SIJ Arthrodesis 27278 in Non-Facility Settings

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drusso

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"We proposed the RUC-recommended work RVU of 7.86 for CPT code 27278. We also proposed the RUC-recommended direct PE inputs without refinement."

Comment: Several commenters supported CMS’ proposed valuation of 7.86 work RVUs for CPT code 27278. They also supported CMS’ proposed RUC-recommended direct PE inputs for the non-facility site of service as they noted that current study data has sufficiently demonstrated safety and efficacy in the non-facility setting. However, several commenters expressed concern that the non-facility site of service is not appropriate for this procedure. They stated that the procedure is new and without a pre-established safety record.

Response: We thank commenters for their support of our proposed work RVU and nonfacility direct PE inputs. However, we also acknowledge other commenters’ concerns regarding CPT code 27278 being performed in the non-facility setting. At this time, we agree with the RUC’s recommended valuations, including the non-facility direct PE inputs. However, given consideration of all comments received, we believe that CPT code 27278 could benefit from additional future review by the RUC, as a service that includes a new technology supply item (dorsal SI joint arthrodesis implant), as well as considerations for the site of service.

If we were to receive new RUC recommendations at a future date, we would consider that information and any discussions with interested parties for rulemaking.

Comment: Some commenters expressed concerns about the cost of the direct PE supply item, dorsal SI joint arthrodesis implant, valued at $11,500. They stated that the high cost of this supply will negatively impact PE RVUs and cause undesirable effects on the PFS budget neutrality as a service with one of the highest costs on the fee schedule. Commenters were also concerned with the potential overutilization of the service in the non-facility setting.

Response: The payment for the dorsal SI joint arthrodesis implant is based on invoices received from the manufacturer and a formal review to determine if each direct PE input is typical and medically necessary, which is part of our standard code review process. While we acknowledge that the supply is a high-cost item, we do not believe it is appropriate to undervalue a service to minimize impacts on budget neutrality. We also remind commenters that the utilization for this new CPT category I code is crosswalked from CPT code 0775T. As such, we do not anticipate a large impact on budget neutrality and will continue to monitor utilization as part of our standard ratesetting process.

After consideration of the public comments, we are finalizing the RUC-recommended work RVU of 7.86 and direct PE inputs as proposed for CPT code 27278.

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Let the increased abuse of the procedure code begin, followed by pending slash in reimbursement…
 
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Let the increased abuse of the procedure code begin, followed by pending slash in reimbursement…

I just feel sorry for the poor patients who will have their lives ruined by this procedure, until the pay is inevitably slashed.

So disturbing that SIJ RFA isn’t covered while this monstrosity is.
 
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Keeping the patient comfortable while drilling or box cutting the path for the graft is my primary concern. Then, there is sometimes a lot of bleeding. So you really need irrigation and suction. And gel foam. Cautery would be nice to have as well.

All of this is doable. Wisdom teeth get done everyday in offices and that has similar concerns but we don’t have a definitive dental block to rely on. Caudal with lido? SIJ injx with lido and epi?
 
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Any opinions on Transloc vs Zavation
 
Just saw a failed one by one of our surgeons. She has a ton of right posterior hip pain. Not sure how I’m gonna help her at this point as her lumbar MRI is otherwise negative. I feel like he screwed her, literally
 
Just saw a failed one by one of our surgeons. She has a ton of right posterior hip pain. Not sure how I’m gonna help her at this point as her lumbar MRI is otherwise negative. I feel like he screwed her, literally

Yep. That’s all this procedure is. I don’t get how people can do this and sleep at night.

Now the only option for this patient is what she should have done anyway. Cash SIJ RFA.
 
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I don’t know enough about these and have a bias against SI fusion but I like to see more advanced procedures being paid for in the office setting. I don’t own an asc.

What other surgeries do folks think could be safely done in an office? I get mobile anesthesia marketing flyers weekly.

Intracept? peripheral stim implant?
 
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I don’t know enough about these and have a bias against SI fusion but I like to see more advanced procedures being paid for in the office setting. I don’t own an asc.

What other surgeries do folks think could be safely done in an office? I get mobile anesthesia marketing flyers weekly.

Intracept? peripheral stim implant?
Really not sure about an implant like an SI fusion in the office. I do stim trial - they’re coming out in a week, and kypho - it’s mostly in a sealed container.

Intracept should be doable in office. I’ve wondered if you could just put 16g RF needles in bipedicular, and do a bipolar ablation between the tips.
 
