Non-surgical extended duration therapeutic services (NSEDTS) are services which have a significant monitoring component that can: extend for a lengthy period of time, are not surgical, and typically have a low risk of complications after the assessment at the beginning of the service. In 2011, the Centers for Medicare & Medicaid Services (CMS) established the minimum NSEDTS level of supervision as “direct supervision during the initiation of the service, which may be followed by general supervision at the discretion of the supervising physician or the appropriate nonphysician practitioner.”1 In March 2020, CMS assigned on an interim basis a minimum required level of general supervision for NSEDTS services, including during the initiation portion of the service, in response to the COVID-19 Public Health Emergency (PHE).2 CMS explained that
“[c]hanging the minimum default level of supervision to general supervision for NSEDTS during the initiation of the service will give providers additional flexibility they will need to handle the burdens created by the PHE for the COVID–19 pandemic.”3
On December 2, 2020, CMS published its Calendar Year 2021 Outpatient Prospective Payment Rule (CY21 OPPS Rule) and finalized the minimum default level of supervision for NSEDTS to general supervision for the entire service, including the initiation portion of the service.4 CMS stated that general supervision for NSEDTS “is consistent with the minimum required level of general supervision that currently applies for most outpatient hospital therapeutic services,”5 and believes that “Medicare providers will provide a similar quality of hospital outpatient therapeutic services, including NSEDTS, regardless of whether the minimum level of supervision required under the Medicare program is direct or general.”6
General supervision, as defined in 42 C.F.R. § 410.32(b)(3)(i), “means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.”7
CMS believes “changing the level of supervision for NSEDTS permanently for the duration of the service would be beneficial to patients and outpatient hospital providers as it would allow greater flexibility in providing these services and reduce provider burden, and thus, improve access to these services in cases where the direct supervision requirement may have otherwise prevented some services from being furnished due to lack of availability of the supervising physician or nonphysician practitioner.”8
However, CMS cautioned that “[m]any outpatient therapeutic services, including NSEDTS, may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required. In addition, CAHs and hospitals in general continue to be subject to conditions of participation (CoPs) that complement the general supervision requirements for hospital outpatient therapeutic services, including NSEDTS, to ensure that the medical services Medicare patients receive are properly supervised. . . . In addition, physicians must also follow state laws regarding scope of practice.”9 Therefore, CMS assured providers that “the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so.”10
1 42 C.F.R. § 410.27(a)(1)(iv)(E).
2 85 Fed. Reg. 19230, 19266 (Apr. 6, 2020).
3 Id.
4 CTRS. FOR MEDICARE AND MEDICAID SERVS., Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots, Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and to Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19) (Dec. 2, 2020), https://www.cms.gov/files/document/12220-opps-final-rule-cms-1736-fc.pdf (prepublication copy) (hereafter CY21 OPPS Rule), at 19.
5 CY21 OPPS Rule at 19.
6 CY21 OPPS Rule at 730.
7 CY21 OPPS Rule at 731.
8 CY21 OPPS Rule at 730.
9 CY21 OPPS Rule at 730-31.
10 CY21 OPPS Rule at 730.
