What Will Relaxation of Supervision Rules Mean for Cancer Care?

CMS is loosening the rules for physician supervision of chemotherapy and radiation treatment of cancer patients in hospital outpatient departments. The relaxation of the rules, which means that physicians won’t have to be on the premises to supervise care, could be one of these very specific rule changes that wind up having a major effect, in this case on cancer care delivery - where it is delivered, by whom, and, possibly, at what cost, according to an opinion piece published today in JAMA Oncology.

The new rules lower the supervision requirement from “direct” to “general” for Medicare patients. Direct supervision means the physician must be physically on the premises. General supervision has a broad definition, said lead author Trevor J. Royce, MD, a radiation oncologist at the University of North Carolina, in an interview with MHE. “You have to be reachable, but you could be [physically] hours away.”

The change from direct to general supervision was included in the final rule for hospital outpatient prospective payment system that CMS issued in November 2019.

A large proportion of cancer care is delivered in an outpatient setting. Citing government and academic sources, Royce and his colleagues say that 60% of Medicare Part B drug and radiation therapy services are delivered in hospital outpatient departments with the remaining 40% occurring in freestanding physician offices. The rule change that allows for general supervision instead of direct supervision applies only to hospital outpatient departments.

In the interview with MHE and in the JAMA Oncology viewpoint, Royce said the shift to general supervision could improve access to care, especially in rural areas, because oncologists will be able to supervise outpatient departments in remote places. The looser rules will also allow administrators more flexibility in staffing outpatient department and perhaps lead to a greater dependence on nonphysician health care professionals: “Someone has to be there with the patient, and if not a physician it has to be someone else,” noted Royce.

The potential drawbacks include declines in the quality of care and patient safety, although Royce and his coauthors say that CMS is moving to general supervision after not enforcing the stricter, direct supervision rules at outpatient departments at critical access and rural hospitals for the past 10 years. Presumably, the agency would not have relaxed the rules if that 10-year experience showed that patients were harmed or the quality of care declined, commented Royce.

The JAMA Oncology Viewpoint says changing the requirement to general supervision could encourage innovative approaches to rural health care and accelerate the use of telemedicine (which has taken off because of the COVID-19 outbreak and the relaxation of Medicare rules).

“General supervision should not be confused with no supervision,” Royce and his colleagues say in JAMA Oncology. “Rather, it represents a minimum supervision - physicians now have discretion to apply greater supervision when the level of complexity and risk of services justifies increased scrutiny.”

Royce said in the interview that highly targeted radiation treatments that use high doses must be supervised closely by radiation oncologists if they are to be done safely. But other kinds of radiation treatment - such as low-dose treatment for palliative purposes - can be done safely by someone other than a physician and be supervised remotely, in his opinion.

One ripple effect of general supervision maybe further consolidation of providers; instead of hospitals outpatient departments needing oncologist on site, they can operate with oncologists at a major hospital miles away. General supervision may “further expedite consolidation and horizontal integration” of providers, note Royce and his co-authors, Ethan Basch, MD, a medical oncologist at University of North Carolina, and Justin Bekelman, a radiation oncologist at the University of Pennsylvania.

Another indirect consequence may be further differentiation between hospital outpatient departments and freestanding clinic because the clinics will still be required to operate under the direct supervision rule.

However, just because CMS is relaxing its rules, doesn’t mean that hospitals, professional societies, and accrediting organizations will follow suit, observe Royce and his co-authors. If those organizations don’t, then the effect of the rule change may be muted.

Presuming, though, that there is a shift to general supervision, Royce and his colleagues say  additional quality measures may be needed to guard against slippage in the quality of care and patient safety. Those measures could range from implementing safe practice standards to using prospective risk assessment systems that would spot problems early to IT applications designed with patient safety in mind (“smart pumps,” for example, that would be set to prevent dosing errors).