ProPublica Picks Protons

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winstonfoot5

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While I know that people here have a deep-seated and reflexive disdain for all things protons, it sounds like the case turned on the use of these utilization review company guidelines to make coverage decisions.

Having fought on peer to peers and been told explicitly that they ignore NCCN and only use their own internal guidelines, I 100% support insurance companies being bent over for making up their own nonsensical guidelines that it ignore NCCN (in general).

Also, shame on MD Anderson for charging 3x out of pocket compared to what BCBS would have paid for protons
 
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Thanks for posting.

I am assuming the randomized trial will be + (whatever that means) for proton benefit (caveat: that oropharynx trial /endpoints are a mess but hopefully we can glean something).

But I always think....what if it's not?
 
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While I know that people here have a deep-seated and reflexive disdain for all things protons, it sounds like the case turned on the use of these utilization review company guidelines to make coverage decisions.

Having fought on peer to peers and been told explicitly that they ignore NCCN and only use their own internal guidelines, I 100% support insurance companies being bent over for making up their own nonsensical guidelines that it ignore NCCN (in general).

Also, shame on MD Anderson for charging 3x out of pocket compared to what BCBS would have paid for protons
Hahahaha

Wow, you somehow wrote the 3 sentences which precisely describe how I feel but couldn't put into words.

The other thing, the "4th sentence", is how frustrated I get reading about radiation in the news.

Specifically, we all know there's this giant background debate over everything described in this article.

The general population will ONLY see this story as "protons were good and needed, the entire medical and legal systems agree!"

Alas...
 
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Propublica, the very best in agenda driven journalism that money can buy. Wouldn't be surprised if this article had direct finical sponsorship.
 
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Also, shame on MD Anderson for charging 3x out of pocket compared to what BCBS would have paid for protons
I mean, who's the real villain here. They confused the patient and maximized revenue at his expense.

Almost certainly an HPV positive case in a non or rare-smoker. Outcomes are overwhelmingly good at most community clinics.

Sort of like a wealthy prostate patient. (a bit tougher)

Also, I wince every time I see the word "precise" attributed to proton therapy.

From where I sit, insurance denial seems usually appropriate at this point.

Of course, if true case based rates with equal compensation, I would absolutely trust the docs to determine clinical appropriateness. Now, that would be nice.
 
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This is the definition of IMRT I got off CMS:

"Intensity Modulated Radiation Therapy (IMRT) is a technology in radiation oncology that delivers radiation more precisely to the tumor while relatively sparing the surrounding normal tissues. It is an advanced form of three-dimensional conformal radiation therapy (3D CRT) that allows for varying intensities of radiation to produce dose distributions that are more conformal than those possible with standard 3D CRT. It introduces inverse planning and computer-controlled radiation deposition, and normal tissue avoidance in contrast to the conventional trial-and-error approach.

The clinical objectives are defined mathematically and the IMRT optimization process determines the beam parameters that will lead to the desired solution while sparing normal tissues.

Examples of situations where IMRT is covered include tumors of the prostate, head and neck, brain, and paraspinal regions when needed to reduce the incidence and severity of the side effects of radiation, including compromise of visual function, mucositis, and xerostomia.

An IMRT candidate includes a patient who has already received a maximum amount of radiation delivered by conventional means. IMRT allows these patients to receive additional radiation safely, which can result in a prolonged survival and an improved quality of life."

I've seen "linear accelerator" used in the definition on a separate site, but this was what I saw on CMS. If this is it, all of the above applies to protons doesn't it? Why couldn't MDACC just enter CPT 77386? I'm sure IMRT was approved, and it's been a minute since I reviewed physics, but I believe protons qualify as "radiation."
 
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I mean, who's the real villain here. They confused the patient and maximized revenue at his expense.

Almost certainly an HPV positive case in a non or rare-smoker. Outcomes are overwhelmingly good at most community clinics.

Sort of like a wealthy prostate patient. (a bit tougher)

Also, I wince every time I see the word "precise" attributed to proton therapy.

From where I sit, insurance denial seems usually appropriate at this point.

