Treatment with Mid Level Providers

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BobbyHeenan

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I have some question(s)....

From what I saw on the interview trail a while back, a lot of rural centers use NP/PA to treat when doctors aren't there. It's my understanding that it's just not financially feasible to keep a doctor in an office that is in the middle of nowhere and only treats less than 20 patients/day. Hence, people often use an NP just as a provider presence while machines are going - not for consults, under treats, sims, SBRT, brachy, etc while the doctor is only there 3 days/week. From my research it appears that medicare has been OK with this as long as it is a hospital based practice.

However, my biller is telling us that at a recent billing conference this phenomenon was discussed with the expert panel (including an ASTRO physician representative ?Zeitman maybe?) and they really frowned on this practice - suggesting (but not declaring) that this was fraudulent.

Could anyone shed some light on this or give any insight about your experience with this? It just seems that a lot of rural centers will cease to exist if you can't treat with a mid level in the building.

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You need an MD physically present while radiation treatments are ongoing, period. No mid-level provider qualifies as such. However, in a pinch you can substitute with any other MD on an emergency basis.

Despite this, I personally know of rural centers where this practice occurs - it is just not possible for them to recruit a full-time MD. However, it is fraudulent and they put themselves at risk for audit and penalties. Furthermore, if a disgruntled employee whistleblows to the Feds, they will get a lucrative finder's fee.

I found a relevant quote from a Bogardus seminar I attended in 2013:

"Under the earlier interpretation of the Incident to Rules, hospitals were thought to be exempt from the requirement to have a physician available in the department while patients were being treated. The CY 2009 OPPS/ASC Proposal Rule (73FR41518) 413.65 states that, "Services furnished at a department of a provider in relation to a hospital must be under the DIRECT supervision of a physician. The physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure."

They then go on to say that in the hospital setting, it is probably ok if you are making rounds, attending conferences, or in the OR as long as all of these activities are "in the hospital." However, if you leave the hospital without adequate MD supervision, then you put yourself at risk.
 
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Thanks for the input.

I know at least one academic center that uses a med onc to "supervise" the linac while they treat at a satellite center as well on a routine basis (ie not emergent), so that is going on out there too.

If they do start cutting down on this, that is going to seriously hamper the ability of rural centers to recruit and keep their doors open. Off the top of my head I can think of at least six centers I know of spread throughout the U.S. (both academic and private) that use med oncs or NP as supervision for their treatments at least one day/week.
 
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Medicare guidelines are pretty clear about needing direct supervision from someone trained to furnish assistance with the "procedure", i.e. IGRT. A mid-level or med onc doesn't cut it.

There is a white paper from ASTRO on the topic.

https://www.astro.org/Practice-Management/Reimbursement/Medicare/Supervision.aspx

I believe there are certain "rural" hospitals that get a special designation from medicare that allow an exemption to the above, can't remember the exact term.

Bottom line, be careful, unless you have an exemption from medicare. You only need to google around to find a number of recent medicare whistleblower lawsuits regarding cases involving rad oncs in BOTH freestanding and hospital-based practices.
 
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You need an MD physically present while radiation treatments are ongoing, period. No mid-level provider qualifies as such. However, in a pinch you can substitute with any other MD on an emergency basis.

Despite this, I personally know of rural centers where this practice occurs - it is just not possible for them to recruit a full-time MD. However, it is fraudulent and they put themselves at risk for audit and penalties. Furthermore, if a disgruntled employee whistleblows to the Feds, they will get a lucrative finder's fee.

I found a relevant quote from a Bogardus seminar I attended in 2013:

"Under the earlier interpretation of the Incident to Rules, hospitals were thought to be exempt from the requirement to have a physician available in the department while patients were being treated. The CY 2009 OPPS/ASC Proposal Rule (73FR41518) 413.65 states that, "Services furnished at a department of a provider in relation to a hospital must be under the DIRECT supervision of a physician. The physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure."

They then go on to say that in the hospital setting, it is probably ok if you are making rounds, attending conferences, or in the OR as long as all of these activities are "in the hospital." However, if you leave the hospital without adequate MD supervision, then you put yourself at risk.


