.
The financial upheavals of the past two months are discussed below. Congress did its part, first seriously tangling up and obstructing the financial rescue package it was asked for by the White House, then modifying it and passing it before leaving town October 3 to campaign for re-election, leaving implementation entirely to the administration. It also passed a Continuing Resolution to fund government programs from the beginning of this month, largely at the same levels as last year despite growing needs especially in the health care arena. Also included in the Wall Street bailout was a huge bailout package for the automobile industry; another may be in the works. Plans for a second, larger Economic Stimulus package, sending checks to every American household as was done in the spring, failed to pass before adjournment but may again see the light of day if and when Congress reconvenes later in November.
.
As the Obama transition proceeds, health advocates in Congress, vow to keep it on the front burner despite the financial situation. Introduction of new health care reform legislation has been promised by Inauguration Day, Sen. Edward M. Kennedy (D-MA) announced November 11th. In addition at the same time the Senate Finance Committee issued a “Call to Action” for Health Reform in 2009.
.
As we approach the new-year and a new administration in Washington D.C one of the questions before us is Whose Voice will be heard in the debate on healthcare reform and chronic disease. Will it be a grass-roots hemophilia perspective or will it be only the voice of those with a financial stake in the outcome? For COTT, it must be about an independent community voice and perspective. There is certainly room for all perspectives and approaches, however that openness cannot be at the expense of the grass-roots community. At COTT, we are excited about the opportunities presented by a new administration and are certainly ready to roll-up our sleeves and work cooperatively with other organizations to protect our community. We must remain mindful of the fact that many of the infected, HIV/AIDS and/or HCV, community are struggling to keep their heads above water. Infected and affected families are facing challenges and threats to their treatment and care from third-party payers and state Medicaid programs. This is of course being exacerbated by the country’s worsening economic crisis and the loss of jobs. The infected segment of our community is confronting these issues without the support and services they require to attain some modicum of health and wellness. As we enter the new year it is imperative that we come together and address the needs of our entire community.
.
.
> THE ECONOMY
Congress’ role in the federal response to the downturn in the economy began when the Administration placed the two huge quasi-governmental entities, Fannie Mae and Freddie Mac, under conservatorship in September. This triggered major questions about past Congressional oversight of these mammoths. However, this change was followed almost at once by the failure of Lehman Bros. and its purchase by Barclays, the sudden negotiation of the failure of insurance giant AIG being headed off only by the huge infusion of government money – the first of several actual ‘nationalizations’ to come – then the failure of Bear Stearns and the subsuming of Merrill Lynch.
.
There followed ten days of negotiations with the White House over a ‘bailout package’ proposed by Treasury Secretary Paulsen, which would give him almost unchecked authority over disposition of $700 Billion dollars. A huge public outcry against this via inundation of Congress’ phone lines and mail boxes communicated strong orders to members; the bill failed. A Senate bill then included many of the controls that had been sought (and a goodly number of other additions); it passed readily and, faced with adjournment, the House approved it as well.
.
The sub-prime mortgage foreclosure crisis, which began a year earlier, by this fall had seriously frozen the residential real estate market. “Securitized” mortgages (healthy or not) being bought and sold as derivatives, a totally unregulated new financial product, had created a fiery hot market, leading major houses to become far too overextended (credit offered in excess of capital available). When this house of cards began to crumble, it clamped a freeze on credit at some of the biggest financial houses, meaning that, with the mortgage freeze, the entire system top to bottom was frozen. In the short time since this became serious, some layoffs have begun, more and more small- and mid-size businesses have had to reduce shifts or stop production entirely, hoping for an early resolution before they go under. Infusion of huge amounts of money from the government at that point was aimed primarily at the very soft goal of increasing the recipients’ confidence, from the top of the financial ladder first, so they would be willing to lend once more.
.
Unfortunately, as our attention was interrupted in the last weeks of October and the first week in November by the elections, the reality in the financial world seems to be that this infusion hasn’t worked as well as expected. The longer the freeze remains in place in terms of weeks, the longer we can expect the economy to be damaged, repairs coming only in terms of months and years.
.
Also unfortunately the world’s major economies have also been drawn into this crisis, to the degree that their credit markets have been near-frozen. Capital, often from multiple countries, has also been poured into their markets, but the results, as here, are slow to show improvement – and the financial burden on these governments, as ours, mean stringent measures on a full spectrum of services – education and health care as two major items – will be severe. The half-Trillion dollar infusion announced by China to calm its own markets may aid world efforts due to its size.
.
.
> STATE-LEVEL ISSUES
.
For our community the already deteriorating landscape in healthcare has become even more fluid and insecure in light of the escalating economic crisis. In States such as California steep budget cuts have been already implemented and we are being told that further healthcare cuts is a necessity. Companies doing business in the hemophilia/bleeding disorders community are all being squeezed by the current deep cuts by states in the rapidly shrinking available healthcare dollars. Our community is facing challenges at an increasingly alarming pace as numerous state capitals looking to cut costs and stretch existing healthcare dollars. The Center for Budget and Policy Priorities reports that while more than 25 states cut spending or raised revenues to balance the current year’s budget, all of these and several more are facing unexpected and severe mid-year budget gaps yawning before them. As tax revenues fall, for example, due to the failing economy, additional reductions in expenditures must be made at once. Even greater cuts, to meet the coming year’s expected shortfalls, are also having to be planned.
.
California: Implementation of the $7.1 Billion in program cuts required as part of the final budget approved September 18th is spreading out and downward through programs and local economies. A special November session of the Legislature is being planned to begin discussions of next year’s (2009-10: July ’09-June ’10) estimated $9 Billion deficit; further deep program cuts are expected.
.
Massachusetts: Ten years ago this month COTT Co-Vice-Presidents Mary Lou Murphy and Terry McNeill began a concentrated effort to establish a physical memorial site to remember all those lost in the AIDS/blood epidemic. Through the persistence of Mary Lou, Terry and others this initiative may now be within reach. In late October COTT and The New England Hemophilia Association (NEHA) met with staff to Senator John Kerry (D-MA) to discuss the establishment of a memorial site in the State of Massachusetts. COTT is working closely with Steve May, Advocate (Staff) and Kate Muir, Advocacy Committee Chair (Board) of NEHA.COTT is asking for a grant of public lands for the memorial and has drafted a letter to Senator Kerry to gain his assistance in this important effort. We have sent a copy of our letter to the National Hemophilia Foundation and the Hemophilia Federation of America as well, seeking support letters from those two national organizations. The COTT letter can be found as Attachment #3 to this Update. If you wish to be a part of this important community initiative, please contact us.
The hemophilia community was and continues to be the early warning radar for the nation’s blood supply. Our community was economically, physically and emotionally devastated by the AIDS/blood epidemic and it is high time we ensure that a permanent, tasteful memorial be established to honor and remember all those who have passed into the spirit world due to this worst medical disaster in United States history.
Connecticut: A meeting of community members was hosted by AHF, a community-based home care / specialty pharmacy company, to discuss the impact of pending implementation of Wellpoint sole-provider requirements on hemophilia clients. A state legislator, briefed on the problems earlier in the year when a May 2008 implementation was expected, also attended the October meeting. The state Attorney General’s office indicated a willingness to look into any cases of Wellpoint failing to provide the promised terms of its coverage, once the program starts.
.
Texas: A Senate Finance Committee Hearing and a meeting of the new state hemophilia advisory council both benefited from chapter advocacy on improved Medicaid reimbursement rates. COTT submitted a support letter for use in this campaign.
.
Vermont: In October the Vermont Medicaid program announced that a sole provider had been selected for hemophilia and selected other conditions, effective November 3rd. Based apparently on a competition won by the lowest bidder, the program will require persons with hemophilia who are on Medicaid to purchase factor only from ICORE Healthcare, LLC, through the state’s pharmacy benefits administrator, MedMetrics Health Partners. Efforts are under way to delay implementation or at least allow community collaboration in the oversight of this contract.
.
Chapters and other organizations in numerous states have been working on, and sometimes succeeding in securing establishment of state hemophilia advisory committees. It is a major aid in our community’s legislative efforts to have such state-level entities briefed and able to work for passage from ‘within’ the state government. COTT offers one suggestion. The model legislation that is often being used in these efforts defines the categories of affiliation of each of the proposed members – doctor, insurance industry representative, HTC, and so forth. When it comes to actual patients, the language, for no doubt the best of intentions, stipulates ‘person with, or caregiver for’ hemophilia and related conditions. What this can do is create a seated hemophilia advisory committee having no one with hemophilia on it.
.
It is VERY important to have family members, caregivers etcetera on such panels. However, from many such meetings, and FDA advisory committees as well, we have seen repeatedly that there is no substitute for the insights of a person who has hemophilia. First-hand reports about the uncertainty after being jolted or jarred as to whether to infuse or not, and dangers from encountering Emergency Room visits with medical staff completely ignorant of hemophilia much less how to treat it, etcetera, are invaluable in grounding the group’s work in the reality of hemophilia. Many ‘caregivers’ can recount these experiences, having heard many stories. However, the person who can say, in the middle of a discussion, ‘that happened to me,’ commands the immediate attention of the room.
.
