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Until recently, strict Medicare rules allowed only fully licensed physicians to take responsibility for the supervision of diagnostic tests. The Centers for Medicare and Medicaid Services (CMS) this year revised these long-standing rules, handing an expansion of purview to non-physician practitioners. But unfortunately, ambiguities in the drafting of the rule might have created compliance confusion on which levels of diagnostic tests allow supervision under the more flexible requirements.
As early as January 2019, CMS began to offer more flexibility in how diagnostic tests could be performed and who could take responsibility for their supervision. The first step toward flexibility that month was recognition that radiologist assistants (RAs) and radiology practitioner assistants (RPAs), who have higher levels of training, should be allowed to perform Level 3 tests even when the physician is not in the room, so long as the RAs and RPAs act within their scope of practice under state licensing laws. Not all states have defined such licensure for these practitioners, but the vast majority of states have such rules, facilitating increased flexibility in the performance of certain image-guided tests.
Pandemic brought change
In addition to expanding the role of RAs and RPAs, the COVID-19 public health emergency created a need for CMS to liberalize long-standing requirements that only fully licensed physicians could supervise many tests. CMS did this first on an interim basis and then, later, permanently. But, as we discuss below, the actual language of the new rules adopted this year raises questions as to how they should be applied.
Expanded purview for non-physician practitioners
The interim rule released in 2020 allowed for the first time, during the public health emergency, nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs), and certified nurse-midwives (CNMs) – collectively referred to by CMS as non-physician practitioners (NPPs) – to supervise diagnostic tests. The interim rule change applied to tests performed in physician offices, hospital outpatient departments, and provider-based facilities. Only in the independent diagnostic testing facility setting were these NPPs still barred from supervising diagnostic tests.
As a result, during the public health emergency, no physician presence was required, even for Level 2 and Level 3 tests, if an NPP provided the necessary supervision of the technologist performing that test.
These reforms created considerable anticipation in the diagnostic imaging industry that CMS would extend the relaxed requirements when it created new permanent rules. As anticipated, CMS made such changes in its 2021 rules, but whether they fully accomplished these reforms is an open question.
Supervision rule: Is change overdue?
The supervision rules have not kept pace with the skills and training of ancillary personnel such as radiologic technologists and radiologist assistants.
The experience and capabilities of advanced practice providers that CMS refers to as nonphysician practitioners have evolved as well.
When the supervision rules were created in the late 1990s, many advanced diagnostic imaging services (MRI, CT, and PET) were in their relative infancy, and the mandate that only physicians could supervise these tests was accepted as appropriate.
Changes in clinical practice, safety protocols, and equipment have caused stakeholders, including CMS, to reconsider the supervision rules.
Failing on supervision can be costly
Diagnostic imaging facilities have had to be cognizant of these rules and how to manage the performance of the tests they furnish. Failure to provide the appropriate level of supervision for a diagnostic test can render the service not “reasonable and necessary” and, therefore, not reimbursable under Medicare rules. More concerning, failure to provide for diagnostic test supervision consistent with Medicare’s requirements has resulted in fraud and abuse allegations by the government that claims submitted by various providers for such testing services were false claims. Those investigations often have led to substantial monetary settlements and corporate integrity agreements with the government that often accompany such settlements.