You listed the "proposed" rule. After comment the final rule was...

"In the CY 2010 OPPS/ASC final rule with comment period, we finalized our proposal to allow, in addition to clinical psychologists, certain other nonphysician practitioners to directly supervise services that they may perform themselves under their State license and scope of practice and hospital-granted or CAH-granted privileges. The nonphysician practitioners that were permitted to provide direct supervision of therapeutic services under the CY 2010 OPPS/ASC final rule with comment period are physician assistants, nurse practitioners, clinical nurse specialists, certified nursemidwives, and licensed clinical social workers. These nonphysician practitioners may directly supervise outpatient therapeutic services that they may personally furnish in accordance with State law and all additional requirements, including the Medicare coverage rules relating to their services specified in our regulations at 42 CFR 410.71, 410.73, 410.74, 410.75, 410.76, and 410.77 (for example, requirements for collaboration with, or GENERAL supervision by, a physician)."

"In the CY 2010 OPPS/ASC final rule with comment period, we also finalized our proposal to add paragraph (a)(1)(iv)(B) to §410.27. This paragraph updated our previous regulation at §410.27(f) to reflect that, for off-campus PBDs of hospitals, the physician or nonphysician practitioner must be present in the off-campus PBD, as defined in §413.65, and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician or nonphysician practitioner must be in the room when the procedure is performed. In addition, we finalized the proposed technical change to clarify the language in §410.27(f) by removing the phrase “present and on the premises of the location” and replacing it with the phrase “present in the off-campus provider-based department.”

http://www.wsha.org/files/83/Physician_Supervision_Proposed_Rule.pdf
Page 407-409


Additionally, straight from the ASTRO Q&A regarding physician supervision (drawing directly from the final rule as above)....

"Q: Can the CMS requirements for supervising physician or nonphysician practitioner be fulfilled using a physician assistant in the field of radiation oncology or nurse practitioner in the field of radiation oncology, or a physician that is not in the field of radiation oncology, such as a medical oncologist?

A: CMS requires the supervising physician or nonphysician practitioner to be able to immediately step in and perform the procedure not just in the event of an emergency but to also be able to furnish assistance and direction throughout the performance of the procedure. CMS has indicated that the supervising physician or nonphysician practitioner must also be a person who is “clinically appropriate” to supervise the services or procedures and unless a non-radiation oncologist physician or a nonphysician practitioner has within his or her State scope of practice, licensure, training and hospitalgranted privileges the ability to perform the service or procedure, this would not meet the supervision requirements. It is ASTRO’s view that the Radiation Oncologist is always considered a clinically appropriate physician but there may be others who meet these requirements."

https://www.astro.org/uploadedFiles...agement/Reimbursement/Medicare/SVFAQs0210.pdf



Not sure if something has changed recently, but use of trained nonphysician providers, under the general supervision of a physician is allowed as of the 2010 rule. Though it may depend on your reading of things.
 
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Not sure if something has changed recently, but use of trained nonphysician providers, under the general supervision of a physician is allowed as of the 2010 rule. Though it may depend on your reading of things.

Sadly this is what it boils down to. I read it as MDs only, others may disagree.
 
Sadly this is what it boils down to. I read it as MDs only, others may disagree.

Let's look at the legal cases from the last several years

http://www.prweb.com/releases/2015/03/prweb12597612.htm
http://www.nytimes.com/2010/02/26/us/26radiation.html?_r=0
http://www.bizjournals.com/orlando/blog/2013/09/20-million-whistleblower-lawsuit.html?page=all
http://www.dallasnews.com/news/comm...over-allegations-of-false-medicare-claims.ece
http://www.auntminnie.com/index.aspx?sec=sup_n&sub=imc&pag=dis&itemId=99701
http://www.justice.gov/opa/pr/vanta...e-medicare-claims-radiation-oncology-services

every one of those cases dealt with MD supervision in IMRT/IGRT cases. The safest thing to do if you aren't a "rural" critical-access hospital with a waiver from medicare would be to have a rad onc present.
 
