Physicians are being forced to the weigh risks vs benefits of previously routine treatments and procedures in light of capacity concerns and COVID infection risk. While Medicare fee-for-service has historically had limited involvement in direct utilization control, this is changing in the face of ever-increasing demand and responsibilities with less and less resources. The pandemic has caused an acceleration in the creation and use of value-based care strategies that have, until now, been only gradually and cautiously implemented. Actions in this area are being taken by the Centers for Medicare & Medicaid Services (CMS) as well as by physician organizations who recognize the immediate need to make better decisions about clinical recommendations with efficient utilization in mind. With their focus on high-quality, high-value care that also decreases inappropriate care and resource use, pathways are primed to become an even greater force in health care in the current climate.
Today’s environment is undergoing major changes following the COVID-19 crisis, which has led to an increase in government involvement in the US health care system. These shifts have come as a result of higher rates of unemployment, bringing with it the potential for certain changes, such as the lowering of the Medicare-eligible age as well as Medicaid expansion. The pandemic has also caused health systems to reevaluate resources and prioritize procedures. Providers and administrators are being forced to weigh risks vs benefits of previously routine treatments and procedures in light of capacity concerns and COVID infection risk. While Medicare fee-for-service has historically had limited involvement in direct utilization control, this is changing in the face of ever-increasing demand and responsibilities with less and less resources. Together, the pandemic and the ongoing decrease of resources is paving the way for the government to become a more significant leader in utilization management with more value-based approaches to care, like clinical pathways, becoming standard.
CMS’ Utilization Efforts
Of course, CMS has always to some extent been involved in utilization controls. For instance, they perform retrospective reviews to ensure providers are utilizing services within approved label or compendium information. The Medicare Fee for Service Recovery Audit Program’s (RAP) mission is to identify and correct improper Medicare payments through the efficient detection and collection of overpayments made on claims of health care services provided to Medicare beneficiaries. An interesting note is that CMS has suspended RAP reviews for the duration of the COVID-19 Public Health Emergency (PHE).1
While the RAP is retrospective, there are other examples of CMS involvement in utilization management, such as use of National and Local Coverage Determinations (NCDs and LCDs). Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). NCDs are made through an evidence-based process, with opportunities for public participation. In some cases, CMS’ own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a LCD. These coverage determinations are meant as a guide for providers to ensure appropriate use of services, especially in areas of confusion or those with potential for overutilization.
Recently, CMS has stepped up its utilization efforts through the use of appropriate use criteria (AUC). An “appropriate” procedure is one for which the expected health benefits exceed the expected health risks by a wide margin. AUC is criteria only developed or endorsed by national professional medical specialty societies or other provider-led entities, so ordering and furnishing professionals can make the most patient-appropriate treatment decision for the specific clinical condition. To the extent possible, criteria must be evidence based. The AUC program requires that ordering providers consult a qualified clinical decision support mechanism (CDSM),2 which is an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition. A CDSM may be modules within operating room (OR) available through certified electronic health record technology. The first application of this by CMS is around advance radiologic studies,3 and while there are no payment consequences associated with the AUC program during CY 2020, CMS is encouraging stakeholders to use this year to learn, test, and prepare for the AUC program.
Physician Societies Respond to Shifting Resource Needs
Another formulation of AUC is being used to ensure appropriate use of elective procedures. The COVID-19 crisis led to a hold on elective procedures to preserve medical resources, but, as the crisis continues and elective procedures come back online, CMS and others are looking to ensure that procedures are prioritized. To evaluate the necessity of care based on clinical needs, the American College of Surgeons (ACS) and physician specialty societies have rolled out guidelines. The ACS framework, called medically-necessary time-sensitive (MeNTS)4 prioritization guidelines, helps organizations objectively score each potential surgical case using 21 factors identified as significant contributors to MeNTS procedure triage and prioritization in the setting of the COVID-19 pandemic. These identified factors, detailed below, fall into three general categories: procedure (seven factors), disease (six factors), and patient (eight factors). Such guidance as MeNTS from professional societies and other measures from CMS, have and will become more standard in care with the pressing resource and capacity concerns (Table 1).
