Amniotic Fluid Injections - Alert

[OblivionDPM]

So a few days ago, the APMA released this statement:​

"Important Alert on Amniotic Fluid Injections​

For over 40 years, APMA and PICA have enjoyed a mutual partnership rooted in advocating for podiatric physicians. The following alert is offered to provide risk advice to podiatrists. So just last week, the APMA released this statement:

In the past five years, a number of physicians, including podiatric physicians, have seen great patient benefits from the emerging use of amniotic fluid injections to treat musculoskeletal conditions, such as plantar fasciitis and tendonitis. Despite these patient benefits, the FDA has recently stated that it has not approved the use of such products and that further study is needed.

On February 28, 2022, all Medicare Administrative Contractors (MACs) announced that they would be denying claims for amniotic fluid injections effective March 16, 2022. Worse yet, the MACs may be recouping payment for claims going back to December 6, 2019, a period of more than two years. There may be certain legal defenses to recoupment action, but these defenses will have to be developed on a case-by-case basis.

Because of this development, and until APMA and PICA obtain additional information, we recommend that podiatrists (1) discontinue submitting claims to Medicare for amniotic injections, and (2) notify their malpractice insurer, which may provide administrative defense coverage, if they receive a notice of a post-payment audit from Medicare. Taking such actions will provide the greatest level of protection to podiatrists."




Can anyone comment as to how the heck something like this could happen? Was everyone using Amniotic Fluid Injections doing so knowing that this was a potential risk or was this something one truly could not see coming?

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[Feli]

Yeah, you never want to be the first guy or the last guy doing something. Podiatry is historically excellent at the trying to do the former.

There are always risks to using unproven stuff reps pitch simply because it reimburses well or because you want to be a cowboy. In my relatively short time as a student and resident and attending, I've already seen sclerosing injects, arthroeresis, Regranex, ex-fix for virtually everything, HBO, Vioxx, nail laser, EPFs, various wound wizard grafts, opening base wedge, and many others essentially come and go. There are risks with fad treatments in terms of reimburse claw-back risks, legal risks, patient harm/recall risks, ethics risks, and the list goes on and on. Most are primarily just an ethics risk of using something with no EBM since it pays good, but it can always be worse. A good hint that it is potentially bogus is typically when you find out "there's not a code for the treatment/procedure yet" and/or it needs a serious amount of prior auth (yet you could heal the wound or do the surgery easily without it)... your decision tree can typically end right there.

One of my attendings said it well (replying to my co-resident about using early placenta grafts for tendon repairs at the time):
"Really? You think it sounds promising, huh? I bet you will look real smart when it comes out in 5 or 10yrs that those cause cancer or something... and you put in on some kid's tendon when you didn't even need it."
Another attending had an even more simple approach:
"Quit putting **** in the foot!" (he was basically anti- anything except stainless steel, sutures, and autograft... and he's not wrong)

The one that absolutely blows my mind are the MPJ implants and total ankles. There is a trail of skeletons of failed models a mile long and plentiful Xrays and documentation of surgical cripples in the literature. I have no idea why most payers will still approve them. I am curious to see how long they keep going and going and saying, "well, we don't use those anymore... this model is different." I think we are on the probably the 15th generation of MPJ implants and at least 3rd or 4th gen of ankle implants by now... to treat pathology that has fine and proven solutions already. I wonder if, by the time I retire, the MPJ implant and TAA indications and approval rates aren't paper thin. I get it that some skilled surgeons get decent results with them (comparable to the long-time gold standard of fusion), but continued long-term follow-up always is the mofo of good outcomes. The overall adjunct procedures, return to OR rates, etc are ridiculous if any payers view them from an implant costs and re-op or re-admit standpoint.

 

[heybrother]

So a few days ago, the APMA released this statement:​

"Important Alert on Amniotic Fluid Injections​

For over 40 years, APMA and PICA have enjoyed a mutual partnership rooted in advocating for podiatric physicians. The following alert is offered to provide risk advice to podiatrists. So just last week, the APMA released this statement:

In the past five years, a number of physicians, including podiatric physicians, have seen great patient benefits from the emerging use of amniotic fluid injections to treat musculoskeletal conditions, such as plantar fasciitis and tendonitis. Despite these patient benefits, the FDA has recently stated that it has not approved the use of such products and that further study is needed.

On February 28, 2022, all Medicare Administrative Contractors (MACs) announced that they would be denying claims for amniotic fluid injections effective March 16, 2022. Worse yet, the MACs may be recouping payment for claims going back to December 6, 2019, a period of more than two years. There may be certain legal defenses to recoupment action, but these defenses will have to be developed on a case-by-case basis.

Because of this development, and until APMA and PICA obtain additional information, we recommend that podiatrists (1) discontinue submitting claims to Medicare for amniotic injections, and (2) notify their malpractice insurer, which may provide administrative defense coverage, if they receive a notice of a post-payment audit from Medicare. Taking such actions will provide the greatest level of protection to podiatrists."




Can anyone comment as to how the heck something like this could happen? Was everyone using Amniotic Fluid Injections doing so knowing that this was a potential risk or was this something one truly could not see coming?

The pain medicine forum covered this way before we did. The Amnion company (a bunch of them) contacts you. They tell you that you can bill Medicare, Tricare, Medicaid for amnion injections for plantar fasciitis/tendonitis etc. They send you a bunch of paperwork including an EOB where someone got paid. They tell you they won't charge you for the product unless Medicare pays you and then you can split the money or give them some of it or something like that. The EOB shows you will be paid THOUSANDS of dollars. They send you some materials - all the materials relate to the treatment of diabetic wounds etc. They tell you their MAC LCD covers treatment for musculoskeletal problems.

Except. It doesn't. Chris Centeno has oodles of articles about this. One pertinent one is linked below but he has a series about how LCD etc work.

Birth Tissue Injection Medicare Clawback Quickly Expands to the ENTIRE Nation - Regenexx

Dr. Centeno reviews the recent Medicare clawback of all amniotic and umbilical cord stem cell injections.

regenexx.com

Here's another link from the pain forum.

