In social sciences, unintended consequences describe the outcomes of actions that were not intended or foreseen. Sometimes these unintended consequences are helpful. However, sometimes they are harmful, as in the case of the article “Standard of care for lipedema in the United States,” published in Phlebology, The Journal of Venous Disease. We are sure that the authors of this document intended it to serve as a standard that would expand and improve the care of patients with lipedema. We are sure the authors did not intend to create a document used by insurance companies and independent review organizations to deny lipedema surgery coverage. We are also sure the authors did not intend to promote unsafe and ineffective lipedema surgery practices. Unfortunately, those are the unintended consequences of the “Standard.”
Simple Errors can have Serious Consequences
Coverlipedema.com has advocated for lipedema patients to have safe and effective lipedema surgery fully covered by insurance for six years. We have learned that health insurance companies do not really want to cover this disease. They have put forward every excuse, including that lipedema surgery is experimental, unproven, and purely cosmetic. They do not need much to be able to create reasons to deny coverage. A single mistake in the first line of the Introduction of the “Standard” is all that many insurers have needed. That line reads: Lipedema is a disease of fibrotic loose connective (adipose) tissue (LCT) on the lower abdomen, hips, buttocks, and limbs of females, sparing the trunk, hands, and feet. Anyone who knows lipedema would instantly see the error in the sentence (without having us bold it). Lipedema spares the upper torso but not the trunk. This error has led to the insurance denials of women seeking surgery to remove lipedema from their trunks. This has happened even though that line includes the abdomen, hips, and buttocks as affected areas! However, because the trunk includes the abdomen, hips, and buttocks, this uncertainty has allowed insurance companies to deny coverage and independent review organizations to defend those denials in appeals.
The Consequence of a Lack of Clarity
We have often encountered another issue with the “Standard” regarding insurance coverage. The “Standard’s” focus on the coincidence of joint hypermobility and lipedema has created another opportunity for insurance companies to deny coverage and for independent reviewers to support those denials. The authors of the “Standard” note in several places that women with lipedema also exhibit joint hypermobility but never make clear where this hypermobility occurs and imply that it mostly impacts the legs. While one section notes that only 50 percent of women with lipedema have this condition, the overall impression is that these are common comorbidities. This impression has led to further insurance denials based on the lack of patient hypermobility or that lipedema cannot affect the trunk, upper torso, or arms because of a lack of joint involvement.
Simple Errors and Lack of Clarity Harm the Usefulness of the “Standard”
We have been able to overturn most of these denials based on the “Standard,” even in cases where the decision is considered “final.” Unfortunately, these denials have caused a delay in care for the women who were denied and had to appeal. We have reached out to many of the authors, including Dr. Karen Herbst, with our concerns. We have never received a response to our request for correction or an explanation of how these errors could have passed by the eyes of the many authors of the “Standard.” Unfortunately, until corrections are made, insurance companies and independent review organizations will use the “Standard” to deny lipedema treatment. For this reason, we warn our members never to include the “Standard” in their preauthorization packages, and we request in advance that independent reviewers not refer to the article.
The Incomplete Standard of Care for Surgical Treatment
However, as much as the errors in the “Standard” have caused denials, we are more concerned that the “Standard” promotes unsafe and ineffective lipedema surgery. Coverlipedema.com is committed to the highest level of lipedema surgery performed by the most qualified surgeons in the most effective manner at the safest locations. For us, this means board-certified plastic surgeons with experience treating lipedema who operate in acute-care hospitals or equivalent settings and who use overnight observation in an appropriate facility to ensure the safety of their patients. This is especially important for lipedema patients who are in stage two and later. To reduce the number of procedures, these patients require large-volume liposuction, which means removing more than five liters of aspirate per procedure. Large-volume liposuction is safest when performed in an acute care hospital by a board-certified plastic surgeon. The “Standard” does not properly address the need for large-volume liposuction performed in hospital-level settings.
The Incomplete Recommendation of Surgeons
We believe that the knowledge, training, and experience of board-certified plastic surgeons best qualify them to perform large-volume liposuction safely and effectively. Coverlipedema.com relies on the American Society of Plastic Surgeons (ASPS) and its highly competent lipedema specialists to guide us in safe and effective lipedema removal surgery. Although dermatologists, OB/GYNs, vascular specialists, internal medicine doctors, and otolaryngologists perform lipedema surgery, they usually avoid hospitals because hospitals would not grant them privileges for liposuction procedures. The state of New York limits liposuction to plastic surgeons, dermatologists, and otolaryngologists who have hospital admitting privileges, even if they are not operating in a hospital. Several insurance companies, including Blue Cross Blue Shield of Michigan and of North Carolina, require plastic surgeons to perform lipedema surgery in their policies. The “Standard” does not indicate a preference of the surgeon to perform lipedema surgery, and it only mentions that it can be safely performed in an outpatient setting without regard to the amount of aspirate. Further, it states that “Lipedema reduction surgery utilizes suction lipectomy (liposuction), excision and manual extraction that spares blood and lymphatic vessels.” without noting that only plastic surgeons can perform skin excisions.