.
> AGENCIES
.
COTT has called for an expanded regulatory framework regarding the collection of source plasma for the production of plasma derivatives such as factor concentrates, immune-globulins IV, and other biologics. We first raised this question in 2007 in response to revelations regarding source plasma collection along the Texas-Mexico border. Our perspective remains that we, as a nation, need to revisit the nation’s current regulatory framework for blood and plasma collection. An expanded regulatory framework would include issues of captive poverty populations, especially those residing in polluted free-trade zones such as the one along the US-Mexico border. COTT began this discussion with FDA’s Center for Biologics Evaluation and Research (CBER). In discussion with Drs. Jay Epstein and Mark Weinstein from the Office of Blood, and Dr. Jesse Goodman, CBER Director, COTT first articulated its vision for an expanded regulatory framework. We were reminded that our perspective has much broader implications for plasma collection throughout the United States, as many centers are location in poor and polluted neighborhoods.
.
COTT is currently continuing to formulate it proposal for an expanded framework for the regulation of source plasma collection. We seek a robust debate within the biologics end user community regarding this important safety initiative. We cannot continue to depend on technology alone to solve the problems of unknown pathogens entering the blood supply. It is not a question of whether or not it will occur, but when it will occur and if we can contain the impact on end user communities.
.
Supreme Court / FDA
.
In the February 2008 Update we mentioned a suit heard by the US Supreme Court and decided for industry which now prohibits liability lawsuits against a medical device manufacturer if the device in question has been approved for use by the FDA. On learning of that ruling, Rep. Henry Waxman (D-CA), Chairman of the House Committee on Government Operations, said “The Supreme Court’s decision strips consumers of rights they’ve had for decades. This isn’t what Congress intended.” One could easily term the decision and the potential for similar decisions regarding drugs and biologics as nothing short of a get out of jail free card for the manufacturers.
.
The horrific constraint against patient recourse in cases of true manufacturer liability posed by this decision has been followed by a second in what we fear will be a series of three related cases: devices, then drugs, then biologics. Oral arguments were heard November 3rd before the Court on a case seeking to prohibit liability lawsuits against a pharmaceutical manufacturer if a drug in question has been approved for use by the FDA. This ruling would have a much more widespread effect on abrogating the rights of patients injured by the side effects of drugs – such as blindness or heart attacks, to cite two recent examples from ED and pain relief drugs (both heavily advertised on television, driving up sales).
.
The argument is that suits brought in state court are pre-empted because a Federal agency has approved of the products in question. Yet the Director of the FDA Office of New Drugs recently said, "Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false."
.
The case at hand concerned a patient whose intravenous use of the drug Phenergan resulted, when an artery was accidentally punctured in the process, in the onset of gangrene, requiring amputation of her arm. Phenergan has been widely used, including in the hemophilia community, to counteract nausea from other drugs. The plaintiff contended that the drug maker had failed in its duty to warn of this risk, and was awarded $7 million. The manufacturer appealed on grounds that although the FDA did not require such notice on the drug label, the manufacturer was protected from state litigation by the federal FDA labeling decision.
.
Contrary to widespread belief, FDA approval is far more about the efficacy of a given drug or medical device than it is about the safety. The most important vehicle for ensuring the safety of medical devices and drugs and biologics for that matter is post-market surveillance, or what is known as phase IV testing. The FDA’s longstanding lack of authority to require phase IV testing once a product is in the marketplace was somewhat reduced in the FDA reform legislation of last year, but by and large drug or biologic manufacturers are not required to perform the post-market testing.
.
Much more troublesome to our community would be the third possible case in this series, should the second case stand. If the Court were petitioned, and then, consistent with these other two cases, found that liability lawsuits against a manufacturer of biologics -- such as clotting factor, immune globulin, or vaccines – could be prohibited if the product in question has been approved for use by the FDA, then all hemophilia community access to liability relief (such as the Ricky Ray Hemophilia Relief legislation provided) would be prohibited.
.
Deregulation
.
In the last few months of the current administration, it has been reported, there has been a massive effort within the White House Office of Management and Budget to alter regulations in many areas so as to leave a legacy of this President’s policies favoring less regulation over industry, to last well into subsequent years. Examples of nearly 100 such changes under way include areas such as easing limits on pollution from power plants, allowing millions of tons of additional carbon dioxide into the atmosphere annually; allowing increased emissions from oil refineries, chemical factories and other industrial plants; allowing natural gas pipelines to operate at higher pressures; allowing decisions over the management of fisheries to be vested in regional councils controlled by fishery interests (vs. local community needs), and increasing Medicare payment rates for kidney dialysis. As an example of how far removed from understanding the needs of the community such large industry companies are, a spokesman for the electricity industry said these Clean Air Act changes would “help keep citizens' lawsuits from obstructing new technologies.” The Natural Resources Defense Council, on the other hand, said these rules would “force Americans to choke on dirtier air for years to come, unless Congress or the new administration reverses these eleventh-hour abuses."
.
The Clinton administration made a large-scale effort to put in place increased consumer protections in many areas of industry just before it left office as well. However, many were not completed by the time the Bush Administration took office. The day after the Bush inauguration, the new President’s chief of staff issued an order stopping work on over 250 such regulatory improvements.
.
With a new administration arriving in Washington, COTT sees 2009 as an opportunity to seriously reform the FDA and restore it as an independent body committed to ensuring the safety of the drugs, medical devices and biologics that many of our community depend on for their health and wellness. While there continue to be many good and effective public servants at the FDA, the Bush Administration has done serious damage to the entire health structure, especially the Food & Drug Administration and the Centers for Disease Control & Prevention (CDC), as well as the all-important Public Health Service (PHS). We remain hopeful that the time is now to demand an independent and fully funded and staffed FDA
.
Our regular feature of excerpts from recent FDA Enforcement Reports can be found at the end of this Update as Attachment #1.
.
.
> INDUSTRY
.
A year and a half ago, a new organization was presented to the hemophilia community, a product of the Alliance and affiliated 340b HTCs, called ATHN – the American Thrombosis and Hemophilia Network. COTT was deeply concerned about the way in which this was thrust on the community, especially given its proposed method of ‘extracting’ health information from HTC clients, and plans, first suspected then confirmed, to sell the subsequently compiled databases to insurers, manufacturers and the like.
.
We posed several questions to them in April of last year, and received their responses some months later. We printed our letter, but have been delayed in printing their responses, and our comments on them, due to alarms last year concerning Wellpoint and Precision Rx’ strong actions against people with hemophilia in 14 states, urgent demands on resources concerning state fiscal and program crises, and other matters.
We did attend last October what we thought was to be a Consumer ADVISORY Committee which ATHN had formed; instead it was a Community LIAISON Committee -- ATHN considered federal agencies to be some of the communities involved, so in fact true consumer community representatives had little voice. COTT made three points there:
· objection to the entire development of the organization in secret from the community in 2006 and 2007, and, related to that,
> objection to the strongly overlapping Boards of Directors of ATHN, the
Alliance, and Federal officials running the Regional HTC programs
· objection to the lack of safeguards protecting clients from misrepresentation and/or retribution in the process of obtaining permission for access to their medical records, and
· objection to the plans, not admitted during the first year of public information about ATHN but confirmed at this meeting, to sell health profile information on the hemophilia community to insurers and/or others who might use it to restrict choice and access, when a) the consumers are asked for it with the promise that it will be only used to advance health research in general, and b) none of the proceeds would be returned to the community.
.
The second annual meeting was held October 29th in Atlanta; COTT staff Dave Cavenaugh and board member Chris Templin attended. As two of the federal agencies could not attend, the three consumer groups made up a larger proportion both of those present and those who were verbal. After a 10-minute welcome and a 15-minute overview of progress and plans, the committee was bundled into a bus, driven cross-town to the CDC ‘campus,’ and shown … a computer room. Adding such a time-consuming trip to a tight agenda was apparently done to allay concerns that the data from ATHN extraction from HTC patients would not be safe from outsiders while stored at CDC. It did nothing however to allay the very strong concerns that even once encrypted and stored, datasets from this database will be sold to private insurers and others.
.
Drafts of patient permission forms, sent to the members for review in advance of the meeting, were then reviewed. Throughout, those who decline to agree to letting their personal medical records go into this to-be-marketed database were identified not as having declined, but as having refused. This much stronger term implies that the signer has almost a hostility to the enterprise, which may be a strong overstatement of the reality of the situation. “Decline” is a more neutral and much more commonly used term in such situations.
.
The meeting also included a lengthy discussion, led by a representative of one of the federal agencies, of the need for patient consent, a major sticking point for COTT as well. ATHN staff and board members present responded by indicating that there was no requirement for them to develop a consent form; they were only providing consent forms in order to remain transparent! This stance, patently incorrect, could unfortunately mean that, as the program develops, ATHN would approve of HTCs collecting the data without consent.
.
COTT believes this strong bias against the clients of the HTCs participating stems from the decisions early in the program to include no clients or their representatives, in the program’s design. This may not have even been a conscious decision; the players operate in such isolation from the clientele of their programs and the needs and interests they and their families represent, that the thought of considering their views never occurred to them.
.
.
> COALITIONS
.