The legal cases are what scare me, but from reading the things posted from Mandelin Rain, I think there certainly is wiggle room for a well trained mid level. ASTRO even says "others" may meet these requirements.

I'd be interested to know the exact details of those legal cases above. Were they treating with a mid level or just treating with no practitioner in the building at all?

There's no doubt you're in the clear with a rad onc, but as mentioned there are lots of rural centers that can't recruit or support a full time rad onc. I'm not sure if it's worth the risk, but certainly some clinics (both private and academic) are taking the risk at present.
 
My take is you can use non-radiation oncologists to provide supervision, but you should never bill any professional fees if the radiation oncologist is not physically present in the clinic for free-standing centers or not on campus grounds for hospital-based facilities.
 
My take is you can use non-radiation oncologists to provide supervision, but you should never bill any professional fees if the radiation oncologist is not physically present in the clinic for free-standing centers or not on campus grounds for hospital-based facilities.

This is my understanding as well. You should definitely not be billing physician professional fees without a physical presence in the clinic. That's the way docs get in trouble, unless if they own the equipment and are also billing the technical incorrectly. Most don't have to worry about that, but some definitely do. This technical aspect is a bit less cut and dry, IMO. At least for hospital based practices, my reading is that non-radiation oncologist physicians and/or non-physician independent providers can supervise (i.e. run the linac) if appropriately trained, appropriately credentialed with the hospital, and within their given scope of practice.
 
Additionally, it's sad that there is not a clear, easily identifiable answer to what seems to be a rather cut and dry question.
 
This is my understanding as well. You should definitely not be billing physician professional fees without a physical presence in the clinic. That's the way docs get in trouble, unless if they own the equipment and are also billing the technical incorrectly. Most don't have to worry about that, but some definitely do. This technical aspect is a bit less cut and dry, IMO. At least for hospital based practices, my reading is that non-radiation oncologist physicians and/or non-physician independent providers can supervise (i.e. run the linac) if appropriately trained, appropriately credentialed with the hospital, and within their given scope of practice.

This interpretation is what I saw from most centers that do this. However, I have seen such a range of interpretations from physicians and administrators (from "oh hell no" to "yeah, it's perfectly fine - you can be an inpatient with a CHF exacerbation and on day two of admission only be seen by a mid level and not be seen by an attending for almost 24 hours and we still consider that appropriate supervision, of course it's fine to have them babysitting machines on an outpatient basis.") I'm just trying to educate myself and get info from others. We're looking into mid levels and trying to get an idea of how we could (or couldn't) use them...

The latest info from ASTRO is from 2010 (as posted above), but here is some hearsay I'm hearing from my administrators and billers. Again, this is just hearsay, so take it for what it's worth on an internet message board.....

They have "called ASTRO on the phone" recently and report to me that ASTRO is reluctant to issue a new statement different from that posted above. ASTRO administrators in informal conversation think the Medicare language is a little too lenient (seemingly leaving room for mid levels - something ASTRO interprets Medicare is OK with given appropriate credentialing, but something ASTRO is not very enthusiastic about). ASTRO has been "getting a very heavy volume of calls related to this issue and will be forced to take a stand." Administrators here are suggesting that ASTRO has hinted that they're not going to look favorably on the mid level issue, but do not want to differ significantly from medicare for obvious reasons. You can see it in the 2010 language (ie Rad onc is "always appropriate"), but our administrators here are saying they're going to issue a more strongly worded statement soon that may more directly answer the question and exclude mid levels.

====

Speaking from a logistics standpoint, I think if this issue is cleared up it could cause MAJOR changes to how rural community cancer centers function. There are a lot of single linac rural centers out there treating ~15 patients a day that don't have MD coverage every day that will probably cease to exist if no mid level or med onc treatments are allowed.
 
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With regard to Rad Onc specifically, what the hell is an "appropriately credentialed" mid level anyway?