Of course, if true case based rates with equal compensation, I would absolutely trust the docs to determine clinical appropriateness. Now, that would be nice.
The irony here is that protons are very likely to be worse in this situation. No proven benefit, and suggested 10% case of osteoradionecrosis etc
 
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The irony here is that protons are very likely to be worse in this situation. No proven benefit, and suggested 10% case of osteoradionecrosis etc
I just call balls and strikes. NCCN says it’s fine
 
This is the definition of IMRT I got off CMS:

"Intensity Modulated Radiation Therapy (IMRT) is a technology in radiation oncology that delivers radiation more precisely to the tumor while relatively sparing the surrounding normal tissues. It is an advanced form of three-dimensional conformal radiation therapy (3D CRT) that allows for varying intensities of radiation to produce dose distributions that are more conformal than those possible with standard 3D CRT. It introduces inverse planning and computer-controlled radiation deposition, and normal tissue avoidance in contrast to the conventional trial-and-error approach.

The clinical objectives are defined mathematically and the IMRT optimization process determines the beam parameters that will lead to the desired solution while sparing normal tissues.

Examples of situations where IMRT is covered include tumors of the prostate, head and neck, brain, and paraspinal regions when needed to reduce the incidence and severity of the side effects of radiation, including compromise of visual function, mucositis, and xerostomia.

An IMRT candidate includes a patient who has already received a maximum amount of radiation delivered by conventional means. IMRT allows these patients to receive additional radiation safely, which can result in a prolonged survival and an improved quality of life."

I've seen "linear accelerator" used in the definition on a separate site, but this was what I saw on CMS. If this is it, all of the above applies to protons doesn't it? Why couldn't MDACC just enter CPT 77386? I'm sure IMRT was approved, and it's been a minute since I reviewed physics, but I believe protons qualify as "radiation."
MDACC absolutely could bill (with righteousness and purity) iMPT as IMRT. And, for certain, all IMPT centers bill 77301 (IMRT planning code) on all patients.
 
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Propublica, the very best in agenda driven journalism that money can buy. Wouldn't be surprised if this article had direct finical sponsorship.
They've had some good hits over the years, not sure why all the hate. The tax and scotus stuff has been gold
 
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Speaking for the article…

I don’t like it, at all.

Makes it sound like photons are substandard

And they are a standard of care.
 
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Speaking for the article…

I don’t like it, at all.

Makes it sound like photons are substandard

And they are a standard of care.

Couldn't agree more. I only skimmed it, but no mention of an ongoing randomized trial from what little I read.

It would be easy to say "some in the medical community think protons may be a superior treatment, but this is currently under investigation in a randomized study comparing protons and photons. A recent similar study comparing protons and photons for lung cancer from Dr. Fuller's institution did not show any difference between these two techniques in spite of prior hope that protons would be superior."
 
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Speaking for the article…

I don’t like it, at all.

Makes it sound like photons are substandard

And they are a standard of care.
Every question, no matter how complex, has an answer which is simple, neat, and wrong.

The argument that protons stop and are therefore are more precise is just easy to understand. And precise has to be better right?
 
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Speaking for the article…

I don’t like it, at all.

Makes it sound like photons are substandard

And they are a standard of care.

The article reads like it was either written by the trial lawyer or MDACC. No attempt by Propublica to put into a larger context or to even ask why protons maybe rejected.
 
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Rich guy wants protons, PPO refuses. Rich guy pays out of pocket at a much higher rate than PPO would because he can.

Rich guy eventually gets a refund from the PPO.

The world keeps spinning, MDACC continues to offer protons without proven benefit, ROCR is implemented, breadlines.
 
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The article reads like it was either written by the trial lawyer or MDACC. No attempt by Propublica to put into a larger context or to even ask why protons maybe rejected.

I know this is not news to anyone, but stating the obvious....I think in the U.S. we've all been so conditioned (arguably rightly) to approach the issue with a high level of skepticism that the insurance company is always in the wrong. Usually that's a safe bet. Plus, how could a cancer center ever be in the wrong? They treat cancer for goodness sake.

You've got to be very in the weeds/in the know to have an understanding of other dynamics at play.
 
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The question is about inappropriate care and lack of medical necessity.

I am unclear why this would/should be approved based on guidelines.

ASTRO says that “Advanced stage and unresectable head and neck cancers” are among the “sites that frequently support the use of PBT” but still require documentation of necessity -

1. The target volume is near one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s), which would portend a higher risk of toxicity.