COTT continues to work with local organizations in order to move the grass-roots hemophilia / bleeding disorders community agenda. We are also working to reinvigorate the Plasma Users Coalition, first formed in the 1990s, in order to ensure that our collective chronic disease communities have a voice in the national healthcare debate. It is imperative that we work to bridge our differences to ensure that our collective community is able to impact the national debate. At the local level we are working closely with NEHA, the Southern California Hemophilia Foundation (SoCal), and a local grass-roots formation in Southern California called Hombre. We continue to work with NHF and HFA on issues that we are in agreement about. COTT will hold a Town Meeting at the Denver NHF Annual Meeting Nov.13-16, Friday night at 6:30 PM in Room 103 of the Convention Center. We urge people to attend, as we will be discussing a number of critical issues and challenges facing our community.
.
Standards of Care, Standards of Service
.
In 2000, the New Jersey Legislature passed and then-Governor Whitman signed into law SB 786, An Act Concerning Health Care Coverage for Treatment of Hemophilia. This language, spearheaded by HANJ, was designed to set a minimum level of care which would have to be met by any provider serving people with hemophilia in New Jersey.
The law has been augmented since passage by other stipulations, but has stood the test of time, becoming known as the “New Jersey Standard of Care” provisions (or requirements).
.
Over the last three years, another effort, originating with the Wisconsin chapter’s Advocacy Committee, has emerged. The draft was circulated for comment, NHF held a national meeting with a broad cross-section of the community to discuss it, and, after almost a half-year of review, MASAC endorsed it last spring, with modifications.
.
Along the way there arose considerable opposition to the new draft. Adherents to the New Jersey language contended that it represents a standard of excellence, and were the other one adopted, organizations would relax the level of care they provide, to meet only the lesser standard.
.
To many, it appeared that the two simply separately defined the capacities of the two major methods of provision of hemophilia care in this country: The New Jersey document describes what home care vendors must be capable of, and the Wisconsin one, what Hemophilia Treatment Centers (HTCs) can be expected to provide. However, this duality was resisted by advocates on both sides of the issue. In the end, a difference in nomenclature was used for simple distinction: The New Jersey document defines “Standards of Care,” and the Wisconsin document defines “Standards of Service.” Even that distinction, however, is waning in usefulness, particularly as state-level efforts to avoid single-provider insurance arrangements increase.
.
Conventionally, the term “Standard of Care” refers not to the mechanics of provision of treatment, but to current recognized treatments as part of clinical care. For hemophilia, these are under the purview of the National Heart, Blood and Lung Institute (NHLBI) of the National Institutes of Health (NIH). Although NHLBI has issued full Clinical Practice Guidelines for only a few conditions, not including hemophilia at present although recently von Willebrand’s Disease guidelines were added to this short list, it does offer patient information on hemophilia, including treatments. Preference for recombinant over plasma-derived factor is explained, as is use of prophylaxis where practical, especially for children. These treatment recommendations for hemophilia care can be found here.
.
Differences between the two approaches
.
The two documents are included in Attachment #2 to this Update in their entirety, for your perusal. In both cases, introductory material prepared by the sponsoring organization has been deleted, in order to focus more explicitly on the language of the documents themselves.
The table on page 11 (readers receiving this Update in plain text are invited to contact COTT for a copy) summarizes the requirements of each for eight areas of operation:
.
• Substitution • Recordkeeping/Recall Ability
• Choice of Product • Reimbursement Assistance
• Timeliness of Delivery • Medical Waste Disposal and
• Knowledge & Experience • Nursing
.
While the summary statements in the chart cannot capture every stipulation given, it does indicate many similarities between the requirements of the two documents. Since both are now acknowledged models, chapters and organizations will likely be using either one, or drawing desired points from both, as efforts to ensure adequate care continue.
.
As the third-party payer and State Medicaid landscape continues to deteriorate, Standards of Care and /or Service become more and more important if we are to protect our treatment and care. Will we be proactive and organized, or will the community face and be forced to accept terms dictated by the payers? Some in the community may already believe that any such challenges we face from private payers and state Medicaid programs are so-called ‘done deals,’ that we should do our best to live with them, to make them work. This is a critical period in the community’s history and it is going to require a strong grass-roots effort if we are to protect the gains we have made. In the current fluid environment, there is no more important time than now for the grass-roots voice to be heard.
.
.
> CLINICAL UPDATE
.
In the February 2008 Update we reported on a statement released by the Federal Commission on AIDS of Switzerland. It announced that, based on a review of four studies, it could be safely said that HIV-positive individuals in sero-discordant (HIV+/HIV-) relationships, who have been on AIDS Anti-Retroviral medications successfully for at least six months, and who have an undetectable HIV viral load, could consider unsafe sex to be of extremely low risk for HIV transmission. That study sparked serious controversy in the global AIDS community and warnings from the British Health Ministry and other governments.
.
In August French researchers released a similar but somewhat conflicting study on sero-discordant couples and unprotected sex. Out of 145 men, seven were found, despite having un-measurable viral load in their bloodstream, to have HIV virus in their semen. The French study would appear to contradict the conclusions of the Swiss HIV Commission. However, the presence of HIV in semen in an individual does not necessarily correlate with transmission, as the detectable HIV could be the result of either active virus or inactive viral particles. And, although the correlation between semen viral load and HIV transmission appears logical, there is insufficient data available to make any serious conclusions. Certainly, if even one instance of transmission had occurred in the four studies reviewed by the Swiss Commission, it would not have endorsed unprotected sex in serodiscordant couples in any way. COTT continues to believe that the choice of sexual practices is between a couple and their doctors. However, given the current debate, we would continue to recommend the use of condoms in serodiscordant couples.
.
In the September Update, the warning about Phosphocol used in radiosynovectomies contained a recommendation to discontinue use of (do not elect to have) radiosynovectomies altogether. It should instead have read discontinue use of only radiosynovectomies in which Phosphocol would be used.
.
.
BLOOD SAFETY SUMMARY
.
The Supreme Court may be headed for completion of a trio of decisions this year and next which could prohibit liability suits against blood products manufacturers because they are FDA-licensed.
Selections from current FDA Enforcement Reports are included in this Update as Attachment #1.
COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network
in publication of this issue of the COTT Washington Update.
Comparison of New Jersey, MASAC Standards of Care
| | | | |
| | | | | | | | | |
Topic
|
|
| New Jersey
|
|
|
| MASAC
|
|
|
| | |
| | |
| | | |
Substitution
| | • Prohibitions on substitution of blood products
|
| • Fill prescriptions promptly, as written, within 10% of
|
| | | without prior approval of the attending physician
|
| prescribed assay. Changes/substitutions only per the
|
| | |
| | |
| MD. If no brand specified, ask the physician.
|
| | |
| | |
| | | |
choice of product
| | • Provide all brands of clotting factor products, in
|
| • Provide the full range of available concentrates, in-
|
| | | S/M/L assays, and all needed ancillary supplies
|
| cluding all available assays and vial sizes, and ancil-
|
| | |
| | |
| laries. Use of short date products need MD, patient OK
|
| | |
| | |
| | | |
timeliness of delivery
| • Deliver prescribed blood products within three hrs,
|
| • Regular Rx delivered in 48 hrs. Open during business
|
| | | have 24-hour on-call service to accommodate this
|
| hours, service within 3 hrs. 24-hr interpreters. Have
|
| | |
| | |
| natural disaster plan for meeting these requirements
|
| | |
| | |
| | | |
Knowledge & Experience
| • Demonstrated experience with and knowledge of
|
| • Knowledge sufficient to follow physician instructions,
|
| | | bleeding disorders and the management thereof
|
| assure high quality services
| |
| | |
| | |
| | | |
Recordkeeping, recall ability
| • Demonstrated record keeping ability, and the ability
|
| • Accurate, compliant system. Info available to MD, patient
|
| | | to expedite product recall notifications;
|
| Ability to trace vials to consumers
| |
| | |
| | |
| | | |
Reimbursement assistance
| • Assist covered persons in obtaining third party
|
| • Explain caps, co-pays/deductibles on 1st order
|
| | | Reimbursement
| | |
| and annually. Cost per unit info for patient
|
| | |
| | |
| | | |
Medical Waste Disposal
| • Proper removal and disposal of hazardous waste
|
| • Provision of and knowledge about containers for the
|
| | | pursuant to State and federal law.
| |
| disposal of hazardous waste.
| |
| | |
| | |
| | | |
Nursing
| | | • Provision or coordination of nursing services
| | |
| |
| | |
| | |
| | | |
.
.
Attachment #1: Recent FDA Enforcement Report excerpts
.
October 1, 2008
.
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0651-08
CODE
Unit: 9953790, Part 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 12, 2007. Firm initiated recall is complete.
