Experience with Intracept.

[nvrsumr]

So modic changes can be due to trauma?

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[RoloTomassi]

So modic changes can be due to trauma?

Aggravation of preexisting condition

 

[Taus]

When do you typically see the maximal pain relief
that a patient is going to obtain from the procedure? <2 weeks, 6 weeks? 3 months?

I have heard that if not better by 3 months it has
failed, but how often do you see a delayed benefit,
particularly if zero improvement at let's say 2 weeks? In my limited sample so far, those who haven't been much better by two weeks have rarely gotten better after that.

Thanks

 

[RoloTomassi]

When do you typically see the maximal pain relief
that a patient is going to obtain from the procedure? <2 weeks, 6 weeks? 3 months?

I have heard that if not better by 3 months it has
failed, but how often do you see a delayed benefit,
particularly if zero improvement at let's say 2 weeks? In my limited sample so far, those who haven't been much better by two weeks have rarely gotten better after that.

Thanks

Same

 

[oneforfighting]

Looks like it didn't work out for Carson Daly

Carson Daly Returns to Today Show After 'Hardcore' Spinal Surgery

 

[Taus]

Looks like it didn't work out for Carson Daly

Carson Daly Returns to Today Show After 'Hardcore' Spinal Surgery

Doing 2-3/week now. Results still mirroring literature. Saw this patient back today for three month follow up. 45 years old, severe axial pain for a decade. Pretty impressive MRI imo. No listhesis or instability on xray. Was ready to roll dice on fusion….. now 60-70% improved, constant 7-8, now intermittent 3/10. Off all meds. I’m impressed.

 

[pmrmd]

Doing 2-3/week now. Results still mirroring literature. Saw this patient back today for three month follow up. 45 years old, severe axial pain for a decade. Pretty impressive MRI imo. No listhesis or instability on xray. Was ready to roll dice on fusion….. now 60-70% improved, constant 7-8, now intermittent 3/10. Off all meds. I’m impressed.

45y old? Which commercial insurance is paying for this in your area?

 

[Taus]

45y old? Which commercial insurance is paying for this in your area?

Highmark. Have had some IBC and United approved as well. Dozens still in auth portal. Flat out denied after all available appeals on aetna, cigna, horizon so far. Should improve every year, but a slow process with a new cpt code.

 

[Ferrismonk]

I was looking at maybe doing this procedure, but it looks like in my area Medicare pays $454 for this procedure. Hard to make that pencil out for the time it takes. Are those of you who do this procedure getting referrals specifically for this? Is it worth the hassle?

 

[Taus]

I was looking at maybe doing this procedure, but it looks like in my area Medicare pays $454 for this procedure. Hard to make that pencil out for the time it takes. Are those of you who do this procedure getting referrals specifically for this? Is it worth the hassle?

Thats a single level (2 vert body) case. Should be 40 mins tops. Generally less. Look at the Medicare pro fees for esi, mbb, rfa. For the amount of those I would do in the same time as an intracept it was about neutral. Just more volume of procedures overall at about the same medicare pro fee/hour.

 

[crunchymedicine]

Would you consider intracept on the same level same side of a prior laminectomy?

 

[RoloTomassi]

Would you consider intracept on the same level same side of a prior laminectomy?

Depends how wide of a lami. If pedicle is intact or at least wide enough for 8 ga trocar, yes (get CT if unsure). But why not just go the other side if hemi lami? Extrapedicular is an option too.

 

[Taus]

Would you consider intracept on the same level same side of a prior laminectomy?

Sure. Done several. As long as anatomy you’re accessing is intact, as in above post.
Only other minor concern is if a multi level laminectomy without spinous processes present contiguous levels, and any vertebral body rotation, hard to say youre dead midline on AP. I default to 15 min lesion on these to account for possible imperfect lesion targeting.

 

[Magnus Acus]

I know several on this thread were starting to ramp up the # of intracept cases, results still encouraging? Regressing to mean?

 

[RoloTomassi]

I know several on this thread were starting to ramp up the # of intracept cases, results still encouraging? Regressing to mean?

Still consistent with studies. I make sure to manage expectations regarding success rates.

 

[bedrock]

Still consistent with studies. I make sure to manage expectations regarding success rates.

What exactly do you tell patients in terms of expected percentage relief, likelihood of success, and duration of effect?

 

[RoloTomassi]

What exactly do you tell patients in terms of expected percentage relief, likelihood of success, and duration of effect?

