| Posted by
Dave Cavenaugh 08-29-2008 |
WASHINGTON UPDATE |
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August, 2008 Vol. 10 No. 7
> STATE –LEVEL ISSUES
As we approach the end of summer and the final election run, the serious economic situation in the country does not appear to have yet hit bottom. As we have reported, according to the Center for Budget & Policy Priorities, 27 states face serious deficits totaling almost $50 billion this year; California’s deficit, the largest, equals roughly one-third of this amount. As the national economy deteriorates, incomes fall and less taxes are paid; state revenues are reduced accordingly.
For chronic disease communities such as hemophilia the situation is rapidly going from bad to worse. Expensive chronic diseases are on the radar screen of those states facing serious deficits. Local hemophilia organizations and the three national organizations, COTT, NHF and HFA, are all spending a greater degree of time and resources putting out fires in places like Sacramento, California; Austin, Texas; and Frankfort, Kentucky as well as elsewhere. In all of these capitals the story is similar: a relatively small number of state-assisted chronic disease clients are found to have been spending a comparatively inordinate amount of a given state’s available health care dollars. Therefore states immediately look at hemophilia treatment and care as a line item that certainly must be adjusted downward to save critical dollars. No medical decision-making is involved when this is then done. For chronic disease communities, the impact of these cuts is substantial and for some chronic diseases communities catastrophic.
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-- California: Sacramento continues to operate without an adopted budget as its Legislative year ends September 1 – two months into the state’s fiscal year. Since it approved a 2008-2009 Budget in February including an across-the-board 10% cut each year (including but not limited to health provider reimbursement rates) in response to the Governor’s request, efforts to blunt that cut legislatively have continued nonstop. Several alternatives have been tried -- the Legislature is being kept in session weekends (and even through the Republican Convention) as a solution is sought. On August 29th after receiving indications of support from the (Republican) Governor, (Democratic) Senate President Don Perata proposed a three-year one-cent increase in sales taxes. This had been proposed before, coupled with a one-quarter-cent cut in the current levels of the sales tax after the three-year increase; this had been voted down. That measure would have reduced the cuts previously approved to only 7% (vs. the Governor’s 10%), an almost one-third reinstatement of program funds. Without the subsequent removal of the increase and enactment of a reduction, the measure would bring in much less revenue. Sen. Perata had been assured by the Governor of sufficient Republican votes to carry the measure, but even to these top-rank principals the outcome was unsure; in fact the measure failed.
-- Kentucky: The state’s Health and Family Services agency solicited comments and announced a hearing for August 21 concerning a proposed regulatory change which would put the 37 persons with hemophilia enrolled in Medicaid onto the 340b program, by having their care transferred to the state’s only HTC, a 340b. COTT submitted comments on this all-but-done deal (Attachment #2 to this Update), as we cannot support sole provider arrangements, and given current reporting and oversight processes concerning the hemophilia 340b program are concerned about locking people into it.
-- Texas: The Texas Legislature’s Senate Finance Committee is holding a hearing on Medicaid reimbursement rates for factor September 16th. The current rate structure is one of the lowest in the country, and jeopardizes the viability of home care providers operations in Texas. At press time the Texas chapters contacting committee members in their districts, and compiling graphics on the present crisis.
> CONGRESS
Both chambers of Congress recessed Friday August 1 for five weeks, as is normal. What is not normal is that there was no rush to pass (or at least move along) as many of the 13 Appropriations bills as possible before leaving. Almost without exception the FY09 Appropriations bills, for operation of the federal government starting this October 1, are being kicked into next year’s workload, through adoption of a blanket Continuing Resolution for all programs until then. The logic seems to be that there will be a friendlier White House then, and very likely a bigger Democratic majority in both chambers of Congress. No arrangements have been made to print more money, however, so the wished-for higher levels of program spending than we have seen for almost a decade will have to be tempered by acknowledging its impact on the deficit, up by 1/3 in the Bush years alone to $9,626,000,000,000. This is over $31,500 for each one of us. China owns most of that debt; hope they don’t call it in anytime soon! Congressional activity in late July centered instead around various program reauthorizations (higher education, product safety, juvenile justice) and ways to buttress the sagging economy through legislation to control the speculation on energy product pricing that has fanned the flames of the downturn in the economy since the foreclosure crisis began 15 months ago. A second stimulus bill is still planned as well, but Republican opposition to it remains strong.