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I have seen excellent results in carefully selected patients.
 
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Good clinical results. Reimbursement is good too.
 
How do the ASC's and HOPD's limit abuse?
I have a whole new understanding of the regulations now that I own and manage a surgery center. In the facility there are regulations that require certain oversight for privileging regarding each and every procedure that is done. We’ve turned several doctors away from our facility during the credentialing process because of things that we have uncovered. By allowing this procedure to be done in the office literally anyone that wants to put it in will be allowed to. The family medicine doctors down the street from me who are “pain management” will start doing this. There is no oversight whatsoever in the office and without a doubt this will be over utilized and abused.
 
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I have a whole new understanding of the regulations now that I own and manage a surgery center. In the facility there are regulations that require certain oversight for privileging regarding each and every procedure that is done. We’ve turned several doctors away from our facility during the credentialing process because of things that we have uncovered. By allowing this procedure to be done in the office literally anyone that wants to put it in will be allowed to. The family medicine doctors down the street from me who are “pain management” will start doing this. There is no oversight whatsoever in the office and without a doubt this will be over utilized and abused.

You think that a site of service determination for a CPT code protects against fraud and abuse?


"As part of our strategy to address health care fraud, the FBI cooperates with the Department of Justice and the various United States Attorney Offices throughout the country to pursue offenders through parallel criminal and civil remedies. These cases typically target large-scale medical providers, such as hospitals and corporations, who engage in criminal activity to commit fraud against the government which undermines the credibility of the health care system."
 
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By results, do you mean getting reimbursed? Or something else?

If you think the clinical efficacy is low for this procedure in carefully selected patients, I would respectfully disagree
 
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If you think the clinical efficacy is low for this procedure in carefully selected patients, I would respectfully disagree
I applaud your disagreement.
And I welcome any literature free of industry bias (just kidding).
I also welcome a mechanism where the joint is unstable and needs fusion.
 
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I applaud your disagreement.
And I welcome any literature free of industry bias (just kidding).
I also welcome a mechanism where the joint is unstable and needs fusion.
You won’t find much meaningful literature free of industry bias in our field. If you find some let me know.

The distraction of the degenerated joint definitely provides relief to patients. Long before any fusion has time to occur.
 
You won’t find much meaningful literature free of industry bias in our field. If you find some let me know.

The distraction of the degenerated joint definitely provides relief to patients. Long before any fusion has time to occur.
doesnt mean that there isnt some data out there to post. as an advocate for the procedure, it falls upon you to post, if you are going to support the contention that the procedure is beneficial

and if there is a complete dearth of data - that suggests that there is no data to support. because device companies will not support or publish those studies.
 
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I've been an attending since 2017. Many of you have more experience than I do, but I've seen a decent number of pts in my time.

Surely I'd have come across at least one patient who would benefit from SIJ fusion...I'm sure I'm too strict on patient selection, just like how I can't for the life of me find enough pts that would benefit from Intracept to get trained (I am trying my best to get trained but I just can't find the pts).
 
I've been an attending since 2017. Many of you have more experience than I do, but I've seen a decent number of pts in my time.

Surely I'd have come across at least one patient who would benefit from SIJ fusion...I'm sure I'm too strict on patient selection, just like how I can't for the life of me find enough pts that would benefit from Intracept to get trained (I am trying my best to get trained but I just can't find the pts).
Not to derail the SI Fusion thread but for Intracept patients in my limited experience I find them to be older but not too old, active, not overweight and devoid of depression/anxiety. They’re able to localize their pain to the actual middle of the back. Usually they’ve failed other usual injections and have had it for a longer period of time. I do some aggressive lumbar extension and facet loading and they don’t wince. They tell me pain is worse standing and leaning forward washing dishes or shaving.
 
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I see a place for it.

PT-->steroid-->PRP-->RFA.

That's not a 100% effective (or financially feasible) algorithm. Reasonable next step if not.
 
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Does anyone know what this procedure will actually pay in office? Is there a a margin on the device cost? I dont speak rvu.
 
Does anyone know what this procedure will actually pay in office? Is there a a margin on the device cost? I dont speak rvu.

The total payment will be about $12K. Word on the street is that an allograft company is assembling a single-use pre-sterilized procedure kit (think like MILD or SCS trial leads) to use in the office.

You have to supply your own mallet.

Buy two kits and get a 1 cluneal nerve PNS free.
 
