Popularity of breast ultrasound raises questions of quality

Patients often ask sonographer Cynthia Rapp just what it takes to perform ultrasound. Her frank response about the necessary qualifications sometimes comes as a surprise.

"I tell them that the person cutting their hair may have to be certified, but the person performing their ultrasound does not," said Rapp, a certified sonographer at Radiology Imaging Associates in Denver.

Questions about quality in breast ultrasound in particular are being raised more often for a number of reasons. Congress is seriously considering extending the Mammography Quality Standards Act (MQSA) to other breast imaging modalities. Currently, there are no mandatory standards for breast ultrasound, so physicians without a foundation in radiology can legally perform and bill for the study. Supporters of broader breast imaging legislation have been asking why mammography is highly regulated but new technologies such as breast ultrasound are neglected.

Breast ultrasound studies are difficult to perform, and success is highly dependent on the operator. Experts say meticulous attention to detail is necessary for differentiating benign from malignant lesions. In the right hands, ultrasound is highly accurate in characterizing lesions of just 3 to 4 mm in size. Breast imaging specialists question whether general radiologists have enough training and experience to perform breast ultrasound well-let alone nonradiologists, who may seldom work with the modality.

Surgeons are increasingly performing ultrasound in the breast for a range of reasons, including characterization of lesions, cyst aspiration, fine-needle aspiration of solid lesions, core needle biopsy, and vacuum-assisted biopsy.

Radiology residents generally complete several months of ultrasound training, covering physics, evaluation, and pitfalls of the technology. Yet at some hospitals, credentialing committees do not differentiate between an experienced radiologist and a surgeon who has taken a short course to perform breast ultrasound, according to Dr. Richard Ellis, codirector of the Norma J. Vinger Center for Breast Care/ Gundersen Lutheran Medical Center in La Crosse, WI.

"Why the double standard at the same institution?" Ellis asked.

Outside the hospital environment, some surgeons are performing breast ultrasound studies in their private offices rather than referring them to a radiologist. If a surgeon had the same training as a radiologist and did the study with the same frequency, this would be acceptable. However, it is not acceptable for surgeons to take a course in breast ultrasound and use the technology sporadically, said Lillie Shockney, administrative director at Johns Hopkins Avon Foundation Breast Center.

"You need to do the studies every day-and a lot of them-to maintain that skill level," Shockney said.

Dr. R. James Brenner, president of the Society of Breast Imaging, expressed similar views.

"There is nothing inherently wrong with a surgeon performing ultrasound. Some of the best high-risk fetal sonographers are gynecologists who have taken a great deal of time to develop expertise," Brenner said. "A breast surgeon who is very well trained in ultrasound can perform as well as a radiologist."

It's unclear how many surgeons are performing breast ultrasound. The American Society of Breast Surgeons (ASBS) has about 2000 members and estimates that a "significant proportion" performs ultrasound. The American College of Surgeons (ACS), which has 64,000 members, does not publicize specific figures, but it acknowledges that "many surgeons perform ultrasound-guided procedures, most commonly in the breast."

On average, surgeons obtain 10 hours of ultrasound training through the ACS. According to figures on the ACS Web site, breast studies are the most popular ultrasound courses offered. The ASBS advises a minimum of 15 hours of formal ultrasound training.

BATTLE SCARS

Traditionally, surgeons were at the center of breast care, and alternatives to surgery were limited. About a decade ago, practice shifted away from open surgical biopsy and toward minimally invasive, image-guided core biopsy, kicking off a turf battle. Today, radiologists perform more breast biopsies than surgeons.

In a study by researchers at Thomas Jefferson University Hospital, radiologists in 2003 performed 62% of breast biopsies compared with 33% conducted by surgeons. Of the total number of biopsies performed, 83% were image-guided. Radiologists performed 70% of the image-guided procedures compared with 24% conducted by surgeons.

Radiologists have taken a lot of money out of the pockets of breast surgeons, whose open surgical breast biopsies were a main source of income, Shockney said. In response to the clinical trend, some breast surgeons have purchased expensive equipment for performing stereotactic breast biopsies, procedures that are reimbursed at rates roughly equivalent to open surgical biopsy, from $2000 to $4000.

