The best methods of diagnosing breast cancer have long hinged on accurate imaging and biopsy procedures. While an increasing number of nonpalpable abnormalities requiring biopsy are being identified with screening mammography, an across-the-board consensus about the best biopsy procedure for diagnosis remains to be reached.

According to a Joint Task Force consisting of representatives from the American College of Radiology (ACR), the American College of Surgeons (ACS), and the College of American Pathologists (CAP), it is estimated that 500,000 to 1,000,000 excisional breast biopsies are still performed each year, with between 300,000 and 900,000 of those results being benign. The task force report found that “excessive biopsies for benign lesions have adverse effects on society and on the women who undergo them because they increase the costs of screening, cause morbidity and anxiety, and add to the barriers that keep women from using a potentially life-saving procedure. A body of data suggests the efficacy of stereotactic core-needle biopsy for occult mammographic lesions.”1

So if core needle biopsy is recognized for being less invasive, costing less, and exposing the patient to fewer risks than surgical excision, why is it not yet the gold standard? A recent Wall Street Journal article posited “the way doctors are paid often encourages the use of older, more expensive and sometimes riskier medical procedures when better options exist.”2 The article also noted that “both Medicare and health insurers concede that core-needle biopsies are as effective as surgical biopsies in hunting for breast cancer. Yet, 78% of women who got breast biopsies under Medicare in 1998 got surgical ones.”2

The Clinical Picture

Steven Parker, MD

The shift is occurring, but slowly. The Department of Radiology at Brigham and Women’s Hospital in Boston, the Iris Cantor Center for Breast Imaging at the University of California Los Angeles, and the Sally Jobe Breast Center in Denver made a shift from doing almost all surgical biopsies in 1991 to doing 95% core biopsies 5 years later. In fact, Sally Jobe radiology imaging associate Steven Parker, MD, notes that of the 1,500 breast cancers diagnosed in Colorado in 2000, 500 of those were diagnosed at his center.

“Virtually all the surgeons in south Denver send their patients over to us,” says Parker, who adds that there was never a battle at Sally Jobe over the procedures going to radiologists instead of surgeons. Indeed, that has been the case for each of the facilities now preferring core biopsies for diagnosis.

“Our surgeons were extremely supportive of us doing this,” says Lawrence Bassett, MD, director of the Iris Cantor Center. “Our surgeons are very busy, and they would rather spend their time on surgical treatment than biopsy.”

“Whether patients should have a surgical or core needle biopsy is not a contentious issue here,” adds Jessica Leung, MD,? instructor of radiology, Brigham and Women’s Hospital, Harvard Medical School. “We recognize that core needle biopsy is helpful in benign cases because surgery can be obviated. On the other hand, in malignant cases, a preoperative diagnosis of cancer allows the surgeon to perform the definitive surgery. One-step surgery reduces both patient morbidity and monetary costs.”

Leung cites a study that found patients without initial core needle biopsies need 2.01 surgeries as compared to 1.25 surgeries for those who do have a core needle biopsy.3 She also notes that the procedure narrows the number of surgical procedures to those more likely to discover cancer. In a study of 1,103 women conducted from July 1998 to June 2000 at Brigham and Women’s Hospital, 42% of surgical biopsies revealed cancer. That compares to a previous study done from January 1987 to December 1988 before core biopsy was readily available. Out of 1,160 women, cancer was present in only 19% of the surgical biopsies.4

While Leung notes that some might argue that core biopsy adds another step in the diagnostic process, its value lies in the ability to screen out those for whom surgery is unnecessary. Also, a positive core biopsy provides the surgeon with valuable information for treatment planning.4

“An open surgical biopsy is best done after you know what you are dealing with,” says Norman Sadowsky, MD, director of the Faulkner-Sagoff Centre at Faulkner Hospital, Boston, Mass, which also has made a shift to offering more core needle biopsies over the last decade. “The days of biopsying lesions surgically without knowing what they are preoperatively are over. There have been too many people having biopsies done when it is not necessary. If the lesion is benign, then you can leave it there unless the patient wants it removed.”

While Sadowsky says that some surgeons in this country still think they should be doing all the diagnostic procedures related to breasts, he is adamant that “it is not good for the patient.

“It is wasteful. When we are faced with a patient with a solid mass, we can do a simple procedure under ultrasound and let the patient know what it is tomorrow, or we can do a surgical biopsy, which necessitates deeper anesthesia and postoperative discomfort and postoperative scarring,” he says. “If it is benign, the patient may not need surgery. If it is malignant, then the surgeon can do the proper procedure, which is an excision and sentinel node dissection.”

Many of those who prefer core needle biopsies for the majority of diagnostic cases have in fact become champions of the procedure. Parker, who admits some consider him “way off the bell curve” on the issue, maintains that there is no reason to do an open biopsy for diagnostic purposes. Furthermore, he expresses frustration with other facilities that have not yet come to accept core needle biopsies over surgical procedures.

“The only case where we need to do surgery is if the patient has a large mass that is benign-appearing and she wants it out for cosmetic or psychological reasons,” Parker says. “Otherwise, for diagnostic purposes, it is not legitimate.

?”For the last 6 to 7 years, there have been virtually no surgical biopsies being done in south Denver,” Parker says. “So the question is, why can’t the rest of the country be like that? Why can’t north Denver be like that? What is keeping other medical communities from moving from conventional to modern medical technology?”