Amniotic Injection Fraud? CID? What You Need to Know | Federal Lawyer

Is your healthcare practice or business under investigation for amniotic injection fraud? Our federal healthcare fraud defense lawyers explain what you need to know.

federal-lawyer.com

Interestingly, Chris Centeno has another article in which he discusses our very own Jeff Lehrman (APMA Coder, plastered all over PM News) who is apparently trying to tell people that LCDs don't matter (good luck with that).

Anyway - below is from a Medicare MAC.

Some podiatrists, orthos, pain specialists are going to lose thousands (tens of thousands etc) back. I just spoke to a friend who has done 5-10 of them. With the numbers I was given by an Amnion company they are likely to owe $40K back.

Now I will say my things. Should you have known? Theoretically anything we do can be researched/found in the LCDs for your area. For example, if you want to perform covered nailcare historically you could find a page in your MAC LCD that explained what diagnoses were qualifying etc and which ones required a MD/DO visits.

More skeptically and unkind why in the world should an injection given in your clinic be worth thousands of dollars when Medicare pays $1K for an open ankle fusion. Medicare is -not- a good payor.

I'm curious to see what will happen with the other $$$-freakout-fest-that is billing Medicare for grafts. Organogenesis won't stop coming by my office trying to push their grafts which are supposed to make me hundreds to thousands of dollars a week.

 

[josebiwasabi]

I did a few of those in private practice for Achilles tendinopathy but mine were cash pay only ($500 per injection) because I knew they were considered experimental.

 

[heybrother]

I'm sort of rushing these answers because I want to get some links down for future discussion. That said. I found the APMA message spineless. Anything in the world that a podiatrist does for a patient can be written as some version of "we did it and the patient benefited". Patients who don't qualify for nailcare still love it when DPMs do it. Except its fraud if it doesn't follow the rules. This didn't follow the rules and some people are going to lose everything over it. Some of the people who lose will have truly been fooled and simply thought they had received a "powerful modality". Others literally devoted websites to receiving a wonderful non-steroid injection. I don't remember the exact wording I used but I looked up amnion fluid flowable amnion podiatry injection the other day and there were practices with pages to devoted to it. If you've been sitting there pushing this on everyone and billing 100 of these a year - good luck to you. Paying the money back may be the least of your problems.

 

[wakaflocka88]

And this is why I stick with tried and true stuff - both surgical procedures, hardware/implants and keep it simple. Been telling students and residents this for a long time and even before this APMA release came out, I already know of grads out 3-4 years having to pay back huge amounts of $$ to Medicare for improper billing and use of allografts in office. Again, do not let these smoking hot reps sway you or chase the money. You will be audited and caught

 

[heybrother]

I did a few of those in private practice for Achilles tendinopathy but mine were cash pay only ($500 per injection) because I knew they were considered experimental.

Cash pay shouldn't be an issue.

 

[DYK343]

These injections have been "all the rage" for a few years now. It would be really easy to get sucked into it - glad I wasnt.

I know of a few DPMs in my area that have been using it.

 

[Utvolsdpm]

Yea I didn’t know anyone was actually trying to submit these through insurance. I always tell patients it is available in the Private sector but it is going to be cash pay.

 

[ExperiencedDPM]

It’s fraud. Over the past year or two I was constantly receiving emails that I can get paid for injecting amniotic injections. I don’t know what codes they recommended, but I know it was never correct.

With most insurers, IF amniotic grafts are covered, it’s only for wounds. It’s not to enhance the healing of bone, tendon, nerve, etc. And if you look up the legit code for an amniotic graft, it’s ONLY for sheet goods and not for injectable or powder form.

Again, I know they were likely not telling people to use 15275, but if they did, it’s never covered in any form other than sheet.

I know a lot of young docs who are paying back big bucks for listening to reps. The most common:

-Billing an ORIF of a talo-tarsal dislocation for an arthroereisis—-100% FRAUD

-Billing for a subtalar arthrodesis when performing an arthroereisis——100% fraud.

-Billing for an ORIF or a tarsal-metatarsal dislocation when performing a Lapidus—100% fraud. (This is a new trick)

-Billing for an ORIF for multiple fractures for “insufficiency” fractures (subchondroplasty) by placing a cannula and injecting some bone matrix—-100% fraud

-Billing a 28730 (multi fusion of the midtarsal joint) when performing a Lapidus and throwing a screw across the intercuneifom joint. Placing a screw across a joint with no prep is not an arthrodesis—-100% fraud.

-Billing a 28292 with 28740 for a Lapidus instead of the single code 28297. Think I’m incorrect? Tell that to the 31 docs who just got audited for this issue and all lost.

-Unbundling ANY procedure—100% fraud.

NCCI policy specifically addresses unbundling and your responsibility to bill to the highest specificity.

I can go on and on. But the biggest offenders are the reps for these newer Lapidus systems. Do not listen to these reps. No matter how you slice it, you’ve performed one procedure. A 28297.

I’m on retainer with several major insurers specifically to review these claims. It’s become an issue and it’s high up on their radar.

 

[heybrother]

It’s fraud. Over the past year or two I was constantly receiving emails that I can get paid for injecting amniotic injections. I don’t know what codes they recommended, but I know it was never correct.

With most insurers, IF amniotic grafts are covered, it’s only for wounds. It’s not to enhance the healing of bone, tendon, nerve, etc. And if you look up the legit code for an amniotic graft, it’s ONLY for sheet goods and not for injectable or powder form.

Again, I know they were likely not telling people to use 15275, but if they did, it’s never covered in any form other than sheet.

I know a lot of young docs who are paying back big bucks for listening to reps. The most common:

-Billing an ORIF of a talo-tarsal dislocation for an arthroereisis—-100% FRAUD

-Billing for a subtalar arthrodesis when performing an arthroereisis——100% fraud.

-Billing for an ORIF or a tarsal-metatarsal dislocation when performing a Lapidus—100% fraud. (This is a new trick)

-Billing for an ORIF for multiple fractures for “insufficiency” fractures (subchondroplasty) by placing a cannula and injecting some bone matrix—-100% fraud

-Billing a 28730 (multi fusion of the midtarsal joint) when performing a Lapidus and throwing a screw across the intercuneifom joint. Placing a screw across a joint with no prep is not an arthrodesis—-100% fraud.

