Letter to HCFA re: PM submitted by the Ultrasound Coalition

May 3, 2001

Mr. Tom Scully
Administrator
Health Care Financing Administration
7500 Security Boulevard
Baltimore, Maryland 21244

Dear Mr. Scully:

This comment letter on the Physician Supervision Program Memorandum ("the PM") released by the Health Care Financing Administration ("HCFA") on Thursday, April 19, 2001 is submitted by the Ultrasound Coalition (the "Coalition"), which consists of the Society of Diagnostic Medical Sonography ("SDMS"), the American Society of Cataract and Refractive Surgery ("ASCRS"), the American Society of Neuroimaging ("ASN"), the American Academy of Ophthalmology ("AAO"), the Society of Vascular Technology ("SVT"), the National Electrical Manufacturers Association ("NEMA"), the Society of Vascular Surgery ("SVS"), the American Association of Vascular Surgery ("AAVS"), and the Society for Excellence in Eye Care ("SEE").

First, the Coalition wishes to thank HCFA and, particularly, Mr. Terrence Kay and Mr. Paul Kim, for their tireless efforts to bring consistency to the standards for physician supervision in diagnostic services payable under the physician fee schedule. In many cases, the Coalition is very pleased with the PM because, by and large, HCFA has followed our suggestion that the physician supervision levels set by HCFA should reflect those levels that are the accepted standard of practice and care in the United States.

With that said, however, there are a number of services for which HCFA has assigned levels of supervision that (1) would fundamentally threaten access to these services, (2) are completely inconsistent with the standards of practice and care, (3) are inconsistent with the current standards under which Medicare, through its carriers and intermediaries, have permitted these services to be performed for, in many cases, as long as twenty (20) years, (4) are inconsistent with other determinations HCFA has made in its PM, and (5) would be inconsistent with HCFA's own efforts to clarify the in-office ancillary services exception under the Physician Self-Referral Law in a manner designed to make that exception practical and reflective of the manner in which physician services are provided. We believe that it is critical that HCFA address these services in its planned clarifications to the PM prior to the July 1, 2001 implementation date.

Generally speaking, the PM quite correctly assigns non-stress ultrasound services, such as the vascular ultrasound, the echocardiography, and a number of the general ultrasound services, to general supervision. As approximately forty (40) medical societies stated at the 1998 meeting that HCFA convened in the wake of the concerns surrounding the October 31, 1997 supervision final rule, the clear consensus in the health care community is that general supervision is both the standard of practice and the standard of care in the United States for all basic ultrasound services. It was our understanding that HCFA agreed with this consensus and that this was precisely why HCFA stayed the October 31, 1997 rule pending the development of the PM. Task studies undertaken by members of the Coalition have confirmed that general supervision is the standard practice in physician office, free-standing imaging center, and hospital sites of service.

Notwithstanding this, the following codes, which consist of certain obstetric, pediatric, and ophthalmic uses of ultrasound, were incorrectly assigned in the PM to a direct supervision level:

§ 76506 Echoencephalography, B-scan and/or real time with image documentation (gray scale) (for determination of ventricular size, delineation of cerebral contents and detection of fluid masses or other intracranial abnormalities), including A-mode encephalography as secondary component where indicated;
§ 76516 Ophthalmic biometry by ultrasound echography, A-scan;
§ 76519 With intraocular lens power calculation;
§ 76529 Ophthalmic ultrasonic foreign body localization;
§ 76800 Echography, spinal canal and contents;
§ 76805 Echography, pregnant uterus, B-scan and/or real time with image documentation; complete (complete fetal and maternal evaluation);
§ 76810 Complete (complete fetal and maternal evaluation), multiple gestation, after the first trimester;
§ 76815 Limited (fetal size, heart beat, placental location, fetal position, or emergency in the delivery room);
§ 76825 Echocardiography, fetal, cardiovascular system, real time with image documentation (2D) with or without M-mode recording;
§ 76885 Echography of infant hips, real time with imaging documentation; dynamic (e.g., requiring manipulation).

Further, the following ophthalmic codes were assigned to personal supervision:
§ 76511 Ophthalmic ultrasound, echography, diagnostic, A-scan only, with amplitude quantification;
§ 76512 Contact B-scan (with or without simultaneous A-scan);
§ 76513 Anterior segment ultrasound, immersion (water bath) B-scan or high resolution biomicroscopy.

