What Does “Direct Supervision” Mean in Non-Hospital Diagnostic Testing Facilities?

The Centers for Medicare and Medicaid Services, commonly known as CMS, requires physician supervision of certain services as a condition for reimbursement. The required supervision level depends on the type of service performed, the setting where the service is performed and the physical location of where the service is performed. Adhering to the proper protocol is critical, as services furnished without the required level of physician supervision are not reimbursable by Medicare and may potentially have even more significant consequences, including civil and criminal penalties.

Types of Physician Supervision

Generally, there are three levels of supervision for diagnostic testing in non-hospital facilities:

  • General supervision, which means the procedure is furnished under the supervising physician’s overall direction and control, but the physician’s physical presence is not required during the procedure’s performance.
  • Direct supervision, which means the supervising physician must be present and immediately available to furnish assistance and direction throughout the procedure’s performance. It does not mean the physician must be physically present in the room when the procedure is performed.
  • Personal supervision, which means the physician must be physically present in the room during the procedure’s performance.  

Direct Supervision in Hospital Settings v. Non-Hospital Settings

CMS regulations tell us that the required direct supervision for diagnostic tests performed directly or under arrangement with a hospital or in an on-campus or off-campus outpatient department of the hospital (i.e., hospital settings) differs from the required direct supervision for diagnostic tests performed in a free-standing facility, physician’s office or independent diagnostic testing facility (i.e., non-hospital settings).

For diagnostic tests performed in hospital settings, direct supervision does not require the supervising physician to be present within any physical boundary as long as he or she is immediately available.

In contrast, when services are provided in non-hospital settings or under arrangement with hospitals in non-hospital settings, direct supervision requires the supervising physician to remain present in the “office suite” where the service is being performed and be immediately available to give assistance and direction throughout the performance of the procedure.

What Does Office Suite Mean in Non-Hospital Settings?

While we know that supervising physicians are not physically bound in hospital settings and that they are physically bound in non-hospital settings, a question arises: what are the physical boundaries supervising physicians must comply with in non-hospital settings?

Does office suite mean one space, as identified in a lease, containing a collection of smaller offices or rooms? Does it allow for one primary office suite with sub-suites within? What if two separate office suites have a connecting door in between them?

No CMS regulation, Medicare Benefit Policy Manual provision or any other authority defines “office suite,” nor is there any directive case law or advisement interpreting the meaning of “office suite.” In addition, there is a lack of guidance regarding interest in enforcing the relevant CMS regulations and consequences for failing to comply with the relevant CMS regulations.

Consequences of Failing to Comply with the Required Physician Supervision Requirements

Nevertheless, knowing your options and risks are critical. Should CMS find physician supervision practices noncompliant with CMS regulations, billing entities and supervising physicians may be subject to claims’ denials, be required to reimburse CMS, be subject to whistleblower lawsuits and medical malpractice lawsuits, and potentially face civil and criminal penalties.

COVID-19 Temporary Waivers and New Rules Issued by CMS to Combat the Pandemic

covid-19 temporary waiver

covid-19 temporary waiverBy: Susan St. John

CMS has issued temporary waivers and new rules to help the American health care system address the increased need for health care services caused by COVID-19. Among the waivers, CMS is allowing hospitals to set up services in alternative sites to accommodate increased patient census. Hospitals may be allowed to use ASCs, inpatient rehab hospitals, hotels and dormitories for non-COVID-19 patients or patients not requiring critical inpatient services. Hospitals are also being encouraged to increase staffing, allowing hospitals to increase staff through hiring of local and non-local providers/practitioners as long as they are appropriately licensed in the same state as the hospital or another state. However, even though CMS has created flexibility for rendering services during this pandemic, use of alternative “hospital” sites and expansion of hiring staff must comport with a state’s emergency preparedness or pandemic response plan.Continue reading

Medicare Opt Out: Part II

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medicare opt outBy: Susan St. John

As noted in Opting Out of Medicare Part I, opting out of Medicare may be an option for some physicians and practitioners. After determining whether you are eligible for opt-out or if it is financially feasible, there are a few other considerations. Part I discussed the Private Contract a physician must enter into with each Medicare beneficiary he or she treats; here, we will address the opt-out affidavit and other nuances of opting out. Let’s get started!

The Medicare Opt Out Affidavit

Provisions in an Opt Out Affidavit are similar to provisions that must be included in the opted out physician’s or practitioner’s private contract with Medicare beneficiaries. The opt-out affidavit must state that the physician or practitioner will only provide services to Medicare beneficiaries with whom they have a written and signed private contract and that the physician or practitioner will not submit claims to Medicare on behalf of Medicare beneficiaries. Medicare does allow for an exception here, but that is only when an opted out physician or practitioner treats a Medicare beneficiary who is not under private contract, and that beneficiary presents with a medical emergency or urgent care problem. Keep in mind, that if a Medicare beneficiary presents with a medical emergency or urgent care problem, the physician or practitioner cannot require that patient to sign a private contract at that time.Continue reading