Healthcare Crisis Hits Medicare Patients Needing Immune Globulin; Medicare Modernization Act Has Unintended but Devastating Repercussions for Seriously Ill Beneficiaries
Healthcare Crisis Hits Medicare Patients Needing Immune Globulin; Medicare Modernization Act Has Unintended but Devastating Repercussions for Seriously Ill Beneficiaries
16 May 05
Genetic Engineering News
Patient advocacy organizations are joining with the healthcare industry to alert the public and legislators to an emerging healthcare crisis that is likely to cost lives if Congress and the Centers for Medicare and Medicaid Services (CMS) do not act quickly.
The Immune Deficiency Foundation and The Neuropathy Association, two national patient advocacy groups, and FFF Enterprises Inc., a biopharmaceuticals distributor, have joined forces to send an emergency alert to Medicare policy makers and the public that new reimbursement rates for intravenous immune globulin (IVIG) are putting patients' lives at risk and increasing healthcare costs for taxpayers.
The January 1 congressionally mandated reduction in Medicare Part B reimbursement rates and the April 1 two-tier rates for liquid and lyophilized (powdered) IVIG established two rates for administering IVIG to patients, depending on where they receive treatment: in the physician office and at home, or in hospital outpatient settings. The new reimbursement methodology significantly lowers the rate paid to physician offices and homecare companies for IVIG infusions - at a time when IVIG prices are rising and supplies of some IVIG products are tightening.
The combination of reduced reimbursement, rising prices and tightening supply has created a dangerous situation in which seriously ill, low-income patients with primary immune deficiencies or neuropathies are struggling to maintain access to care - and in some cases are unable to obtain care, causing their health to deteriorate. Because private insurers typically follow Medicare's lead, the problem will likely expand to include private-pay patients who depend on IVIG infusions.
Patients at Risk
"This is a healthcare crisis for patients whose health - whose lives - depend on regular IVIG treatments," said Michelle Vogel of the Immune Deficiency Foundation, based in Towson, Md. "We have received over 300 phone calls from Medicare patients who can no longer receive their IVIG treatments in their physicians' offices, infusion suites or homecare settings (see attached testimonials). Many of these patients were referred to hospitals that cannot or will not provide their treatment, or that have waiting periods of up to six months. In six months these patients could be dead - essentially because of an inadequately informed decision to lower Medicare reimbursement rates!
"We are hoping that we can draw enough attention to this crisis," Vogel continued, "that CMS, with congressional support, will take immediate action and save these patients' lives."
Patients across the country are calling and writing their representatives, attempting to seek assistance on an individual basis to obtain treatment. Marsha Bond, who lives in Irving, Texas, is an immunodeficiency patient. She has missed her monthly IVIG infusion, and her physician has been unable to convince any of the local hospitals to treat her.
"I'm now two weeks late for my treatment," Bond said, "and I am definitely seeing and feeling the difference. I'm having a lot of symptoms ... I need the IVIG treatments; I'll just continue becoming more ill without them. On the other hand, we're exposed to lots of opportunistic germs in a hospital, more so than we'd encounter in the community, and many hospitals aren't equipped to administer infusions with the same level of expertise that we receive in the doctor's office. So, by going into the hospital to get our treatments, we're taking on a lot more risks at the same time that we're trying to get better. Of course, I can't get treated in any hospital right now, and I'm not sure what I'm going to do. But I can't believe people will sit by, knowing that people will die, before they fix this problem. I pray that not a single one does, but I don't know."
The new reimbursement rate is so low, that physicians cannot continue to provide patient care without putting their practices at financial risk (see attached testimonials). Across the country, physicians are now referring their patients to hospitals, where outpatient reimbursement is higher.
According to Dr. Mark Stein, an immunologist practicing in Palm Beach County, Fla., the reduction in IVIG reimbursement rates for physician offices is not resulting in reduced Medicare costs. "I have one immunodeficiency patient whose IVIG cost about $1,700 in my office," Stein said. "She just received a hospital bill pricing her IVIG at over $13,000! Any suggestion that Medicare reform is saving tax dollars is a fallacy."