The clear standard of practice and care for these services is general, not direct, supervision. Members of the Coalition solicited experts in ultrasound to provide their recommendations for a supervision level for these services. Experts consulted included clinicians at such leading centers as Stanford, the Mayo Clinic-Rochester, Massachusetts Eye and Ear Infirmary, the University of New Mexico Health Sciences Center (Department of Obstetrics and Gynecology), California Pacific Medical Center, Ohio State University, the University of Colorado, Cornell University, New York University, and the Cleveland Clinic. They unanimously endorsed general supervision for the procedures they reviewed.

Failing to recognize that these services are regularly provided under general supervision would necessarily have severe and disturbing access implications. Obstetricians cannot be physically present at all times in their offices to provide (wholly unnecessary) direct supervision of these services, as they have clinical commitments, including deliveries, that mandate that they be elsewhere for periods of time. In response to the PM, obstetricians have flatly told the Coalition that they would not be able to continue to provide the services at issue. Similar issues exist with respect to the ophthalmic services, as ophthalmologists are required to treat patients at hospitals and ambulatory surgery centers.

Significantly, a review of existing, published Medicare Carrier Local Medical Review Policies ("LMRP") demonstrates that the level of supervision sought by the Coalition for the procedures at issue is the level of supervision that is currently in effect under the Medicare program. The attached written policies for Colorado, North Dakota, South Dakota, Wyoming, North Carolina, Arkansas, Missouri, Oklahoma, South Carolina, and New Mexico all, without exception, permit each of the services listed above to be performed under general supervision. The only published LMRP that we could find that did not provide for general supervision was the Louisiana LMRP, which provided for direct supervision. As your agency may know, however, the Medical Director for Louisiana recently announced his intention to change his Carrier's supervision requirement to general supervision. Indeed, even in Louisiana, the current level of supervision for the services at issue when performed in a physician office setting is general supervision.

Further, we note that the PM is internally inconsistent and inconsistent with other HCFA policy. For instance, the PM suggests that CPT 76825 should be done under direct supervision (contrary to the standard of practice and care), when the PM simultaneously would permit both CPT 76826 (a repeat examination involving the same study as CPT 76825) and CPT 76827 (a service performed at the same time as CPT 76825) to be performed under general supervision. Although numerous other specific examples can be cited, the different treatment of adult echocardiography, vascular ultrasound, and most general ultrasound as general supervision services, on the one hand, and obstetric and ophthalmic services, as direct or personal supervision services, on the other, is clinically indefensible. Significantly, HCFA permits all of the services at issue to be provided on the main campus of a hospital under general supervision.

Recently, HCFA altered the supervision standard under the Stark Law's in-office ancillary services exception to follow the applicable "coverage and payment" rules. Based on educational efforts made by Coalition members, one of the purposes of this change was to allow the Stark Law to require general supervision for ultrasound services, in keeping with the standard of practice and care. That effort, which was widely applauded, will be undercut, unless the changes the Coalition requests are implemented.

AAO, ASCRS, and SEE also wish to make one non-ultrasound recommendation. CPT 99285, which involves simply a photograph taken using a slit lamp, is listed as requiring direct supervision, when general supervision is clearly the correct standard.

* * *

Our representatives will be in touch with your office shortly to discuss these issues further. Thank you, as always, for HCFA's diligent efforts on the part of the Medicare program.

Sincerely,

Patricia Marques, RN, RVT, FSVU
President
Society of Vascular Technology

Suzanne Stone, Esq.
Executive Director
Society of Vascular Technology

Stephen McLaughlin, BS, RT, RDMS
President
Society of Diagnostic Medical Sonography

Donald F. Haydon
CAE, Executive Director
Society of Diagnostic Medical Sonography

Cathy Greely Cohen
Regulatory Affairs
American Academy of Ophthalmology

David Karcher
Executive Director
American Society of Cataract and Refractive Surgery

Richard Eaton
Industry Manager
National Electrical Manufacturers Association

Peter Anas
Executive Director
Society for Excellence in Eye Care

Michael A. Sloan, M.D.
American Society of Neuroimaging

Robert Zwolak, M.D.
American Association of Vascular Surgery