2. A proton-based technique would decrease the probability of clinically meaningful normal tissue toxicity by lowering an integral dose-based metric and/or organ at risk dose volume constraint associated with toxicity.

3. The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

NCCN guidelines state: “Use of proton therapy is an area of active investigation. Proton therapy may be considered when normal tissue constraints cannot be met with photon-based therapy.” and “has typically been used to treat patients with the most challenging disease, for which other RT options were not felt to be safe or of any benefit.”

ASTRO and NCCN guidelines should not be a rationale for blanket coverage of proton therapy for head and neck cancer, nor should enrollment on a registry that includes anyone treated with proton therapy for the sole purpose of having a basis to approve an unnecessary treatment.
 
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The article reads like it was either written by the trial lawyer or MDACC. No attempt by Propublica to put into a larger context or to even ask why protons maybe rejected.
Guys, of course not. They are not writing an article about proton therapy. The story is about a heartless insurance company who picked a fight with the wrong layer by denying them the lifesaving treatment recommended by a top doctor at America's leading hospital. The fact that they did not deny treatment, but rather a specific treatment with no proven benefit over the existing therapy which they would approve, is a major inconvenience to the overall narrative and not the goal of the article or interest of the target audience.
 
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I am unclear why this would/should be approved based on guidelines.

ASTRO says that “Advanced stage and unresectable head and neck cancers” are among the “sites that frequently support the use of PBT” but still require documentation of necessity -

1. The target volume is near one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s), which would portend a higher risk of toxicity.

2. A proton-based technique would decrease the probability of clinically meaningful normal tissue toxicity by lowering an integral dose-based metric and/or organ at risk dose volume constraint associated with toxicity.

3. The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

NCCN guidelines state: “Use of proton therapy is an area of active investigation. Proton therapy may be considered when normal tissue constraints cannot be met with photon-based therapy.” and “has typically been used to treat patients with the most challenging disease, for which other RT options were not felt to be safe or of any benefit.”

ASTRO and NCCN guidelines should not be a rationale for blanket coverage of proton therapy for head and neck cancer, nor should enrollment on a registry that includes anyone treated with proton therapy for the sole purpose of having a basis to approve an unnecessary treatment.
If being a purist based on the guidelines you’re showing here, if a comparison proton vs IMRT showed proton advantages, the protons should be covered.

Surprisingly many proton centers will not run comparison plans because they won’t even agree to simulate and scan the patient until the protons get approved. So they submit case matched, non patient specific comparisons to insurance companies. Very shoot selves in foot stuff when the proton centers do that imho.

If I had to guess, Fuller and MDACC never simulated the patient and performed good IMRT and proton plans and submitted comparison DVHs to insurance. DVHs that show clear proton superiority? This case never goes to court; BCBS capitulates.
 
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Every question, no matter how complex, has an answer which is simple, neat, and wrong.

The argument that protons stop and are therefore are more precise is just easy to understand. And precise has to be better right?
Protons=precise uncertainty

They do stop but on a daily basis not exactly sure where they stop

Range uncertainty is rarely mentioned on these websites that talk about "collateral damage"
 
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I am unclear why this would/should be approved based on guidelines.

ASTRO says that “Advanced stage and unresectable head and neck cancers” are among the “sites that frequently support the use of PBT” but still require documentation of necessity -

1. The target volume is near one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s), which would portend a higher risk of toxicity.

2. A proton-based technique would decrease the probability of clinically meaningful normal tissue toxicity by lowering an integral dose-based metric and/or organ at risk dose volume constraint associated with toxicity.

3. The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

NCCN guidelines state: “Use of proton therapy is an area of active investigation. Proton therapy may be considered when normal tissue constraints cannot be met with photon-based therapy.” and “has typically been used to treat patients with the most challenging disease, for which other RT options were not felt to be safe or of any benefit.”

ASTRO and NCCN guidelines should not be a rationale for blanket coverage of proton therapy for head and neck cancer, nor should enrollment on a registry that includes anyone treated with proton therapy for the sole purpose of having a basis to approve an unnecessary treatment.

You have the ASTRO updated model policy a little out of out of context. You only need to meet 1 of those criteria, not all. #2 is incredibly vague and you could probably make an argument for literally any indication given the language "lowering an integral dose-based metric"

The policy also says "Coverage decisions may extend beyond ICD-10 codes to incorporate additional considerations of clinical scenario and medical necessity with appropriate documentation, which in certain circumstances may include comparative dose volume histograms."