COTT and HFA Washington-based staff met with the office of Rep. Phil English (R-PA), the sponsor of the MediGap bill on which all three organizations and many others have labored for three years. Not only was the meeting to introduce the new HFA staffer, Kisa Carter, to Kelly Lavin of that office, but to learn their thinking about the future of the bill. Ms. Lavin said unequivocally that it would be re-introduced in January as the next session of Congress – the 111th – gets under way. There are strong prospects for a more substantial Democratic majority in the House after the November elections. Rep. English would thus seek a committed, activist Democrat as an original co-sponsor, who could help get the number of co-sponsors signed on next spring to equal and then surpass the current bill’s 53 co-sponsors.
> AGENCIES
-- PRESIDENTIAL CAMPAIGN. The policy issues of critical importance to our community and the larger health and disability communities are not being claimed as part of the national party platforms. Evidence from Denver shows that the required level of detail for this is being given no time, on the podium much less on camera. It is vital that we work to make these points heard. As the autumn progresses, our community members should seek out appearances by the candidates and urge them to respond. On Sen. Obama’s website, www.barackobama.com/issues, you will find may of the basic issues including health and disability as they have been presented to date by Obama. Underneath each video there is a link to respond with ideas from the public. The McCain website, www.JohnMcCain.com, has a feature called ‘Spread the Word’ that links to blogs on which comments can be left. Access, choice, fairness, and support for families with high-cost diseases are some of our priorities.
FDA’s Blood Products Advisory Committee meets in September, and will take up a draft regulation released in May concerning Draft Guidance for Industry regarding the re-qualification method for re-entry of blood donors deferred because of one or more reactive test results to Hepatitis B Core Antigen (Anti-HBc). The basis for the proposed change and the re-entry of these previously deferred donors is the issue of false positives in HBV core antigen testing. Although the potential for multiple false positives in a single donor is low, there is an assumption here that with the more sensitive NAT (Nucleic Acid Test) testing, a number of donors who were deferred may be eligible for re-entry as donors given the false positive issue associated with past less-sensitive HBV core antigen testing. While COTT supports the concept of donor re-entry, if in fact it can be determined through NAT testing that an earlier reactive HBV core test was a false positive, we again need to remind FDA/CBER and the blood industry that humans run the computers, and humans move the supplies around, so humans will still make errors. Example: one production facility was recently cited because a flashing light and alarm sound built into the machinery to signal when a unit being processed tested positive for HIV or other pathogens was found annoying by the staff working the machine and deactivated– so contaminated product slipped through.
The ongoing inability of the American Red Cross to fix its operating procedures, correctly screen donors and get its overall blood operations in order, even after tens of millions of dollars in fines, proves our point. COTT continues to counsel caution when changes in donor screening and eligibility are proposed.
We are mindful of the need to expand the nation’s donor pool, yet we continue to believe that without the political will necessary to connect blood donations to good citizenship, the situation will remain difficult and the donor pool will not grow significantly enough to meet demand. The blood industry and our political leadership should teach our children in the schools the importance of regular blood donations. In this election year we need to put regular blood donations on the political table. If former Presidents Bush and Clinton can raise awareness about Hurricane Katrina in television spots then it is also not possible regarding the need to expand our nation’s blood donor pool. The draft guidance on donor re-entry can be found at http://www.fda.gov/cber/gdlns/reentrybld.htm
> INDUSTRY
On August 19th COTT was notified by CSL Behring of a recall of four lots of Monoclate-P. All released since August 4, these lots, amounting to hundreds of doses, are in the distribution pipeline currently. Lot numbers include J91504, J91604, J91705 and J91806. A test of potency was the reason for the recall – two lots were below required levels after 3 months; two other lots produced at the same time were included in the recall as well. These lots carry no added risk for consumers -- infusion of doses included in the recall would simply produce less result than would a normal dose; so one may need additional units to compensate. However, in a travel situation, where it could turn out that one had brought along only vials from the affected lots, low-potency results could necessitate disruption of travel plans to seek out a supplementary supply such as from an ER or by overnight delivery from one’s specialty pharmacy. In addition to direct contact with national associations and announcement on its website by FDA, Stericycle, the new contractor for PPTA’s Patient Notification System, sent out emails, calls and letters the same day informing those who are enrolled of the recall. Since the company and the FDA announcements are aimed primarily at distributors, we recommend all consumers of blood products contact Stericyle to enroll themselves in this rapid notification system. They can be reached at 1-888-UPDATE-U or on the web at www.patientnotificationsystem.org.