I may be mistaken, but I think sometimes I/we use the term "credentials" interchangeably with "privileges" with regard to hospital coverage privileges.

I had this same question, and the people I've spoken to say in order for Medicare to be OK with a mid level, the hospital (technical biller) also has to be on board and "independently" verify that the mid level has adequate training to serve as the supervising practitioner. Thus, a formal document and priveledging process review from hospital administration has to say that they have given hospital "privileges/credentials"to the mid level and outline their scope of care. Some places make their NP's get ONS/ONCC radiation oncology nursing certification as well.

From what I can tell, most places do some variation on this theme...
- have a mid level shadow an attending for 3-6 months, get them nursing certification like the ONS one mentioned above, then have a formal document from the attending that says they're competent to evaluate radiation patients
- define in writing the scope of care of the mid level (ie they can see follow ups, babysit the clinic, Rx flomax for prostate patients, etc...but cannot do CT sims, Rx radiation, HDR, etc).
- then the hospital gives the mid level "hospital credentials" to be a babysitter for the linac

Others that use mid levels may be able to clarify, but I think it goes something like that....
 
I may be mistaken, but I think sometimes I/we use the term "credentials" interchangeably with "privileges" with regard to hospital coverage privileges.

I had this same question, and the people I've spoken to say in order for Medicare to be OK with a mid level, the hospital (technical biller) also has to be on board and "independently" verify that the mid level has adequate training to serve as the supervising practitioner. Thus, a formal document and priveledging process review from hospital administration has to say that they have given hospital "privileges/credentials"to the mid level and outline their scope of care. Some places make their NP's get ONS/ONCC radiation oncology nursing certification as well.

From what I can tell, most places do some variation on this theme...
- have a mid level shadow an attending for 3-6 months, get them nursing certification like the ONS one mentioned above, then have a formal document from the attending that says they're competent to evaluate radiation patients
- define in writing the scope of care of the mid level (ie they can see follow ups, babysit the clinic, Rx flomax for prostate patients, etc...but cannot do CT sims, Rx radiation, HDR, etc).
- then the hospital gives the mid level "hospital credentials" to be a babysitter for the linac

Others that use mid levels may be able to clarify, but I think it goes something like that....

I wouldn't do it like this esp. if the center isn't a critical access facility. You do run the risk of fairly heavy legal action against your facility. I'd sleep better hiring a locums instead.
 
I think it's safest to just not do it, largely based on some speculation that at some point soon this issue will be more clarified, and I suspect ASTRO will more strongly go against the mid level usage.

However, at this point both ASTRO and medicare in my mind allow use of mid level, as long as you're not billing anything professional while they cover. ASTRO specifically says "others may meet requirements," so if they felt at that point that only rad oncs fit the requirement, they would have stated that or not put put in the statement about "others."
 
I think it's safest to just not do it, largely based on some speculation that at some point soon this issue will be more clarified, and I suspect ASTRO will more strongly go against the mid level usage.

However, at this point both ASTRO and medicare in my mind allow use of mid level, as long as you're not billing anything professional while they cover. ASTRO specifically says "others may meet requirements," so if they felt at that point that only rad oncs fit the requirement, they would have stated that or not put put in the statement about "others."

You can't bill technical either in a free-standing setting if you read the rules above. And in some of the cases I previously mentioned, the hospital had to pay back technical charges as well.
 
You can't bill technical either in a free-standing setting if you read the rules above. And in some of the cases I previously mentioned, the hospital had to pay back technical charges as well.

That's my understanding as well - for freestanding centers the mid level thing seems less appropriate (or not at all) in the eyes of medicare. My inquiries about mid levels stem from coverage of rural (though not critical access) hospital based centers. I don't think it's anything our group will do given the risk, but I am intrigued now and find this issue very frustrating.

I'm trying to get more info on the cases you mentioned above. There is some obvious shadyness going on in all of them (it's very clear to me in the rules that no one but a rad onc physically present can perform/bill a CT-sim, and lots of places in those examples above were breaking that rule). But, it's unclear as to whether they even tried to have a mid level there for treatment or if they were just treating with no designated provider at all. I suspect if they're billing CT-sims without a rad onc present they're certainly not sticking to the "rules" of mid level providers mentioned above (basically just babysitting, not covering sims or SBRT or verification sims, etc).
 