The Unintended Consequence of Failing to Set a Standard for Large-Volume Liposuction
Given the amount of fat, blood, and fluid removed in large-volume liposuction, The American Society of Plastic Surgeons (ASPS) published guidelines to determine safe practices in this situation in their Practice Advisory on Liposuction:
Regardless of the anesthetic route, large volume liposuction (greater than 5,000 cc total aspirate) should be performed in an acute-care hospital or in a facility that is either accredited or licensed. Postoperative vital signs and urinary output should be monitored overnight in an appropriate facility by qualified and competent staff who are familiar with perioperative care of the liposuction patient.
The “Standard” does note to “Consider overnight observation after surgery for significant comorbid medical illness or high-volume aspirate.” after stating that lipedema reduction surgery can be safely performed in an outpatient setting. Nevertheless, there is a significant difference between liposuction to remove two liters from an otherwise healthy early-stage lipedema patient and liposuction to remove 15 liters as a part of several staged surgeries for a patient with multiple comorbidities. This is not addressed in “Standard.” The failure to set a standard for large-volume liposuction is a crucial failure. Without a proper standard of care that lays out the need and the preference for large-volume liposuction to handle severe cases of lipedema, some surgeons who cannot remove large volumes will force patients to schedule far too many procedures in their office-based facilities. Instead of having three to six surgeries in a hospital, patients will be forced to have eight to ten or more separate surgeries in an office-based location that still do not include the skin excisions that will have to be performed by a plastic surgeon. Without a proper standard of care, patients cannot be aware that they are receiving the safest and most effective treatment for their disease.
The Unintended Consequence of Failing to Address Skin Excisions
Skin excisions are the removal of excess loose skin after liposuction. This is often needed by patients who suffer from later-stage lipedema. This procedure that can only be performed by a plastic surgeon. The “Standard” mentions excision once as a method of surgical treatment. It is not clear whether this means the widely discredited method of removing lipedema by direct excision of the lipedema tissue or if it means the removal of excess skin. Nevertheless, because it is not explained, an independent insurance reviewer used the lack of information about this common procedure to deny one of our member’s medically necessary skin excisions. While we were able to overcome this denial and have the patient’s skin excisions covered, we are still concerned about the future impact of this failure to address skin excisions.
Why is the Standard of Surgical Treatment Incomplete?
We cannot speculate on why the surgical treatment section of the “Standard” fails to properly address large-volume liposuction in a hospital setting. Unfortunately, the committee that wrote the “Standard” does not include board-certified plastic surgeons who regularly perform large-volume liposuction in a hospital setting. Although two of the surgeons are board-certified plastic surgeons, they mostly perform liposuction in their self-owned, office-based settings. The other surgeons are not board-certified plastic surgeons with lipedema-related hospital privileges. Given our knowledge of the likely author of the surgical treatment section, we are not surprised that it focuses on vascular issues and favors office-based surgery by non-plastic surgeons, rather than promoting safe and effective surgery performed by the best-qualified surgeons in the best locations with the best post-operative care.
Towards a Better Standard of Care
As lipedema patient advocates, we depend on physicians to prescribe the best treatments according to their abilities and judgment and to refrain from knowingly causing harm. We also rely on the motivation of physicians to pursue the best treatments for patients to treat this disease safely and effectively, and not on treatments that may be only convenient or profitable. While unintended consequences may arise from their actions, we hope they will quickly seek solutions to overcome them. The “Standard of care for lipedema in the United States” sets the lofty goal of an agreed description of lipedema and a consensus standard of care for the United States. Instead, it created a document with significant unintended consequences that harm lipedema patients. First, it has been used by insurance companies and independent review organizations to deny medically necessary care for lipedema patients. Second, it promotes unsafe and ineffective surgical treatment by failing to consider the importance of large-volume liposuction in an appropriate location. We hope that by pointing out these significant unintended consequences, the authors of this consensus document might move towards updating their work and creating a better standard of care for lipedema. In the meantime, we recommend that no one include the “Standard” in their insurance preauthorizations or appeals.