being treated with insulin. In response to a question from Dr. Hoots, COL Fitzpatrick noted that the Department of Defense continued to state its opposition to the deferral policy, but that it would comply with the guidelines as published when they become final. In response to a question from Ms. Jones, Dr. Scott noted that it was not the intent of FDA to require inclusion of every risk in a product label; instead, CJD was being included as an example of a risk. Dr. Caplan asked for clarification of how cases of vCJD, as opposed to classic CJD, would be identified; Dr. Chamberland briefly outined CDC surveillance programs for these diseases. Dr. Hoots emphasized the importance of communicating to the public that our understanding of the transmissible spongiform encephalopathies (TSEs) is a dynamic process, and that our understanding, and actions based on that understanding, will continue to evolve as new information becomes available.

Dr. Nightingale read a memorandum dated August 10, 1999 from Dr. Claude Lenfant, Director, NHLBI, to Dr. Ruth Kirschstein, Deputy Director, NIH, regarding the NHLBI intent to commit up to $300,000 annually to support monthly collection of data on the adequacy of the United States blood supply. Dr. McCurdy observed that the definition of adequate is blood group- and component-specific, and not as simple as it appears. He discussed various approaches to monitoring the blood supply, and how to begin doing so as quickly as possible.

Dr. Gilcher commented that his blood center routinely collected much of the information that Dr. McCurdy had mentioned; Dr. Davey commented that the Red Cross would have similar data available. In a discussion of inventories, Dr. Gilcher noted that on the day of the Oklahoma City bombing, about 350 units of blood in excess of usual demand were used within four hours, and it had been essential that these units were actually in inventory. Ms. Marian Sullivan of the National Blood Data Resource Center then discussed her organization's data collection efforts, including those to be performed in collaboration with NHLBI.

CAPT Mary Gustafson of FDA discussed a letter dated August 10, 1999 from FDA Commissioner Jane Henney, M. D. to Dr. Satcher regarding FDA policy on blood donations from individuals with hemochromatosis. The letter states that for blood establishments that can verify that they provide therapeutic phlebotomy for hemochromatosis at no expense to the patient, FDA will consider case-by-case exemptions to existing regulations that require disease-state labeling and limit the frequency of blood collections. Any exemption will be accompanied by a request that safety data be collected. Upon a finding that undue financial incentives have been removed and that surveillance data is favorable, FDA can propose revisions to existing regulations. The letter notes that any proposed funding of therapeutic phlebotomy would have to be reviewed to determine its adequacy in removing financial incentives. The full text of this letter is appended at TAB C.

CAPT Gustafson clarified that the data collection would take place after the exemption was granted, because at the present time FDA does not feel there is an inherent risk in this population. In response to a question from Dr. Hoots, CAPT Gustafson noted that the FDA does not restrict the age of blood donors, although the standards of the American Association of Blood Banks (AABB), and age requirements for informed consent, have this effect.

CAPT Gustafson then reviewed the Public Health Service (PHS) Report commissioned by Dr. Satcher on strategies for increasing the blood supply. She noted the participation of the blood industry in the development of this report. The core recommendations of the report were to

  1. Monitor the blood supply on an ongoing basis.

  2. Encourage more donations by eligible donors.

  3. Improve donor relations to facilitate recruitment and retention.

  4. Remove restrictions to safe donations

  5. Address economic issues facing the blood industry.

CAPT Gustafson noted that specific initiatives in each of these areas were already under way. The full text of this Report is appended to this summary at TAB D.

In the public comment period, Ms. Kay Gregory of AABB noted their opposition and that of America's Blood Centers (ABC) and the American Red Cross (ARC) to deferral of donors who may have been exposed to injectable drugs manufactured from cattle raised in BSE-implicated countries. At the same time, she expressed AABB support for the recommendations of the PHS Report, many of which were also prior AABB recommendations. Ms. Gregory also stated that AABB supported the FDA approach to blood donations by individuals with hemochromatosis.

Ms. Kristin Smith of ABC requested that the Department of Health and Human Services develop a national campaign to increase blood donations. ABC requested a steady stream of messages from high-ranking government officials regarding blood donation, and government funding to support proven techniques for increasing blood donation. ABC then asked DHHS to remedy the time lag between the implementation of new blood safety measures and proportionate increase in third party payments for these measures. ABC also asked DHHS to develop a professional education program of blood use, and educational materials for deferred donors. Finally, ABC asked DHHS to publish the circumstances under which it would rescind its current guidance on British donor deferrals.