-Billing a 28292 with 28740 for a Lapidus instead of the single code 28297. Think I’m incorrect? Tell that to the 31 docs who just got audited for this issue and all lost.

-Unbundling ANY procedure—100% fraud.

NCCI policy specifically addresses unbundling and your responsibility to bill to the highest specificity.

I can go on and on. But the biggest offenders are the reps for these newer Lapidus systems. Do not listen to these reps. No matter how you slice it, you’ve performed one procedure. A 28297.

I’m on retainer with several major insurers specifically to review these claims. It’s become an issue and it’s high up on their radar.

I feel like these pages used to be on their website but aren't anymore. Anyway, they want you to bill either 28297 or 28740 + 28270 for the lateral release. I almost laughed outloud when my rep suggested this.

Last of all - this is actually one of the top things that turns up when you look for lapiplasty reimbursement:

https://www.utoledo.edu/depts/supplychain/pdfs/3.2.21meetingmin.docx

Its an internal document of some people discussing hardware at the University of Toledo (yes, its a word file) where they discuss 28740 will occur with another code basically everytime.

 

[DYK343]

Just about everyone I know unbundles the lapidus. Actually I dont think I know anyone who doesnt.

I would guess 80+ percent of podiatrists bill it at 1st TMT fusion (or transvere/multiple fusion with intercuneiform screw) and Silver/Mcbride.

Im not saying thats right or how I personally bill it. But its how its being billed out by a large portion of foot providers (DPM or MD) in the country.

 

[HardRoadPaved]

I would guess 80+ percent of podiatrists bill it at 1st TMT fusion (or transvere/multiple fusion with intercuneiform screw) and Silver/Mcbride.

Yea and they do it by saying there is joint instability and do a stress exam under anesthesia.

http://www.podiatryinstitute.com/pdfs/Update_2016/2016_02.pdf

I'll stick to the 28297 and stay out of fraud jail.

 

[josebiwasabi]

I agree with all of the above for any isolated lapidus procedure, inclusive of soft tissue work and bumpectomy of the met head.

But how do you guys bill a Lapidus/Akin? And what dx are you linking to each procedure?

 

[HardRoadPaved]

But how do you guys bill a Lapidus/Akin? And what dx are you linking to each procedure?

Technically you cant bill two types of bunionectomy codes: so many stick to option 1 below:

-------------------

The correct billing for a Lapidus-type bunionectomy and an Akin-type osteotomy is:


#1 CPT 28297 (correction, hallux valgus (bunion), with or without sesamoidectomy; Lapidus type procedure); and CPT 28310-59 (osteotomy, shortening, angular or rotational correction; proximal phalanx, first toe). or


#2 CPT 28740 (arthrodesis, midtarsal or tarsometatarsal, single joint); and CPT 28298-59 (correction, hallux valgus (bunion), with or without sesamoidectomy; by phalangeal osteotomy).


Both coding methods are correct. By the way, the value of coding example #2 is higher than #1. The payer was incorrect in denying CPT 28310 as inclusive (unless you did not add a "-59" modifier to the code). I recommend you appeal with submission of a corrected claim with either one of the coding examples listed above.


It should be noted that CPT 28310 is a designated "separate procedure" code. Separate procedure means that in order to be independently reimbursed, the procedure must not be an integral part of a comprehensive procedure being billed. CPT 28310 needs to be distinct, and in coding example #1, it is.


Harry Goldsmith, DPM, Cerritos, CA

 

[ExperiencedDPM]

Just about everyone I know unbundles the lapidus. Actually I dont think I know anyone who doesnt.

I would guess 80+ percent of podiatrists bill it at 1st TMT fusion (or transvere/multiple fusion with intercuneiform screw) and Silver/Mcbride.

Im not saying thats right or how I personally bill it. But its how its being billed out by a large portion of foot providers (DPM or MD) in the country.

It’s fraud. Period. Read NCCI chapter 4 and it clearly addresses this issue early in the chapter. Even though there is no CCI edit, NCCI policy trumps CCI edits.

Yes, NCCI is a government document, but rather than reinventing the wheel, most if not all carriers default to NCCI policy.

And I do not agree that most are unbundling the procedure. I’ve seen the actual stats from 4 of the major insurers

 

[ExperiencedDPM]

Yea and they do it by saying there is joint instability and do a stress exam under anesthesia.

http://www.podiatryinstitute.com/pdfs/Update_2016/2016_02.pdf

I'll stick to the 28297 and stay out of fraud jail.

Does not matter if the provider states it’s unstable, hypermobile or arthritic. The procedure performed is a bunionectomy with first met-cun arthrodesis. It doesn’t matter what the pathology is for the arthrodesis. It’s still a bunionectomy with met-cun arthrodesis. That’s a 28297. Period

 

[DYK343]

Yea and they do it by saying there is joint instability and do a stress exam under anesthesia.

http://www.podiatryinstitute.com/pdfs/Update_2016/2016_02.pdf

I'll stick to the 28297 and stay out of fraud jail.

"Intercuneiform instability was documented. The intermetatarsal angle was reduced again and stabilized with Kirschner wires and the “diastasis” screw was employed following decortication of the facing sides of the first and second metatarsal bases and additional placement of bone graft (“spot-weld fusion”) to assist in the maintenance of the intermetatarsal correction"

At least its fusing the 1st and 2nd. That is a LOT of dissection though. I would be worried the 1st TMT fusion wouldnt heal with that much trauma to the local blood supply. Deep branch of the dorsalis pedis and 1st dorsal metatarsal artery would be 100% roasted to get that decortication for fusion.