On August 9 Grifols, Inc., a producer of plasma-derived therapies, which acquired the former Alpha Therapeutics, sponsored a leadership meeting and tour of their plasma fractionation plant in Los Angeles, California. All three national hemophilia community organizations were present, COTT, HFA (Hemophilia Federation of America) and the NHF (National Hemophilia Foundation), along with representatives of local NHF Chapters and HFA affiliated local organizations. There were two discussion sessions between senior Grifols management and the community’s representatives, including NHF CEO Val Bias, HFA Advocacy Chair, Paul Brayshaw and COTT President Corey Dubin. Also in attendance was HFA Washington DC staff Kisa Carter and COTT Board Secretary Chris Templin.
The sessions were open discussion. Main topics emerging included recombinant therapies and plasma-based therapies in the marketplace. With the cost of recombinant therapies continuing to rise, the question of plasma-derived clotting factor has taken on a greater importance in the landscape of hemophilia treatment. There was also a robust discussion of the safety of plasma-derived clotting factors and the efficacy of current viral inactivation technologies. COTT also raised the issue of source plasma collection along the Texas-Mexico border. In 2007 COTT raised this question, in the context of safety, both with Grifols and the FDA Center for Biologics Evaluation & Research (CBER). COTT continues to call for an expanded regulatory framework that is inclusive of issues such as poverty and access to health care in the context of plasma donors and potential donor populations.
> COALITIONS
COTT was able to be of assistance as the new Executive Director of the Hemophilia Federation of America, Ms. Kimberly Haugstad, visited Washington to choose office space for the Fed’s offices, which will be moved here from Louisiana shortly. Like COTT they favor close proximity to Congress, and will be making a choice soon from several offerings under consideration. We congratulate Ms. Haugstad, who will be remaining in Milwaukee with her family and her own firm, but traveling a lot, and wish her well as the Federation grows and prospers.
BLOOD SAFETY SUMMARY
FDA is considering allowing those deferred for life from donating blood due to repeatedly reactive tests for Hepatitis B antigen to be allowed to re-enter the donor pool, once nucleic acid testing (NAT) shows proves that the earlier tests were false positives, often a problem in earlier, less-specific tests.
CSL Behring announced August 18th a recall of four lots of Monoclate-P for failures to meet required potency tests, contacting the national hemophilia groups by telephone the same day.
Grifols conducted a tour of its southern California facility for representatives of the consumer community, and hosted several useful round-table discussions during the visit.
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
August 13
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1713-08
CODE
Unit: 113074950
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone on May 21, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a human bite within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1741-08
CODE
Unit: 72E651935
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Dunwoody, GA, by telephone on February 20, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1771-08
CODE
Unit: 0035789
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated August 4, 2006. Firm initiated recall is complete.