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doesnt mean that there isnt some data out there to post. as an advocate for the procedure, it falls upon you to post, if you are going to support the contention that the procedure is beneficial

and if there is a complete dearth of data - that suggests that there is no data to support. because device companies will not support or publish those studies.

I’m not advocating that you do it.

But here is the best there is to offer, as limited as it is. Looking forward to seeing the 12 month.

Aaron K. Calodney, Nomen Azeem, Patrick Buchanan, Ioannis Skaribas, AjayAntony, Christopher Kim, GeorgeGirardi, Chau Vu, Christopher Bovinet, Rainer S. Vogel, Sean Li, Naveep Jassal, Youssef Josephson, Timothy R.Lubenow, Nicholas Girardi & Jason E.Pope (2022) Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device, Expert Review of Medical Devices, 19:5, 451-461, DOI: 10.1080/17434440.2022.2090244
 
I’m not advocating that you do it.

But here is the best there is to offer, as limited as it is. Looking forward to seeing the 12 month.

Aaron K. Calodney, Nomen Azeem, Patrick Buchanan, Ioannis Skaribas, AjayAntony, Christopher Kim, GeorgeGirardi, Chau Vu, Christopher Bovinet, Rainer S. Vogel, Sean Li, Naveep Jassal, Youssef Josephson, Timothy R.Lubenow, Nicholas Girardi & Jason E.Pope (2022) Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device, Expert Review of Medical Devices, 19:5, 451-461, DOI: 10.1080/17434440.2022.2090244
Single arm. 6 mo. Sponsored by Painteq. It took me 6 mo to read the KOL endorsement deals.

Declaration of interest​

AK Calodney serves as a consultant or receives research support from Medtronic, Nevro, Stryker, Saluda, Nalu, Boston Scientific, Vertos, Painteq, Stimgenics, Spine BioPharma, Saol Therapeutics, Tissuetech, BioRestorative, FUSMobile, APEX Biologix.

JE Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, Thermaquil; and is a shareholder of: Vertos, SPR Therapeutics, Painteq Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil and Anesthetic Gas Reclamation.

N Azeem serves on the Medical Advisory Board for Painteq.

P Buchanan serves as a consultant and Principal Investigator for Abbott and Painteq.

TR Lubenow serves as a consultant for Abbott, Medtronic, Boston Scientific, Painteq, and Nevro.

S Li is on the scientific advisory boards of: Saluda Medical, Scientific Research: Avanos, Biotronik, Boston Scientific, SGX Medical, Nalu Medical, PainTeq, Saluda Medical, SPR Therapeutics.

Consultant: Abbott, Avanos, Averitas Pharm, Biotronik, Boston Scientific, Nalu Medical, Nevro, PainTeq, Saluda Medical, SPR Therapeutics, Vertos Medical; is on the speaker’s bureau of: Scilex Pharm; and has stock options in: Nalu Medical.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

This is not a study. It is a paid advertisement.
 
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I’m not advocating that you do it.

But here is the best there is to offer, as limited as it is. Looking forward to seeing the 12 month.

Aaron K. Calodney, Nomen Azeem, Patrick Buchanan, Ioannis Skaribas, AjayAntony, Christopher Kim, GeorgeGirardi, Chau Vu, Christopher Bovinet, Rainer S. Vogel, Sean Li, Naveep Jassal, Youssef Josephson, Timothy R.Lubenow, Nicholas Girardi & Jason E.Pope (2022) Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device, Expert Review of Medical Devices, 19:5, 451-461, DOI: 10.1080/17434440.2022.2090244

Was this the one that was brought up at IPSIS in Chicago?
 
Single arm. 6 mo. Sponsored by Painteq. It took me 6 mo to read the KOL endorsement deals.

Declaration of interest​

AK Calodney serves as a consultant or receives research support from Medtronic, Nevro, Stryker, Saluda, Nalu, Boston Scientific, Vertos, Painteq, Stimgenics, Spine BioPharma, Saol Therapeutics, Tissuetech, BioRestorative, FUSMobile, APEX Biologix.

JE Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, Thermaquil; and is a shareholder of: Vertos, SPR Therapeutics, Painteq Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil and Anesthetic Gas Reclamation.

N Azeem serves on the Medical Advisory Board for Painteq.

P Buchanan serves as a consultant and Principal Investigator for Abbott and Painteq.

TR Lubenow serves as a consultant for Abbott, Medtronic, Boston Scientific, Painteq, and Nevro.

S Li is on the scientific advisory boards of: Saluda Medical, Scientific Research: Avanos, Biotronik, Boston Scientific, SGX Medical, Nalu Medical, PainTeq, Saluda Medical, SPR Therapeutics.