 

[heybrother]

"Intercuneiform instability was documented. The intermetatarsal angle was reduced again and stabilized with Kirschner wires and the “diastasis” screw was employed following decortication of the facing sides of the first and second metatarsal bases and additional placement of bone graft (“spot-weld fusion”) to assist in the maintenance of the intermetatarsal correction"

They can say whatever they want in the op note but no one is actually doing this. The Treace people will literally tell you to limit dorsolateral dissection. The most lateral dissection is the most minimal release necessary to place the fulcrum. No one is exposing this interval. No one is prepping this interval. The plates and screws are being placed and then another screw is being thrown.

#1 - Spot-weld fusion is an invented Treace term. Has anyone else heard it elsewhere?

#2 - I first read this term in like 2018 or 2019. There was no discussion of the amount of prep at that time. I still remember the first time I was told to include it in a note. I felt sick. This new beefed up material is there to suggest that the components of a fusion are being performed but we know they aren't. The clear giveaway is that they are still mentioning spot-weld fusion which is the nothing screw. If they had actually performed it they wouldn't bother using this term.

#3 - A review of Treace images online from doctors and the company will show all sorts of different screw positions ie. 1st to 2nd, diastasis type throw, cuneiform to cuneiform. So here's one. Does anyone think people doing this are preparing the medial to intermediate cuneiform interval? No one is entering or preparing this space.

#4 - I've done the Treace first lab. I've done at least 1 more at a conference. I had the 3 cases with traveling reps. There's no point in any of these labs or exercises or events where we opened up, exposed, prepared, etc these fusion intervals. They just say - do you want to throw the screw? Or - humor me and throw the screw.

#5 - Commercial insurance aside - if Medicare comes down on this its going to be pursued like a criminal conspiracy. Surgery centers/hospitals etc aren't going to let you perform lapiplasty on Medicare patients because the cost of the set is almost the value of the Medicare reimbursement to the facility. There's a reason they (Treace) are desperately pointing us to additional procedures - some of which are inclusive, some of which are fictional. When the doctor bills the 28740 they bump their reimbursement up a few hundred dollars, but the facility picks up an extra $6000 allowing the whole event to occur but also creating a much more massive expenditure that will ultimately be worth pursuing as a fraud.

 

[air bud]

So a few days ago, the APMA released this statement:​

"Important Alert on Amniotic Fluid Injections​

For over 40 years, APMA and PICA have enjoyed a mutual partnership rooted in advocating for podiatric physicians. The following alert is offered to provide risk advice to podiatrists. So just last week, the APMA released this statement:

In the past five years, a number of physicians, including podiatric physicians, have seen great patient benefits from the emerging use of amniotic fluid injections to treat musculoskeletal conditions, such as plantar fasciitis and tendonitis. Despite these patient benefits, the FDA has recently stated that it has not approved the use of such products and that further study is needed.

On February 28, 2022, all Medicare Administrative Contractors (MACs) announced that they would be denying claims for amniotic fluid injections effective March 16, 2022. Worse yet, the MACs may be recouping payment for claims going back to December 6, 2019, a period of more than two years. There may be certain legal defenses to recoupment action, but these defenses will have to be developed on a case-by-case basis.

Because of this development, and until APMA and PICA obtain additional information, we recommend that podiatrists (1) discontinue submitting claims to Medicare for amniotic injections, and (2) notify their malpractice insurer, which may provide administrative defense coverage, if they receive a notice of a post-payment audit from Medicare. Taking such actions will provide the greatest level of protection to podiatrists."




Can anyone comment as to how the heck something like this could happen? Was everyone using Amniotic Fluid Injections doing so knowing that this was a potential risk or was this something one truly could not see coming?

It’s fraud. Over the past year or two I was constantly receiving emails that I can get paid for injecting amniotic injections. I don’t know what codes they recommended, but I know it was never correct.

With most insurers, IF amniotic grafts are covered, it’s only for wounds. It’s not to enhance the healing of bone, tendon, nerve, etc. And if you look up the legit code for an amniotic graft, it’s ONLY for sheet goods and not for injectable or powder form.

Again, I know they were likely not telling people to use 15275, but if they did, it’s never covered in any form other than sheet.

I know a lot of young docs who are paying back big bucks for listening to reps. The most common:

-Billing an ORIF of a talo-tarsal dislocation for an arthroereisis—-100% FRAUD

-Billing for a subtalar arthrodesis when performing an arthroereisis——100% fraud.

-Billing for an ORIF or a tarsal-metatarsal dislocation when performing a Lapidus—100% fraud. (This is a new trick)

-Billing for an ORIF for multiple fractures for “insufficiency” fractures (subchondroplasty) by placing a cannula and injecting some bone matrix—-100% fraud

-Billing a 28730 (multi fusion of the midtarsal joint) when performing a Lapidus and throwing a screw across the intercuneifom joint. Placing a screw across a joint with no prep is not an arthrodesis—-100% fraud.

-Billing a 28292 with 28740 for a Lapidus instead of the single code 28297. Think I’m incorrect? Tell that to the 31 docs who just got audited for this issue and all lost.

-Unbundling ANY procedure—100% fraud.

NCCI policy specifically addresses unbundling and your responsibility to bill to the highest specificity.

I can go on and on. But the biggest offenders are the reps for these newer Lapidus systems. Do not listen to these reps. No matter how you slice it, you’ve performed one procedure. A 28297.

I’m on retainer with several major insurers specifically to review these claims. It’s become an issue and it’s high up on their radar.

Whew....only done of those and very rarely.

 

[air bud]

I agree with all of the above for any isolated lapidus procedure, inclusive of soft tissue work and bumpectomy of the met head.

But how do you guys bill a Lapidus/Akin? And what dx are you linking to each procedure?

Lapiplasty and you never have to do an akin .....

 

[Feli]

...the biggest offenders are the reps for these newer Lapidus systems. Do not listen to these reps. No matter how you slice it, you’ve performed one procedure. A 28297...

They should be able to bill shortening of first metatarsal also with the system?

I think I just boarded my third revision of a L*piplasty where I need to put in a decent sized graft and plate it (real plate, not baby titanium plates that I can bend with my fingers) and do Weil 2 or 2+3 in order to get the first met head bearing weight well (pt failed met pads, orthotics). Just when I am seldom seeing the dorsiflexed Lapidus with sub 2nd pain from the older guard anymore, this new system comes along and effectively causes the same post-op problem via over-shortening.

