| Posted by
Dave Cavenaugh 06-27-2008 |
WASHINGTON UPDATE |
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June, 2008 Vol. 10 No. 5
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> STATE-LEVEL ISSUES
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In California, draconian budget cuts resulting from a 2 year 20 billion dollar deficit for fiscal years 2008 and 2009 has resulted in the Governor calling for 10% across the board cut in state program reimbursement for health care services. Starting July 1, these cuts will result in a 10% cut in reimbursement for factor concentrates for those enrolled in state-funded programs. This is likely to create a significant, and in some cases unworkable situation for many of the home care providers and Hemophilia Treatment Centers who deliver factor concentrates and associated services to the hemophilia/bleeding disorders community. For some chronic disease communities, such as pulmonary hypertension, these cuts will result in a serious interruption in access to care. In our community the cuts certainly will impact both access to care and the quality of that care. As we go to press the California Senate Budget Committee will meet to consider the cuts and the Budget Legislation that is the roadmap for the budget. Meanwhile the Assembly continues to oppose the cuts in health care. The entire budget debate in Sacramento is even more convoluted on the revenue side of the equation as State law mandates a two-thirds vote in the Legislature to raise revenues through new taxes. This rule allows the Republican minority to block any revenue-raising proposal, even those emanating from the Republican Governor, leaving only program cuts as a means to reduce the deficit. However, across the board cuts, including health in with all other state functions, clearly is the most damaging plan.
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In a surprising twist to the California budget campaign, it was learned in late May that language that contained serious implications for our community had been included in the new cost and program description estimates released by the Governor. The state’s hemophilia assistance program, the Genetically Handicapped Persons Program, currently provides over $50 million each year to aid persons with hemophilia. The language in question would authorize the office administering that program to sign an exclusive contract with a provider (pharmacy) of clotting factor. Although the language contained in the proposed legislation permits this action rather than requiring it, community advocates, led by the Hemophilia Council of California, HCC, and the Committee of Ten Thousand/West mobilized and fought doubly hard as the specter of damaging exclusive or sole source factor contracts was present. These efforts were rewarded when the Senate Budget Committee, meeting on May 30 instructed the Department of Health Care Services to enter into non-exclusive contracts for the acquisition of “blood clotting factors.” The Hemophilia Council, COTTWest and others submitted alternative language to the Deaprtment. While a victory, this certainly did not ensure that the language in question would be altered or removed by the Department of Health Care Services, DHCS. . Recently both the Hemophilia Council and COTT held conference calls with officials from the Department of Health Care Services to discuss the proposed language. As a result of these discussions the Department, in mid-June, proposed new language to address the concerns of our community. Through our joint efforts, the Department proposed language that ensured there would be both choice of provider and choice of product. In a conference call with COTT, DHCS stated that they “have no intention of limiting access to the range of blood clotting factors currently available to the hemophilia/bleeding disorders community.” They also stated their commitment to ensure a “network of providers”, both homecare and HTC, to ensure choice of provider in our community. .
The HCC and COTT both took issue with the use of the term “medically necessary” in relation to blood clotting factors. HCC proposed usage of the definition, “all FDA approved Blood clotting factors” which COTT agreed with. Our collective concern is that the “medically necessary” threshold could result in the State refusing to pay for recombinant and higher purity human factors currently in widespread usage, in favor of lower cost and lower quality products that still meet the “medically necessary” threshold. COTT was seriously concerned that this definition would allow the State to move the HIV and/or HCV infected subset of our community onto cheaper, lower purity products on the grounds that we are already infected with one or two serious pathogens and therefore would not benefit from the increased safety of the high purity and recombinant products. The Department assured us that it was not their intention to interfere in the doctor-client relationship and that ultimately “which product a given client used was between the physician and the client.”
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We certainly were relieved to hear this from DHCS and believed that, at least for this fiscal year, our collective efforts have overcome another push for exclusive sole-source contracts in the delivery of hemophilia treatment and care. COTT believes that at the end of the day, what is important is how these decisions in Sacramento impact the access to care and quality of care for members of our community in Fresno or San Diego California. We must remain vigilant and proactive if we are to protect the hard fought gains made by this community following the AIDS/blood epidemic.
. COTT also raised the issue of standards of care/service in California as the best possible criteria for assessing what providers become part of California’s network. COTT has been working in various states on the issue of standards of care/service and continue to view this type of legislation as critical to ensuring quality care for our community. HCC has introduced standards legislation this year which COTT supports. However it appears that it will not move in the current session and will have to be again taken up next year.