Consultant: Abbott, Avanos, Averitas Pharm, Biotronik, Boston Scientific, Nalu Medical, Nevro, PainTeq, Saluda Medical, SPR Therapeutics, Vertos Medical; is on the speaker’s bureau of: Scilex Pharm; and has stock options in: Nalu Medical.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

This is not a study. It is a paid advertisement.

I’ve been searching for the double blinded non industry funded RCT for some time, nothing turns up it seems…

If you have done the procedure you probably think positively of it. If you think it’s an open fusion procedure and haven’t seen any outcomes in your hands, you probably think like negatively of it.
 
Any opinions on the best posterior fusion allograft for the office setting?

CMS is forcing adoption of this procedure with the weird si joint block prior to steroid game and no more sacral rfa.
 
Any opinions on the best posterior fusion allograft for the office setting?

CMS is forcing adoption of this procedure with the weird si joint block prior to steroid game and no more sacral rfa.

I believe that first SI joint block called “diagnostic” can still have a steroid in it. Is anyone else seeing it differently?

I do not think this is a great office procedure. There is a real incision. 99% of the time it would be fine but the “what if” is not favorable.
 
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If you have done the procedure you probably think po$itively of it. If you think it’$ an open fu$ion procedure and haven’t $een any outcome$ in your hand$, you probably think like negatively of it.
fixed it for you.

and agree. procedure bias is high.
 
I have a whole new understanding of the regulations now that I own and manage a surgery center. In the facility there are regulations that require certain oversight for privileging regarding each and every procedure that is done. We’ve turned several doctors away from our facility during the credentialing process because of things that we have uncovered. By allowing this procedure to be done in the office literally anyone that wants to put it in will be allowed to. The family medicine doctors down the street from me who are “pain management” will start doing this. There is no oversight whatsoever in the office and without a doubt this will be over utilized and abused.
I own shares of an ASC but I don’t know what you mean, can you explain further
 
I own shares of an ASC but I don’t know what you mean, can you explain further

ASCs don’t credential doctors with checkered pasts because they will be liable for any malpractice that occurs in their facility. There are some places that are desperate for doctors and will turn a blind eye (see Dr Death, Season 1). These shady doctors would do procedures in office in a heartbeat if they could get away with it, so the extra layer of protection that comes with witnesses goes away.
 
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Agast is correct. Facilities have to credential any doc that practices within the facility. Part of the requirements for credentialing are things like background checks, state board action reviews, and a national provider database query. For us this has brought to light a lot of info that lead us not to credential doctors we thought we wanted to work with. No one wants to put their facility at risk by allowing fringe procedures or unscrupulous docs in their ASC. Of course there will be the facilities that are owned by the unscrupulous docs themselves or turn a blind eye because they’re desperate for business. Still, the level of oversight and restriction is leaps and bounds higher than letting every doc with a C arm in their office have ability to do as they please.
 
Does anyone know what this procedure will actually pay in office? Is there a a margin on the device cost? I dont speak rvu.
This is not a procedure that can be done in an office.
 
ASCs don’t credential doctors with checkered pasts because they will be liable for any malpractice that occurs in their facility. There are some places that are desperate for doctors and will turn a blind eye (see Dr Death, Season 1). These shady doctors would do procedures in office in a heartbeat if they could get away with it, so the extra layer of protection that comes with witnesses goes away.

Ah gotya. Yeah I guess I didn't know what you meant - so malpractice suits (hopefully within reason given you can get sued for some BS) and board complaints.
 
You are placing an implant in a joint. You need OR sterility

You need access to cautery and suction.

You need MAC sedation and in some cases general anesthesia
 
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There are already docs who do trials in office who drop their stuff on the ground, too cheap to purchase another stim lead, wash it off and stick it in the patient. Their MAs don’t know any better and the reps keep their mouth shut.
 
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I've been an attending since 2017. Many of you have more experience than I do, but I've seen a decent number of pts in my time.

Surely I'd have come across at least one patient who would benefit from SIJ fusion...I'm sure I'm too strict on patient selection, just like how I can't for the life of me find enough pts that would benefit from Intracept to get trained (I am trying my best to get trained but I just can't find the pts).
i see maybe 100 patients/week (give or take)

i find one that is a reasonable Intracept candidate maybe once or twice a month.

then there are the insurance hurdles, etc. they are out there. but not the "epidemic of modic changes" that drusso would suggest
 
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