I think they often shorten the 1st pathologically it since they can't plantar translate with all the "jig" crap in the way? Who knows since I have only seen the animated video, but it is dumb to be seeing this need for what I have to explain to the pt is bona fide 'salvage' bunion return to the OR within a couple years in folks 30s and 40s age.

I don't know anything, though... I have not taken the weekend master legend contraption expert geometric champion surgeon course. I was going to take it to get onto their website list (I will admit they have great marketing... just see Lap chapter in new 5th Ed of McGlamry), but then I realized you actually have to use it for cases a few times and I wouldn't want to do that with how crazy it is in terms of cost, the intermetatarsal nerve smasher device, all the holes for the jig, how easy and well Lapidus turns out with a few $50-75 screws or $800 lock plate + screws, etc. I can't justify it... probably couldn't even if it cost the same as basic AO stuff.

Just about everyone I know unbundles the lapidus. Actually I dont think I know anyone who doesnt.

I would guess 80+ percent of podiatrists bill it at 1st TMT fusion (or transvere/multiple fusion with intercuneiform screw) and Silver/Mcbride.

Im not saying thats right or how I personally bill it. But its how its being billed out by a large portion of foot providers (DPM or MD) in the country.

I'm not saying either. Look at them gas prices!

 

[ExperiencedDPM]

I’ve read a LOT of op reports when the provider uses this proprietary system. They provide a canned op report and every report that throws that screw across the intercuneiform says the same thing “after the hardware was placed, the foot was loaded and there was gapping and widening of the intercuneiform joint and a screw was placed across the joint”.

Sorry , that’s not a fusion, spot fusion, etc. Spot fusion is like being half pregnant.

This company is perpetuating fraud.

 

[air bud]

I’ve read a LOT of op reports when the provider uses this proprietary system. They provide a canned op report and every report that throws that screw across the intercuneiform says the same thing “after the hardware was placed, the foot was loaded and there was gapping and widening of the intercuneiform joint and a screw was placed across the joint”.

Sorry , that’s not a fusion, spot fusion, etc. Spot fusion is like being half pregnant.

This company is perpetuating fraud.

Honestly never heard anyone from the company or reps tell me about this. Must not be hanging out with the right people, just the poors.

 

[DYK343]

I was going to take it to get onto their website list

Ive had at least 7-10 patients come in asking if I do the lapiplasty procedure.
Their marketing is really good.

 

[DYK343]

They can say whatever they want in the op note but no one is actually doing this. The Treace people will literally tell you to limit dorsolateral dissection. The most lateral dissection is the most minimal release necessary to place the fulcrum. No one is exposing this interval. No one is prepping this interval. The plates and screws are being placed and then another screw is being thrown.

#1 - Spot-weld fusion is an invented Treace term. Has anyone else heard it elsewhere?

#2 - I first read this term in like 2018 or 2019. There was no discussion of the amount of prep at that time. I still remember the first time I was told to include it in a note. I felt sick. This new beefed up material is there to suggest that the components of a fusion are being performed but we know they aren't. The clear giveaway is that they are still mentioning spot-weld fusion which is the nothing screw. If they had actually performed it they wouldn't bother using this term.

#3 - A review of Treace images online from doctors and the company will show all sorts of different screw positions ie. 1st to 2nd, diastasis type throw, cuneiform to cuneiform. So here's one. Does anyone think people doing this are preparing the medial to intermediate cuneiform interval? No one is entering or preparing this space.

#4 - I've done the Treace first lab. I've done at least 1 more at a conference. I had the 3 cases with traveling reps. There's no point in any of these labs or exercises or events where we opened up, exposed, prepared, etc these fusion intervals. They just say - do you want to throw the screw? Or - humor me and throw the screw.

#5 - Commercial insurance aside - if Medicare comes down on this its going to be pursued like a criminal conspiracy. Surgery centers/hospitals etc aren't going to let you perform lapiplasty on Medicare patients because the cost of the set is almost the value of the Medicare reimbursement to the facility. There's a reason they (Treace) are desperately pointing us to additional procedures - some of which are inclusive, some of which are fictional. When the doctor bills the 28740 they bump their reimbursement up a few hundred dollars, but the facility picks up an extra $6000 allowing the whole event to occur but also creating a much more massive expenditure that will ultimately be worth pursuing as a fraud.

I 100% agree. And no I had to google what spot weld meant in terms of bunionectomy or surgery in general.

Artilce is from 2016 and wikipedia states Treace started 2014. Not sure if they really invented that term but I must say ive never heard it described before.

 

[air bud]

Ive had at least 7-10 patients come in asking if I do the lapiplasty procedure.
Their marketing is really good.

Lol I had a 75 year old lady in a small ass town of 3k in the middle of nowhere ask if I did that new bunion procedure....I was like Lapiplasty? She said yes that is it. I said yup I do. That was about 2 months before doing my first one.

 

[Feli]

...Their marketing is really good.

Oh for sure, that's why I considered it.

I just tell people that bunion procedure, and the Lapidus procedure has been around nearly 100yrs... but I do it much more cost effectively so the hospital doesn't dislike me and I don't have to dissect as much off the bones.
If they're not cool with that, I'm still potentially available for their revision.

 

[ExperiencedDPM]

I’m seeing lots of revisions. The problem is not usually the actual set. The problem is that many providers who never performed a Lapidus before are now using this set. It does walk you through each step, but the problem is that this subset of surgeons don’t know what to do if something goes wrong.

I can name dozens of DPMs who never felt “comfortable” performing a Lapidus who are now using this set. Those are the cases often requiring revision.

For those who are skilled, it can make things more reproducible at a significant increased expense and increased OR time.

 

[HardRoadPaved]

For those who are skilled, it can make things more reproducible at a significant increased expense and increased OR time.

Just like the majority of PIPJ implants

 

[DYK343]

Just like the majority of PIPJ implants

Peg and hole or bust! Bury the k-wire if desired.
Zero issues with this method.

