The Diapulse Machine
The following story is true except that the names have been changed. It is typical of cases in which doctors want to try treatments that are not yet considered mainstream but that do offer hope for patients.
In April of 1999, when I was a marketing consultant for the Diapulse Corporation of America, an attending internist, Dr. Chadra, of a hospital-based medical clinic, ordered the Diapulse Wound Treatment System for Mary Kaye, a sixty-eight-year-old Jamaican-born female.* She had two pressure ulcers on the outer aspect of her right leg. They were at stage II, which was full-thickness skin loss with exposure of fatty tissue. The causes of the ulcers were poor circulation, with the leg pressing against the side of the wheelchair where she spent most of her day. She had suffered a severe stroke two years earlier. After reviewing multiple reports in various medical journals, Dr. Chadra learned that many medical researchers had reported success in healing such wounds, thus avoiding amputation.
Dr. Chadra called me, as the equipment vendor and independent nurse-consultant for wound care, to come to the clinic to see Mrs. Kaye. I examined her wounds and took several digital photographs to send to the HMO with the doctor's request for precertification. We did not anticipate a problem because the HMO had included Diapulse in the network of medical equipment vendors. There was a contract between the two companies. The doctor wrote the prescription and letter of medical necessity and sent it to the medical review department. Several days went by and we had not received any response. Dr. Chadra called Dr. Stein, the medical director of the HMO, and asked for the approval. Dr. Stein said she had heard of Diapulse before but she had no knowledge of its effectiveness. Dr. Chadra suggested that Dr. Stein speak to me for more information.
Within a few days, I was speaking to Dr. Stein on the phone. She said she needed more information about the Diapulse technology. I gave her reprints of six research studies published within the previous ten years, all showing the same conclusive results - that all of the Diapulse-treated ulcers healed.
Dr. Stein then said she wanted Mrs. Kaye to go to a vascular surgeon to rule out arterial obstruction. Dr. Chadra tried to explain that Mrs. Kaye had already seen a vascular surgeon six months earlier and that there was no arterial obstruction. However, this did not make any difference to the medical director. Consequently, Mrs. Kaye saw the vascular surgeon after waiting two weeks for her appointment. The diagnosis remained the same. Her condition was inoperable.
Two weeks after receiving the vascular surgeon's opinion that surgery would not improve the circulation, Dr. Stein called and asked me to take another set of pictures to see if the wounds had gotten any worse with conventional treatment. More than thirty days had passed since we made the initial request. When I arrived at Mary Kaye's home, I found that her condition had deteriorated. The two wounds had gotten worse with exposed muscle and bone, and there was a large stage IV ulceration of her right heel. The left leg had also developed two wounds in the calf area at the stage II level, and all the ulcers were infected. I took the new set of pictures and hand delivered them to Dr. Stein because I was so concerned.
"Doctor, you can see from the wounds that her condition has deteriorated. If we do not treat her soon, she is going to lose first her right leg and then the other.
- Well, it is obvious that she is headed toward amputation. But we still have no assurance that your Diapulse machine is going to make any difference.
- Since you know there is no risk to the patient, don't you believe it is worth trying if there is any reasonable chance of saving her legs?
- If I were the treating physician I would agree. However, I am not. My job is to evaluate whether the use of Diapulse is worth the financial risk with a chance of saving money. Obviously, it would be much cheaper to use Diapulse than to amputate. But if it turns out that we have to pay for an amputation after paying for Diapulse, then my job is on the line.
- Please give this woman a chance to save her legs.
- I have to discuss this in committee. We will let the member know of our decision. You are merely the equipment vendor, so I will not get into any further discussion with you. Thank you for the information you provided."
One week later, Mrs. Kaye received a denial letter. About thirty days following that, Dr. Chadra called and said that Mary Kaye was in the hospital scheduled for amputation of the right leg in ten days. "The family wants to know if you could bring the Diapulse machine into the hospital.
- I could, but we will need an order and I will have to get administrative approval.
- I am not following the case now. The medical attending is Dr. Rubinsky."