Procedure factors include: OR time in minutes, estimated length of stay, postoperative intensive care unit (ICU) need, anticipated blood loss, surgical team size, intubation probability, and surgical site. A higher score for each factor is associated with poorer perioperative patient outcome, increased risk of COVID-19 transmission to the health care team, and/or increased hospital resource utilization.4 OR time takes into consideration the sequestration of OR resources during the predicted length of the procedure. Anticipated length of stay captures the personnel and hospital resources required and reduced inpatient capacity and flexibility associated with increased postoperative hospitalization and ICU resources. Estimated blood loss was felt to be important due to shortage of blood availability related to shelter-in-place requirements that reduce public access to blood donation facilities. Surgical team size captures the increased risk of virus transmission from patient to the surgical team as well as between team members given the inability to adhere to physical distancing recommendations intraoperatively.
Disease factors include: nonoperative treatment option effectiveness, nonoperative treatment option resource/exposure risk, impact of 2-week delay in disease outcome, impact of 2-week delay in surgical difficult/risk, impact of 6-week delay in disease outcome, and impact of 6-week delay in surgical difficulty/risk.
A higher score in the disease factors group, authors saw, was generally indicative of less harm to the patient when nonoperative treatment of the disease is pursued and/or surgical treatment is delayed.4 In the setting of the COVID-19 pandemic, it is felt that limited resources are better deployed for diseases where nonoperative care is significantly less effective or is not an option. For this reason, authors included an assessment of “nonoperative treatment option effectiveness” that highlights not only the availability of nonsurgical treatment but its comparative effectiveness to surgery.4
To capture the time sensitivity of a procedure, authors of this approach chose to independently assess the impact of surgical delay on disease outcome and surgical outcome at two different time points (2 weeks, 6 weeks) so as to integrate the natural history of the disease and time-sensitivity of surgical safety and technical feasibility into the prioritization process.4
The patient factors include those that are known to be associated with greater severity of COVID-19 illness (ie, requiring mechanical ventilation and ICU care) and worse outcomes (including mortality). These include advanced age, preexisting pulmonary disease, cardiovascular disease, diabetes, and immunocompromised state. It also captures instances where there is greater likelihood that the patient has COVID-19, either asymptomatic or symptomatic, when their infection status is not known.
A higher cumulative MeNTS score, which can range from 21 to 105, is associated with poorer perioperative patient outcome, increased risk of COVID-19 transmission to the health care team, and/or increased hospital resource utilization. Given the need to maintain OR capacity for trauma, emergency, and highly urgent cases, an upper threshold MeNTS score can be designated by surgical and perioperative leadership based on the immediately anticipated conditions and resources at each institution. Performing a MeNTS procedure whose score exceeds this upper threshold at that particular time is unlikely to be justifiable given the associated risks, though sound clinical judgement always takes precedent. In a similar but complementary manner, a lower threshold MeNTS score can be assigned, below which it would be reasonable to proceed with MeNTS procedures while preserving OR capacity for trauma, emergency, and highly urgent cases. Once again, both thresholds can be dynamically adjusted so as to respond to the immediate and anticipated availability of resources and local conditions applied well beyond the current COVID crisis to assure appropriate utilization of resources.
The pandemic has caused an acceleration in the creation and use of value-based care strategies that have, until now, been only gradually and cautiously implemented. Actions are being taken by CMS as well as by physician organizations who recognize the immediate need to make better decisions about clinical recommendations with efficient utilization in mind. This has been the aim of clinical pathways since their inception—to provide high-quality care with utmost value while decreasing inappropriate care and resource use. Pathways are primed to become an even greater force in health care in the current climate.
As the government further increases its involvement in health care, it will surely use AUC in many forms as utilization management tools to ensure appropriate use of services. Clinical pathways will also likely be utilized for this process, either with their incorporation of CMS and professional society guidance or to guide CMS and others. As such, clinical pathways developers need to be well aware of the utilization measures being developed now as they will surely have a significant impact on how services are accessed tomorrow.
1. Centers for Medicare & Medicaid Services. COVID-19 emergency declaration blanket waivers for health care providers. March 30, 2020. Accessed August 4, 2020. https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf
2. Centers for Medicare & Medicaid Services. Clinical decision support mechanisms. Updated June 30, 2020. Accessed August 4, 2020. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM
3. Centers for Medicare & Medicaid Services, Medicare Learning Network. Appropriate use criteria for advanced diagnostic imaging. December 2018. Accessed August 4, 2020. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AUCDiagnosticImaging-909377.pdf
4. Prachand VN, Milner R, Angelos P, et al. Medically necessary, time-sensitive procedures: scoring system to ethically and efficiently manage resource scarcity and provider risk during the COVID-19 pandemic [special article]. J Am Coll Surg. 2020;231(2):281-288. doi:10.1016/j.jamcollsurg.2020.04.011