. The exclusivity and related language changes are now in the hands of the legislature. Busy over the larger budget cuts issue, they may not have had time to consider the problems we bring forward regarding sole-source contracting. In the last days before the July 1 deadline, there was essentially no change from months ago in the positions regarding cuts vs. revenue increases: the Assembly favors eliminating almost all the cuts, if revenues can be found; the Senate is in the same camp but only half as far, and the minority Republican caucus is standing fast on “no new taxes.”
. COTT views the California budget fight as just the beginning. According to the National Conference of State Legislatures, 23 states are facing budget deficits totaling 26 billion dollars in fiscal year 2009 while the Center for Budget & Policy Priorities sets the number at 27 states and the combined deficit at 39 billion dollars for 2009. In many of these states hemophilia is high on the radar due to the costs of treatment and care for our community. Cooperative and joint initiatives by local, regional and national community advocacy groups are imperative if we are to protect our access to care and the quality of that care. COTT is currently working with local groups in California, Alabama, Texas and Missouri on a range of legislation to protect our interests. .
COTT views our work with Tony Maynard and Terri Cowger Hill of the Hemophilia Council of California as a roadmap for collective and proactive action to protect access to care and quality of care, exportable to other states. It is another example of the importance of joint and cooperative work at the level of State capitals to ensure that our community is not harmed in this serious time of state deficits.
. . > CONGRESS
. Congress is fast approaching the end of this year’s session, in the minds of many on the Hill. This is an election year, and not just for the White House of course. EVERY member of the House stands for re-election every two years, and one-third of Senators do as well. So, members want a shorter-than-normal session, so they can be free to go home and campaign. All funding bills for next year’s budget have to be done before they leave. These Appropriations bills are usually what keeps Congress in session, often dragging adjournment until November or December. (The last thing any member wants is being forced to return to an after-elections session to finish up. A Congress in which members know who among them has been voted out and is slated to depart in a month is one within which it is hard to line up alliances around votes.)
. Ideally, by Memorial Day most committees like to be done with all hearings. By the Fourth of July, all bills (both authorization and appropriation) have been written and introduced. And by the time of the one-month recess in August, legislation has started on its way through votes toward passage or defeat. If this timeline were to happen this year, they would be able to tie up loose ends when they come back after Labor Day, and hit the campaign trail by mid-October if not earlier. But somehow it never works out that neatly. Conditions this year are not good, as the White House is still conservative in its spending targets although many on the Hill in both parties have become willing to see more generous funding for programs. The feeling is that with the change of administration likely to come, Congress has more leeway to reinstate some of the program cuts of the last eight years. The current President has one more chance to keep that from happening, and can and will cause enormous frustration in the Hill and elsewhere, knowing that the nation has spoken and wishes a more liberal approach to social programs (and undeclared wars).
. An example is the Iraq War Supplemental Funding bill. Growing bipartisan opposition to continuing to fund steady or increased US involvement in the Middle East, combined with the above-mentioned desire to aid long-suffering social programs, has led to proposed bills the President has refused to sign. Yet the war funding cannot be held up entirely, and current funding is nearly depleted. So, Congress has agreed to a modified version of its wishes: the bill went to the President for signature June 26th. On the social programs side, it includes veterans’ benefits, unemployment insurance, flood relief funding, and, closer to home, increased FDA funding for food and drug safety.
On the regular appropriations side, an example of the problem: The House Health Appropriations Subcommittee approved funding June 19th for health and related programs for next year that totals $8 Billion more than last year, and the President’s target was zero increase over last year. So, time will be required to come to agreement, and election campaigning will have to wait.
. . > AGENCIES
. Just at the end of May the US Department of Health and Human Services’ Advisory Committee on Blood Safety and Availability met. First on the agenda were remarks from the office of the new Assistant Secretary for Health within the Department. (Over the last eight years this office has been vacant more than it has been filled.) The remainder of the agenda was devoted to 1) various adverse situations reported as the result of transfusions, in handling plasma, in using stored red blood cells; 2) a review of current science regarding “blood substitutes,” and 3) categorization of certain types of skin grafts relative to the Committee’s charter’s scope for oversight.
. COTT reviewed an article from the World Hemophilia Federation’s journal Haemophilia from earlier this year, which reported a German and British study of the presence of a new form of parvovirus in coagulation factor concentrates. Parvovirus 4, or PARV4, is not related to any known human or animal parvovirus (of which Parvovirus B-19 is the best known).* PARV4 presence was studied in preserved lots of pre-viral-inactivation plasma pools from 1980 and earlier, several from 1997, and a large number from the period October 2000 to February 2003. Findings were that the novel virus was found in 33% of the 1980 lots, in 50% of the 1997 lots (although only two lots were studied), and in nine percent of the recently used lots. It is not yet known whether PARV4 causes harmful effects in humans.