The wording of group 1 has always implied that it should be approved for all cases (assuming you compare to group 2).
 
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Protons=precise uncertainty

They do stop but on a daily basis not exactly sure where they stop

Range uncertainty is rarely mentioned on these websites that talk about "collateral damage"
Oh, you and I are 100% on the same page here. For prostate in particular, I have long said I would not be surprised if protons eventually show more late rectal bleeding than photons. I think it was Zeflesky who put out a pretty big retrospective institutional experience showing something like 5 vs 13%. But not significnatly different so...
 
If being a purist based on the guidelines you’re showing here, if a comparison proton vs IMRT showed proton advantages, the protons should be covered.
I think the driving question is what are the "advantages". Reducing exposure in a non-clinically meaningful way is not an advantage. Some CMS policies include explicit language about using the most cost-effective treatment (which may be why Mayo, Maryland ... adopted IMRT rates).

You have the ASTRO updated model policy a little out of out of context. You only need to meet 1 of those criteria, not all. #2 is incredibly vague and you could probably make an argument for literally any indication given the language "lowering an integral dose-based metric"

The policy also says "Coverage decisions may extend beyond ICD-10 codes to incorporate additional considerations of clinical scenario and medical necessity with appropriate documentation, which in certain circumstances may include comparative dose volume histograms."

The wording of group 1 has always implied that it should be approved for all cases (assuming you compare to group 2).

I understood that these were "or" and not "and" criteria and I should have specified that. While one could assume all Group 1 conditions would meet criteria for medical necessity the policy does not state that. It says "frequently support" and also says:

"Documentation in the patient medical record must: 1. Support one or more medical necessity requirement(s) as provided under the “Indications and Limitations of Coverage and/ or Medical Necessity” section of this policy, if not enrolled on a clinical protocol or registry."

I dont think a registry should be a golden ticket and dont think that insurers would feel the need to abide by that.

The 2nd criteria should be supported by a DVH comparison that shows a reduction that would lead to reduced toxicity risks. I agree that this is vague especially for things like mean heart dose, mean oral cavity dose, etc. though perhaps not vague if your basis is a cord max of 30 Gy vs 20 Gy in 30 fractions.

One could argue that NCCN guidelines are more unbiased since they do not solely represent radiation oncologists (and arguably under-represent radiation oncologists). They explicitly say "when normal tissue constraints cannot be met with photon-based therapy". Even though this is explicit, it is also fuzzy since a crappy IMRT plan is fairly easy to generate.

I know nothing of the specifics of this case with the fancy lawyer, or the 9 page appeal that was submitted. Perhaps MDACC clearly showed they met these criteria (or the 2017 ASTRO criteria which would have been available when he was treated).
 
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I think the driving question is what are the "advantages". Reducing exposure in a non-clinically meaningful way is not an advantage. Some CMS policies include explicit language about using the most cost-effective treatment (which may be why Mayo, Maryland ... adopted IMRT rates).



I understood that these were "or" and not "and" criteria and I should have specified that. While one could assume all Group 1 conditions would meet criteria for medical necessity the policy does not state that. It says "frequently support" and also says:

"Documentation in the patient medical record must: 1. Support one or more medical necessity requirement(s) as provided under the “Indications and Limitations of Coverage and/ or Medical Necessity” section of this policy, if not enrolled on a clinical protocol or registry."

I dont think a registry should be a golden ticket and dont think that insurers would feel the need to abide by that.

The 2nd criteria should be supported by a DVH comparison that shows a reduction that would lead to reduced toxicity risks. I agree that this is vague especially for things like mean heart dose, mean oral cavity dose, etc. though perhaps not vague if your basis is a cord max of 30 Gy vs 20 Gy in 30 fractions.

One could argue that NCCN guidelines are more unbiased since they do not solely represent radiation oncologists (and arguably under-represent radiation oncologists). They explicitly say "when normal tissue constraints cannot be met with photon-based therapy". Even though this is explicit, it is also fuzzy since a crappy IMRT plan is fairly easy to generate.

