RE: ESWT As “Investigational” (Arden Smith, DPM) From: Multiple Respondents
Regarding ESWT, FDA approval only indicates a procedure is safe to do what it claims. It does not deem a piece of equipment effective enough to warrant coverage. Insurance companies now require that techniques not only be effective but that they be either equal or less costly that comparable treatments. Insurance companies have determined that ESWT will be vastly more expensive than other comparable treatments.
APMA, during my tenure on the board, met with people from Dornier and Ossatron and urged them to do the double blind studies necessary for coverage. Now, about five years later, studies are being produced, but the decisions made by companies will be very hard to change.
I perform insurance peer reviews for multiple insurance companies across the US and ESWT therapy is usually denied for the various reasons previously stated in earlier posts. I agree that the main reason driving the denials is monetary. I think that when we started using ESWT we overcharged tremendously. It is still not unusual in San Diego for podiatrists to charge $3,000 procedure fee, plus $6,000 (usually billed by the equipment provider) for use of the machine. In addition, there often are outpatient surgery center charges. I have seen many bills of $12,000 for total expenses for these procedures.
This isn’t the first time that opportunistic behaviors by the early users of a new modality have tainted its long-term acceptance. I believe ESWT would have been generally accepted by the insurers if we had originally charged the same for ESWT as we did for open or laparoscopic plantar fascial procedures, and the companies providing the equipment had considered much reduced charges for use of the equipment. It is conceivable that ESWT may be accepted in the future, but it will be at rates matching (or less than) other procedures used for surgical treatment the same conditions. There’s a lesson here.
The FDA has one job with regard to medical devices: Quote from their mission statement. "there is reasonable assurance of the safety and effectiveness of devices intended for human use" They do not guarantee payment.
If you believe ESWT works so well then charge cash for the procedure. When the patient returns, thrilled with the outcome, they will spread the word. Then we will see the real success numbers. No strings attached.
I just treated four feet this week with ESWT and i think it is a great non-invasive modality. My patients pay cash and we do it in the office. There are some new studies out that justify it usage. I believe that the insurance companies just do not want to pay for it knowing that all of us have hundreds, if not thousands of patients who would benefit from the procedure if it was approved. It was like that in Michigan for the short period when the Blues paid for the procedure. Now it is almost impossible to get a company to bring a machine into our state.
It is not ESWT that insurance companies are after, it is podiatric medicine. Insurance companies almost never cover items considered "experimental" or "investigational" by the FDA. Movies and TV shows have been done about this. So, we do have to wonder what actual standard of care insurance companies are applying FDA-approved modalities like high energy ESWT? I had one medical director cite literature saying ESWT did not work, but when questioned further, he said it was a study, or report, on low-energy treatments. Are we responsible for the blurring of lines as to the difference between high-energy ESWT and low-energy ESWT. Are the insurance companies deliberately using the "blur" to deny coverage of high-energy ESWT ?
Of course, then there is the rapidly decreasing coverage of prescription function foot orthotics, another podiatry mainstay. I am sure you have all received letters from CIGNA stating that this is "experimental" and or "investigational" lacking large population studies. What is "large"? Which groups (quasi professional, and or retail) benefit by these blanket denials? Are we being singled out as a profession?
RESPONSES / COMMENTS (YOU CAN'T MAKE THESE THINGS UP)
RE: Nothing Can Keep "California Girls" Off the Beach (Keith Gurnick, DPM)
From: Martin V. Sloan, DPM
Whether following strapping, casting, or surgery on the extremity, Castguard works fantastically in keeping the extremity dry. It's available at CVS Pharmacy and other outlets. No more walking down the hall with a Baggie full of water after a shower.
These articles are sickening. Most responses focus on two issues: 1. Fraud and 2. Aggressive (or overly aggressive) post-payment audits. Fraud hurts every podiatrists and is fuels the fire for overly aggressive post-payment audits. No one can condone that. Overly aggressive post-payment audits negatively affect the doctor-patient relationship, increase physician psyche on practicing defensive medicine, and cause a reaction from third-party payers (not only the federal government). The response adversely affects the provision of healthcare, and potentially dangerous outcomes for patients. Regulations can be made that are impossible or impractical to follow. The enforcing, or not enforcing these types of regulations is a method of control and intimidation.