Dr. Paul Holland of the Sacramento Medical Foundation Blood Center expressed his strong opposition to the British donor deferral policy. Dr. Holland queried whether this policy was enforceable when stated only in Guidance form. CAPT Gustafson cautioned against a simplistic response to this question.

Dr. Paul Cummings described preliminary results of a proprietary computer-assisted donor screening program. Ms. Jan Hamilton of the Hemophilia Federation of America discussed efforts by her organization to promote blood donation. She stated that

... we asked for stricter guidelines, we got stricter guidelines, and we must stand behind them and do our part to see that the 2.2 per cent decline in donations is overcome.

Mr. Patrick Collins of the National Hemophilia Foundation also supported the British donor deferral policy.

After lunch, Dr. Caplan invited motions from the floor. Dr. Piliavin moved, and Ms. O'Connor seconded, a motion that the Advisory Committee concurs with the guidelines that have been put forth regarding vCJD donor exclusion. In the extensive discussion that followed, several members stated that they did not feel well enough informed on this issue at this time to vote on it. Five of the fourteen present members of the Committee voted in favor of the motion, three against, and five abstained. The Chairman did not vote.

Dr. Caplan then proposed, and Dr. Hoots seconded, a motion that the Advisory Committee requests that it be advised at each meeting about the status of the British donor deferral policy and its impact. The motion was approved unanimously.

II CURRENT AVAILABILITY OF BLOOD PRODUCTS

Mr. Dennis Jackman of the International Plasma Products Industry Association (IPPIA) noted that the industry had responded to previous recommendations by the Committee to publish monthly production figures, develop emergency supply programs, expand capacity, comply with good manufacturing practices, pursue research, and explore importation of products to alleviate shortages. Mr. Jackman emphasized a point made earlier in the meeting by the blood industry that product availability was itself a safety issue. He noted that the plasma industry was in ongoing discussions with FDA about algorithms for managing post-donation information, and he was hopeful that the pace of regulatory review of therapeutic biologics could be accelerated.

In response to a question from Mr. Allen, Mr. Jackman noted that there were legal constraints on industry collaboration to project demand, and that measurement of future demand was inherently imprecise.

Mr. Larry Guiheen of Baxter then reported that his company had completed the three initiatives to increase production it had announced to the Advisory Committee in April 1998. These were licensure of an additional production facility, licensure of a new plasma purification process, and importation from his company's European facility. Mr. Guiheen estimated that these steps would increase Baxter's production by 30% in 1999 and by an additional 30% in 2000.

Dr. Jerry Winkelstein of Johns Hopkins University and the Immune Deficiency Foundation (IDF) reviewed the needs of individuals with the roughly 70 characterized immune deficiencies for plasma derivatives. He noted that these diseases are not rare - collectively, they are more common in children than leukemia and lymphoma; that - in part because of effective treatment - there are more adults than children with these diseases; and that - again because of effective treatment - individuals with these diseases can usually hope to live full, productive lives. As an example, Dr. Winkelstein noted that the first patient with Bruton's x-linked agammaglobulinemia had become a successful investment banker. Dr. Winkelstein noted that the efficacy of intravenous immunoglobulin (IVIG) in various immune deficiency states had generally been shown by comparing health status and outcomes of affected individuals during the time product was available and during the time product was not available, or by correlating health status and outcomes to trough levels of immunoglobulins in serum.

Dr. Winkelstein noted that the health status of most individuals with immune deficiencies permitted them to infuse themselves at home. He then presented the results of consecutive surveys by the IDF that indicated that the availability of IVIG had improved but was not yet adequate. Dr. Winkelstein cited various maneuvers that patients and providers were taking to deal with residual shortages, such as reducing the dose of IVIG or prolonging the interval between doses. One third of the physicians surveyed felt that the health of their patients was suffering because of the persistent shortfall.

In response to a question from Mr. Walsh, Dr. Winkelstein stated that the IDF does have a physician, though not a patient, registry for immunodeficiencies, and that the IDF plans to expand this activity, partly in collaboration with the ARC, to monitor the long-term effects of IVIG therapy.

Mr. Thomas Moran of the IDF then emphasized the concerns of the patient community over the facts that, while IVIG production appeared stable in 1999 at roughly 15,700 kg/year, this remained substantially below 1997 production of roughly 17,000 kg/year. He expressed relief that Baxter production was projected to increase, but concern over closure of other manufacturing facilities. He requested that the government fund a study to determine the health consequences of the current IVIG shortage, and to make this a component of a surveillance program to monitor the health status of the immune deficient population. He also requested continued industry support for emergency allocation programs, and to address the needs patients who move - or who are forced by unavailability of IVIG to move - from one part of the country to another. He also requested further acceleration of the review of IVIG experimental protocols, licensure applications, and product releases by FDA.

