Advocacy: Single Source Provider Policy : Hemophilia Federation of America

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Policy on Single Source Providers

The Hemophilia Federation of America (HFA) is adamantly opposed to any plan to implement a single source provider reimbursement program for anti-hemophilia factor concentrates. Single Source programs will not realize any cost savings and will cause needlessly prolonged and aggravated hemophilia induced bleeding. The result is additional and costly medical intervention which could have been avoided had the patient received proper product at the onset of a bleeding episode.

Hemophilia is a hereditary blood-clotting disorder that results in excessive bleeding which occurs either spontaneously or after injury. Hemophilia is treated with factor replacement therapies to compensate temporarily for the clotting factor the hemophilia patient is unable to produce. Clotting factor concentrates are available in plasma-based form (monoclonal factor) and a synthetic or recombinant analogue. The standard of care for patients with hemophilia is self-infusion clotting factor at the very outset of hemorrhaging, pursuant to a dosing schedule earlier prescribed by a physician. Therefore, the hemophilia patient or a family member may infuse the dose of clotting factor without costly and time consuming travel to a hospital, emergency room or doctor's office. Thus, self-infusion with clotting factor provides the fastest, most medically efficient treatment at costs much lower than traveling to the offices of physicians and/or hospitals.

Understandably, the Hemophilia Federation works to ensure that all hemophilia patients, in consultation with their doctors, have ready access to the choice of clotting product, the choice of treatment regimen, and the choice of provider to ensure the most effective and efficient treatment of hemophilia induced bleeding and attendant conditions. Our collective experience shows that access to the proper medications, including choice of the precise clotting factor that best treats a particular patient's condition, is not only the best treatment - treatment geared to the particular needs of each individual with hemophilia - but stops hemophiliacs' bleeding in the shortest amount of time, with the lowest possibility of re-bleeding, side effects, damage to immune systems and other factors that lead to additional, expensive medical interventions. Nonetheless, too often over the last 25 years, the hemophilia community has suffered because its right to choose the best health regimen for each individual patient has been challenged by industry and government officials who see only the very short term cost savings rather than the needless suffering and resulting additional medical care the costs of which quickly dwarf any short-term savings.

Why Single Source Provider Contracts are Detrimental for the Hemophilia Community

As earlier noted, hemophilia patients treat their internal hemorrhaging and other bleedings episodes by self-infusing clotting factor. Intravenous infusions of blood clotting products replace the missing or deficient proteins needed for the blood to clot. Infusions must be given as soon as possible after the start of a bleeding episode to minimize damage from the bleeding. Clearly, the longer bleeding lasts, the greater the amount of clotting factor will be required to stop the hemorrhaging and more hemorrhagic damage will result, likely resulting in additional medical costs for physical therapy, orthopedic treatment, weakened immune systems, pain killers and the like.

Alternately, due to their very frequent bleeding, some patients are prescribed doses of factor at regular intervals as preventative prophylaxis treatment. In addition, many patients develop antibodies known as "inhibitors," rendering substantial ineffective the very factor therapies that formerly prevented or stopped their bleeding episodes.

It is vital to note that there are different types of clotting factors because some types or forms of clotting factors may be significantly less effective than others in stopping a particular patient's bleeding. Likewise, some forms are more appropriate for patients with weakened immune systems. Along similar lines, patients coping with inhibitors will need increased amounts of factor concentrates as well as different brands. They must have access to different types of factor concentrates than those patients with the same type of hemophilia who have not developed inhibitors. In summation, sound, cost effective medicine has proven that a single type of factor cannot fit all hemophilic patients.

Understandably, each patient's expert medical treaters, such as a hematologist, will prescribe the type and quantity of clotting factor best suited to stop bleeding as quickly and completely as possible, taking into account the overall medical condition of the given patient. Therefore, a single source provider strategy threatens the efficiency - including economic efficiency - of medical treatment for the entire hemophilia community. Thus, a single source provider of anti-hemophilia concentrates could have a negative safety impact because:

Single source providers are not subject to any standards of care for product distribution. Patients could be limited by the providers as to what type of product to take and how many days a week a product will be covered, regardless of the treating physician's best medical opinions. Plasma-based anti-hemophilia factor concentrates are no longer the standard of care for hemophilia patients. If payors adopt that policy, patient care will be set back two decades.
Plasma based medicines can be dangerous for many in the hemophilia community coping with the effects of HIV/AIDS, Hepatitis C (HCV) and other infectious diseases because blood products contain extraneous materials that cause further complications of immune systems. This could lead to hospitalization stays and increased costs for extra medications to treat the effects of these deadly diseases.
The emergence of infectious diseases poses a continued threat to the hemophilia community. Only recently The hemophilia community was decimated by infection with HIV/AIDS and the Hepatitis C virus (HCV) which, at the beginning, industry and government officials reassured the community was not a significant threat. Scientists have yet to determine if many of these more prevalent infectious disease of our time are blood based pathogens such as new variant Creutzfeldt-Jacob Disease (nvCJD), West Nile Virus, and Severe Acute Respiratory Syndrome (SARS) as well as other emerging pathogens. By limiting choice of product to a single source and single type of product, the state could be creating a potential safety nightmare in the future. This would result in a repeat performance to a community still carrying scars from the first.

The adoption and implementation of single source providers by payors will be far from the economic cost-savers they are reputed to be for one clear reason: in a surprisingly short time, costs to the State and medical institutions resulting from the infirmities of single-source treatment will greatly overwhelm any very short term merger saving. These are very serious economic as well as health impacts to observe.

The hemophilia community is in a unique position to be able to receive its vital medical treatments in a home setting. A single source provider of anti-hemophilia concentrates will diminish competition of hemophilia home care providers thereby endangering access to product. If home care providers leave the market; hemophilia patients could be forced to receive their treatment in an emergency room or doctor's office setting. HFA has collected anecdotal but consistent and reliable evidence that too often emergency room settings provide poor hemophilia treatment. The standard of care as a response to trauma is to infuse with factor as soon as possible otherwise patients' health and lives are placed at risk. Moreover, even if properly done, ER care is much more expensive and slower than home infusion of clotting factor. There is no economic or medical rationale to channel hemophilia patients into ERs.
Single source providers are not only bad from a patient's health viewpoint but it can lead to increased costs because of the need for extra doses of medication, more numerous medications, more doctors, increased hospitalization times, more emergency room treatments, and greater loss of productivity. Any immediate savings would quickly be eclipsed by extraordinary and needless additional costs not only in terms of pain and suffering but also in terms of dollars for treatment.

A one-size fits all approach does not work for the hemophilia community. Access to the proper type of clotting factor is smart medicine, the efficiencies of which should not be threatened by a single source supplier's exclusive contract any one payor. Because the solicitation and implementation of single source provider contracts by various payors threatens continued access to care for the hemophilia patient community throughout the United States, The Hemophilia Federation of America emphatically urges the complete rejection of single-source funding and similar schemes.

Revised 8-08-06

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