News Alert: Policy Contradiction Requires Physicians to Personally Supervise Therapeutic Pheresis

In another example of Medicare Administrative Contractors (MACs) contradicting the Centers for Medicare & Medicaid Services (CMS), National Government Services (NGS) on Friday issued a news and alert bulletin that was both controversial and confusing. In the alert, NGS stated that outpatient therapeutic pheresis procedures “must be performed by physicians or furnished under the direct, personal supervision of a physician,” and went on to note that “personal supervision means a physician must be in attendance in the room during the performance of the procedure.”

This appears to set a new precedent for a procedure that is generally performed by licensed personnel such as nurses based on the order of a physician, but requires no hands-on work or minute-by-minute adjustments by the physician. Similar to dialysis, therapeutic pheresis is a procedure wherein blood is taken from the patient, processed, and returned to the patient as part of a continuous procedure. Therapeutic pheresis is used to treat such conditions as myasthenia gravis, Guillain-Barre syndrome, Waldenstrom’s macroglobulinemia, thrombotic thrombocytopenic purpura, severe hyperlipidemia, and many others. Depending on the condition and the response to treatment, patients may need apheresis treatments on a range of regularity, from daily to weekly to monthly. 

Levels of supervision are set by CMS and must be met in order for the service to be covered. It should also be noted that supervision only applies to outpatient services; CMS defers to hospital policy and accreditation agency requirements for inpatient services. For example, for treatments such as outpatient chemotherapy administration, radiation therapy treatments, or even observation services, CMS requires direct supervision of the service. That means a physician must be on site and immediately available in the event of an emergency.

You may have also heard about supervision requirements in relation to rural and critical access hospitals. These are currently required by CMS regulation to have direct supervision for those designated services, but for the last few years, that requirement has not been enforced. Still, if you read the many CMS publications on levels of supervision or search the CMS database, you will find several levels, including general, direct, and personal. An example of personal supervision is when a videofluoroscopy is performed to assess obstruction; this task is performed by a radiology technician, but the radiologist’s attendance in the room is required to give specific directions to the technician and patient.

But according to NGS, pheresis does not require direct supervision or personal supervision; it requires direct, personal supervision. 

If one reviews National Coverage Determination 110.14 for apheresis, CMS indicates that it “is covered only when performed in a hospital setting (either inpatient or outpatient) or in a nonhospital setting, e.g., a physician directed clinic when the following conditions are met: A physician (or a number of physicians) is present to perform medical services and to respond to medical emergencies at all times during patient care hours; Each patient is under the care of a physician; and All non-physician services are furnished under the direct, personal supervision of a physician.”

It is this third point, the “direct, personal supervision” that appears to be the source of NGS’s claim that a physician must be present in the room throughout the pheresis.

But this instruction is in direct conflict with an answer provided by CMS when this issue was raised in the past. In 2010, the phrase “direct, personal supervision” in the NCD was called into question by the American Society for Apheresis. The Society discussed the issue with CMS, and the agency concluded that “the intent of ‘direct, personal’ was more generic with reference to ‘personal’, meaning literally the regulatory definition of ‘direct’ supervision. It was not intended to require the more recent regulatory definition of ‘personal supervision’ in 42 CFR 410.32(b)(3)(iii).”

It is also interesting to note that the alert discusses the billing of the technical component of the pheresis, but makes no mention of the physician’s professional billing. A single pheresis session can take several hours, depending on the condition being treated and the patient’s ability to tolerate the procedure. During that time, if the physician is required to be in the room, he or she cannot be seeing other patients. While there are codes for physician supervision of pheresis (CPT 36511-5, depending on indication), it has a relative value roughly equivalent to physician supervision of dialysis (CPT 90935). Dialysis is assigned direct supervision and not personal supervision, and the dialysis code covers a visit to the patient during their dialysis session and not bedside attendance throughout the whole dialysis. A physician would need to use the prolonged service codes (CPT 99354-99355), which are billed based on time, in order to be compensated. But will the use of those codes by the physician then lead to an audit and denial since “all the physician did” was stand by in case a problem arose?

Why did NGS issue this directive at this time? There is no indication if this was the result of an event investigation, a patient complaint, or a routine review of all policies. Perhaps NGS and the staff at CMS were unaware that this issue had already been addressed. But the fact that they did issue it is ominous, and such edits are usually followed by enforcement activities.

If you are in an NGS jurisdiction and perform outpatient pheresis, you may want to review this alert and your procedures to ensure that you are compliant – and to consider whether further discussion with NGS is in order. I will also point out that in its alert, NGS noted that it made this determination “after… consulting with CMS.” If this represents the new official stance of CMS, does that mean we will be hearing about this from other MACs? I have alerted the American Society of Pheresis, and perhaps with their intervention, this can be quickly clarified.