 

[air bud]

I’m seeing lots of revisions. The problem is not usually the actual set. The problem is that many providers who never performed a Lapidus before are now using this set. It does walk you through each step, but the problem is that this subset of surgeons don’t know what to do if something goes wrong.

I can name dozens of DPMs who never felt “comfortable” performing a Lapidus who are now using this set. Those are the cases often requiring revision.

For those who are skilled, it can make things more reproducible at a significant increased expense and increased OR time.

Interesting, didn't think about people who didn't do a lapidus before who now do it ....yes to the expense....no the OR time, at least for me. A lapidus is a technically challenging procedure, especially when doing by yourself (no residents, no assist and the tech is having to help you ANd their job) and maybe 1 to 2 a month like myself. I have found it to be significantly faster. I can do one skin to skin in less than an hour, whereas often was 75 to 80 mins with plate/screws (although I used crossroads for a few years and that helped...I remember hearing stuff about 2 hours and that always turned me off...first one took 1:15 and that was taking our sweet ass time and discussing stuff while doing the case.

 

[air bud]

Peg and hole or bust! Bury the k-wire if desired.
Zero issues with this method.

Peg and hole? How old are you?
I use k wires 95 percent of the time. Saw proximal, rongeur distal. I tell patients the 2 ends of the bone just have to be in the same zip code and they will heal just fine.

Now if we want to talk about fancy bendy dynamic k wires....yowza!

 

[DYK343]

Peg and hole? How old are you?
I use k wires 95 percent of the time. Saw proximal, rongeur distal. I tell patients the 2 ends of the bone just have to be in the same zip code and they will heal just fine.

Now if we want to talk about fancy bendy dynamic k wires....yowza!

Peg and hole works really well. Really really well. I think I have 100% fusion with the procedure. I had 1 attending in residency who thats all he did. now that im out thats all I do as well. its quick and easy and doesnt require a fancy implant.

End to end with kwire also works. But do they ever really actually fuse or just arthrose and not move anymore?

 

[air bud]

Peg and hole works really well. Really really well. I think I have 100% fusion with the procedure. I had 1 attending in residency who thats all he did. now that im out thats all I do as well. its quick and easy and doesnt require a fancy implant.

End to end with kwire also works. But do they ever really actually fuse or just arthrose and not move anymore?

Arthose. Works

 

[Feli]

Lapidus is a very cool procedure... everyone does it different.
It is not easy, but I don't consider it hard anymore. Making the cuts and positioning it for temp fix are certainly the make-or-break money steps.

I think mine are almost all under an hour, sometimes 40 or 45mins if I get the position right the first try. I only use the cuff up for the joint work and fixation part (try to do it all wet w epi lido, but medial marginal and its branches usually dictates cuff up to get past it quickly). The joint is usually 20 or 25mins of cuff up (back down again once capsule layer is closed). I do a lateral capsule and adductor release and met head exostectomy on all of them before I go to the 1MC... EHL lengthen and capsularis tendonotomy on most after the fixation and re-eval.

Maybe I am cave man style, but I just do 1MC with basic saw (long bunion blade) resect and hold the IM closure + rotate + plantar translate position at the site and have the tech temp pin x2 it before I check visual/loaded (and sometimes flouro) and fixate it. That is the part that can occasionally take awhile and is almost impossible to do yourself - but is key to success. I fixate about 2/3 of them lag screw and lock plate and one third with 2-3 screws (all across 1MC). One place I go now has only large c-arm (huge time waste), so I usually just do non-cannulated screws and just take a pic at the end to make sure none are too long.

I think I would be significantly slower with the "system" jig and guide and clamp, and etc multiple plates, a lot more xrays and many blades and pins and other moving parts for the tech to bumble with. Maybe I am poooo-diatry and not ortho, haha. The Lapidus tools I find useful are an osteotome to open the 1MC joint and then to get your bone cuts out, 22ga needle (to put into the joint before cuts to visually align my cuts parallel-ish in frontal-ish plane), and a screw set metal top (to load the foot while it's temp fixated, see how it will look, and see if first ray purchases well... just like you should do for MPJ1 fusions)... the hospital tells me my needle and screw set top tech is a lot cheaper than a $5k "system."

I used to fool around with trying to do hand resection 1MC to try to save length and avoid wedges and blah blah as some authors say, but it just doesn't work well for any reasonably large IM, it is much slower, and I probably under-corrected a few of my early ones or wasted a lot of OR time taking a bit more, a bit more, medial base of the 2nd, etc to the point where cuneiform wedge from the start would have been better. I think it also probably ups your chance of non-union if you don't just use a saw and totally remove the subchondral plates. The bit of shortening is really not a big deal if you plantar translate the first met and/or do Weils. I also never understood the not opening the first MPJ idea... it sounds sophisticated at meetings, but the lateral capsule and EHL is usually pretty tight on most HAV that I ever see.

 

[wakaflocka88]

Technically you cant bill two types of bunionectomy codes: so many stick to option 1 below:

-------------------

The correct billing for a Lapidus-type bunionectomy and an Akin-type osteotomy is:


#1 CPT 28297 (correction, hallux valgus (bunion), with or without sesamoidectomy; Lapidus type procedure); and CPT 28310-59 (osteotomy, shortening, angular or rotational correction; proximal phalanx, first toe). or


#2 CPT 28740 (arthrodesis, midtarsal or tarsometatarsal, single joint); and CPT 28298-59 (correction, hallux valgus (bunion), with or without sesamoidectomy; by phalangeal osteotomy).


Both coding methods are correct. By the way, the value of coding example #2 is higher than #1. The payer was incorrect in denying CPT 28310 as inclusive (unless you did not add a "-59" modifier to the code). I recommend you appeal with submission of a corrected claim with either one of the coding examples listed above.


It should be noted that CPT 28310 is a designated "separate procedure" code. Separate procedure means that in order to be independently reimbursed, the procedure must not be an integral part of a comprehensive procedure being billed. CPT 28310 needs to be distinct, and in coding example #1, it is.


