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CMS is seeking comments on virtual direct supervision. Comment period closes tomorrow.
Anyone can comment. Below is what someone else said; you could copy it and use it as your comment, or change it completely. Or ignore CMS's comment request altogether.
Of the ~29,000 comments submitted thus far, there has been one comment re: rad onc specifically. It's from ASTRO. They are asking CMS to kill the virtual direct supervision flexibility which was created by CMS during the COVID PHE.
LETTER TO CMS
In proposed rule CMS-1751-P, CMS seeks input regarding the following:
In summary, CMS asks:
1) Do MDs now rely on direct supervision flexibility?
2) Should the flexibility be made permanent, or “sunset” at a future time?
3) Should all, or only a portion, of direct supervision services fall under this flexibility; specifically, are there safety concerns?
4) Should service modifiers be in place to note when virtual direct supervision is being used?
A HISTORY OF CHANGING RADIATION THERAPY SUPERVISION STANDARDS
In theory, radiation therapy in both hospitals and non-hospital settings has always required direct supervision (the physician should be present in the building and/or immediately available, but is not actively participating in the procedure nor in the room with the patient). However, CMS explicitly stated a direct supervision requirement in 2011. But this was not evenly applied to all doctors/facilities throughout the U.S.: there were specific rules in place allowing for non-enforcement of direct supervision in rural hospitals. It has been noted by CMS that “[there were no] supervision-related complaints from beneficiaries and… no data showing quality was adversely affected at CAHs and small rural hospitals that have only been required to maintain general supervision (for radiation therapy).”
There were numerous supervision inconsistencies on CMS’s part before 2011. Image guided radiation therapy (IGRT) came into use clinically in the early 2000s using cone beam CTs and in-room 2D kV X-raying. However, there were no billing codes for its use until Jan 1, 2005. The first true IGRT code was C9722 for stereoscopic X-ray guidance. Since this was a “C” code, there was no supervision level assigned the code by CMS. CMS then created CPT code 77421 on Jan 1, 2006; C9722 was thus eliminated. The 77421 code was assigned a personal level (physician must be in the room with the patient) of supervision. Then in mid-2009, CMS assigned a personal level of supervision to 77421-26 but a direct level to 77421-TC. Within months, CMS changed the IGRT supervision levels again to pure direct supervision for 77421 and making this retroactive to Jan 1, 2009. (77421 was eventually replaced by G6002.) IGRT code 77014 for cone beam CT, which is a much more complex form of IGRT and involves more radiation dose than 77421/G6002, had always been a direct, not personal, level of supervision. Finally, CPT 77417, weekly port films, which is also technically a very simple form of IGRT, has always been listed and assigned as a general supervision code in the CMS CPT database (i.e. requiring no physician physical presence). Throughout all these confusing/conflicting/changing supervision requirements, not a single adverse incident associated with a physician not being in the building when the radiation therapists were performing radiation or doing IGRT has been reliably reported.
The last few years have seen CMS changing supervision levels in radiation therapy again. In 2020, CMS allowed general supervision for radiation therapy in hospitals. (As noted, these requirements have been “vexing” for hospitals. In truth, they have been vexing for freestanding centers, and all radiation oncologists, as well.) Then in 2021 CMS eliminated the requirement for physician physical presence for diagnostic tests (which cover IGRT) in hospitals thereby allowing non-physician practitioners to “cover” these “tests” (IGRT is not a test, nor diagnostic… but this is how CMS quixotically defines IGRT). Again, notably, no safety incidents have been published or reported as a result of these last two mentioned supervision “sea changes.” Since the COVID PHE and CMS’s start of direct virtual supervision, we are also unaware of safety incidents or beneficiary complaints from virtual, instead of non-virtual, direct supervision.
A PRAGMATIC VIEW?
In most of the world the concept of the “direct supervision” of radiation therapy as an inviolable rule does not exist. In Canada, there are too many rural centers and locales to insist on a doctor being in the building every time a patient receives radiotherapy. Therefore, the Canadian public health service explicitly allows for direct supervision flexibility (and it needn’t even be virtual; it can be general). This concept is also true in the United Kingdom (whose breast treatment protocols especially have now been widely adopted in the U.S.) where “specialist radiographers,” equivalent to the “techs” in U.S. departments, see and supervise patients. There are no known radiation safety incident issues in these countries versus U.S. outcomes pertaining to where the MDs were exactly located at the time of patients’ treatments.
