During the 2010 presidential campaign, Sarah Palin, the former governor of Alaska, quipped during a debate that then presidential candidate Obama's health care reform contained within it "death panels": bureaucrats with limited or no medical training making life and death decisions. She suffered interminable criticism for the comment and political fact checkers dubbed it the "lie of the year."
A diabetic foot ulcer (DFU) is a medical emergency. According to a 10 year Scandinavian study the presence of a DFU alone carries a 47% annual mortality rate. More importantly, 85% of amputations in people with diabetes are preceded by a plantar foot ulceration; and the mortality figures for the patient population with diabetes who undergo lower extremity amputation are well documented: the one and five year survival rates are far below those for breast and colon cancer. The key to preventing amputation, and in turn saving lives, is timely intervention, including the addition of hyperbaric oxygen therapy for the more severe Wagner Grade III and IV diabetic ulcers.
On August 1st, the prior authorization project for the approval of hyperbaric oxygen therapy was imposed in New Jersey and Michigan. Historically, the institution of prior authorizations by commercial carriers raised no alarms and was manageable. However, the Medicare intermediaries have proven to be ill-prepared and incapable of providing a process that ensures appropriate utilization while protecting patients.
It is an unprecedented threat to patient safety.
In the last six weeks, we have documented numerous denials of appropriate, well-documented claims for approved indications for hyperbaric oxygen therapy. The reviews are often late, well outside the published timelines. Our staff has had to fax the same paperwork numerous times while patients in need of care languish. Peer to peer requests for urgent reviews in patients with critical disease have been too slow to help many patients. A number of these calls have gone unanswered, leaving us wondering: who is practicing medicine? If Medicare has decided to practice they have surely forgotten the age old adage, "First, do no harm."
These inappropriate denials are piling up: Patients denied because they do not have evidence for osteomyelitis when the MRI documenting bone infection has been sent to CMS; a cancer patient denied hyperbaric oxygen for osteoradionecrosis (ORN) because he had not received 30 days of standard of care – when we called the CMS representative he had no idea that ORN had a different set of criteria for HBOT than diabetic foot ulcers – he reiterated the denial. There is a solution: use quality measures to monitor the utilization of HBOT and allow coverage for patients in approved HBOT research and registries – if they will listen – but am I the only one who sees Greeks hidden in the horse?
Sadly, a patient with diabetes in New Jersey will lose her leg as a direct result of this process. She would have been better off with a diagnosis of breast cancer. She would have been much better off if she didn’t live in New Jersey. Sadly, however, moving from New Jersey or Michigan to a neighboring state would only be a short-term solution as Medicare plans to institute this policy nationwide.
The madness goes on and on. Finally, one patient’s denial letter was sent to her home rather than to the hospital wound center. The wound care director called CMS repeatedly to find out if the patient’s HBOT had been approved. She received no response. She learned of the denial of services when the surprised and confused patient brought the denial letter into the clinic.
At the bottom of the letter it read, "This decision cannot be appealed."
"The lie of the year" of 2009 has become the truth of 2015.
About The Author
Dr. Thomas Serena has published more than 75 peer-reviewed papers and has made in excess of 200 presentations worldwide. He has been elected to the Board of Directors of both The Wound Healing Society and the American College of Hyperbaric Medicine (ACHM), the leading academic society in the field of Hyperbaric Medicine. In 2014 Dr. Serena was elected president of the American Professional Wound Care Association (APWCA). Dr. Serena has opened and operates Wound Care and hyperbaric oxygen treatment clinics across the United States.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, HMP Global, its affiliates, or subsidiary companies.