Harry Goldsmith, DPM, Cerritos, CA

Question for y’all - which lapidus code do you usually bill and do you see differences in greater reimbursement / RVU for either 28297 or 28740. I’m RVU based so just trying to legally maximize my credits

 

[Feli]

Peg and hole works really well. Really really well. I think I have 100% fusion with the procedure. I had 1 attending in residency who thats all he did. now that im out thats all I do as well. its quick and easy and doesnt require a fancy implant.

End to end with kwire also works. But do they ever really actually fuse or just arthrose and not move anymore?

I am developing a new HammerNasty system with PIPJ angular cut guides for joint surfaces, triple 4-hole PIPJ plating system med+lat+dorsal (0.75mm screws). It will be done under loupe mag (or operating microscope... surgeon preference).

...or yeah, k-wires work pretty good too. I don't think they usually fuse, but it works. I do 90% buried k-wires, but I have had a few of those come out the dorsal cortex middle phalanx (just take them out in the office and wrap the toe for a week).

 

[DYK343]

Lapidus is a very cool procedure... everyone does it different.
It is not easy, but I don't consider it hard anymore. Making the cuts and positioning it for temp fix are certainly the make-or-break money steps.

I think mine are almost all under an hour, sometimes 40 or 45mins if I get the position right the first try. I only use the cuff up for the joint work and fixation part (try to do it all wet w epi lido, but medial marginal and its branches usually dictates cuff up to get past it quickly). The joint is usually 20 or 25mins of cuff up (back down again once capsule layer is closed). I do a lateral capsule and adductor release and met head exostectomy on all of them before I go to the 1MC... EHL lengthen and capsularis tendonotomy on most after the fixation and re-eval.

Maybe I am cave man style, but I just do 1MC with basic saw (long bunion blade) resect and hold the IM closure + rotate + plantar translate position at the site and have the tech temp pin x2 it before I check visual/loaded (and sometimes flouro) and fixate it. That is the part that can occasionally take awhile and is almost impossible to do yourself - but is key to success. I fixate about 2/3 of them lag screw and lock plate and one third with three screws. One place I go now has only large c-arm (huge time waste), so I usually just do non-cannulated screws and just take a pic at the end to make sure none are too long.

I think I would be significantly slower with the "system" jig and guide and clamp, and etc multiple plates, a lot more xrays and many blades and pins and other moving parts for the tech to bumble with. Maybe I am poooo-diatry and not ortho, haha. The Lapidus tools I find useful are an osteotome to open the 1MC joint and then to get your bone cuts out, 22ga needle (to put into the joint before cuts to visually align my cuts parallel-ish in frontal-ish plane), and a screw set metal top (to load the foot while it's temp fixated, see how it will look, and see if first ray purchases well... just like you should do for MPJ1 fusions)... the hospital tells me my needle and screw set top tech is a lot cheaper than a $5k "system."

I used to fool around with trying to do hand resection 1MC to try to save length and avoid wedges and blah blah as some authors say, but it just doesn't work well for any reasonably large IM, it is much slower, and I probably under-corrected a few of my early ones or wasted a lot of OR time taking a bit more, a bit more, medial base of the 2nd, etc to the point where cuneiform wedge from the start would have been better. I think it also probably ups your chance of non-union if you don't just use a saw and totally remove the subchondral plates. The bit of shortening is really not a big deal if you plantar translate the first met and/or do Weils. I also never understood the not opening the first MPJ idea... it sounds sophisticated at meetings, but the lateral capsule and EHL is usually pretty tight on most HAV that I ever see.

Never used a needle as an axis guide but sounds interesting.

Ever use a bone reduction clamp/tenaculum to hold IM correction? Small stab incision over 4th met then reduce it. Pretty much eliminates the need for a 2nd pair of skilled hands.

 

[DYK343]

I am developing a new HammerNasty system with PIPJ angular cut guides for joint surfaces, triple 4-hole PIPJ plating system med+lat+dorsal (0.75mm screws). It will be done under loupe mag (or operating microscope... surgeon preference).

...or yeah, k-wires work pretty good too. I don't think they usually fuse, but it works. I do 90% buried k-wires, but I have had a few of those come out the dorsal cortex middle phalanx (just take them out in the office and wrap the toe for a week).

I will use the hammer nasty. No convincing needed.

 

[Feli]

Never used a needle as an axis guide but sounds interesting.

Ever use a bone reduction clamp/tenaculum to hold IM correction? Small stab incision over 4th met then reduce it. Pretty much eliminates the need for a 2nd pair of skilled hands.

I use the clamp for most lisfranc fx ORIF or fusion, but not for Lapidus... I am always worried about possible nerve injuries, esp on elective.

Probably not a legit worry and something I should try, but I try to dissect pretty minimal (ask the dozens of residents who I've told they are retracting too hard, they need blunt dissection not sharp, or they don't need their forceps clamping on the amputation flap to suture it, etc).

 

[DYK343]

I use the clamp for most lisfranc fx ORIF or fusion, but not for Lapidus... I am always worried about possible nerve injuries, esp on elective.

Probably not a legit worry and something I sould try, but I try to dissect pretty minimal (ask the dozens of residents who I've told they are retracting too hard, they need blunt dissection not sharp, or they don't need their forceps clamping on the amputation flap to suture it, etc).

I dont do it every time but I do do it when I dont have perfect reduction after first/2nd attempt.

It really helps close in the IM angle. Especially if the cuts are not absolutely perfect. It makes Sagittal reduction a lot easier too.

I havent had any nerve issues to date and ive done it quite a lot. It is a blind leap of faith I suppose.

 

[Podstar]

The majority of my attendings use Lapiplasty and get great results with it. Problems I have seen with it so far are shortening (really just have to make sure the cut guide and joint seeker are positioned perfectly), elevated 1st metatarsal, and gapping when the locking screws suck down their flimsy plates. I am usually around the 65 minute mark start to finish after doing a decent amount first year, but it can definitely go longer if you have to redo some steps due to positioning or running into the issues listed above. We hardly ever throw the intercuneiform screw or use their graft harvest system. It’s nice because it is reproducible and simplifies it from a skill/technique standpoint. As a resident it kinda sucks because I am stuck learning lapidus techniques on cadavers that don’t have an actual deformity because they do so few without a system now, but every patient comes in now wanting a lapiplasty or MIS bunion procedure. Treace’s marketing is impeccable. A decent amount are also doing MIS distal osteotomies, which are pretty sleek and cosmetic with very small incisions and patients are doing well so far. Only time will tell how these hold up, but they love not having the large dorsal incision.