I know nothing of the specifics of this case with the fancy lawyer, or the 9 page appeal that was submitted. Perhaps MDACC clearly showed they met these criteria (or the 2017 ASTRO criteria which would have been available when he was treated).
I want it to say what you are saying, but it does not.

The NCCN is much more broad than that. They also say that randomized studies to test these concepts are unlikely to be done. IMRT is preferred, but nowhere does it mention a restriction of proton beam therapy. In fact, it is all left to clinician's judgment.

My approach is that we have to look at the words themselves. If it is said not preferred or on-study or any sort of restriction, I would hold them to it. But, I think payors/third parties should not ignore NCCN and make their own guidelines. These are clear to me. If I denied, this would go to my partner who would probably approve. But, if he did not, the MCR contractor would deny me. And if not them, 100% that the Medicare judge would.

Lymphoma is another treatment site where it is very broad and I would hesitate to deny.

This is very different than what the article says, how the physician should be viewed and MDACC's business practices. These are all interesting discussions, but as a PA guy, this should not have been denied. I would be happy for NCCN to say "needs to be on study for protons" but they don't listen to me.

1699460633264.png
 
I want it to say what you are saying, but it does not.
Sometimes dreams come true - if you search the head and neck NCCN guidelines pdf for "when normal tissue constraints cannot be met" you'll see this specified multiple times (based on specific condition).

What you pasted above is under the general radiation guidelines (which is of course footnoted multiple times throughout the guidelines). However, I think a PA could choose to adhere to "when normal tissue constraints cannot be met", or choose not to, since it seems vague.
 
the real heroes are 3 radiation oncologists that denied protons for this: upfront, 1st appeal, 2nd appeal
 
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(background music: real american heroes, circa bud beer commercial)

Here's to you, Dr. UM... working tirelessly in a cubicle to ensure care is denied with all the humanity, precision and relentlessness a xerox copier has to give. We salute YOU, for your efforts in ensuring Insurance Company profits remain at a record high, while simultaneously ensuring the greed and misrepresentation of PPS exempt proton centers gets crushed. Your efforts are legend, your devotion unflinching.. you great American Healthcare Hero you..

"...American Hero.." (fades to black)
 
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THANK YOU!!
Good to see some appreciation
 
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Private jets complement protons similar to that of cigarettes/ tuna.

Articles like this make an uninformed reader think that insurance/ rad oncs outside of big protons centers are withholding a treatment with similar efficacy to that of Gleevec for CML. Very disingenuous given the recent push for excluding protons from ROCR.
 
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(background music: real american heroes, circa bud beer commercial)

Here's to you, Dr. UM... working tirelessly in a cubicle to ensure care is denied with all the humanity, precision and relentlessness a xerox copier has to give. We salute YOU, for your efforts in ensuring Insurance Company profits remain at a record high, while simultaneously ensuring the greed and misrepresentation of PPS exempt proton centers gets crushed. Your efforts are legend, your devotion unflinching.. you great American Healthcare Hero you..

"...American Hero.." (fades to black)

Cubicle? This is 2023. Join the laptop class.
 
Seriously. I've never even seen one of my co-workers or bosses in real life.
Most of the work done on a laptop on my kitchen island while my kids make a f'in mess.
The stories we hear that are never corroborated...
 
As someone who can use either protons or Xrays for any given individual, I am really fortunate. My income, luckily, does not depend on the use of just protons or just the Linac. How many rad oncs can say that? In a way, I'm living the dream.

Interestingly, on a per hour basis, I get paid about half as much for the proton cases I do, because the complexity is that much higher in planning (and also the management of higher patient expectations). It's still kind of like how a good IMRT plan used to take 2 weeks and multiple trips to dosimetry back in the day, and you had to be careful to tell the computer to not treat through the lips and stuff like that.

I think that it's worth mentioning that patient expectations are all over the map in regard to what protons can offer. Some people will travel internationally and pay out of pocket for a small chance at reducing a life-long risk of side effects. Others won't drive to the next town over, even if I insist that it's much safer for their particular cancer, and that they are doing themselves a disservice if they don't. Neither of these patients are wrong, by the way, but it just reflects their social and economic conditions at the moment - they are all just trying to do the best they can with what they've got, just like you and me.

The Propublica article is short on nuance, just like all news articles. Most patients who come in seeking protons have generally been exposed to biased information or at least a one-sided marketing approach (just like all marketing - have you ever seen a Ford F150 commercial praise the merits of a Chevy Silverado?).