Ms. Nancy Beulow of the Alpha One Association then presented a patient perspective on the shortage of alpha-1 antitrypsin. She began by noting that a full prescription dose of alpha-1 antitrypsin had not been available to any patient for two years, and than many patients could obtain no product whatever. She expressed particular concern about the rate at which new products to treat alpha-1 antitrypsin deficiency were being developed. She also expressed concern that proposed ambulatory procedure classification (APC) reimbursements would further limit patient access to therapy.

Dr. Mark Brantly of the University of Florida reiterated Ms. Beulow's concern about the pace of development of new therapies. He encouraged industry to develop and share alternative sources for the intermediate plasma product used to make alpha-1 antitrypsin, and he encouraged the FDA to support the development of multiple formulations and delivery mechanisms of aerosolized alpha-1 antitrypsin.

Mr. Jackman returned to the podium to discuss reimbursement issues. He began by pointing out that even if production problems were solved, product would still be unavailable if providers, such as hospitals, did not have sufficient financial resources to stock these products. He then pointed out the negative impact of this situation, or the fear that this situation would develop, on capital investment in new production facilities. He pointed out that the HCFA proposed fee schedule would reduce the current HCFA fee schedule for the clotting factor needed by a hemophiliac with a clinically significant bleed from about $3500 to $99, and that comparable reductions were proposed for treatments of patients with immune and alpha-1 antitrypsin deficiencies. Mr. Jackman pointed out the differences between treatment with these agents and other infusion therapies covered under the same APC.

Mr. Jackman stated that Congress had mandated a pass through to hospitals for clotting factors used to treat hemophiliacs because it had found that hospitals were not stocking this product because of inpatient reimbursement policies. He suggested that proposed outpatient reimbursement policies would have the same effect, and he requested comparable relief for outpatient providers. He concluded by stating that the Secretary has the authority under the enabling legislation to exempt therapies as she sees fit, and he requested that she use this authority in this circumstance.

Ms. Anita Ducca of ARC provided comparable cost estimates, and she supported Mr. Jackman's positions and proposals. She also questioned whether HCFA cost estimation methodologies had systematically excluded bills submitted by the most severely ill patients from analysis.

Dr. Hoots noted the implicit assumption of HCFA methodologies was that all hospitals care for a comparable patient mix. He observed that this was not the case. He predicted that tertiary care hospitals already burdened with a disproportionate load of patients in need of plasma derivatives would have an even greater incentive under the HCFA proposals to discontinue providing services to these patients, and that comparable care would not become available elsewhere.

Dr. Robert Weinstein of St. Elizabeth's Hospital in Boston then spoke to the Committee. His first point was that carve-outs for a limited number of products would not address the needs of the many who needed comparable but different products or services, such as apheresis. He reiterated Ms. Ducca's concerns about the data on which HCFA cost projections were based. He stated an additional concern that these reimbursement policies would stifle innovation.

Dr. Weinstein predicted that hospitals might in response advise patients that they could not provide these treatments on an outpatient basis, but could on an inpatient basis. However, there would be no guarantee that reimbursement for inpatient treatment rendered would be provided, and the patient would have no insurance to cover the substantial costs of these therapies. Dr. Weinstein admitted that he did not know the answer to the problem that he had described, but he asserted forcefully that it was not the one proposed by HCFA. The meeting then adjourned until the following morning.

The first speaker on August 27 was Mr. Patrick Collins of the National Hemophilia Foundation (NHF). He noted that NHF supported previous comments on supply and on reimbursement by IPPIA, ARC, and Dr. Weinstein, and he expressed his satisfaction at the current level of interaction between patients and industry.

Mr. Walsh introduced the following motion:

Whereas the Advisory Committee on Blood Safety and Availability is dedicated to ensuring patient access to safe and effective plasma-based therapies, their recombinant analogs, and blood therapeutic alternatives; and

Whereas the Committee recognizes that the proposed prospective payment system for hospital outpatient department services (OPD services) under the Medicare program may unduly restrict access to those therapies; and

Whereas the Committee concludes that exclusion of these therapies from proposed prospective payment system will protect patient access;

The Advisory Committee on Blood Safety and Availability hereby recommends that the Secretary of Health and Human Services exercise her existing statutory authority to exclude plasma-based therapies, their biotechnology analogs, and blood therapeutic alternatives from the definition of 'covered OPD services' under the Medicare hospital outpatient department prospective payment system. The Committee further recommends that the Medicare program separately reimburse for these therapies, when furnished in a hospital outpatient department, including emergency room, on a reasonable basis.