REASON
Platelets, with insufficient plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0654-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0655-08;
c) Platelets Leukocytes Reduced, Recall # B-0656-08
CODE
a), b) and c) Unit: 019GH77240
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone and facsimile on April 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2046-08
CODE
W045005107990
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, electronically on April 10, 2006. 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
Switzerland
PRODUCT
Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII: C Pasteurized Monoclonal Antibody Purified; an Rx product, for intravenous administration only, store at 2-8 degrees C, US License No. 1767; NDC #0053-7656-04, Recall # B-1892-08
CODE
Lot numbers: J91504, exp. April 25, 2010; J91604, exp. April 30, 2010; J91705, exp. May 02, 2010; J91806, exp. June 9, 2010
RECALLING FIRM/MANUFACTURER
CSL Behring LLC, Kankakee, IL, by telephone and follow-up recall letters dated August 18, 2008. Firm initiated recall is ongoing.
REASON
Monoclate-P lots, which did not meet the potency assay requirements for stability testing at 3 months at 5 degrees C storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
650 vials
DISTRIBUTION
CA, FL, GA, KS, ND, PA, Trinidad and Tobago
.
.
October 8, 2008 – NONE
.
.
October 15, 2008
.
.
PRODUCT
Source Plasma, Recall # B-0035-09
CODE
Units: KP101203, KP101459, 06MTNA3176, and 06MTNA2955
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on December 5, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0036-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0037-09;
c) Fresh Frozen Plasma, Recall # B-0038-09
CODE
a) and c) Unit 6829803; b) Unit 1006583
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on October 29, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma, Recall # B-0045-09
CODE
Unit: 363017769
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on September 22, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not have a complete annual physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0047-09
CODE
Units: 363017557, 363017312, 363016769, 363016547, 363015954, 363015705, 363015149, 363014879, 363012291, and 363009637
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on September 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0101-09;
b) Fresh Frozen Plasma, Recall # B-0103-09;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0104-09;
d) Fresh Frozen Plasma (Apheresis), Recall # B-0105-09;
e) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0106-09;
f) Plasma Frozen, Recall # B-0107-09;
g) Platelets Pheresis Leukocytes Reduced, Recall # B-0108-09;
CODE
a) Units: FE26631 FE26638 FE26641 FE26644 FE26649 FE26652 FE26659 FE27395 FE27399 FE27402 FE27405 FE27411 FE28372 FE28375 FE28378 FE28380 FE28382 FE28387 FE28392 FE28393 FE29229 FE29232 FE29234 FE29237 FE29239 FE29242 FE29245 FE29246 FK15820 FK15821 FK15822 FK15823 FK15824 FK15825 FK15826 FK15832 FK16463 FK16464 FK16465 FK16466 FK16467 FK16468 FK16469 FK16470 FK16471 FK16472 FK16473 FK16474 FK16475 FK16476 FK16477 FK16793 FK16795 FK16796 FK16797 FK16798 FK16799 FK16800 FK16802 FP05891 FP05893 FP05896 FP05899 FP05901 FP05902 FP05904 FP06066 FP06068 FP06069 FP06070 FP06071 FP06072 FP06074 FP06075 FP06076 FP06077 FP06078 FP06080 FY11402 FY11405 FY11406 FY11473 FY11474 FY11476 FY11477 FY11478 FY11479 FY11481 FY11482 FY11484 FY11485 FY11487 FY11506 FY11507 FY11508 FY11509 FY11511 FY11512 FY11514 FY11518 FY11519 FY11520 FY11521 FY11522 FY11524 FY11541 FY11542 FY11543 FY11544 FY11546 FY11548 FY11549 FY11550 FY11551 FY11576 FY11577 FY11578 FY11580 FY11581 FY11582 FY11583 FY11584 FY11585 FY11586 FY11587 FY11588 FY11589 FY11590 FY11591 FY11592 FY11593 FY11594 FY11595 FY11596 FY11597 FY11598 FY11599 FY11601 FY11602 FY11603 FY11604 FY11605 FY11606 FY11607 FY11608 FY11644 FY11645 FY11646 FY11647 FY11648 FY11650 FY11651 FY11652 FY11653 FY11654 FY11655 FY11656 FY11657 FY11658 FY11659 FY11660 FY11661 FY11662 FY11663 FY11666 FY11667 FY11668 FY11967 FY11968 FY11969 FY11970 FY11972 FY11973 FY11974 FY11976 FY11977 FY11978 FY11979 FY11980 FY11981 FY11983 FY11984 FY11986 FY11987 FY11988 FY11989 FY11990 FY11991 FY11999 FY12000 FY12001 FY12008 FY12009 FY12010 FY12011 FY12014 FY12017 FY12018 FY12019 FY12020 FY12021 FY12022 FY12023 FY12024 FY12025 FY12026 FY12027 FY12028 FY12029 FY12030 FY12031 FY12032 FY12033 FY12034 FY12035 FY12036 FY12037 FY12038 FY12039 FY12040 FY12041 FY12042 FY12071 FY12072 FY12073 FY12076 FY12078 FY12079 FY12080 FY12081 FY12083 FY12084 FY12086 FY12087 FY12088 FY12089 FY12090 FY12091 FY12092 FY12093 FY12094 FY12095 FY12096 FY12097 FY12098 FY12101 FY12102 FY12111 FY12112 FY12113 FY12114 FY12115 FY12116 FY12118 FY12119 FY12121 FY12122 FY12123 FY12124 FY12125 FY12126 FY12127 FY12128 FY12129 FY12130 FY12131 FY12133 FY12144 FY12145 FY12146 FY12147 FY12148 FY12149 FY12150 FY12151 FY12152 FY12153 FY12154 FY12155 FY12156 FY12158 FY12159 FY12160 FY12161 FY12162 FY12163 FY12164 FY12165 FY12166 FY12167 FY12168 FY12169 FY12186 FY12187 FY12188 FY12189 FY12190 FY12192 FY12193 FY12194 FY12195 FY12196 FY12223 FY12225 FY12226 FY12227 FY12228 FY12229 FY12230 FY12232 FY12233 FY12234 FY12235 FY12236 FY12247 FY12248 FY12249 FY12250 FY12251 FY12252 FY12253 FY12254 FY12255 FY12256 FY12257 FY12258 FY12259 FY12260 FY12261 FY12262 FY12263 FY12265 FY12266 FY12268 FY12284 FY12285 FY12286 FY12287 FY12288 FY12289 FY12290 FY12291 FY12292 FY12293 FY12294 FY12295 FY12296 FY12297 FY12298 FY12311 FY12312 FY12314 FY12315 FY12316 FY12317 FY12318 FY12323 FY12324 FY12370 FY12371 FY12372 FY12373 FY12374 FY12375 FY12377 FY12378 FY12379 FY12383 FY12384 FY12385 FY12387 FY12389 FY12390 FY12391 FY12392 FY12393 FY12394 FY12395 FY12396 FY12397 FY12398 FY12399 FY12400 FY12401 FY12402 FY12404 FY12405 FY12406 FY12407 FY12408 FY12409 FY12410 FY12411 FY12412 FY12413 FY12443 FY12444 FY12445 FY12446 FY12447 FY12448 FY12449 FY12450 FY12452 FY12453 FY12454 FY12467 FY12469 FY12471 FY12472 FY12473 FY12474 FY12475 FY12476 FY12477 FY12478 FY12479 FY12481 FY12482 