 

[air bud]

I will use the hammer nasty. No convincing needed.

I could get on board with this procedure....but I feel like maybe it needs to be demonstrated to other pods. Maybe with dinner, travel and a nice fee involved.

 

[air bud]

You know, I have never thought about loading the foot on a lapidus like I do a 1st mpj fusion....have never thrown an intercuneiform screw on a lapidus. Hate big c arm....except it actually makes the lapiplasty super easy. I ask for an extra tech for those and they just hold the leg bent and foot flat on the table. Xray tech just has to move in one direction in and out and AP only. No grabbing the mini c and moving around and manipulating.

And listen, I get it. Those plates are flimsy and stupid. But I never hear about non unions being a problem. And people are walking these FAST. So at some point you have to recognize your biases and be open to stuff. But yeah, that **** is expensive.

 

[Scrantonicity]

The majority of my attendings use Lapiplasty and get great results with it. Problems I have seen with it so far are shortening (really just have to make sure the cut guide and joint seeker are positioned perfectly), elevated 1st metatarsal, and gapping when the locking screws suck down their flimsy plates. I am usually around the 65 minute mark start to finish after doing a decent amount first year, but it can definitely go longer if you have to redo some steps due to positioning or running into the issues listed above. We hardly ever throw the intercuneiform screw or use their graft harvest system. It’s nice because it is reproducible and simplifies it from a skill/technique standpoint. As a resident it kinda sucks because I am stuck learning lapidus techniques on cadavers that don’t have an actual deformity because they do so few without a system now, but every patient comes in now wanting a lapiplasty or MIS bunion procedure. Treace’s marketing is impeccable. A decent amount are also doing MIS distal osteotomies, which are pretty sleek and cosmetic with very small incisions and patients are doing well so far. Only time will tell how these hold up, but they love not having the large dorsal incision.

Gapping during the plating? Never seen that yet. I always put the medial plate on first, while the compressor is still on. Are they putting the screws in the two middle holes first? I always put screws into the two end holes (most proximal and most distal) first, so maybe that helps...

Yes, the plates are kinda flimsy, but I haven't had a non-union since I switched over to the dark expensive side. It just works. Also, my OR time for Lapidus has gone down considerably...

 

[Podstar]

Gapping during the plating? Never seen that yet. I always put the medial plate on first, while the compressor is still on. Are they putting the screws in the two middle holes first? I always put screws into the two end holes (most proximal and most distal) first, so maybe that helps...

Yes, the plates are kinda flimsy, but I haven't had a non-union since I switched over to the dark expensive side. It just works. Also, my OR time for Lapidus has gone down considerably...

We typically do the dorsal plate first and outside screws first with the compressor off after throwing our temporary fixation. That’s a good idea though leaving the compressor on and doing medial first. Will have to bring that up and try it. I will say, we have not had issues with gapping since the change from one temporary fixation threaded wire to two. I agree I have not seen any issues with nonunion at all even in the non complaint patients and my attendings echo this. We typically have them walking in a boot 1 week post op and in regular shoe gear if they tolerate it after sutures are out.

 

[ExperiencedDPM]

We typically do the dorsal plate first and outside screws first with the compressor off after throwing our temporary fixation. That’s a good idea though leaving the compressor on and doing medial first. Will have to bring that up and try it. I will say, we have not had issues with gapping since the change from one temporary fixation threaded wire to two. I agree I have not seen any issues with nonunion at all even in the non complaint patients and my attendings echo this. We typically have them walking in a boot 1 week post op and in regular shoe gear if they tolerate it after sutures are out.

Just to make it clear, when I read these templated op reports that all state that when the foot was loaded there was gapping and widening of the intercuneiform joint, I don’t believe it for one second.

It’s simply a ploy to throw a screw and have the balls to bill for a multi-fusion. But of course there is no gapping and the joint wasn’t prepped.

Can you spell fraud?

 

[Feli]

Just to make it clear, when I read these templated op reports that all state that when the foot was loaded there was gapping and widening of the intercuneiform joint, I don’t believe it for one second...

Was this always going on (to a lesser degree) even awhile before Lapidus "systems"?

The intercuinieform screw thing never made any sense to me at meetings and in journals. That joint has strong ligaments all around it, very little motion to begin with. If there was supposedly so much motion, then that screw would break soon after they weightbear (esp cannulated ones)... but it doesn't. Was it just a way to bill midfoot fusions or ORIF tarsal dislocation or something from the start? I swear that half the "promising new research" in foot surgery is just a billing idea

 

[ExperiencedDPM]

Was this always going on (to a lesser degree) even awhile before Lapidus "systems"?

The intercuinieform screw thing never made any sense to me at meetings and in journals. That joint has strong ligaments all around it, very little motion to begin with. If there was supposedly so much motion, then that screw would break soon after they weightbear (esp cannulated ones)... but it doesn't. Was it just a way to bill midfoot fusions or ORIF tarsal dislocation or something from the start? I swear that half the "promising new research" in foot surgery is just a billing idea

The orthopedic surgeons are very aggressive billers and have billed a Lapidus as a 28292/28740 for years. DPMs have now jumped on that bandwagon.

However, it’s aggressive and “creative” reps who “sell” the idea to docs regarding how to make more money. That’s when all this BS come up with billing 28730 for throwing that intercuneiform screw or billing for an ORIF of a tarsal-metatarsal dislocation.

By the way, you can’t get paid for fusing the same joint that is dislocated (even though in this case it’s not a dislocation anyway). You need to reduce a dislocation to fuse the involved joint so the reduction is a component procedure of the fusion. You can’t get paid for 2 procedures when in essence, you’ve only performed one procedure.

Bill honestly, understand the rules and do not look for quick schemes. And do not taking billing advice from reps.