For rural, solo rad oncs the pure direct supervision requirement is burdensome and probably unsafe in and of itself. Patients started on radiation therapy should, in general (except for weekends and holidays), not take “days off” from the radiation therapy. However, if a radiation oncologist has a family or health emergency and he/she is the only physician in the clinic there is really no choice but shut the clinic down for a day or two and let patients experience potentially harmful treatment breaks… or simply let the Medicare patients not get treated whilst the private insurance patients continue on (there is no specific direct supervision rule per se for most private insurance reimbursement situations). It’s the proverbial “rock and a hard place” for many providers.
This is why the COVID PHE direct supervision flexibility has been so valuable. Much of the radiation oncology physician’s patient care work, including radiation planning and design and image analysis, is done via computer… and most times this is done when the patient is not even in the department where a supervision concept has zero applicability. Even when the physician is analyzing patient parameters “real time” while the patient is in the department getting treated, the physician is not in the room with the patient but instead viewing a screen or monitor some remote distance from the patient. All of these activities are highly amenable to the routine safe provisioning of virtual direct supervision.
Anyone can comment. Below is what someone else said; you could copy it and use it as your comment, or change it completely. Or ignore CMS's comment request altogether.
Of the ~29,000 comments submitted thus far, there has been one comment re: rad onc specifically. It's from ASTRO. They are asking CMS to kill the virtual direct supervision flexibility which was created by CMS during the COVID PHE.
LETTER TO CMS
In proposed rule CMS-1751-P, CMS seeks input regarding the following:
We continue to seek information on whether this [direct supervision] flexibility should be continued beyond the later of the end of the PHE for COVID-19 or CY 2021. Specifically, we are seeking comment on the extent to which the flexibility to meet the immediate availability requirement for direct supervision through the use of real-time, audio/video technology is being used during the PHE, and whether physicians and practitioners anticipate relying on this flexibility after the end of the PHE. We are seeking comment on whether this flexibility should potentially be made permanent, meaning that we would revise the definition of “direct supervision” at § 410.32(b)(3)(ii) to include immediate availability through the virtual presence of the supervising physician or practitioner using real-time, interactive audio/video communications technology without limitation after the PHE for COVID-19, or if we should continue the policy in place for a short additional time to facilitate a gradual sunset of the policy. We are soliciting comment on whether the current timeframe for continuing this flexibility at § 410.32(b)(3)(ii), which is currently the later of the end of the year in which the PHE for COVID-19 ends or December 31, 2021, remains appropriate, or if this timeframe should be extended through some later date to facilitate the gathering of additional information in recognition that, due to the on-going nature of the PHE for COVID-19, practitioners may not yet have had time to assess the implications of a permanent change in this policy. We also seek comment regarding the possibility of permanently allowing immediate availability for direct supervision through virtual presence using real-time audio/video technology for only a subset of services, as we recognize that it may be inappropriate to allow direct supervision without physical presence for some services, due to potential concerns over patient safety if the practitioner is not immediately available in-person. We are also seeking comment on, were this policy to be made permanent, if a service level modifier should be required to identify when the requirements for direct supervision were met using two-way, audio/video communications technology.
In summary, CMS asks:
1) Do MDs now rely on direct supervision flexibility?
2) Should the flexibility be made permanent, or “sunset” at a future time?
3) Should all, or only a portion, of direct supervision services fall under this flexibility; specifically, are there safety concerns?
4) Should service modifiers be in place to note when virtual direct supervision is being used?
A HISTORY OF CHANGING RADIATION THERAPY SUPERVISION STANDARDS
In theory, radiation therapy in both hospitals and non-hospital settings has always required direct supervision (the physician should be present in the building and/or immediately available, but is not actively participating in the procedure nor in the room with the patient). However, CMS explicitly stated a direct supervision requirement in 2011. But this was not evenly applied to all doctors/facilities throughout the U.S.: there were specific rules in place allowing for non-enforcement of direct supervision in rural hospitals. It has been noted by CMS that “[there were no] supervision-related complaints from beneficiaries and… no data showing quality was adversely affected at CAHs and small rural hospitals that have only been required to maintain general supervision (for radiation therapy).”