Drilling down the issue to services in nursing homes or geriatric patients, Medicare guidelines are antiquated, unjust, and need revision. It's simply unfair for those podiatrists who provide these needed service, and for the patients who need the care, but don't meet the regulatory requirements. Contact your legislative representatives and explain why these services are needed and why the regulations need to be more humane. Unfortunately, it is the only process that may lead to a resolution.
From: Paul Kesselman, DPM, Richard A. Simmons, DPM
Aside from DME audits, reviewing claims for total or partial nail avulsions really is a slam dunk for carriers. Dr. Rosenblatt is very much on target when he suggests that DPMs benefit insurance carrier auditors by not documenting proper procedure(s) when it comes to nail removals (CPT 11730).
The following documentation should be placed in the patient's chart:
1) A consent form - If the patient cannot sign this for whatever reason, that information should be placed in the chart;
2) Notation of the name and dose of injectable anesthetic (unless you document neuropathy);
3) Removal of a substantial portion of the nail (total border from distal to proximal, or the entire nail)
4) Written post-op instructions should be provided and signed by the patient (give your office patients a copy) or write these orders in the NH or hospital chart.
5) The use of digital photography, while not mandatory by most MCR LCDs and private insurance carriers, is highly recommended.
For some MCR carriers it is mandatory for lessor toenails 2-5.
In the excellent letter written by Dr. Rosenblatt concerning the billing for CPT 11730 part of the procedure that he stated was necessary for correct billing required that the surgeon to “Remove a section of nail that includes eponychium.”
In Florida, our LCD 29318 does not require removing any of the eponychium, but it does require “the entire length of the nail border to and under the eponychium." This is not a procedure that I perform with any great frequency (probably less than once every sixty days); however, I have never done this procedure where it involved such extensive removal of the matrix region as would be required with excision of the eponychium. Is the excision of the eponychium a new requirement by CMS?
This case is thought-provoking and certainly challenging. In the photo, hypertrophic scarring exist at the previous surgical sites. Additionally, the left foot appears to have a giant cell tumor in the plantar aspect of the 3rd toe. Providing an x-ray would be helpful in accessing whether the proximal phalanx head is plantar-flexed or if this is scarring/giant cell.
Treatment will require very fastidious attention to detail, paying homage to hurdles set by previous surgeries. My recommendation would be to perform a through and through minimally invasive osteotomy of the proximal phalanx to allow the toe to slightly float dorsally. Preceding the osteotomy, reduce the phalanx head/fusion site by percutaneous ostectomy. Then redo your flap and cross your fingers.
Perform lesion-marked x-rays. Use a little tip of a paper clip and tape it over the lesion. It is likely these are transfer lesions from adjacent toes or metatarsals. Compare your clinical presentation to the radiographs before planning your surgery. This is especially the case in flatfoot conditions or reafoot to forefoot relationship is unequal in what appears to be a normal longitudinal arch. Remember, if underlying pathology is more cartilage, it not as obvious on your x-Rays. However, use your index of suspicion and fine analysis. Do not waste your patient's time with pads and things.
What is disconcerting about this case history is that it appears that after futile attempts at debridement of the lesions, deep skin followed by tendon and osseous surgical procedures were chosen. Why wasn't a biomechanical exam performed along with an attempt at the judicious use of orthotics? The lesions are symmetrical and on weight-bearing surfaces and if abnormal biomechanics turns out to the culprit, short of amputation, no surgery will alleviate this patient's problems.
Again, we have seen a recent publication of a podiatrist who will serve prison time due to a fraud conviction. His life and family are devastated. Healthcare auditors and prosecutors now regard podiatrists as one of their most accessible and easy sources for personal career advancement. All they have to do is generate computer printouts on repetitive Medicare claims for ingrown nail surgeries, especially in nursing homes. They concentrate on those who have the greatest numbers.
Then, they ask for your chart notes. Sometimes they just go right to the NHs and start interviewing patients. Incredibly, their....
Editor's Note: Dr. Rosenblatt's extended-length letter can be read here.
I agree with all the previous excellent advice. I suggest considering the Artassist device. One may also consider L- argentine in topical or oral forms in lieu of nitroglycerin.