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*Parvo B-19 is quite contagious, transmitted through coughs and sneezes. It causes a brief rash in children ages 5 to 15, with some accompanying discomfort. It is considered otherwise clinically harmless. Research shows that up to 60% of the US population tests positive for past exposure to it, but almost none with these results can remember having these symptoms.
. . > INDUSTRY
. The Plasma Protein Therapeutics Association held its annual Forum in Washington in June. Opening speakers included a young man with Hemophilia A, severe, who has succeeded in obtaining a Nursing degree and is an Emergency Room Nurse in the Philadelphia area. Other speakers included representatives of the Immune Deficiency Foundation, the World Hemophilia Federation, and the Food and Drug Administration. Among other things the group announced support for an end to syphilis testing of blood, under study for several years, as modern nucleic acid testing (NAT) that is now routine renders the older tests obsolete. .
In other industry news, COTT was not surprised to learn that the Hemophilia Alliance, which is comprised of almost all HTCs which participate in the 340b Veterans Pricing Program (permitting very low acquisition costs) has formalized its relationship with the Hemophilia Alliance Group Purchasing Organization (HAGPO) more thoroughly by merging; the product to be referred to as the Alliance. The two have had overlapping boards and missions for some time.
. . > COTT Operations
. The following was posted to the COTT website, www.cott1.org, on June 19th:
Another Unnecessary Passing On Thursday June 4th one of the Committee of Ten Thousand’s founders, Jonathan Wadleigh, passed into the spirit world. Jonathan was the last living member of the original New England support group that in 1989 became the Committee of Ten Thousand. Jonathan’s leadership ensured that the Committee of Ten Thousand would become a force in the AIDS and hemophilia communities. Without the effort, charisma, and energy of Jonathan Wadleigh the struggle in hemophilia would not have been so successful. Jonathan was instrumental in both Ricky Ray and the class action lawsuit that was originally filed by members of COTT. He was a strategic thinker, and one who provided serious leadership in the struggle for economic and social justice for the HIV/AIDS, HCV infected hemophilia community. Jonathan brought experience, commitment and unlimited energy to the struggle and impacted so many lives both within our community and in other communities confronting HIV/AIDS. He possessed vision and the knowledge and understanding of how to implement his vision. He, simply put, was instrumental in ensuring that COTT became a vibrant and active part of the larger global struggle for justice for all peoples infected with HIV/AIDS. He was adamant that COTT always be part and parcel of the larger global AIDS struggle while guiding COTT away from the insular hemophilia perspective that permeated the community’s response to the AIDS/blood epidemic in the 1980s. Jonathan and his surviving wife/partner Joanne were key members of COTT’s original board of directors. I will never forget my first interaction with Jonathan and the core COTT team in Atlanta in 1992, in the community session at the NHF annual meeting. People were expressing their outrage, despair and hopelessness in the face of the devastating AIDS/Blood epidemic. I stood to speak and as I was speaking I could hear a few whispers saying “That’s Al Dubin’s son, look at him and listen, he is just like Al.” When I finished and went to sit down, three individuals, Jonathan Wadleigh, Tom Fahey and Greg Haas, were right in front of me asking, “Who are you and how do you know so much about the community’s history?” They invited me to the COTT booth and right then and there I became a member of the Committee of Ten Thousand. I was intrigued by their knowledge, intensity and commitment to the well-being of our community. I also resonated with their perspective and their approach to the AIDS/blood epidemic in the hemophilia community. COTT’s commitment to the larger global AIDS struggle was immediately obvious to me and it was very clear that Jonathan was the driving force behind the adoption of the larger community perspective by the Committee of Ten Thousand. At that moment I began a personal and organizational journey that continues to this day, almost sixteen years later. Of the group that came together in 1992 around the Atlanta NHF meeting, Dr. Rich Colvin and myself are the only two left. It is sobering to reflect on the sheer magnitude of the loss COTT has suffered as a microcosm of the community’s losses due to the AIDS/Blood epidemic. We are deeply saddened by the passing of Jonathan Wadleigh and remain deeply mindful of the critical role he played in the struggle for individual and community dignity. Jonathan always stood for empowerment and human rights. He was tireless in his pursuit of justice for our community and all communities confronted by the global HIV/AIDS epidemic. He also was committed to those confronting hepatitis C and especially large numbers of people in the hemophilia community co-infected with hepatitis C as well. On behalf of COTT Jonathan also served two terms as the Chair of the Community Constituency Group of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health, working on HIV/AIDS clinical trials and treatment issues. Jonathan worked tirelessly to build structures that provided a forum for the empowerment of the grass-roots hemophilia/bleeding disorders community. His commitment to the grass-roots voice was total and unwavering. I had the honor of working with Jonathan through many of the roughest and most stressful years of the AIDS/blood epidemic. He will be sorely missed and forever honored by the Committee of Ten Thousand and those whose life he touched. At COTT, when one of our own passes into the spirit world we say the persons name followed by the word presenté (in Spanish as this we learned from our brothers and sisters in Latin America) meaning that this person will always remain present and in our hearts and minds. From the men and women at the Committee of Ten Thousand we say, Jonathan Wadleigh Presenté.