50% chance high percentage relief, 75-100%.
25% chance decent relief, 50-75%.
25% chance minimal or no improvement.
Any positive results should be permanent.

 

[Taus]

I know several on this thread were starting to ramp up the # of intracept cases, results still encouraging? Regressing to mean?

Ive done 35-40 cases. Results about on par with published literature quoted above. 3 or 4 only a little better, under 50%. 2 complete failures, zero relief. Post op mri on those 2 cases at 3 months had proper lesion targeting.

I remain impressed overall.

 

[Taus]

You got it! It is the only way to fly. Next time you “fall off” the pedicle just take it and you will be happy with the result. I only go transpedicular inadvertently or if there is a big osteophyte that pushes the trochar too lateral on trying to touch down “parapedicular”. @gdub25 anything to add? B/w me and gdub we probably have 2000 kypho levels done.

Did my first one like this today (aside from 2 post fusion cases around screw). Agreed… Much easier than anticipated. Definitely doing extra- pedicular any time pedicle is skinny, sagittal, long etc. Do you do this for all intracept ie even lower lumbar levels with big pedicles?

 

[clubdeac]

Ive done 35-40 cases. Results about on par with published literature quoted above. 3 or 4 only a little better, under 50%. 2 complete failures, zero relief. Post op mri on those 2 cases at 3 months had proper lesion targeting.

I remain impressed overall.

I remain impressed with you

 

[bedrock]

I remain impressed with you

me too. Taus is a good guy doing things for the right reasons.

 

[Tboned]

@Taus how are you doing so many cases? A lot of Medicare?

 

[Taus]

@Taus how are you doing so many cases? A lot of Medicare?

Yes. Medicare patients who have had axial lbp for decades. Plus Highmark covers it in my area. A few other commercial cases that got approved (united, bcbc). Also lots of internal referrals.

 

[Taus]

I remain impressed with you

So you got my check in the mail?

 

[drrosenrosen]

Yes. Medicare patients who have had axial lbp for decades. Plus Highmark covers it in my area. A few other commercial cases that got approved (united, bcbc). Also lots of internal referrals.

Do you do all your cases in hospital/ASC? Or do you have separate time set aside to do these? What's limiting me from doing more of them is that I only have procedure time in the hospital twice a month, and everything else is in my office. I don't especially want to ramp up time in the hospital or an ASC due to SOS, but I love the way this works for the patients I've done it for so far.

 

[Taus]

Do you do all your cases in hospital/ASC? Or do you have separate time set aside to do these? What's limiting me from doing more of them is that I only have procedure time in the hospital twice a month, and everything else is in my office. I don't especially want to ramp up time in the hospital or an ASC due to SOS, but I love the way this works for the patients I've done it for so far.

ASC. I go to asc 1 day/week and office suite 1 day/week. You could probably do certain select patients in the office with conscious sedation, but need to select these patients carefully. The ones I have done under Mac, not general, In the ASC, have needed pretty heavy sedation. Ive gotten it down to 30 mins consistently for 1 level, 2 vert bodies, add about 15 per level. I leave the room while the last one is burning, take care of dictating, consenting next patient, etc., then go back and remove it and close.

 

[nvrsumr]

ASC. I go to asc 1 day/week and office suite 1 day/week. You could probably do certain select patients in the office with conscious sedation, but need to select these patients carefully. The ones I have done under Mac, not general, In the ASC, have needed pretty heavy sedation. Ive gotten it down to 30 mins consistently for 1 level, 2 vert bodies, add about 15 per level. I leave the room while the last one is burning, take care of dictating, consenting next patient, etc., then go back and remove it and close.

Does the code reimburse in office?

 

[drusso]

Does the code reimburse in office?

No. The manufacturer's pricing is designed to prohibit that.

 

[nvrsumr]

I’m asking about code not device.

 

[drusso]

I’m asking about code not device.

https://www.relievant.com/wp-content/uploads/2022/04/2022-Reimbursement-Guide-1.pdf

 

[nvrsumr]

Thank you. One can always hope. These patients have to be healthier than the 3 level kypho on schedule for Tuesday at the office.

 

[drusso]

Thank you. One can always hope. These patients have to be healthier than the 3 level kypho on schedule for Tuesday at the office.

Exactly.

 

[Sliu238]

How do you all respond to denials for the procedure?

Is it FDA approved or considered investigational?

 

[RoloTomassi]

How do you all respond to denials for the procedure?