As a result, I sometimes have to tell people that another modality is simply better for their specific situation, just like you would do if someone came in requesting 5 fractions of Cyberknife brand for their H&N cancer involving both necks, "and no chemo either, because chemo has side effects - I don't want any side effects." It can be a long discussion to tell someone who came in specifically for protons that they simply won't qualify and I cannot make a convincing case for their insurance company, because I'm not convinced myself, at least, in that specific patient's case.

It should matter though, when a doctor who can choose any modality, does request one that is quantifiably safer. It should matter, when he or she takes half an hour of uncompensated time to compose a signed letter or have a live hearing with a judge to back it up. It should matter when we do produce the patient-specific comparison plans (hours of uncompensated work), where the proton plan does meet multiple published constraints that no IMRT plan can ever meet. It should matter when I submit professional society guidelines and published articles showing reduced need for expensive and risky procedures like feeding tubes or hospital stays for relevant proton-treated patients.

But no matter what their disease site, or how heavily they were pre-treated, or how superior their proton comparison plan; way too many of my patients who truly NEED protons still get denied due to the arbitrary and capricious rules written years ago by financially biased people. These generally are people who have never prescribed protons or created a proton plan, who lump all proton requests into the same box, who don't have a career-safe mechanism to override the health plan on a regular basis, who aren't up to date on the literature in the particle field, and who have no incentive to do so.

I get the same immediate rubber stamp denial that you and I would get if I tried to prescribe 180 fractions of IMRT+IGRT for a bone met patient on hospice.

To me, that is why we need a legal outlet for these patients (and their doctors), to seek recourse against the insurance companies who turn a blind eye and deaf ear on those that we all have an obligation to protect.
 
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Serious question for people in the know: on what basis does Evicore justify peer to peers for IMRT for a standard definitive prostate case? Because they are doing it all of the time now. It’s very frustrating. They always end up approving so it feels on my end the goal is to flood the system and hope people don’t end up jumping through the hoops to get payment for SOC treatments. Am I missing something?
 
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Serious question for people in the know: on what basis does Evicore justify peer to peers for IMRT for a standard definitive prostate case? Because they are doing it all of the time now. It’s very frustrating. They always end up approving so it feels on my end the goal is to flood the system and hope people don’t end up jumping through the hoops to get payment for SOC treatments. Am I missing something?
No
 
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Serious question for people in the know: on what basis does Evicore justify peer to peers for IMRT for a standard definitive prostate case? Because they are doing it all of the time now. It’s very frustrating. They always end up approving so it feels on my end the goal is to flood the system and hope people don’t end up jumping through the hoops to get payment for SOC treatments. Am I missing something?
It’s been really, really terrible for the past 2-3 months. 2 weeks for rejection. 1 seem to schedule peer to peer (because they are understaffed). Can’t get anyone started on treatment.
 
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To me, that is why we need a legal outlet for these patients (and their doctors), to seek recourse against the insurance companies who turn a blind eye and deaf ear on those that we all have an obligation to protect.

I think a lot of what you said regarding insurance is not wrong.

I’m curious, how many patients do you put on randomized trials each year?
 
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I think a lot of what you said regarding insurance is not wrong.

I’m curious, how many patients do you put on randomized trials each year?
We have contributed to all the major trials:

RadComp - node+ breast
COMPPARE - we led the country in Xray prostate patient accruals during many time points
MDACC oropharyngeal trial
NRG GI-006 - esophagus

The biggest problem I have right now is the lack of a major successor to the first 3 trials above. It is a 10 year effort to get a major trial like Radcomp or COMPPARE off the ground and accruing well.

The other big problems in accrual are lack of equipoise in the minds of patients who want to crossover to protons, and insurers, who still refuse to cover patients in a trial
 
We have contributed to all the major trials:

RadComp - node+ breast
COMPPARE - we led the country in Xray prostate patient accruals during many time points
MDACC oropharyngeal trial
NRG GI-006 - esophagus

The biggest problem I have right now is the lack of a major successor to the first 3 trials above. It is a 10 year effort to get a major trial like Radcomp or COMPPARE off the ground and accruing well.