FY12483 FY12496 FY12497 FY12498 FY12499 FY12500 FY12501 FY12502 FY12503 FY12504 FY12505 FY12506 FY12507 FY12508 FY12510 FY12511 FY12512 FY12513 FY12514 FY12515 FY12516 FY12517 FY12518 FY12519 FY12520 FY12521 FY12522 FY12523 FY12541 FY12542 FY12543 FY12544 FY12545 FY12546 FY12547 FY12548 FY12549 FY12550 FY12551 FY12552 FY12553 FY12554 FY12555 FY12556 FY12566 FY12567 FY12568 FY12569 FY12570 FY12571 FY12572 FY12573 FY12574 FY12575 FY12576 FY12577 FY12578 FY12579 FY12581 FY12582 FY12583 FY12585 FY12586 FY12587 FY12589 FY12590 FY12591 FY12615 FY12616 FY12617 FY12618 FY12619 FY12620 FY12621 FY12622 FY12623 FY12624 FY12625 FY12626 FY12641 FY12642 FY12643 FY12644 FY12645 FY12646 FY12647 FY12649 FY12650 FY12651 FY12652 FY12653 FY12654 FY12655 FY12656 FY12657 FY12658 FY12659 FY12669 FY12670 FY12671 FY12673 FY12674 FY12675 FY12676 FY12677 FY12691 FY12692 FY12693 FY12694 GG11191 GG11200 GG11207 GG11217 GG11222 GG11225 GG11235 GG11246 GG11257 GG11267 GG11270 GG11361 GG11370 GG11379 GG11383 GG11396 GG11406 GG11431 GG11436 GG11444 GG11448 GG11455 GG11463 GG11547 GG11552 GG11561 GG11567 GG11574 GG11578 GG11582 GG11594 GG11600 GG11607 GG13374 GG13378 GG13388 GG13395 GG13398 GG13401 GG13404 GG13407 GG13409 GG13456 GG13458 GG13462 GG13465 GG13470 GG13472 GG13476 GG13482 GG17586 GG17590 GG17593 GG17600 GG17604 GG17609 GG17615 GG17621 GG17622 GG17624 GG17627 GG17629 GG17633 GG17638 GG17648 LC68413 LC68432 LC68436 LC68439 LC68443 LC68446 LC68643 LC68645 LC68646 LC68647 LC68653 LC68654 LC68669 LC68671 LC68672 LC68989 LC68997 LC69000 LC69009 LC69014 LC69043 LC69046 LC69048 LC69049 LC69051 LC69053 LC69065 LC69067 LC69070 LC69075 LC69079 LC69081 LC69083 LC69084 LC69085 LC69173 LC69177 LC69180 LC69182 LC69185 LC69188 LC69238 LC69242 LC69244 LC69251 LC69271 LC69292 LC69295 LC69296 LC69309 LC69312 LC69314 LC69316 LC69319 LC69320 LC69451 LC69452 LC69516 LC69520 LC69525 LC69535 LC69573 LC69583 LC69592 LC72836 LC72839 LC72840 LC72846 LC72848 LC72849 LC73053 LC73059 LC73062 LC73065 LC73069 LC73080 LC73085 LC73086 LC73096 LC73300 LC73301 LC73305 LC73307 LC73309 LC73313 LC73319 LC73322 LC74676 LC74679 LC74680 LC74682 LC74685 LC74688 LH88814 LH88819 LH88823 LH88827 LH88838 LH88839 LH88844 LH88855 LH88856 LH88860 LH88862 LH88867 LH88872 LH88875 LH88952 LH88956 LH88964 LH88966 LH92337 LH92341 LH92346 LH92357 LH92363 LH92366 LH92387 LH92391 LH92403 LH92409 LH92412 LH92423 LH92427 LH92432 LH92437 LH92442 LH92806 LH92814 LH93018 LH93021 LH93025 LH93030 LH93034 LH93040 LH93042 LH93046 LH93048 LH93051 LH93057 LH93060 LH93063 LH93186 LH93188 LH93193 LH93257 LH93259 LH93262 LH93265 LH93269 LH93277 LH93279 LH93281 LH93284 LH93289 LH93290 LH93294 LH93297 LH94860 LH94873 LH94877 LH94881 LH94885 LH94929 LH94949 LJ69916 LJ69923 LJ69927 LJ69940 LJ69942 LJ69945 LJ69949 LJ69955 LJ69965 LJ69966 LJ69969 LJ70206 LJ70217 LJ70219 LJ70223 LJ70225 LJ70235 LJ70242 LJ70251 LJ70255 LJ70281 LJ70609 LJ70613 LJ70616 LJ70618 LJ70620 LJ70622 LJ70626 LJ70628 LJ70632 LJ70634 LJ70638 LJ70643 LJ70647 LJ70669 LJ70670 LJ70671 LX20707 LX20710 LX20714 LX20716 LX20718 LX20720 LX20723 LX20725 W 52829 W 52831 W 52833 W 52835 W 52837 W 52839 W 52844 W 52848 W 52850 W 52854 W 52855 W 53301 W 53302 W 53303 W 53306 W 53307 W 53309 W 53311;
b) Units: FE27402 FE27411 FE28392 FE28396 FE29232 FP05894 FP05904 FP06069
FY11473 FY11474 FY11475 FY11476 FY11477 FY11478 FY11481 FY11482
FY11484 FY11485 FY11487 FY11518 FY11519 FY11520 FY11521 FY11524
FY11576 FY11577 FY11578 FY11580 FY11581 FY11582 FY11583 FY11584
FY11585 FY11586 FY11587 FY11588 FY11589 FY11590 FY12018 FY12021
FY12041 FY12074 FY12076 FY12080 FY12096 FY12097 FY12098 FY12099
FY12100 FY12101 FY12112 FY12113 FY12114 FY12115 FY12116 FY12117
FY12118 FY12119 FY12120 FY12150 FY12259 FY12260 FY12261 FY12262
FY12263 FY12264 FY12265 FY12266 FY12268 FY12311 FY12312 FY12320
FY12467 FY12468 FY12474 FY12476 FY12477 FY12481 FY12482 FY12502
FY12544 FY12545 FY12546 FY12547 FY12548 FY12549 FY12551 FY12554
FY12555 FY12556 FY12568 FY12569 FY12570 FY12571 FY12572 FY12573
FY12577 FY12579 FY12581 FY12582 FY12583 FY12585 FY12586 FY12587
FY12589 FY12590 FY12591 FY12657 GG13458 GG13470 GG13472 LC69043
LC69048 LC69177 LC69180 LC69182 LC69185 LC69238 LC69242 LC69271
LC69292 LC69295 LC69296 LC69308 LC69309 LC69312 LC69314 LC69316
LC69319 LC69320 LC69518 LC69525 LC69535 LC69592 LC73300 LC73301
LC73305 LC73307 LC73309 LC73313 LC73319 LC73322 LC74679 LC74680
LC74685 LH88872 LH88956 LH92357 LH92376 LH92387 LH92419 LH92423
LH92442 LH92814 LH93179 LH93186 LH93193 LH94929 LH94949 LJ69965
LJ70647 LX20725 W 53306 W 53309 W 53311;
c) FE26655 FK16792 FP06073 FY11486 FY11513 FY11547 FY11664 FY11982
FY11985 FY12007 FY12012 FY12013 FY12015 FY12016 FY12074 FY12075
FY12085 FY12099 FY12100 FY12117 FY12120 FY12191 FY12320 FY12376
FY12386 FY12468 FY12648 FY12672 GG17617 LC68434 LC68667 LC69012
LC69172 LC69308 LC72834 LC72843 LC73071 LC73090 LH88812 LH92351
LH92371 LH92419 LH93179 LH94850 LJ69911 LJ70202 LJ70211 LJ70229
LJ70238 LX20712 LX20722 LX20727 W 52843 W 52852 W 53312;
d) Unit: P 80264;
e) Units: P 80226 P 80256 P 80257 P 80264 P 82582;
f) Units: FY12157 LH88844 LH93046 LJ69940;
g) Units: P 80137 P 80221 P 80221 P 80223 P 80223 P 80224 P 80224 P 80225 P 80225
P 80226 P 80227 P 80228 P 80228 P 80229 P 80229 P 80230 P 80256 P 80257
P 82575 P 82582
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Wichita, KA, by telephone on June 2, 2007 and later by fax. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1,769 units (including Recall # B-0102-09 – Class III)
DISTRIBUTION
AL, KS, OK, TX, TN, MO, PR, AR, IL, CA, MI and Switzerland
___________________________________
PRODUCT
Source Plasma, Recall # B-0039-09
CODE
Unit: 06MTNA2590
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on August 8, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donors who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0043-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0044-09
CODE
a) Unit: 0126589;
b) Unit: 1004595
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on April 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
.
.
October 22
.
.