Is it FDA approved or considered investigational?

Relevant takes care of all the denial appeals. FDA approved. Investigational is a determination made by each plan.

 

[Sliu238]

MRI L5-S1 severe disc space narrowing with minor reactive change. There is annular bulging with a degree of lateral recess stenosis on left. Minor b/l foraminal stenosis, effacement L > R S1 nerve root. MRI otherwise unremarkable. XR with mild facet hypertrophy at this level. Pain chronic, primarily axial (> unclear radicular L Foot pain), has failed meds/PT/ILESI L5-S1, ADL impaction. Does not want fusion.

Would you appeal denial or try something else (e.g. MBB) first?

 

[RoloTomassi]

Would you appeal denial or try something else (e.g. MBB) first?

Do MBB/RFA +/- SIJ while appealing

 

[Taus]

MRI L5-S1 severe disc space narrowing with minor reactive change. There is annular bulging with a degree of lateral recess stenosis on left. Minor b/l foraminal stenosis, effacement L > R S1 nerve root. MRI otherwise unremarkable. XR with mild facet hypertrophy at this level. Pain chronic, primarily axial (> unclear radicular L Foot pain), has failed meds/PT/ILESI L5-S1, ADL impaction. Does not want fusion.

Would you appeal denial or try something else (e.g. MBB) first?

Is your clinical impression that the pain is from the facet joints or anterior column? Any instability on flexion/extension x-rays? Really no clear role for surgery unless the latter. If clinically a mix picture MBB makes sense first. If all axial pain in a stable spine without deformity, then, yes, intracept.

 

[callmeanesthesia]

MRI L5-S1 severe disc space narrowing with minor reactive change. There is annular bulging with a degree of lateral recess stenosis on left. Minor b/l foraminal stenosis, effacement L > R S1 nerve root. MRI otherwise unremarkable. XR with mild facet hypertrophy at this level. Pain chronic, primarily axial (> unclear radicular L Foot pain), has failed meds/PT/ILESI L5-S1, ADL impaction. Does not want fusion.

Would you appeal denial or try something else (e.g. MBB) first?

Caveat that I don’t do Intracept yet, but I’d certainly try MBB/RFA and SIJ first.

 

[Sliu238]

Is your clinical impression that the pain is from the facet joints or anterior column?

pain is worse with sitting, standing, lifting, bending. Exam NONtenderness to palpation. Neg SIJ provocative tests.. No neuro deficits. Despite signs/symptoms pointing to posterior column, I am assuming there is literature stating it is difficult by H/P alone to distinguish anterior/posterior column disease and thus to rule out posterior column via facet workup, as an initial step?

 

[callmeanesthesia]

pain is worse with sitting, standing, lifting, bending. Exam NONtenderness to palpation. Neg SIJ provocative tests.. No neuro deficits. Despite signs/symptoms pointing to posterior column, I am assuming there is literature stating it is difficult by H/P alone to distinguish anterior/posterior column disease and thus to rule out posterior column via facet workup, as an initial step?

Here’s a review; there’s a bunch of studies. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints - PubMed
Physical exam is not good enough to exclude facets. Gold standard is still the MBB.

 

[bedrock]

Here’s a review; there’s a bunch of studies. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints - PubMed
Physical exam is not good enough to exclude facets. Gold standard is still the MBB.

Agree. Always do MBB for axial spine pain except acute disc herniation. Just don’t do RFA unless MBB clearly positive.

I’ve had several patients for whom I thought RFA would not work, who then achieved 50–70% relief afterwards. Not the home run 90% relief in classic RFA patients but still very worthwhile for these 50-70% relief patients.

 

[RoloTomassi]

I've had it go both ways. Great Intracept candidates who while pending approval, got 90% from RFA and didn't pursue Intracept. Then there's those with terrible facets, just a speck of Modic, zero relief from RFA, great with Intracept. History exam is helpful but don't put too much weight on that either.

 

[Taus]

Here’s a review; there’s a bunch of studies. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints - PubMed
Physical exam is not good enough to exclude facets. Gold standard is still the MBB.

I will post the studies shortly, but localized paramidline tenderness and pain on extension/rotation are highly sensitive, but very poorly specific. No tenderness, no pain on extension? Very unlikely facets, but I may still consider mbb in select cases, particularly an older/comorbid patient who would need general anesthesia for intracept.

tender and/or pain on extension? very low specificity, should do mbb.

