American Society for Apheresis Announces the Clarification of 1992 National Medicare Coverage Determination

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The American Society for Apheresis is pleased to announce the clarification of 1992 National Medicare Coverage Determination.

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“The intent of "direct, personal" was more generic with reference to "personal", and means literally the regulatory definition of "direct" supervision. It was not intended to require the more recent regulatory definition of "personal supervision"..."

The American Society for Apheresis is pleased to announce the clarification of 1992 National Medicare Coverage Determination.

For years, language inserted in the 1992 National Coverage document (NCD) for Medicare has been confusing to apheresis professionals.

The confusion can be found in the Medicare National Coverage Determinations Manual Chapter 1, Part 2 (Sections 90 – 160.26) - Coverage Determinations: section 110.14 - Apheresis (Therapeutic Pheresis). It pertains to the last sentence in that section.

Specifically, the sentence “All nonphysician services are furnished under the direct, personal supervision of a physician.”

The confusion is the result of the juxtaposition of the words direct and personal. Direct implies the non-physician personnel have a direct reporting and oversight relationship to the apheresis physician who is immediately available to them. The word “personal” suggests an alternative interpretation. Specifically, some suggest this implies that the physician is in the apheresis patient suite during the entirety of the process overseeing the nonphysician personnel.

On occasion, Medicare contractors have denied payment for apheresis services based upon the lack of evidence that the apheresis professional was personally present to the patient during the entirety of the procedure. Others have reported that they have been compelled to arrange service coverage in order to eliminate any chance of being perceived as non-compliant leading to inefficient use of resources.

In order to help clarify this situation, ASFA’s Public Relations and Advocacy committee submitted a request for clarification to CMS.

The CMS section responsible for this portion of the 1992 NCD convened internally and with their contract medical directors to address this issue. They clarified the intent of the wording as follows:

“The intent of 'direct, personal' was more generic with reference to 'personal', and means 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)”.

Moreover, CMS stated that “There was no definition of 'personal' supervision until after 1997”.

This is good news for apheresis professionals as provision of “direct” supervision of nonphysician personal during a plasma exchange is customary.

So what is the precise definition of direct?

For services furnished in the hospital or CAH (critical access hospital) including an on campus or off campus outpatient department of the hospital, direct supervision is defined at 42 CFR 410.27(a)(1)(iv).

As of 1/1/2011, “direct supervision” means that the physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician or nonphysician practitioner must be present in the room when the procedure is performed."

Quoting directly from the Medicare Benefit Policy Manual, chapter 6, (Rev 137, 12-30-10),

“Immediate availability” requires the immediate physical presence of the supervisory physician or nonphysician practitioner. CMS has not specifically defined the word “immediate” in terms of time or distance. However, examples of a lack of immediate availability would be situations where the supervisory practitioner is performing another procedure or service that he or she could not interrupt, or where he or she is so physically far away from the location where services are being furnished that he or she could not intervene right away. The hospital or supervisory practitioner must judge their relative location to ensure that they are immediately available. Therefore, a supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available”.

For services in a physician's office, direct supervision is defined in 42 CFR 410.32(b)(3). Please note the subtle difference.

“Direct supervision in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed."

The Public Relations and Advocacy committee encourages all members to become familiar with the 1992 NCD section pertaining to apheresis. Though the confusion to direct and personal is clarified, proper practice also includes:

1)    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;

2)    Each patient is under the care of a physician; and

3)    All nonphysician services are furnished under the direct, personal supervision of a physician.

Note: Directive #3 has now been clarified.

The ASFA Public Relations and Advocacy committee would also like to report that working with CMS was very efficient and very helpful.

For further information, contact:
Sarah McCarthy, MSc, MBA
Executive Director
American Society for Apheresis
375 West 5th Avenue, Suite 201
Vancouver, BC, Canada V5Y 1J6
T 604.484.2851
E asfa(at)apheresis(dot)org
http://www.apheresis.org

About the American Society for Apheresis:
The American Society for Apheresis (ASFA) is an organization of physicians, scientists, and allied health professionals whose mission is lead the field of apheresis through patient and donor care, research, education and advocacy. Visit http://www.apheresis.org for further information.

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Sarah McCarthy, MSc, MBA
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