--Corey Dubin BLOOD SAFETY SUMMARY
An article from the journal Haemophilia reported a study of the presence of a new form of parvovirus in coagulation factor concentrates. Parvovirus 4, or PARV4, is not related to any known human or animal parvovirus. PARV4 presence was studied in preserved lots of pre-viral-inactivation plasma pools from 1980 and earlier, several from 1997, and a large number from the period October 2000 to February 2003. The virus was found in 33% of the 1980 lots, in 50% of the 1997 lots (only two lots were studied), and in nine percent of the recently used lots. It is not yet known whether PARV4 causes harmful effects in humans.
COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network in publication of this issue of the COTT Washington Update. Attachment #1: Recent FDA Enforcement Report excerpts
June 18, 2008
PRODUCT
Red Blood Cells (Apheresis), Recall # B-1047-08
CODE
Unit: N36878
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone on June 4, 2007 and by letter dated July 3, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of platelets that was found to be contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
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PRODUCT
Fresh Frozen Plasma, Recall # B-1376-08
CODE
Unit: 6980982
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by letter dated April 19, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Red Blood Cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1386-08
CODE
Units: 9724256 – part A and part B
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on January 9, 2008.
Manufacturer: LifeSource Skokie, Skokie, IL. Firm initiated recall is complete.
REASON
Blood products, collected without quality control testing during apheresis machine validation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1387-08;
b) Frozen Plasma, Recall # B-1388-08;
c) Recovered Plasma, Recall # B-1389-08
CODE
a) Unit: 40GL13775;
b) Unit: 40FY49248;
c) Units: 40GL13775 and 40KF01329
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria IL, by facsimile on February 15, 2008 and March 4, 2008 and electronically on February 15, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IL and CA
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PRODUCT
Source Plasma, Recall # B-1450-08
CODE
Unit: 3870008336
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Springfield, IL, by facsimile on November 30, 2007. Firm initiated recall is complete.
REASON
Blood product, in which the sample tubes for viral marker testing were not maintained at an appropriate temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
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PRODUCT
a) Red Blood Cells, Recall # B-1456-08;
b) Plasma Frozen, Recall # B-1457-08
CODE
a) and b) Unit: N63357
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter on October 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1458-08
CODE
Unit: 17FR36218
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter dated November 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
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PRODUCT
Red Blood Cells, Recall # B-1460-08
CODE
Unit: J59798
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone on March 8, 2007 and letter dated March 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1472-08
CODE
Unit: 012Z75557
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone, electronic notification or letter on December 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
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PRODUCT
Source Plasma, Recall # B-1483-08
CODE
Units: 382014678, 382014345, 382013969, 382013222, 382013064, 382012378, 382012145, 382011557, 382011308, 382010651, 382010513, 382009888, 382009789, 382004843, 382004825
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by facsimile on November 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC
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PRODUCT
Plasma Cryoprecipitated Reduced, Recall # B-1491-08
CODE
Units: 72C931702; 72C935958
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Birmingham Region, Birmingham, AL, by fax on October 31, 2007. Firm initiated recall is complete.
REASON
Blood products, associated with units of Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
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PRODUCT
a) Red Blood Cells, Recall # B-1519-08;
b) Recovered Plasma, Recall # B-1520-08
CODE
a) and b) Units: P01056
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated May 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for HIV Group O, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, VA
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Washington Update is a bi-monthly primer on government related issues of importance to COTT's constituency. From health care legislation, to regulatory affairs to Administration policy for chronic diseases. A hands-on journal for grass roots health care advocacy in our Nation's capital.
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COTT News A range of information, reportage and viewpoints regarding issues and events of importance to grass roots health care advocacy and support. In COTTÂ’s vision information is power and part of the empowered community equation. From Washington D.C. to State capitals to the HIH and the FDA, look to COTT for grass roots health care news.
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COTT Canary tracks safety issues in our Nation's blood supply. It provides regular reporting, information and viewpoints from the grass roots end user communities. It is based on the historical practice of taking Canaries into the coalmines to gauge problems with breathable air. If the Canary passed out then it was time to evacuate the mine. Persons with hemophilia and other bleeding disorders are the canaries in the coalmine, the blood supply. If problems are present they will surface first in the hemophilia community.
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Treatment Updates: News, information and analysis about living with HIV/AIDS, hepatitis C, and hemophilia and related problems associated with living with multiple life threatening diseases.
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