I think it is irrelevant that this occurred under the care of an orthopedist. The same outcome could of easily occurred to a podiatrist. I think the case is horrible and pray the patient gets better.
I have seen about 10 of these lesions in the last 35 years. They are usually on the second toe and many times bilateral. I have had great success doing an MIS partial plantar proximal phalangeal head resections, and occasionally an MIS proximal phalangeal head resection. As far as I know, everyone of these surgeries has been successful in getting rid of these lesions.
Once again, the 9/11 PM News contains a pointed reminder of the evil lurking in our world that so horribly expressed itself that fateful day. The words of the editor, as he attempted to process the events as was witnessed in real-time, are prolific and remain a reminder of the horrors of that day. They need never be forgotten, both for the human losses and some of our very innocence, as well as that the same evil continues to exist in our world today.
But as bad as those events surely were, in the same edition a wonderful story of good a loving concern for others, appears as well. The success of the Musella Foundation, begun by our colleague Al Musella, hitting ONE MILLION DOLLARS, given to help others, is staggering in a wonderful, heart-warming way. This is a true example of good which, thank God, also continues to exist today. And it is in every one of us, giving the opportunity to make real, positive differences. Thanks, Dr. Musella, for being such a wonderful example and an inspiration.
The concern is recurring hyperkeratotic lesions. The pathology report on biopsy stated: “Clavi x2.” I recommend another biopsy (2-3 mm punch) and send the specimens to a dermatopathologist for a more comprehensive report. My office utilizes the services of Bako Pathology.
Disclosure: I have no financial interest or relationship to Bako Pathology.
These keratotic lesions look like foreign body reaction to warts. The skin appears to be moist and there appears to be a small raised lesion proximal to the main lesion on the left foot. A biopsy may prove the culprit. I have seen similar lesions. Shaving the callus may disclose deeper mosaic lesions.
I find the objective findings to be a bit puzzling. If intrinsic muscle i.e., the FDB, plantarflexed the head of the proximal phalanx, the distal portion of the toe would either be through the ground or dorsally subluxed. In the picture shown, the toe looks like an average hammertoe, other than the lesion. There does not appear to be any dorsal dislocation of the distal end of the toe. How exactly could the head of the proximal phalanx be plantarflexed otherwise? In traditional hammertoes, the head of the proximal phalanx are dorsiflexed.
It sounds like you have done all you could. Referring this patient to a vascular surgeon at the outset was absolutely the correct (and possibly the only thing) you could do. Unfortunately, this patient will have to live with this situation for his entire lifetime. Nature undoubtedly will take its course. I have no doubt.
So will the legal system. While you are to be admired for taking on this case, Beware! Any sharp attorney handling this case, will no doubt look to spread the wealth, naming as many parties as possible to include in any legal case.
Blaine laboratories has a product called Revitaderm Sweat Stop Foot Soak Tablets. We have dispensed them in our office and have had very promising results.
After you have exhausted topical OTC products, find a physician who will do or does Botox injections to the feet, or radio frequency ablation to the sympathetic ganglion. I have had patients previously who have had the Botox therapy. The Botox injections will have to be repeated 6 or so months later. For RFA, I have only read about.
RESPONSES / COMMENTS (NEWS STORIES) PART 2B (CLOSED)
RE: NY Podiatrist Roughed Up by Former Boyfriend
From: Jennifer Barlow, DPM
In response to Drs. Gordon and Sullivan's comments: I appreciate where you are coming from. However in this case, I don't believe the article reports any regrettable behavior on Dr. Splichal's part. I don't believe pictures had anything to do with what happened. I have to respectfully disagree with the "you are asking for publicity because of these pictures" rationale.
I believe PM News is a valuable resource. I learned of Dr. Splichal's work through PM News, as well as found my current job, and for these things, among others, I am greatly appreciative. I believe in freedom of the press. I just think that good judgment dictates that something of such a personal nature be kept private, unless permission is given. In my opinion, no pictures justified the publication of this information.
I was a consultant for Arthrocare for many years and helped to develop the TOPAZ technique. One of the things I was always asked during lectures was about coding. I think it boils down to how the procedure was performed. Did you use the percutaneous method or the endoscopic method? If you used the endoscopic method, I advocated a "scoring" or partial transection of the medial band by turning off the timer. The newer Quantum generator does not have that ability and therefore requires a bit more effort to accomplish this, yet still possible. I would use CPT 29893 if you used the endoscopic technique. IF you did it via percutaneous method, I would agree with the previous poster.