Dr. Hoots seconded the motion. Dr. AuBuchon proposed that the motion be amended to add human-derived biologicals in front of the words and blood therapeutic alternatives. There was discussion about whether to include blood products and plasma derivatives in one resolution or to make separate resolutions on each subject. Dr. Haas proposed, and Dr. Aubuchon seconded, a motion to table the resolution under discussion until the hepatitis C lookback agenda item could be heard, and until the Committee had heard presentations from the floor on the proposed APC for blood products. The motion to table was unanimously approved.

III STATUS OF HEPATITIS C LOOKBACK

Dr. Paul Mied of FDA then reviewed the June 1999 Guidance to Industry on this subject. He noted that the revised Guidance incorporates the recommendation of the Advisory Committee regarding repeatedly reactive EIA 1.0 screening tests with a signal to cutoff ration greater than or equal to 2.5. The Guidance now also recommends lookback for an indefinite period, as long as electronically or other readily retrievable records exist, because the previous cutoff for lookback would have provided limited scope for EIA 1.0-triggered lookbacks. The Guidance also specifies conditions for use of the recently licensed RIBA 3.0 test, and it provides additional time for the blood establishments to complete record searches for events prior to January 1988. The target for completion of patient notification by consignees is September 30, 2001. These modifications have been incorporated into a Proposed Rule that would codify the Guidance to Industry. This proposed rule was submitted to the Department in July 1999.

Ms. Gregory reported on behalf of an AABB, ABC, and ARC Interorganizational Committee on HCV Lookback on an AABB survey of the status of direct notification. Ms. Gregory first noted that this Committee had developed standard notification letters for both physicians and recipients, with the assistance of CDC. The Committee has also developed a flowsheet and an information packet for providers, and a list of resources for both providers and patients. Returning to the survey, Ms. Gregory noted an approximately 40% return rate. She then noted that, in April 1999, 27% of blood establishments reported they had completed their lookback; in July, that figure had risen to 43%. Also in April 1999, transfusion services reported that they had notified about 3,000 recipients; in July, that figure had risen to about 4,000.

Dr. Mary Chamberland reported on the status of the CDC general notification effort. She mentioned software CDC had developed to assist transfusion services monitor the status of their notification efforts, and to facilitate evaluation by CDC, FDA, and the Agency for Health Care Planning and Research of the direct notification component of the lookback effort. CDC hopes that preliminary data from this initiative will be available in January 2000. Dr. Chamberland then reminded the Committee of provider education programs that CDC had sponsored in the past two years in advance of the public education program. She then reviewed the rollout of the public education campaign on hepatitis C that was held at the National Press Club on May 5, 1999. This event, which was sponsored by CDC, was attended by the Surgeon General, Dr. Caplan, and many other stakeholders.

Dr. Chamberland presented examples of a print campaign to reach transfusion recipients who may be unaware of their risk; this campaign is to begin in September 1999. She also mentioned CDC hotlines and web sites, and the desire of CDC to partner with non-governmental organizations to increase the impact of this campaign. Dr. Chamberland concluded by mentioning that CDC will fund three Epidemiology and Laboratory Capacity Sites demonstration projects to explore integration of hepatitis C initiatives with other infectious disease control activities, and that CDC is exploring the possibility of funding hepatitis C coordinators within state health departments.

Dr. Nightingale concluded the presentation of government activities related to hepatitis C by referring the Committee to a summary published in the June 30, 1999 Science of the Sixth International Conference on Hepatitis C, held at the NIH in June 1999, and a paper by Drs. Alter, Margolis, and colleages in the August 19, 1999 New England Journal of Medicine.

In the public comment period, Ms. Gregory stated the opposition of the Interorganizational Committee on HCV Lookback to the indefinite extension component of the June 1999 FDA Guidance to Industry. She also requested a rolling 10 year limit on any future lookbacks. Dr. Holland expressed doubts about the effectiveness of the lookback. Mr. David Cavanaugh expressed his concern about the timeliness of the implementation of the lookback, and concern whether there would be adequate funding for the public education effort that Drs. Alter and Margolis had designed. In response to a question, Dr. Mied clarified that the deadline for consignee notification had been extended by six months to permit completion of the extended search in all readily retrievable records, but all other timelines specified in the September 1998 Guidance were unchanged.