PRODUCT
a) Red Blood Cells, Recall # B-0001-09;
b) Platelets, Recall # B-0002-09;
c) Fresh Frozen Plasma, Recall # B-0003-09;
d) Red Blood Cells Leukocytes Reduced, Recall # B-0004-09
CODE
a) Unit: 033GF06971;
b) and d) Unit: 033LV62427;
c) Units: 033GF06971, 033LV62427
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone/ facsimile on July 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing repeat reactive for the antibody to Hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CT
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0005-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0006-09;
c) Platelets; Recall # B-0007-09;
d) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0008-09;
e) Fresh Frozen Plasma (Apheresis), Recall # B-0009-09;
f) Platelets Irradiated, Recall # B-0010-09;
g) Platelets Pheresis Leukocytes Reduced, Recall # B-0011-09
CODE
a) Units: 6251508, 6249857, 6254792, 6248375, 6250131, 6251049, 6249880, 6251050, 6251053, 6249876, 6251052, 6251056, 6251044, 6251046, 6249882, 6257979, 6254800, 6249873, 6255146, 6248374, 6251509, 6254812, 6250152, 6255115, 6250149, 6248295, 6251054, 6251516, 6248143, 6253259, 6253076, 6254918, 6255224, 6253264, 6255131, 6255132, 6250365, 6249875, 6251051, 6249925, 6250368, 6250050, 6251042, 6250127, 6251512, 6254793, 6250129, 6250137, 6250216, 6250125, 6249859, 6257894, 6255117, 6253074, 6254923, 6254928, 6254710, 6254711, 6255162, 6251510, 6250153, 6251043, 6255070, 6257885, 6250128, 6248554, 6248417, 6248555, 6253266, 6250384, 6250383, 6252879, 6254925, 6257948, 6253075, 6250372, 6250215, 6257794, 6257863, 6250134, 6257890, 6251200, 6254976, 6257881, 6250285, 6254920, 6254911, 6254910, 6258035, 6251518, 6255153, 6251513, 6251514, 6250133, 6250144, 6250135, 6248045, 6254906, 6248499, 6253255, 6251511, 6253256, 6253257, 6248497, 6249858, 6253071, 6250150, 6253023, 6250270, 6255007, 6248533, 6253072, 6252877, 6253073, 6254908, 6257980, 6255151, 6254924, 6255213, 6255225, 6258030, 6254914, 6258033, 6254975, 6254985, 6254973, 6258170, 6257895, 6255116, 6255139, 6255145, 6257893, 6251036, 6251055, 6248265, 6251048, 6251045, 6248376, 6254722, 6251257, 6248424, 6254799, 6250005, 6250030, 6250107, 6249944, 6249885, 6250138, 6248425, 6248463, 6248492, 6249874, 6249881, 6249883, 6254749, 6252950, 6252961, 6252960, 6252962, 6251507, 6256481, 6251621, 6251520, 6251521, 6257897;
b) Units: 6249859, 6253331, 6250131, 6253329, 6249858, 6254792, 6253080, 6250129, 6250140, 6250152, 6250365, 6250366, 6255145, 6255152, 6250107, 6248375, 6249925, 6250368, 6254708, 6250383, 6250269, 6246410, 6246701, 6251202, 6248266, 6251045, 6249845, 6256508, 6249876, 6254920, 6256474, 6253073, 6252950, 6255225, 6249875, 6252951, 6249857, 6256739, 6251518, 6249883, 6256742, 6249873, 6248143, 6250375, 6254749, 6251194, 6249874, 6250391, 6252956, 6257893, 6254914, 6250370, 6253074, 6253144, 6254722, 6253165, 6256788, 6252976, 6250127, 6252979, 6257939, 6250379, 6257948, 6253160, 6255132, 6248295, 6255131, 6253179, 6258005, 6253253, 6256770, 6256791, 6256817, 6256814, 6256760, 6251257, 6254908, 6254911, 6253084, 6246711, 6246708, 6254910, 6257820, 6249909, 6247415, 6257671, 6256670, 6253202, 6253339, 6257681, 6256721, 6250168, 6254793, 6256815, 6256809, 6250142, 6258169, 6249843, 6256808, 6250138, 6250184, 6250135, 6250285, 6250161, 6250183, 6250126, 6250373, 6253182, 6253166, 6251052, 6251051, 6251044, 6253359, 6253366, 6258033, 6253077, 6253081, 6252903, 6253088, 6253132, 6253143, 6253082, 6254647, 6257691, 6250377, 6255004, 6250390, 6255162, 6250389, 6250388, 6258175, 6251510, 6253255, 6255151, 6250378, 6257895, 6250134, 6251451, 6250376, 6256467, 6250372, 6258030, 6252975, 6252955, 6252952, 6246415, 6252977, 6253334, 6251516, 6249880, 6253264, 6256527, 6258170, 6253133, 6251513, 6258029, 6253071, 6248324, 6253076, 6253338, 6251450, 6250374, 6248265, 6250137, 6251453, 6250128, 6257638, 6257818, 6250030, 6254694, 6255213, 6256671, 6248157, 6257897, 6250143, 6249906, 6250130, 6248466, 6256993, 6248554, 6253254, 6253340, 6249836, 6256727, 6255000, 6249854, 6250182, 6253350, 6256723, 6250172, 6257885, 6256816, 6248555, 6248425, 6250175, 6256707, 6255015, 6254995, 6246704, 6257822, 6254812, 6250216, 6251036, 6253328, 6254973, 6251200, 6251048, 6250384, 6255021, 6250380, 6254693, 6250381, 6250382, 6256716, 6253425, 6250385, 6254999, 6254996, 6254711, 6253083, 6252953, 6252954, 6252960, 6252961, 6256564, 6258006, 6256547, 6256528, 6257980, 6256472, 6257979, 6253180, 6257894, 6253256, 6255070, 6251242, 6257794, 6251252, 6253183, 6253089, 6253259, 6251297, 6254925, 6251509, 6256738, 6256722, 6250144, 6248323, 6250133, 6248326, 6248533, 6247383, 6248499, 6249884, 6249881, 6249885, 6255116, 6255115, 6256821, 6248376, 6248556, 6256898, 6250050, 6250148, 6250146, 6249832, 6248374, 6250125, 6251449, 6248497, 6249944, 6255078, 6254649, 6254645, 6254644, 6254648, 6254976, 6257641, 6250386, 6248424, 6250151, 6254985, 6249882, 6257682, 6254646, 6254918, 6254924, 6254928, 6255153, 6254929, 6256476, 6258035, 6256717, 6254922, 6254923, 6254906, 6254975, 6255117, 6257863, 6257668, 6256887, 6257823, 6255146, 6255139, 6257878, 6257890, 6257881, 6248325, 6251055, 6248045, 6251054, 6251053, 6251049, 6251046, 6251043, 6248417, 6251042, 6251050, 6251298, 6251253, 6251056, 6250215, 6254799, 6254800, 6253072, 6251204, 6254710, 6250140, 6250005, 6250139, 6250145, 6250150, 6250270, 6250153, 6248552, 6248463, 6250393, 6248492, 6249844, 6253177, 6253181, 6253257, 6253200, 6253201, 6253175, 6253131, 6252978, 6253174, 6253146, 6256563, 6253148, 6252962, 6256562, 6251517, 6251511, 6253337, 6251519, 6256517, 6256481, 6253070, 6253023, 6251520, 6253261, 6253330, 6253267, 6251621, 6253266, 6253079, 6254967, 6253332, 6250147;
c) Units: 6254646, 6248157, 6253330, 6253165, 6250107, 6254924, 6254985, 6254812, 6257878, 6253133, 6251516, 6253070, 6253072, 6251517, 6251450, 6253332, 6248265, 6248266, 6253329, 6253328, 6257820, 6256563, 6250138, 6248499, 6251511, 6251509, 6248497, 6254923, 6252962, 6255153, 6252961, 6252960, 6249858, 6257638, 6252513, 6248533, 6248374, 6258006, 6253179, 6253180, 6253177, 6251451, 6254693, 6255145, 6254694, 6254918, 6254973, 6256742, 6251194, 6250381, 6250382, 6255117, 6257794, 6251202, 6251520, 6256547, 6256467, 6256517, 6255131, 6251257, 6249883, 6250128, 6250129, 6250131, 6250135, 6250140, 6250137, 6250139, 6250005, 6256671, 6256739, 6255116, 6250147, 6256738, 6256815, 6255162, 6256788, 6254914, 6255224, 6256770, 6256809, 6256760, 6254976, 6256898, 6255139, 6256817, 6255146, 6248045, 6248376, 6248554, 6248417, 6250127, 6248463, 6249857, 6256528, 6253266, 6256527, 6253264;
d) Units: 6256449, 6256851, 6251276, 6251269, 6251283, 6251283, 6248384, 6236490, 6254663, 6236485, 6236490, 6251327, 6251121, 6252999, 6256456, 6248384, 6256449, 6236485, 6248584, 6248570, 6256851, 6248584, 6248570, 6256643, 6256445, 6236488, 6236488, 6254861, 6248586, 6256866, 6248586, 6236482, 6248598, 6251293, 6251128, 6251332, 6248573, 6251292, 6251327, 6248573, 6251121, 6248612, 6250193, 6257735, 6251288, 6253374, 6252857, 6256457, 6256456, 6251288, 6257735, 6257730, 6251269, 6251276, 6256445, 6252857, 6236484, 6256922, 6256922, 6257730, 6251098, 6251127, 6251127, 6255026, 6250359, 6250359, 6256595, 6254861, 6251279, 6251279, 6251287, 6255183, 6256595, 6236482, 6236491, 6248612, 6256831, 6236491, 6248601, 6251119, 6251119, 6252999, 6256459, 6254859, 6256459, 6254855, 6254859, 6254853, 6256457, 6254962, 6256878, 6255045, 6258105, 6256885, 6254945, 6254959, 6254954, 6254958, 6251332, 6251329, 6251293, 6251292, 6251287, 6254853, 6254855, 6236484, 6249990, 6250316, 6250315, 6248598, 6248600, 6248601, 6253000, 6253000, 6252985, 6252927, 6252851, 6252992, 6252982, 6252982, 6252985, 6252990, 6252990, 6252995, 6252995, 6252992, 6253374, 6252851, 6251470, 6253396, 6253396, 6253397, 6253397, 6253399, 6253399, 6251128, 6249985, 6248600;
e) Units: 6255034 (Part A and B);
f) Unit: 6250391;
g) Units: 6255196, 6255045, 6253290, 6253229, 6248517, 6248517, 6249985, 6249953, 6256946, 6254941, 6253227, 6251470, 6255031, 6255026, 6250323, 6254950, 6254941, 6258105, 6248524, 6249995, 6249959, 6254954, 6256689, 6256687, 6254934, 6256689, 6255196, 6255185, 6255183, 6256879, 6256879, 6256878, 6256872, 6257708, 6257708, 6254962, 6254962, 6254962, 6256872, 6255029, 6255035, 6256946, 6255034, 6255029, 6257708, 6258064, 6256885, 6256883, 6254952, 6256643, 6254952, 6254950, 6254949, 6254949, 6254954, 6254945, 6256687, 6254961, 6256872, 6254961, 6254959, 6254959, 6254959, 6256871, 6254934, 6256871, 6254958, 6256869, 6256866, 6251098, 6251103, 6251221, 6249990, 6250315, 6250193, 6250193, 6248523, 6249965, 6248524, 6251215, 6254834, 6248523, 6252927, 6252927, 6253243, 6252945, 6253227, 6251473, 6251473, 6253290, 6248524, 6249953
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on April 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
867 units
DISTRIBUTION
MS, AR, AL, CA, MI, FL, Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0072-09
CODE
Units: 7221567, 7213546, 3786729, 3780456
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile on August 16, 2006. 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
Austria
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0134-09;
b) Fresh Frozen Plasma, Recall # B-0135-09
CODE
a) and b) Unit: 2255344
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by letter on February 5, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been deferred due to high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0136-09;
b) Fresh Frozen Plasma, Recall # B-0137-09
CODE
a) and b) Units: 4016807
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by letter on February 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received the rabies vaccine within one year of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0012-09
CODE