That's my understanding as well - for freestanding centers the mid level thing seems less appropriate (or not at all) in the eyes of medicare. My inquiries about mid levels stem from coverage of rural (though not critical access) hospital based centers. I don't think it's anything our group will do given the risk, but I am intrigued now and find this issue very frustrating.

I'm trying to get more info on the cases you mentioned above. There is some obvious shadyness going on in all of them (it's very clear to me in the rules that no one but a rad onc physically present can perform/bill a CT-sim, and lots of places in those examples above were breaking that rule). But, it's unclear as to whether they even tried to have a mid level there for treatment or if they were just treating with no designated provider at all. I suspect if they're billing CT-sims without a rad onc present they're certainly not sticking to the "rules" of mid level providers mentioned above (basically just babysitting, not covering sims or SBRT or verification sims, etc).
It's not just the CT SIMs, but also anything requiring "image guidance" Med Oncs aren't trained in IGRT, and typically mid-levels aren't either. I think in the above cases, no one was covering, whether it be a mid-level or a med onc or a rad onc. It just seems like shades of gray.
 
Yeah, the image guidance thing I agree is the grey area.

The vast majority of the time, I check my films after treatment toward the end of the day. I know some (probably the minority, though) rad oncs check them at the machine prior to treatment each fraction, but that's not how we did it in training and not how my group does it. The facilities that I know of that use mid levels (both academic and private) review their films remotely on the day when the mid levels cover.

The grey area as I see it, is that if you're ordering IGRT you're indicating that you feel the patient needs/would benefit from accurate daily set ups. Sure, the therapists can line up the patient 99% of the time without your input, but if you ordered IGRT and you (or another rad onc) aren't there to check it or "assist" with the procedure if they're running into problems, then that is where the rub lies. I absolutely do not think a mid level or med onc can help with IGRT.

However, the other part of me says that if you can't have mid levels then a lot of these rural centers will shut down. I grew up in a rural area and sympathize with the folks there - many just don't have the means or family support to travel an hour or two to the big hospital for treatment, so at some point there needs to be some concession that maybe a mid level might be OK if used appropriately.
 
Yeah, the image guidance thing I agree is the grey area.

The vast majority of the time, I check my films after treatment toward the end of the day. I know some (probably the minority, though) rad oncs check them at the machine prior to treatment each fraction, but that's not how we did it in training and not how my group does it. The facilities that I know of that use mid levels (both academic and private) review their films remotely on the day when the mid levels cover.

The grey area as I see it, is that if you're ordering IGRT you're indicating that you feel the patient needs/would benefit from accurate daily set ups. Sure, the therapists can line up the patient 99% of the time without your input, but if you ordered IGRT and you (or another rad onc) aren't there to check it or "assist" with the procedure if they're running into problems, then that is where the rub lies. I absolutely do not think a mid level or med onc can help with IGRT.

However, the other part of me says that if you can't have mid levels then a lot of these rural centers will shut down. I grew up in a rural area and sympathize with the folks there - many just don't have the means or family support to travel an hour or two to the big hospital for treatment, so at some point there needs to be some concession that maybe a mid level might be OK if used appropriately.

The ability to be able to furnish "immediate" assistance with IGRT I think is what medicare and ASTRO is trying to get at. An exception does exist for designated rural "Critical Access hospitals", but beyond that, you're taking a risk considering the cases above.
 
The ability to be able to furnish "immediate" assistance with IGRT I think is what medicare and ASTRO is trying to get at. An exception does exist for designated rural "Critical Access hospitals", but beyond that, you're taking a risk considering the cases above.

Agree.

Thanks to all for the input, everyone has been helpful. If I stumble across any additional input or pearls I'll try to post for anyone interested and would appreciate it if anyone else has any further input.
 