Dr. Caplan invited the Committee to make motions, and Dr. AuBuchon moved that the Committee recommends that the Secretary direct FDA to construct the HCV lookback in accordance with the prior recommendations of the Committee. Dr. Piliavin seconded the motion. Ten members voted for the resolution, one against, and one abstained. One member had left the meeting prior to the vote, and the Chairman did not vote.

The Committee then turned to testimony on the proposed APC 369, which covers blood services. Ms. Theresa Lauerhass of AABB expressed her opposition to the current formulation of this APC, which would bundle transfusion therapies with apheresis therapies. She disagreed with the data on which the reimbursement was based. She requested that the cost of the infused product, the infusion procedure, and overhead costs be reimbursed separately. She also objected to the reduction in reimbursement for multiple procedures, and she requested that reimbursement schedules be updated more frequently than every two years.

Ms. Anita Ducca of ARC expressed similar opinions. She emphasized the disparity of an order of magnitude between current charges for many blood related services and the proposed reimbursement under APC 369. Dr. Holland then expressed his concern that the proposed HCFA policy would make it impossible for hospitals to provide current services.

The Committee then resumed discussion of the motion by Mr. Walsh that had been previously tabled. Dr. AuBuchon proposed an amendment to Mr. Walsh's motion that, in addition to adding human-derived biologicals as previously proposed, would add the following paragraph to be the third paragraph of the motion:

Whereas, the proposed reimbursement payment for therapies under APC 369, which involve the administration of human-derived biologicals, including blood. components, is inadequate and miscategorized, and therefore threatens patient access to quality and potentially life-saving blood-related therapies,

Dr. Guerra seconded this amendment. The amendment was approved unanimously.

Dr. AuBuchon then moved, and Mr. Walsh seconded, an amendment to remove the words 'human-derived biologicals' from the motion and instead add the following paragraph to be the final paragraph of the motion:

The Committee recommends that the Secretary use her existing authority to exclude therapies under APC 369 from the prospective payment system for hospital outpatient services and reimburse them on a reasonable cost basis.

This amendment was approved unanimously.

Mr. Walsh's motion as amended was then approved unanimously.

Before consideration of the final agenda item, Dr. Nightingale thanked the seven Committee members whose terms will expire on September 30, 1999 for their service.

IV HOW SHOULD FEDERALLY MANDATED BLOOD SAFETY MEASURES BE FINANCED?

Ms. Nancy Edwards of HCFA began this session by providing a Medicare perspective on this issue. Ms. Edwards noted that HCFA implements Medicare, but that almost all of the implementation, as well as the exceptions, are dictated by statute. For example, the reimbursement of blood clotting factors outside DRGs is based on a 1989 law, and APCs are mandated by the Balanced Budget Act of 1997. This law specifies that HCFA was to use actual claims data from 1996 for Medicare beneficiaries to determine reimbursement. The original target for implementing a prospective outpatient payment system was January 1, 1999, but the expected implementation date is now estimated to be April 1, 2000.

Ms. Edwards noted that, during the last year, HCFA has met with virtually every industry group affected by the prospective outpatient payment system. Ms. Edwards indicated that these meetings will result in substantial changes to the final payment system, and she indicated that HCFA would ameliorate as best they could the concerns raised about blood-related APCs. However, Ms. Edwards also indicated that HCFA was not favorably inclined towards a pass-through for blood products.

Ms. Edwards indicated that many of the concerns about introduction of APCs had been expressed when DRGs were introduced, and those concerns proved unjustified. Dr. Hoots responded that there may have been more excess money in the health care system then than now, and he asked what plans HCFA had to prevent hospitals from discontinuing care for rare, expensive diseases. Ms. Edwards responded by citing the extra money paid to teaching hospitals, and Dr. Hoots noted that a recent study had found substantial geographic disparities in these payments. In response to a question from Dr. Caplan, Ms. Edwards said there may need to be many more specific APCs for blood, and that HCFA was totally open to dealing with that possibility.

After lunch, Dr. Lou Rossiter of Virginia Blood Services proposed that HCFA should anticipate, and prospectively compensate for, the costs of any new blood safety measures expected to be enacted in the coming year. He justified this unique approach on the basis of the voluntary, 'non-market'act of donation.