Units: 6253120, 6252877, 6251521, 6251507, 6251508, 6253075, 6251512, 6251514, 6256474, 6257682, 6256517, 6257878, 6253143, 6253120, 6256791, 6253332, 6256887, 6257819, 6257818, 6248466, 6249906, 6256671, 6256674, 6254929, 6250142, 6250130, 6251519, 6249884, 6254915, 6252956, 6250380, 6250373, 6258005, 6250269, 6250374, 6250376, 6250366, 6250370, 6250375, 6250377, 6252955, 6251450, 6251449, 6251253, 6251453, 6251252, 6251242, 6251204, 6251202, 6251194, 6252951, 6252952, 6252953, 6250393, 6250391, 6250385, 6252979, 6252978, 6252977, 6250379, 6252976, 6252954, 6250382, 6251451, 6252975, 6250386, 6250388, 6250389, 6250390, 6250378, 6250381, 6253329, 6257691, 6253180, 6253181, 6253182, 6253200, 6253201, 6253202, 6253253, 6253254, 6253260, 6253261, 6253177, 6253328, 6253175, 6253330, 6257823, 6253331, 6257822, 6257820, 6253334, 6253337, 6253338, 6253339, 6253425, 6254644, 6248552, 6253267, 6253084, 6256472, 6256467, 6256527, 6256528, 6256547, 6256562, 6256564, 6253077, 6253079, 6253080, 6253081, 6253179, 6253083, 6254646, 6253088, 6253089, 6253131, 6253132, 6253133, 6253144, 6253146, 6253148, 6253160, 6253165, 6253166, 6253174, 6253082, 6256739, 6254645, 6256817, 6256816, 6256815, 6256814, 6256809, 6256808, 6256788, 6256770, 6256476, 6256760, 6248354, 6248556, 6248326, 6256738, 6249909, 6256670, 6250126, 6250139, 6250140, 6250143, 6250145, 6250146, 6250147, 6250148, 6250151, 6256742, 6246410, 6254647, 6254648, 6257681, 6254649, 6257671, 6254693, 6257668, 6254694, 6257641, 6254708, 6257638, 6256821, 6246407, 6255078, 6246415, 6246701, 6246704, 6246708, 6246711, 6247383, 6247415, 6248157, 6248266, 6248323, 6248324, 6248325, 6256898
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on April 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
183 units
DISTRIBUTION
MS, AR, AL, CA, MI, FL, Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0145-09
CODE
Units: 161678979 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on October 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, Enterococcus species, and coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS, AL
___________________________________
.
.
Attachment #2: Standards of Care / Standards of Service Documents
Below is the New Jersey law, the text of which is also accessible on the web at http://www.csg.org/programs/ssl/documents/Hemophilia.pdf (this is an Adobe file):
State of New Jersey
Chapter 121 of 2000
Section 1. [Short Title.] This Act may be cited as
“An Act Concerning Health Care Coverage for Treatment of Hemophilia”
Section 2. [Definitions.] As used in this Act:
a. “Blood Product” includes, but is not limited to, Factor VIII, Factor IX and cryoprecipitate; and
b. “Blood Infusion Equipment” includes, but is not limited to, syringes and needles.
Section 3. [Home Treatment For Bleeding Episodes Associated With Hemophilia:
Required Coverage.]
a. A carrier which offers a managed care plan that provides benefits or health care services, as applicable, for the home treatment of bleeding episodes associated with hemophilia, including the purchase of blood products and blood infusion equipment, shall comply with the provisions of this section. For the purpose of providing home treatment
services for bleeding episodes associated with hemophilia, the carrier shall be required to contract with, and exclusively use, providers that comply with standards adopted by regulation of the [state Department of Health and Senior Services] in consultation with the [Hemophilia Association of this state]. At a minimum, the standards shall require that each provider:
.
(1) provide services pursuant to a prescription from the covered person’s attending physician and not make any substitutions of blood products without prior approval of the attending physician;
(2) provide all brands of clotting factor products in low, medium and high assay range levels to execute treatment regimens as prescribed by a covered person’s attending physician, and all needed ancillary supplies for the treatment or prevention of bleeding episodes, including, but not limited to, needles, syringes and cold compression packs;
(3) have the ability to deliver prescribed blood products, medications and nursing services within [three hours] after receipt of a prescription for an emergent situation, and maintain 24-hour on-call service to accommodate this requirement;
(4) demonstrate experience with and knowledge of bleeding disorders and the management thereof;
(5) demonstrate the ability for appropriate and necessary record keeping and documentation, including the ability to expedite product recall or notification systems and the ability to assist covered persons in obtaining third party reimbursement;
(6) provide for proper removal and disposal of hazardous waste pursuant to State and federal law;
(7) provide covered persons with a written copy of the agency’s policy regarding discontinuation of services related to loss of health benefits plan coverage or inability to pay; and
(8) provide covered persons, upon request, with information about the expected costs for medications and services provided by the agency that are not otherwise covered by the covered person’s health benefits plan.
b. The [Department of Health and Senior Services] shall compile a list of providers who meet the minimum standards established pursuant to this section and shall make the list available to carriers and covered persons, upon request.
c. The [Department of Health and Senior Services], pursuant to [insert citation], shall adopt regulations to carry out the provisions of this section.
Section 4. [Clinical Laboratory Services At Outpatient Regional Hemophilia Care Center: Required Coverage.]
a. A carrier which offers a managed care plan shall provide payment for services to the clinical laboratory at a hospital with a State-designated outpatient regional hemophilia care center regardless of whether the hospital’s clinical laboratory is a participating provider in the managed care plan, if the covered person’s attending physician determines that use of the hospital’s clinical laboratory is necessary because:
.
(1) the results of laboratory tests are medically necessary immediately or sooner than the normal return time for the carrier’s participating clinical laboratory; or
(2) accurate test results need to be determined by closely supervised procedures in venipuncture and laboratory techniques in controlled environments that cannot be achieved by the carrier’s participating clinical laboratory.
b. The carrier shall pay the hospital’s clinical laboratory for the laboratory services at the same rate it would pay a participating clinical laboratory for comparable services.
c. The carrier shall retain the right to review all services provided pursuant to this section for medical necessity.
d. The [state Department of Health and Senior Services], pursuant to [insert citation], shall adopt regulations to carry out the provisions of this section.
Section 5. [Coverage for Hemophilia by Individual Health Insurers.]
Notwithstanding the provisions of [insert citation] to the contrary, no policy shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the policy meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all policies in which the insurer has reserved the right to change the premium.
Section 6. [Coverage for Hemophilia Services by Group Health Insurers.]
Notwithstanding the provisions of [insert citation] to the contrary, no policy shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the policy meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all policies in which the insurer has reserved the right to change the premium.
Section 7. [Coverage for Hemophilia Services by Small Employer Plan.]
Notwithstanding the provisions of [insert citation] to the contrary, no policy or contract shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the policy or contract meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all policies or contracts in which the carrier has reserved the right to change the premium.
Section 8. [Coverage for Hemophilia Services by Individual Health Policy.]
Notwithstanding the provisions of [insert citation] to the contrary, no policy or contract shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the policy or contract meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all policies or contracts in which the carrier has reserved the right to change the premium.
Section 9. [Coverage for Hemophilia Services by Hospital Service Corporations.]
Notwithstanding the provisions of [insert citation] to the contrary, no individual or group contract shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the contract meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all contracts in which the hospital service corporation has reserved the right to change the premium.
Section 10. [Coverage for Hemophilia Services by Medical Services Corporation.]
Notwithstanding the provisions of [insert citation] to the contrary, no individual or group contract shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the contract meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all contracts in which the medical service corporation has reserved the right to change the premium.
Section 11. [Coverage for Hemophilia Services by Health Service Corporation.]
Notwithstanding the provisions of [insert citation] to the contrary, no individual or group contract shall be delivered, issued, executed or renewed on or after the effective date of this Act unless the contract meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all contracts in which the health service corporation has reserved the right to change the premium.
Section 12. [Coverage for Hemophilia Services by HMO.]
Notwithstanding the provisions of [insert citation] to the contrary, a certificate of authority to establish and operate a health maintenance organization in this State shall not be issued or continued on or after the effective date of this Act unless the health maintenance organization meets the requirements of Sections 3 and 4 of this Act and the regulations adopted thereto. The provisions of this section shall apply to all enrollee agreements in which the health maintenance organization has reserved the right to change the schedule of charges.
Section 13. [Severability.] [Insert severability clause.]
Section 14. [Repealer.] [Insert repealer clause.]
Section 15. [Effective Date.] [Insert effective date.]