I posted this in another thread but it really is a great read and well written. It does not solve the mid level billing issue debate (they specifically address it in the article, declaring it a gray area still but largely deferring the decision to use NP/PA to the hospital credentialling committees), but it's still a worthwhile read for anyone in a busy practice where you're trying to determine where to be when and what is safe/best practices.

The cases cited have some pretty egregious things going on - e.g. SBRT's without physicians present, putting an ENT as the authorized user on a gamma knife, etc...but the arguments made within the cases sheds some light on supervision issues that are always discussed and debated.

http://www.appliedradiationoncology...act-allegations-against-radiation-oncologists
 
I posted this in another thread but it really is a great read and well written. It does not solve the mid level billing issue debate (they specifically address it in the article, declaring it a gray area still but largely deferring the decision to use NP/PA to the hospital credentialling committees), but it's still a worthwhile read for anyone in a busy practice where you're trying to determine where to be when and what is safe/best practices.

The cases cited have some pretty egregious things going on - e.g. SBRT's without physicians present, putting an ENT as the authorized user on a gamma knife, etc...but the arguments made within the cases sheds some light on supervision issues that are always discussed and debated.

http://www.appliedradiationoncology...act-allegations-against-radiation-oncologists

I don't see why anyone would risk the ability to see future medicare patients by hiring an NP to do a radoncs job.
 
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I don't see why anyone would risk the ability to see future medicare patients by hiring an NP to do a radoncs job.

Our group doesn't (and I'm not planning on it), but I can see where they could be helpful. As mentioned above, in the rural clinic scenario I know both academic satellite centers and private practices across the country are using mid levels to cover.

In rural clinics where machines treat only 15 patients/day it can be very hard to recruit a full time doc, especially because the salary for a rad onc only treating 15/day is not really that great (unless the hospital is willing to pay/employ the doc and pay them above what they're billing out). Plus, the workload for 15 patients/day type of clinic is pretty light and can easily be accomplished in 3 days. Some rural centers get the "critical access" label and are exempt from rules, but a lot of centers don't have that label.

I practice in a mid size city but some surrounding rural clinics are having trouble staffing their facilities. I know another rad onc group in town staffs a rural center an hour or so away by using a NP or med onc 2-3 days a week there. Basically, the NP's just babysit. A very similar situation goes on for a rural academic satellite facility I'm familiar with as well. Neither of those two centers have the "critical access" designation.
 
Timely local news relevant to this discussion:

http://www.contracostatimes.com/crime-courts/ci_28418852/john-muir-health-walnut-creek-pay-550-000

SAN FRANCISCO -- John Muir Health agreed to pay the government $550,000 after a whistle-blower claimed the company submitted false claims for Medicare reimbursement, federal officials said.



The whistle-blower said that physicians, contracted with John Muir Health in Walnut Creek to do radiation therapy, failed to supervise such treatment between January 2009 and December 2013, according to a news release from the U.S. Department of Justice. Supervising the treatment is a requirement of receiving payment through Medicare.

We can argue this topic until we are blue in the face, but at the end of the day it only takes one disgruntled employee to make it come crashing down.
 
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And almost every radonc practice I know has at least one disgruntled employee.

Yup. This is the main reason why we shy away.

When someone blows the whistle, look out. The government comes in and it's guilty until proven innocent. They have the means and time to stretch out and rack up any legal fees you would have to pay to fight it, so you just settle - even if by the letter of the law there's a gray area.

Maybe I'm wrong, but if this sort of thing keeps happening more often (it sure seems like it), I think we're going to see a lot of rural clinics shut down.
 
Timely local news relevant to this discussion:

http://www.contracostatimes.com/crime-courts/ci_28418852/john-muir-health-walnut-creek-pay-550-000



We can argue this topic until we are blue in the face, but at the end of the day it only takes one disgruntled employee to make it come crashing down.
Bingo.

Unless you have a "critical access" designation as alluded to by BobbyHeenan above, you're playing with fire on the supervision issues IMO when you don't cover IGRT/IMRT/SRS cases and/or use mid-levels to see OTVs and cover treatments.
 
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