I visited Dr. Rubinsky. He said he had never heard of this machine before, but after looking at the brochure and the medical journal articles, he said, "I am not familiar with this technology. However, I can see that there is no risk of harming the patient. If there is any possibility of avoiding or reducing the amputation, we are obliged to offer it to Mrs. Kaye." He then called the nurses' station on the floor where Mary Kaye was staying and ordered the treatment three times per day for thirty minutes each.
The next day, I was attempting to deliver the Diapulse machine at the hospital when my cell phone rang. It was Dr. Stein. She sounded upset. "Tom, you tried to outflank me with the Diapulse machine, didn't you?
- Look, Dr. Stein, Dr. Rubinsky called me and wanted to use it on Mrs. Kaye for ten days to try to save her leg. Since she was in the hospital, I did not think that I was required to notify you. This is a deal with the hospital.
- The purchasing director called me to request approval for special reimbursement. You really want to sell your machine pretty badly, don't you?"
At this point, I told her that my commission was 20 percent. For ten days, that came to $150. I offered to waive my commission and discount the price by that amount. I just wanted to give this poor woman one last chance to save her leg.
Dr. Stein said to me, "At this late stage, I don't see any hope for your machine being of any use. I am going to deny payment.
- There is certainly less chance than there would have been if you had said yes two months ago. I think I shall offer the hospital a free rental.
- You can do that, but don't be shocked when you find out that Dr. Rubinsky canceled his order.
- Why are you so determined to chop off this woman's legs? Are you so attached to being right?
- I am not going to discuss this with you anymore."
After Dr. Stein hung up on me, I went directly to Dr. Rubinsky's office. His receptionist told me that he had canceled the order and he would talk to me about it if I wanted to wait. He kept me waiting for three hours until he finished seeing his last patient. When he finally invited me into his office, I could barely talk. "Why would you do this to that poor woman?
- Look, Mr. Sharon. You are a nice man, so full of compassion. So, I will be honest. Dr. Stein called me. First she said, 'How could you order a machine that you know nothing about?' I told her that I read the literature that you gave me and that there was no risk of any harmful effect, so there was no harm in trying. I was determined. Then she hit me where it hurts.
- Did she threaten your livelihood?
- If you repeat this to anyone, I'll deny it. Yes, she did. She reminded me that 70 percent of my patients are members of her Medicare HMO. She did not have to spell it out for me. I canceled the order."
Dr. Rubinsky buckled under the threat of losing 70 percent of his practice. He probably convinced himself that the machine would never have worked. Nevertheless, he will never know if it could have worked, and he will always have a nagging doubt. I, too, could not guarantee anyone that Mrs. Kaye's leg would have been saved by the machine. But it certainly seemed worth a try.
I called Mrs. Kaye's daughter and told her what had happened. She still had the opportunity to threaten to sue the doctors if they did not allow her mother to have access to a risk-free possibility of saving her leg. The patient had a right to know that this technology was available and that other patients in the past with similar conditions had enjoyed a successful outcome. I have not heard from the patient or her daughter since that time, so I don't know whether they took any legal action.
In conclusion, there is no easy answer when an insurance bureaucrat decides to obstruct your physician's medical practice, but unless you get angry and get active, you will not get the treatment that your doctor prescribed. If you are willing to fight some battles for a righteous cause, you can also contact your state assembly member, your congressional representative, and the local news media. If you are fighting against injustice, you will find among them several pairs of sympathetic ears.
If you find yourself or a loved one in a similar position of denied care, don't simply accept the judgment. You may not win every time, but you certainly won't win if you don't try. Following are some steps to follow.
* I should mention at this point that I have in the past worked for the Diapulse Corporation of America in marketing their product, and I have received compensation for setting up successful wound-healing programs on hundreds of patients at various health-care institutions and in people's homes. As of this writing, I no longer have any affiliation with the company, and I am not a stockholder. I do not expect to gain financially from mentioning the machine here. Also, the management at Diapulse has never asked me to write about their product, and I have not received nor do I expect to receive any compensation for doing so. I fully intend to use this device again under physician's orders in providing wound care should the opportunity arise.