February 22, 2000

Mr. Terrence Kay
Health Care Financing Administration
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Mr. Kay:

I am writing to you on behalf of the Society of Vascular Technology, the Society of Diagnostic Medical Sonographers (“SDMS”), the Society of Vascular Surgery (“SVS”), and the American Society of Neuroimaging (“ASN”). Thank you very much for attending the SVT’s Current Issues Conference at the end of last year. SVT was most grateful for your attendance and presentation at this important conference. As we indicated at the conference, our group is extremely appreciative for the thoughtful and careful consideration of our concerns that the Health Care Financing Administration, in general, and you, in particular, have shown us on a large number of issues over the last several years.

During the course of the discussion following your presentation, a number of the members indicated an interest in the status of the Program Memorandum regarding the modifications to the supervision levels set forth in the final rule that appeared in the Federal Register on October 31, 1997. As our members indicated, there have been a large number of problems across the country in terms of the Medicare carriers’ understanding of the current status of the final rule and the appropriate levels of supervision for basic ultrasound services.

In Northern California, Ohio, and elsewhere, for instance, we have received a large number of calls from members who have been deeply disturbed by questions from Independent Diagnostic Testing Facility surveyors who have inquired whether the laboratory is in compliance with “the supervision standards in the October 31, 1997 rule.” Apparently, some Independent Diagnostic Testing Facilities’ approval has been delayed pending a discussion of what exactly is the required level of supervision for basic ultrasound services.

In Montana, members have had to proceed to administrative law judge proceedings in order to be permitted to perform certain ultrasound services under what we believe to be the appropriate level of physician supervision. Although our members’ position has been upheld in the administrative law judge process, this litigation has been extremely costly and time consuming to those members.

The issue appears particularly acute now as HCFA is about to make the Part B fee schedule requirements for physician supervision applicable to “off-campus” hospital providers. Many members are asking what that means and have been frustrated by attempts to clarify this issue with the Medicare carriers and intermediaries.

Our members have also expressed concern about the potential False Claims Act implications of the final rule. Although we appreciate that the final rule’s implementation was “halted” and that carriers were directed to use their previous supervision requirements, it is often not clear what those “prior” standards are. Members in California, Ohio, Kentucky, Indiana, Illinois, and elsewhere have reported inconsistent guidance from their carriers or, in some cases, carriers reporting that they are “not sure” what the standard is. Unfortunately, the False Claims Act becomes an unfair threat in unsettled situations such as this.

Given these and other problems that have occurred, the SVT, SDMS, SVS, and ASN request the HCFA either finalize a Program Memorandum or modify the October 31, 1999, final rule in this year’s proposed rule on the physician fee schedule. I would be very appreciative if you could call me and let me know what HCFA’s plans are in this important area.

Thank you for your kind attention to this matter.

Very truly yours,
William A. Sarraille