Over about a decade of practice, I can count on one hand the amount of patients who have had anything remotely positive come out of mbb/rfa who had zero focal tenderness, and zero pain on extension/rotation. Most common outcome has been probable false positive MBB and minimal to no response from RFA….

 

[bedrock]

I will post the studies shortly, but localized paramidline tenderness and pain on extension/rotation are highly sensitive, but very poorly specific. No tenderness, no pain on extension? Very unlikely facets, but I may still consider mbb in select cases, particularly an older/comorbid patient who would need general anesthesia for intracept.

tender and/or pain on extension? very low specificity, should do mbb.

Over about a decade of practice, I can count on one hand the amount of patients who have had anything remotely positive come out of mbb/rfa who had zero focal tenderness, and zero pain on extension/rotation. Most common outcome has been probable false positive MBB and minimal to no response from RFA….

I see your point but at least 1/4 axial spine pain patients complain of significant pain in multiple planes of movement.

If they have all pain with flexion and zero pain with extension, I see your point but the world of pain patients often isn’t that cut and dried.

 

[Taus]

I see your point but at least 1/4 axial spine pain patients complain of significant pain in multiple planes of movement.

If they have all pain with flexion and zero pain with extension, I see your point but the world of pain patients often isn’t that cut and dried.

I don’t disagree with you. I see more of the clear-cut ones at the extremes of age, which fits the data (Depalma). Young classic discogenic patients. Old classic arthritic patients. Much more of a mixed bag in between, of course, exceptions always exist.

We really can’t be at a point where clinical acumen literally means nothing and if you have axial pain, you should get an mbb even if you are a 20 year old with big annular fissure. Are we back to “only the needle know” -Slipman ?

 

[bedrock]

I don’t disagree with you. I see more of the clear-cut ones at the extremes of age, which fits the data (Depalma). Young classic discogenic patients. Old classic arthritic patients. Much more of a mixed bag in between, of course, exceptions always exist.

We really can’t be at a point where clinical acumen literally means nothing and if you have axial pain, you should get an mbb even if you are a 20 year old with big annular fissure. Are we back to “only the needle know” -Slipman ?

Annular tears certainly can cause extension based pain and I treat as such. Outside of post MVA or autoimmune patients I've never done an RFA on a patient under 30. (but those RFA on young MVA/autoimmune were home runs).

I was taught what you were taught and it held true for my first practice in PA near you, and for LA.
However things are definitely different in the Rocky Mountains, and a high percentage of my patients are very active outdoors, they ride horses, build houses themselves, fix their cars, still play sports, etc. These people are different from city slickers in Philly and LA.

I have seen many patients here with fairly minimal extension pain, but that do very well with RFA. Even 40 year old patients.
So now if someone under 55 has axial spine pain, and doesn't respond to ESI, I always offer MBB and many of them do quite well after RFA.

YMMV due to our different patient populations.

 

[Taus]

Annular tears certainly can cause extension based pain and I treat as such.

Exactly. As above, this is a highly sensitive, but completely non-specific maneuver. That said, if not a whiff of extension pain, I can bend you over backwards and it doesn’t hurt at all, plus the wrong age range = not your facets. Im not doing mbb. Will be negative or false positive. Hurts just a little bit at terminal extension/rotation, just a little bit of tenderness to palpation?… Sure. Mbb. I have had a few of these where I was pretty convinced was anterior column, started auth for intracept. But, as I was not 100% sure, did branch block x2, did RF. Generally mixed results….. not consistent good to excellent results I typically see in my classic old/facet patients. So either their block was false positive or they truly have mixed pain. Hard to know for certain.

I reiterate, we really cannot be at a place where truly only the needle nose and clinical acumen, H&P means nothing for patient selection in axial

 

[Norepi]

This is a snippet from Benzon, written by Steve Cohen. The best and only reliable PE maneuver is paraspinal tenderness. I am happy to see other literature supporting other PE maneuvers. Can we even claim that extension best exacerbates the most commonly implicated joints of 4-5 and 5-1?

 

[SSdoc33]

View attachment 365162
This is a snippet from Benzon, written by Steve Cohen. The best and only reliable PE maneuver is paraspinal tenderness. I am happy to see other literature supporting other PE maneuvers. Can we even claim that extension best exacerbates the most commonly implicated joints of 4-5 and 5-1?

steve cohen is wrong

 

[bedrock]

steve cohen is wrong

Agree