Professional component reimbursement for breast ultrasound ranges from $13 to $200 for a single CPT code (some procedures involve multiple codes), while global payments range from $70 to $580 for a single code.

But breast ultrasound equipment is also less expensive than stereotactic biopsy equipment. It's possible to buy a second-hand ultrasound system for $10,000. SonoSite markets new handheld or compact ultrasound systems to nonradiologists for $35,000 to $65,000 and offers Internet downloads for surgeons outlining reimbursement rules, proper coding, and average Medicare payments.

Toshiba, which sells ultrasound systems to surgeons and radiologists for $50,000 to $100,000, says sales to breast surgeons rose by 15% from 2004 to 2005. Increasingly, physicians want to own their own equipment, said Gordon Parhar, Toshiba's ultrasound business unit director.

Dr. Thomas Stavros, a breast ultrasound expert based at Sally Jobe Breast Center in Denver, questions the quality of some equipment commonly used by surgeons.

"Some of the compact units have adequate high-frequency, near-field performance for breast ultrasound, but others do not," he said.

Vendors have found a selling point with surgeons when they say that ultrasound can help with physical exams, said Brenner, who is also chief of breast imaging at the University of California, San Francisco.

"Surgeons less versed in limitations and pitfalls of imaging may encounter something they cannot accurately evaluate," he said.

PAYMENT AND CERTIFICATION

One gray area for surgeons is reimbursement. In most states, certification is not a requirement to gain reimbursement for breast ultrasound, although in some regional pockets, surgeons are being asked to prove qualifications.

In 2003, surgeons were routinely denied payment for ultrasound-guided breast exams and biopsies, according to an ACS bulletin. That prompted the organization to petition insurers on behalf of its members. For the most part, it was successful in making its case for reimbursement.

The reimbursement case is based partly on the ability to demonstrate quality. In 2002, the ASBS launched a breast ultrasound certification program for surgeons. The program was necessary because there was no other way for breast surgeons to prove their qualifications for performing breast ultrasound in their offices as well as the OR, according to the organization. The American College of Radiology and the American Institute of Ultrasound in Medicine offer a facility accreditation program specifically for breast ultrasound, which includes requirements for practitioners.

"We were not aware of a quality issue, but we wanted a mechanism for surgeons to meet standards that are peer reviewed and to document that for the outside world," said Dr. Eric Whitacre, chair of the ASBS committee on breast ultrasound certification.

The process is rigorous, Whitacre said (see "Certification rules for surgeons rival radiologists'," page 45). To date, 272 people have ordered the application, 106 have submitted it, and 74 surgeons have been certified in the ASBS breast ultrasound program. A 2004 survey indicated high interest in receiving certification.

"If a patient comes in with a painful lump and you see an abscess, you can drain it with ultrasound right then and there. This is what makes breast ultrasound so compelling for breast surgeons," Whitacre said.

If the lesion is solid, the surgeon can perform an image-guided core biopsy. The stressful "ping-pong effect" of sending women back and forth for follow-up visits to other facilities disappears, he said.

Clearly, a palpable lump, if it is a simple cyst, is a straightforward diagnosis most of the time, said Dr. Wendie Berg, principal investigator for the Screening Breast Ultrasound in High-Risk Women Trial, sponsored by the American College of Radiology Imaging Network. It is reasonable for a surgeon to be able to put an ultrasound transducer on a palpable lump, see it is a simple cyst, and aspirate if needed with ultrasound guidance.

"Where problems arise is in considering more subtle findings, such as something found by a mammogram initially or something remote from the lump, and we want to look at the rest of the breast to see if there are more cancers. These sorts of things are very demanding and require absolutely meticulous technique," Berg said.

In some cases, surgeons have attempted needle localization of a nonpalpable lesion and had trouble finding the lesion during the procedure, Brenner said. In such cases, the radiologist may not be available to help and the patient needs to return. The subtleties of nonpalpable lesions are so extraordinary that it is risky even for many general radiologists to perform breast ultrasound.

As clinical uses of breast ultrasound expand and legislators address staffing issues in breast imaging overall, there is bound to be greater attention to ultrasound training and standards, regardless of who is performing the study.

"Ultrasound is a rapidly evolving field. Further standardization of technique, labeling, and equipment should improve its performance across specialties," Berg said.

Ms. Hayes is feature editor of Diagnostic Imaging.