The other big problems in accrual are lack of equipoise in the minds of patients who want to crossover to protons, and insurers, who still refuse to cover patients in a trial
We cover it on any RCT w/ NCT #
 
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It should matter though, when a doctor who can choose any modality, does request one that is quantifiably safer.
It's a good post.

I just don't believe proton dosimetry. Which means that comparing plans becomes a relatively low value proposition to me.

Would it make sense (given the present state of data) to approve protons for reirradiation H&N plan where you have absolutely met dose tolerance on the brainstem and even the 30% IDL of your photon plan presents significant risk? I think so, but I would still be concerned with those dosimetric uncertainties within 1 cm of my re-irradiation target.

Is there ever a first course of head and neck treatment where protons are the safer intervention regarding outcomes like necrosis?

I need convincing.


 
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It's a good post.

I just don't believe proton dosimetry. Which means that comparing plans becomes a relatively low value proposition to me.

Would it make sense (given the present state of data) to approve protons for reirradiation H&N plan where you have absolutely met dose tolerance on the brainstem and even the 30% IDL of your photon plan presents significant risk? I think so, but I would still be concerned with those dosimetric uncertainties within 1 cm of my re-irradiation target.

Is there ever a first course of head and neck treatment where protons are the safer intervention regarding outcomes like necrosis?

I need convincing.


I'm sure the dosimetry of protons for prostate look better than IMRT in silico. IRL, we have data, and I have anecdotes, that protons could be worse for toxicity.

I'm sure the dosimetry of protons for breast look better than IMRT in silico. IRL, there is data that breast proton toxicity is not better than photons.

I'm sure the dosimetry of protons for HNSCC look better than IMRT in silico. IRL, we have data that protons could be worse for toxicity.

I'm sure—when cancer spreads through the whole craniospinal axis—the survival outcomes for protons treating the entire craniospinal axis are better than photons treating just a fraction of the craniospinal axis. IRL, we have data.
 
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It's a good post.

I just don't believe proton dosimetry. Which means that comparing plans becomes a relatively low value proposition to me.

Would it make sense (given the present state of data) to approve protons for reirradiation H&N plan where you have absolutely met dose tolerance on the brainstem and even the 30% IDL of your photon plan presents significant risk? I think so, but I would still be concerned with those dosimetric uncertainties within 1 cm of my re-irradiation target.

Is there ever a first course of head and neck treatment where protons are the safer intervention regarding outcomes like necrosis?

I need convincing.


You are correct, range uncertainty and high LET at end-range are real concerns. They and other considerations (RBE, robust planning, interest in other particles like
Alpha beams and Carbon) are among the reasons why I did a proton fellowship.

I just started using in clinic a variable RBE model, that does not assume RBE =1.1, but rather calculates in the high RBE of 1.3 to 1.5 in the distal tail. I had never seen proton RBE-weighted dose on screen before, and it has already affected my planning.

Case in point, I was recently treating a kid with brainstem tumor. Normal DVH in Eclipse showed max brainstem point dose = 56 Gy, or about 104% of 54 Gy rx dose. The variable RBE plan shows a 61 Gy max dose. Needless to say, we changed the beam arrangement and got it back down around 56 Gy.

I've been waiting a while for that feature, and feel much safer now that it's here.
 
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You are correct, range uncertainty and high LET at end-range are real concerns. They and other considerations (RBE, robust planning, interest in other particles like
Alpha beams and Carbon) are among the reasons why I did a proton fellowship.

I just started using in clinic a variable RBE model, that does not assume RBE =1.1, but rather calculates in the high RBE of 1.3 to 1.5 in the distal tail. I had never seen proton RBE-weighted dose on screen before, and it has already affected my planning.

Case in point, I was recently treating a kid with brainstem tumor. Normal DVH in Eclipse showed max brainstem point dose = 56 Gy, or about 104% of 54 Gy rx dose. The variable RBE plan shows a 61 Gy max dose. Needless to say, we changed the beam arrangement and got it back down around 56 Gy.

I've been waiting a while for that feature, and feel much safer now that it's here.
Kudos to you for admitting that you are concerned with RBE at the end of the peak. ABout 15- 20 years ago an MGH faculty member admitted to me that they were hesitant to place a proton beam with an organ at risk at the end of the peak. I asked him why this wasn't in the (only) proton planning book available at the time; ...no comment with wry smile
 
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