Dr. Nightingale asked Dr. Rossiter how he would ensure that the increased payment for services to the hospital industry would be passed on to the blood industry; Dr. Rossiter acknowledged that there was no assurance. Dr. Nightingale then asked Dr. Rossiter what might differentiate blood from other public goods or common resources that are shared, or from other voluntary donations, and Dr. Rossiter responded that blood was from one's own body. Dr. Guerra suggested that if access to freely donated blood were viewed as a right, there would be a societal obligation to provide access to it. Dr. Caplan then pointed out that if there were a right to access, there would be a responsibility to donate, and that would obviate the voluntary nature of the donation.

Dr. Paul Ness of Johns Hopkins University and AABB then stated the concern of the industry that inadequate reimbursement is likely to hinder patient access to quality care. He described the growing list of transfusion-based therapies and of safety measures that would not be covered by the proposed reimbursement schedules. He pointed out that there is currently no adequate system in place to insure that Medicare inpatient payments fairly reflect the value and costs of new blood products and services in a timely manner. He stated that the time lag between the introduction of a new therapy and revision of DRGs to recognize that therapy constrained innovation. He stressed that non-profit providers of blood services had limited reserves to cover the cost of therapeutic innovation. Dr. Ness proposed that the government recognize the 'unique priority' of blood safety and availability by providing adequate reimbursement to permit providers to continue to take all appropriate steps to safeguard the blood supply and to develop the new technologies and services that enhance these efforts. If necessary to accomplish that goal, blood and related services should be reimbursed separately from DRG and APC categories. Furthermore, reimbursement for blood services should not be at the expense of other vital services.

Dr. Nightingale asked why, if health industries such as the pharmaceutical industry were able to set an introductory price for a new product and to raise it without government intervention, that the blood industry would not be able to do the same. Dr. Ness responded that increases in the price of blood were the result of government mandates. Dr. Nightingale pointed out that other industries were subject to government mandates; Dr. Ness responded that other industries were not subject to a 'zero risk' mandate. Dr. Nightingale pointed out that the airline industry, for one, was so situated. Dr. Hoots pointed out that in the case of blood, the government was both mandating increased costs for a service and, at the same time, decreasing reimbursement, and that the Committee needed to get out the message that this situation was untenable.

Dr. Caplan proposed a motion that the Committee recommends that the Secretary work with Congress to seek additional resources to support the introduction and maintenance of mandated blood safety measures. Dr. Hoots seconded the motion. The motion passed unanimously.

Mr. Walsh proposed a set of motions related to the IVIG and alpha-1 antitrypsin shortages. There was extensive discussion of the specific wording of these motions. Dr. Nightingale summarized the sense of these motions as saying that in April 1998 the Advisory Committee made a set of recommendations about the availability of plasma derivatives. These recommendations have been mostly adopted, and the situation has improved, but it is still not satisfactory. The basic cause of the shortages is limited domestic manufacturing capacity; imports do not presently appear capable of fully compensating for domestic shortfalls. A related concern is the effect of current and proposed reimbursement practices on capital investment in new manufacturing facilities. Dr. Nightingale noted that it is standard practice to permit statements by members to be introduced into the record for up to 28 days after a meeting. Mr. Walsh then withdrew his motion.

Mr. Walsh then moved that the Committee remains concerned about the continued shortage of intravenous immunoglobulin and alpha-1 antitrypsin despite laudable efforts on the part of both industry and government, and the Committee would support new as well as continuing efforts to alleviate these shortages. Dr. Piliavin seconded the motion. It passed unanimously. The meeting was then adjourned at 3:23 PM.

This summary was approved by the Chairman of the Committee on September 2, 1999. It incorporates:

TAB A: Text of remarks to the Committee by the Assistant Secretary for Health and Surgeon General

TAB B: Text of letter dated July 15, 1999 from the Secretary to the Chairman of the Advisory Committee

TAB C: Text of letter dated August 10, 1999 from the Commissioner of the Food and Drug Administration to the Assistant Secretary for Heath and Surgeon General

TAB D: The Report of the Public Health Service Working Group on Strategies for Increasing the Blood Supply

The transcript of this meeting is available on the Committee's web site: www.hhs.gov/bloodsafety

TAB A: Text of remarks to the Committee by the Assistant Secretary for Health and Surgeon General

TAB B: Text of letter dated July 15, 1999 from the Secretary to the Chairman of the Advisory Committee

TAB C: Text of letter dated August 10, 1999 from the Commissioner of the Food and Drug Administration to the Assistant Secretary for Heath and Surgeon General

TAB D: The Report of the Public Health Service Working Group on Strategies for Increasing the Blood Supply