There were numerous supervision inconsistencies on CMS’s part before 2011. Image guided radiation therapy (IGRT) came into use clinically in the early 2000s using cone beam CTs and in-room 2D kV X-raying. However, there were no billing codes for its use until Jan 1, 2005. The first true IGRT code was C9722 for stereoscopic X-ray guidance. Since this was a “C” code, there was no supervision level assigned the code by CMS. CMS then created CPT code 77421 on Jan 1, 2006; C9722 was thus eliminated. The 77421 code was assigned a personal level (physician must be in the room with the patient) of supervision. Then in mid-2009, CMS assigned a personal level of supervision to 77421-26 but a direct level to 77421-TC. Within months, CMS changed the IGRT supervision levels again to pure direct supervision for 77421 and making this retroactive to Jan 1, 2009. (77421 was eventually replaced by G6002.) IGRT code 77014 for cone beam CT, which is a much more complex form of IGRT and involves more radiation dose than 77421/G6002, had always been a direct, not personal, level of supervision. Finally, CPT 77417, weekly port films, which is also technically a very simple form of IGRT, has always been listed and assigned as a general supervision code in the CMS CPT database (i.e. requiring no physician physical presence). Throughout all these confusing/conflicting/changing supervision requirements, not a single adverse incident associated with a physician not being in the building when the radiation therapists were performing radiation or doing IGRT has been reliably reported.
The last few years have seen CMS changing supervision levels in radiation therapy again. In 2020, CMS allowed general supervision for radiation therapy in hospitals. (As noted, these requirements have been “vexing” for hospitals. In truth, they have been vexing for freestanding centers, and all radiation oncologists, as well.) Then in 2021 CMS eliminated the requirement for physician physical presence for diagnostic tests (which cover IGRT) in hospitals thereby allowing non-physician practitioners to “cover” these “tests” (IGRT is not a test, nor diagnostic… but this is how CMS quixotically defines IGRT). Again, notably, no safety incidents have been published or reported as a result of these last two mentioned supervision “sea changes.” Since the COVID PHE and CMS’s start of direct virtual supervision, we are also unaware of safety incidents or beneficiary complaints from virtual, instead of non-virtual, direct supervision.
A PRAGMATIC VIEW?
In most of the world the concept of the “direct supervision” of radiation therapy as an inviolable rule does not exist. In Canada, there are too many rural centers and locales to insist on a doctor being in the building every time a patient receives radiotherapy. Therefore, the Canadian public health service explicitly allows for direct supervision flexibility (and it needn’t even be virtual; it can be general). This concept is also true in the United Kingdom (whose breast treatment protocols especially have now been widely adopted in the U.S.) where “specialist radiographers,” equivalent to the “techs” in U.S. departments, see and supervise patients. There are no known radiation safety incident issues in these countries versus U.S. outcomes pertaining to where the MDs were exactly located at the time of patients’ treatments.
For rural, solo rad oncs the pure direct supervision requirement is burdensome and probably unsafe in and of itself. Patients started on radiation therapy should, in general (except for weekends and holidays), not take “days off” from the radiation therapy. However, if a radiation oncologist has a family or health emergency and he/she is the only physician in the clinic there is really no choice but shut the clinic down for a day or two and let patients experience potentially harmful treatment breaks… or simply let the Medicare patients not get treated whilst the private insurance patients continue on (there is no specific direct supervision rule per se for most private insurance reimbursement situations). It’s the proverbial “rock and a hard place” for many providers.
This is why the COVID PHE direct supervision flexibility has been so valuable. Much of the radiation oncology physician’s patient care work, including radiation planning and design and image analysis, is done via computer… and most times this is done when the patient is not even in the department where a supervision concept has zero applicability. Even when the physician is analyzing patient parameters “real time” while the patient is in the department getting treated, the physician is not in the room with the patient but instead viewing a screen or monitor some remote distance from the patient. All of these activities are highly amenable to the routine safe provisioning of virtual direct supervision.
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