REASON
Blood product, with a platelet count that exceeded the firm’s specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1791-08;
b) Cryoprecipitated AHF, Recall # B-1792-08
CODE
a), and b) Units: 9216368
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on November 19, 2007 and by electronic mail on November 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, TX
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1756-08
CODE
Units: 6780425 Part A, 6780428 Part A
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on December 28, 2006 and by fax on April 11, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not labeled for an unexpected antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B1760-08
CODE
Units: 72E147706 and 72E147811
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on February 8, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
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August 20
PRODUCT
Source Plasma, Recall # B-1759-08
CODE
Units: 05JCTB9101, 05JCTB8805, 05JCTB6239, 05JCTB4117, 05JCTB3888, 05JCTB3377, 05JCTB3196, 05JCTB2949, 05JCTB2621, 05JCTB2291, 05JCTB1964, 05JCTB1804, 05JCTC2311, 05JCTC2113, 05JCTC1200, 05JCTC0625, 05JCTC0147, 05JCTB9786, 05JCTB0991, 05JCTB0365, 05JCTB0112, 35528159, 35524281, 35439684, 35431985, 35408031, 35400769, 35383642, 35381815, 35378969, 35376668, 35367079
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by letter on February 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
CA
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PRODUCT
Fresh Frozen Plasma, Recall # B-1767-08
CODE
Unit: 163902686
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on March 6, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1850-08
CODE
Units: 161673665 Part A; 161673665 Part B
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on January 15, 2008. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, AL
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Attachment #2: COTT Comments on Proposed Kentucky Regulation Assigning Medicaid Patients to 340b HTC
August 20, 2008
Kentucky State Medicaid
Proposed Changes
The Committee of Ten Thousand is a national advocacy and support organization for the HIV and HCV infected hemophilia/bleeding disorders community. As the Country experiences hard economic times, access to treatment and care for our community is becoming more and more complex and difficult. In the United States, the leading cause of bankruptcy is debt related to health care. For many families and individuals health insurance is becoming more and more an unattainable pipe dream. For chronic disease communities such as hemophilia and other bleeding disorders, it is becoming more and more difficult to gain affordable insurance coverage.
Due to the high cost of hemophilia treatment and care, our community is on the radar screen of States facing high deficits and the need to contain spiraling health care costs. Although we are mindful of the difficult situation faced by many states, we are extremely concerned about the manner in which many states are considering changes to the delivery of hemophilia treatment and care. We are concerned that narrowly focused cost containment initiatives at the State level will ultimately lead to reduced access to treatment and care for the HIV/AIDS and HCV infected hemophilia community as well as the larger hemophilia/bleeding disorders community. Our concern flows from the serious deficits faced by 27 states and the impact this is having and will continue to have on persons with hemophilia and other bleeding disorders as well as other chronic disease communities. Ultimately this approach will cost the individual states more than the current price tag for the hemophilia/bleeding disorders community and we suspect other disease communities as well. We are troubled by the apparent direction being undertaken by the State of Kentucky. The lack of clarity in the proposed changes further fuels our concern about the direction of Kentucky Medicaid regarding the hemophilia community and provider choice. Given the special needs of our community it is important to retain a sufficient number of providers to ensure that positive health outcomes are the result. As states look to cut rising health care costs, expensive chronic diseases such as hemophilia are high on the radar screen. The movement to a single provider limits competition on the ground and creates less incentive to provide positive health outcomes for our community. Ultimately this leads to higher costs for state programs.
In the treatment of hemophilia access to all clotting factors and a range of provider choice is not simply a preference of product or provider question. Different brands of factor concentrates have different efficiencies in a given client. Essentially for each of us with hemophilia one product may and frequently does have better efficiencies than another. Therefore product choice is raised to the level of appropriate medical decision-making and any preferred drug list or sole source manufacturer program will have a negative impact on persons with hemophilia and other bleeding disorders. From our perspective this does represent an important treatment issue that is lost in the current cost cutting environment.
At the same time we are mindful of the problem faced by numerous states regarding rising health care costs. It is not our intent to prioritize the care of hemophilia over other chronic disease communities. We understand the need for controlling spiraling health care costs. However, we would approach that question in a manner that ultimately leads to controlling the costs of hemophilia treatment through the attainment of positive health outcomes. We look to positive health outcomes in hemophilia as an important and unfortunately overlooked vehicle for cost containment. We believe that better health outcomes for persons with hemophilia/bleeding disorders results in lower costs to the states due to less joint damage and other debilitating factors. In essence positive outcomes reduce costs in hemophilia/bleeding disorders due to the better health of our community members through improved medication compliance and disease management.
Strong disease management programs have consistently cut costs and resulted in people with hemophilia/bleeding disorders remaining productive working citizens. When positive health outcomes are married to strong disease management programs, the results are better health and lower costs for the states.
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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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