Additionally, if primary immune deficient patients do not receive their IVIG, the secondary infections they will inevitably acquire result in additional healthcare costs, often including expensive hospitalizations.
Providing infusions in the hospital setting also poses additional challenges. Some hospitals are refusing patients, reportedly due to lack of adequate treatment facilities or inadequate IVIG supply. Most hospitals only purchase one type of IVIG (whatever is least expensive when the order is placed), resulting in patients being treated with an alternate product to that recommended by their physicians - and suffering the consequent dangerous adverse effects. And, expensive hospital co-pays are causing some patients to forego their IVIG treatments because they can't afford the higher payments.
One Florida patient, who prefers to use only her first name, Christina, is permanently disabled and on a very limited income. She is now facing hospital co-pays as high as $649, so she has gone without treatment since February, and her health continues to decline.
"At this point," Christina said, "I'm not going to the hospital for infusions because I can't afford to. If I won the lottery, I would, but I can't afford to waste money playing the lottery!"
The Source of the Problem
The unexpected consequences of the Medicare Modernization Act and the Part B rate reduction are due to the unique nature of the human plasma products market and a lack of policy makers' understanding of product supply dynamics, according to Patrick M. Schmidt, president and CEO of FFF Enterprises, the nation's largest distributor of IVIG. He equates current market conditions to the onset of an IVIG supply tightening. "Rising demand coupled with a stable production output is creating a tightened supply market," Schmidt explained. "We are seeing escalating prices in conjunction with tightening supplies against a backdrop of reduced reimbursement that, together, are creating this healthcare crisis. This means that physician offices and homecare companies have access only to products that are significantly higher in price than what Medicare now reimburses. The math is simple: It does not equate. And the human toll is just as simple, but wholly unacceptable: We will begin to lose patients if we do not act swiftly.
"The Medicare Modernization Act created two-tier pricing for the same treatment provided in different care settings," Schmidt continued, "and this is having a severe impact on patient care. Additionally, opportunistic distributors are taking advantage of the tightening supply by raising prices above the reimbursement rate for any healthcare setting. This is diverting the once-responsibly priced supply from where it is needed most."
Don Jacob, executive director of The Neuropathy Association, estimates about 5,000 neuropathy patients are treated with IVIG. He believes that the reimbursement problem reflects a lack of understanding about the diseases that are treated with IVIG and the settings in which treatment is delivered.
"Medicare's artificially created disparity in reimbursement rates for IVIG, based on the treatment setting, serves no purpose," Jacob declared. "Paying one kind of provider more than another does a disservice to the patients. It victimizes people who are already victimized by a disease. I know of one man who, without his IVIG, can't get out of bed. This is not like getting mumps. This disease determines if you can lift your arms and legs or not. We know that IVIG enables people, and then to deny them their treatment or make it difficult to obtain, I just don't get it. I cannot imagine that anyone who actually knows anything about this illness and the necessity for treatment would even consider doing what Medicare has done."
The Solutions
Dr. Daniel Suez is an immunologist, practicing in Irving, Texas. He has been treating primary immune deficient patients for 28 years. He wants a solution to the reimbursement problem that is realistic and best serves his patients. "I think the legislation needs to be rewritten," Suez explained, "to make it feasible for the reimbursement formula to reflect reality: the vacillating cost of the IVIG, the cost of the specialized equipment for administering it and the cost of the specialized nursing and physician skills needed."
Wanda Mench, a Medicare recipient with a chronic immunodeficiency, has been relying on charitable contributions to fund her hospital co-pay so she can continue to be treated. For her, the solution is a matter of making the patients' lives the priority. "All we can do is take it month to month, and try to get the legislation changed. We have to impress people we can't vote for, and that's hard to do. You feel like your hands are tied. They don't understand the consequences of the bills they are passing. The system just doesn't work right. When you have a committee that's making these decisions, it shouldn't matter where you live, whether you're a Democrat or a Republican. What should matter is that people's lives are at risk."
The Immune Deficiency Foundation (IDF) offers several solutions that would result in realistic Medicare rates, including encouraging CMS to declare a public he
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