Letter to HCFA
Supervision Standards Under the October 31, 1997 Rule

February 13, 2001

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

Re: Supervision Standards Under the October 31, 1997 Rule

Dear Mr. Kay:

The Society of Vascular Technology ("SVT"), the Society of Diagnostic Medical Sonography ("SDMS"), the Society of Vascular Surgery ("SVS") and the American Society of Neuroimaging ("ASN") wish to ask the Health Care Financing Administration ("HCFA") to release the Program Memorandum ("PM") with revisions to the October 31, 1997 supervision standards that HCFA has been preparing since 1998. We believe that it is now urgent that HCFA release the PM, as it is approximately three years since work on the PM was first begun. We have seen disturbing signs of carrier activity inconsistent with the general supervision standard which HCFA learned at the 1998 society meeting was the clear standard of practice for basic ultrasound and other services for which HCFA assigned a direct and, in a few cases, a personal supervision standard. The need for action on a national basis has been recently heightened by HCFA's changes to the supervision standards under the in-office ancillary services exception to the Federal Physician Self-Referral Law.

Despite the efforts of many of the societies that are signatories to this letter, the Louisiana carrier has declined to formally alter its direct supervision standard for basic ultrasound services (which should, as a matter of national practice, be assigned a general supervision standard), unless HCFA releases a PM specifying a different level of supervision. Although the carrier has indicated that it will not enforce its current standard, this incident, unfortunately, represents the latest in a string of such problems. We are concerned that the inconsistency in formal and informal policy exposes our members to False Claims Act liability. It is becoming increasingly clear that action by HCFA is necessary to prevent additional incidents like these.

As you know, HCFA recently changed the direct supervision rule under the all important in-office ancillary services exception to the Federal Self-Referral Law, in favor of whatever supervision level is provided for under the applicable Medicare coverage and payment rules. Accordingly, HCFA's failure to provide a consistent, national supervision policy under the coverage and payment rules has created a situation where Stark Law supervision compliance will depend on the carrier jurisdiction in which the services are provided. We do not see how this kind of arbitrary variation in the Stark Law implications of providing a particular level of supervision was intended by HCFA or consistent with HCFA's commitment to a common sense and practical application of the Stark Law. We believe that this would be a fundamentally unacceptable set of circumstances to which Congress and the Administration would be opposed.

We are very mindful of the tremendous number of issues competing for HCFA's limited resources, but we believe very strongly that the PM needs to be released as soon as possible. We would be delighted to assist HCFA in any way that we can. We ask you to communicate with us within the next month on this critical issue. We have appreciated your and HCFA's tremendous commitment to ultrasound issues, and we are hopeful that this issue can be resolved.

Very truly yours,

Stephen M. McLaughlin, BS, RT, RDMS
President, SDMS

Kevin D. Evans, M.S, RT.(R)(M), RDMS
President Elect, SDMS

Laurinda Andrist, BS, RDMS, RDCS
Government Relations Chair, SDMS

Don Haydon, CAE
Executive Director, SDMS

Suzanne Stone, Esq.
Executive Director, SVT

Anne Jones, BSN, RVT, RDMS
Government Relations Chair, SVT

Patricia Marques, RN, RVT, FSVU
President, SVT

Robert Zwolak, M.D.
Chair, Government Relations, SVS/AAVS

Theresa Gutoski
Executive Director, ASN

Michael Sloan, M.D.
Chair, Legislative Affairs Committee, ASN

Charles Tegeler, M.D., ASN
Immediate Past President

cc: Mr. Chris Carey
Mr. Carl Taylor
Joanne Sinsheimer, Esq.
Mr. Paul Kim