I find it is much simpler to institute a “policy” in the office that states we do not offer nor accept solicitations from our patients or each other. This keeps it very simple and protects us all from feeling obligated to stock up on cookies and candy bars. Stating, “All of our children are doing that as well, and it’s for a great cause. That is why we have an office policy to keep our charitable events outside of the office.”
Thank you for continuing the tradition of re-publishing your editor's note of 9-12-01 in PM News. It was a day which touched all of us & one we will never and should never forget.
I remember one of the fire fighters from my elementary school days in Staten Island. I'm sure that there had to be others I knew when growing up or relatives of people I knew. However, all Americans were effected, whether they had a personal connection or not. I think this was an event which should continue to pull us all together as the attack on Pearl Harbor brought the Greatest Generation together.
Prior to reading about Dr. Splichal in PM News, I had not heard of her. It's too bad she had trouble with her boyfriend. I hope they put him in jail. With that said, I believe you are missing something important. Dr. Splichal, has marketed herself, using the term, "Dr. Legs" along with other PR promotions. As far as the media seems to be concerned, "Dr. Legs" has diminished her professional persona in favor of more glam. It might not be fair how the media is treating her, if you only think of her as a DPM. She obviously thinks of herself as for more then just a DPM! She put herself out there for all to notice, and they did.
I do not know the female New York podiatrist involved here and I wish her no disrespect. She may be innovative and new in her approach to how she is perceived by the public. Certainly all publications are not free of any bias, but they do have the duty to at least publish the truth. Unfortunately, sometimes the truth hurts.
I really didn't want to enter the fray about what gets reported on PM News, however, I know that Dr. Block is very careful to report factual news that often displays regrettable behavior by some of our colleagues. I believe the point of the 'mention' was to simply state the news and the facts. I had never heard of Dr. Splichal and when I Goggled her, I was a bit shocked. After all, her Google page looks like a PR piece for a model.
I personally am a staunch defender of women's rights and abhor domestic violence, but you can't have it both ways. You can't have your picture all over the place in salacious poses and costumes and not expect that your every movement will be scrutinized, even by the paparazzi. I think PM News was simply stating the facts.
I would like to weigh in on this case since I have actually seen the patient. I tend to disagree with some of the answers provided and think they are more of a textbook solution. This foot has profound vascular compromise. This is a 16 year old with gangrene to the toes, with 3 weeks of no treatment. Perhaps at the very early stages, some of these treatments may have been appropriate but that is no longer the case.
So first off, this poor child should have been admitted and had an immediate vascular consult 3 days post-op when his toes were purple in...
Editor's note: This extended-length letter can be read here.
It may already be too late, but I would try to instigate the use of oral and topical vasodilators. Using HBOT is a great idea, but keep in mind that O2 is a vasoconstrictor. The blood fluid will be richer in oxygen. If you couple the oxygen therapy with a vasodilator, you will see a much quicker and maximized response. I do not like the response quoted from the ortho doctor. I hope his licensing organization is aware of his callous concern for this patient. Topically, I would rub in 1/2 inch of nitroglycerin pasted to the affected foot's arch, tid. Hold for SBP under 100mm. Discuss with the patient's PMD about using oral medication, like Procardia.
My question to the patient's parent, "how did the child tolerate the significant pain that would accompany this travesty?"
With all due respect, Dr. Wertheimer, what problems are you talking about that need fixing by podiatric med-mal insurance companies? The only problems I see today are those caused by CPME, AACPM, and APMA. They allowed new schools to open and they knew or should have known that there would not be enough residencies.
Dr. Wertheimer, your voice seems to be more for division of our profession instead of unification. We don't need that.
Your idea of HBO is an excellent one. A vascular consult is highly recommended, if for nothing else than to have another name in the records, but more importantly to assess the level of potential outcomes. I think this young man/woman has a great chance of recovery. Young arteries and patients are extraordinarily resilient. Very interesting case. Please keep us posted on the outcomes. Serial photos would be amazing!
.gif)