This ends the copy of the New Jersey law. Below is the MASAC 2008 Standards of Service:
MASAC Document #181
MASAC RECOMMENDATIONS REGARDING
STANDARDS OF SERVICE FOR PHARMACY PROVIDERS OF
CLOTTING FACTOR CONCENTRATES FOR HOME USE
TO PATIENTS WITH BLEEDING DISORDERS
The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) on April 17, 2008, and adopted by the NHF Board of Directors on June 15, 2008.
Patients with bleeding disorders require clotting factor concentrates for prevention and treatment of bleeding episodes. It is essential that any pharmacy provider dispensing clotting factor concentrates for home use provide services that meet the minimal standards delineated below.
A. Pharmacy Provider Staff Knowledge of Clotting Factor Concentrates and Ancillary Supplies
1. Pharmacy provider staff shall have sufficient knowledge and understanding of bleeding disorders to accurately follow the instructions of the prescribing physician and assure high quality service for the patient.
2. Pharmacy provider staff shall be experienced with filling and handling prescriptions for the full range of clotting factor concentrates.
3. Pharmacy provider staff shall be knowledgeable about necessary ancillary supplies.
4. Pharmacy provider staff shall be knowledgeable about containers for the disposal of hazardous waste.
5. Pharmacy provider staff shall direct patients to contact their established treating physicians for all medical and therapeutic questions. Pharmacy provider staff shall direct medical questions and
concerns of staff to the treating physician.
B. Clotting Factor Concentrates and Ancillaries
1. Pharmacy providers shall be able to provide the full range of available concentrates, including all available assays and vial sizes.
2. Pharmacy providers shall be able to provide all necessary ancillary supplies for administration of clotting factor concentrates. Examples of ancillary supplies include, but are not limited to: needles; syringes; gauze; anesthetic creams; sterile field pads; sterile gloves.
3. Pharmacy providers shall provide containers for the disposal of hazardous waste, and the
collection of such containers shall be arranged pursuant to state and federal law.
4. Some consumers of clotting factor concentrates require additional services, such as nursing
services. If the pharmacy providers do not offer these services directly, they shall coordinate with
the providing agencies to ensure that all of the patient’s needs are adequately met.
C. Processing of Prescription Orders
1. Pharmacy provider staff shall work with prescribing physicians to ensure that prescription orders are filled promptly.
2. Prescriptions of clotting factor concentrates shall be dispensed as written by the prescribing
physician. No changes or substitutions shall be made unless approved by the physician.
3. If the prescription does not indicate a specific brand name of product, the pharmacist shall ask the prescribing physician which product should be dispensed.
4. Filling of all prescription orders shall be within plus or minus 5-10 % of prescribed assays,
barring extenuating circumstances. This standard shall not be compromised by dispensing a
number of vials so excessive that it would compromise compliance or so low a dose that it would
compromise medical outcome.
5. Clotting factor concentrates shall have acceptable outdates based on diagnosis and frequency of treatment. Short-dated product (outdate within 6 months) shall only be dispensed after
consultation with both the prescribing physician and the patient in that order.
6. Pharmacy provider staff shall ascertain from patients and supply any required ancillary supplies.
D. Hours of Operation / Access to Staff
1. Pharmacy providers shall be open and available at a minimum during regular business hours in
their service area time zones. A pharmacy serving the 48 contiguous states will need to be open
from 9am until 8 pm Eastern Time, Monday through Friday, not including holidays.
2. Pharmacy provider in consultation with the treating physician shall have plan in place to ensure that, in case of emergent need, patient shall have access to factor concentrate within 3 hours of expressed need. If the pharmacy receives a call about an emergency situation, the treating physician should be notified.
3. Pharmacy provider staff shall have 24-hour access to multilingual interpreters.
E. Delivery
1. Orders from established patients shall be correctly filled and delivered within 48 hours from the time the order is placed.
2. Pharmacy provider in consultation with the treating physician shall have plan in place to ensure that, in case of emergent need, patient shall have access to factor concentrate within 3 hours of expressed need. If the pharmacy receives a call about an emergency situation, the treating physician should be notified.
3. Pharmacy providers shall have a plan in place to meet delivery requirements in the event of a
natural disaster.
4. Product shall be delivered to the location requested by the patient.
5. Shipping of all clotting factor concentrates shall meet all federally mandated standards, including those for temperature control.
6. Pharmacy providers shall adhere to all HIPAA confidentiality guidelines.
7. Pharmacy providers shall have an emergency contact number for customers to report problems
with deliveries.
F. Recordkeeping, Billing and Product Recall
1. Pharmacy providers shall have an accurate record-keeping system that meets state and federal
requirements. In addition, pharmacy providers shall have treatment prescription information
available for patients and prescribing physicians.
2. Pharmacy providers shall explain patient copay, deductible and coinsurance payment
responsibilities, and lifetime cap limits clearly at the time the first order is placed and annually
when updating insurance information, or sooner if there has been a change in insurance.
3. Pharmacy providers shall provide a statement of factor cost per unit dispensed to the consumer.
4. Pharmacy providers must be able to trace the path any bottle of clotting factor concentrate has
taken and the way it has been handled from the time it left the manufacturer until the time it is
delivered to the consumer.
5. Pharmacy providers shall participate in the National Patient Notification System for clotting
factor concentrate recalls.
GLOSSARY
EMERGENCY: a situation in which the patient’s condition requires immediate medical attention and/or treatment.
HOME USE: use of clotting factor concentrate in the home or another outpatient setting.
PHARMACY PROVIDER: an entity that dispenses clotting factor concentrates to patients for home use.
Attachment #3: COTT letter asking Senate Support for AIDS Memorial
Committee of Ten Thousand
Advocates for Persons with HIV/AIDS
236 Massachusetts Ave., NE · Washington, DC 20002
(800) 488-COTT · (202) 543-0988 · www.cott1.org
cott-dc@earthlink.net
Wednesday, November 5, 2008
Senator John Kerry
U. S. Senate
Washington D.C. 20510
Dear Senator Kerry,
The Committee of Ten Thousand and other national and local hemophilia based organizations represent the community hardest hit by the AIDS/blood epidemic of the 1980s and 1990s. Over 50 percent of the hemophilia community was infected with HIV/AIDS and/or hepatitis C through the infusion of tainted factor concentrates in the 1980s. While, for those with severe hemophilia, over 90 percent were infected with HIV/AIDS. We have already buried nearly eight thousand of our community members and the long-term survivors are now at serious risk. For many individuals and families devastated by HIV/AIDS, it would have been understandable to retreat inward to cope with this devastating illness and the reality that government and the medical establishment responded with indifference, inaction and sometimes outright hostility to the nightmare we were experiencing.
However as individuals and as a community, we picked ourselves up, and confronted the Pharmaceutical manufacturers, the government and the medical establishment. Our rallying cry became, “ we will not allow this to occur again”. As a small chronic disease community, we were told that the changes in the business of blood we sought “would never occur”. In retrospect the hemophilia community accomplished many of the objectives we set in the early 1990s. We gained appointments to the FDA, Blood Products Advisory Committee and through the assistance of Senators Kennedy and Graham, the all-important National Academy of Sciences, Institute of Medicine study, “HIV & The Blood Supply, An Analysis of Crisis Decision Making.” We also, through COTT’s initial efforts, and a subsequent six-year community-wide, grass-roots, initiative, gained the passage of the Ricky Ray Hemophilia Relief Fund Act of 1998. Following the IOM Report, COTT played a key community role in the establishment of the DHHS, Blood Safety & Availability Committee, the federal interagency planning committee for the nation’s blood supply, a structure long sought by the Committee of Ten Thousand.
Our community is the “canary in the coalmine,” the nation’s early warning radar for the AIDS/Blood epidemic. A role we had already been shouldered with regarding hepatitis C and the blood supply. From our perspective we shouldered this responsibility with a sense of dignity and a strong commitment to changing the business of blood in this country.
We acknowledge your support for the Ricky Ray Hemophilia Relief Fund Act of 1998 and our efforts to reform the FDA and the federal regulatory structure for blood and blood products. We are very appreciative of the open access your staff has provided, both in Washington D.C. and at your offices in Massachusetts.
For the last ten years COTT has been the focal point of a grass-roots initiative to establish a national, physical, memorial site to honor the thousands of our community members who have passed into the spirit world. In fact, October 5, 2008 was the tenth anniversary of this initiative. Many of the individuals involved in the initial round of meetings and conference calls have since passed into the spirit world. It is in their memory that the long-term survivors and their families continue this important community effort. For the Committee of Ten Thousand, New England is the logical region as Massachusetts is where COTT was founded and incorporated in 1989.
COTT is now working with other national and local New England hemophilia organizations to attain this physical site to commemorate and honor our community’s struggle with the AIDS/Blood epidemic.
We seek a statement of support from Senator Kerry regarding the establishment of this memorial and a grant/commitment of public land to site this place of honor and remembrance. As always we are appreciative of your ongoing support of our community and look forward to working with you on this important project.
On Behalf of COTT Co-Vice Presidents Mary Lou Murphy and Terry McNeill,
Yours In The Public Interest,
Corey S. Dubin
President