Reimbursement Barriers

Failure to provide access to core needle biopsy can be attributed to several factors, including turf wars. Some surgeons do not want radiologists taking away their procedures. That attitude is more prevalent in some areas of the country, as well as in less busy practices. Probably the biggest roadblock, however, is reimbursement, which Parker describes as miserable.

“These factors make for an excruciatingly slow transition to a technique that is better for women and for society. Radiologists might be interested in fighting a turf battle, but as it is now, they get virtually no money,” he says. “So radiologists don’t make a point of fighting for it because there is no incentive, and because fighting for it would create enemies.

“If you follow the money, you know it goes to surgery and not to minimally invasive procedures,” Parker says. “Even if core needle biopsies paid better, it would still be a third to half the cost of open surgical biopsy. The insurance companies screw it right down to the nubbin. Everything gets reimbursed so little that it’s appalling.”

According to the fiscal year 2001 fee schedule for one Medicare carrier in Ohio, reimbursement on Current Procedural Terminology (CPT) code 19100 (biopsy of breast; needle core [separate procedure]) for participating providers is $148.06, or $67.42 in a facility setting. For 19101 (biopsy of breast, incisional), reimbursement is $416.10, or $231.06 in a facility setting.5

“Last year we lost $7 on every mammography procedure we performed, and the center lost $125,000 in the first quarter of this year,” Parker says. “Because we are part of a large radiology group, however, we subsidize this program because we think it’s best for the patient.”

Accordingly, the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration) adopted new payment scales for core needle biopsies in January, at the recommendation of a committee of physicians from the American Medical Association and other specialty physician societies.2 Reimbursement for the various types of core biopsy now more closely reflects actual costs, according to a presentation on “Economics of Needle Biopsy” by Karen K. Lindfors, MD, at the Society of Breast Imaging’s Fifth Postgraduate Course in May 2001.

“Prior to January 1, 2001, when all core biopsies were reimbursed under CPT code 19101, the choice of biopsy device utilized had a great impact on the profitability of core biopsies, but now separate codes exist for 14-gauge automated cores and for cores performed with vacuum-assisted devices,” Lindfors said. “Supplies utilized in vacuum-assisted biopsies are now appropriately reimbursed so these procedures can be profitable with stereotactic and with sonographic guidance and for all types of lesions.”

Further, Lindfors notes that the two variables that now most impact profitability are payor mix and radiologist efficiency. “Efficient use of the radiologist’s time is the major factor influencing economic success for a core biopsy program,” Lindfors says.

Regardless of any current financial barriers, the consensus among those who have shifted to using core needle procedures for diagnosis is clear that this is the wave of the future.

“Reimbursement improved a little on January 1, but we hope there is still a movement afoot to improve it significantly, which will make the conversion to needle biopsies occur much more quickly,” Parker says. “The advantages of these biopsies have been clear for a decade, so it is crazy that it is not standard across the country.

“This is the way to go. The whole field has to go this way eventually, but the factors currently against it are significant roadblocks,” Parker says.

Practitioner Info

Once core needle biopsies become more prevalent, numerous criteria affect their accuracy. Most centers follow ACR recommendations for the types of lesions that should be surgically biopsied. Those in the suspicious category require an open biopsy.

“How to determine what to use and when is a matter of trying to have zero tolerance for false negatives,” Parker says. “Any other scheme runs the small risk of missing a cancer. Even surgical biopsy runs the risk of missing cancer. The data on that note a 2% false negative rate.”

Centers or physicians that do breast diagnosis or biopsy ought to have both ultrasound ability and skills and stereotactic mammography ability and skills. A standard automatic 14-gauge core biopsy needle is used in masses greater than 1 cm, while the 11-gauge needle is used in smaller masses.

“With the 14-gauge needle, there is a small false negative rate from smaller masses and a 5% to 8% false negative rate for calcification cases, which should be done stereotactically,” Parker says. “Data show that we have never missed a cancer in those. The 11-gauge needle has virtually a 0% false negative rate in masses less than 1 cm and for calcifications.”

While the literature reflects only a miniscule number of patients with a false negative biopsy, it is crucial that those cases are not missed in subsequent imaging. Therefore an established program of quality assurance should be in place.

“By some accounts, patients are only 50% compliant with follow-up imaging,” Bassett says. “We can get false results with open biopsies too, so we always encourage patients to have a surveillance follow-up 6 months afterward.”

The method of imaging and the type of needle used likewise make a big impact on the success of a center’s sentinel node program. For sentinel node biopsies, the axilla must be evaluated by ultrasound thoroughly before committing to a node analysis. Parker estimates that half of the false negatives in biopsies occur because there is a nonpalpable but microscopically abnormal node that redirects the lymph flow around the sentinel node.

“This tumor has a damming effect on the lymphatic flow and we can see the abnormality with ultrasound,” he says. “If we scan the axilla and have a question, we can do a core biopsy of the lymph node at the same time as the main lesion. If it is positive, then we do not go to a sentinel node analysis.”

A Greater Responsibility

Bassett also notes that radiologists now have a lot of responsibility that they may not have had before when more biopsies were being carried out by surgeons.

“Radiologists must be aware of the pathology results, and make sure they are concordant with the imaging findings,” he says. “If they are not, then an open biopsy is required.”

At the Iris Cantor Center, a core biopsy diagnosis of atypical ductal hyperplasia requires an open biopsy be performed? because Bassett says it is hard to exclude coexistent cancer in nearby tissue.

“When we do core biopsy and get a diagnosis of atypical ductal hyperplasia, we recommend open biopsy, and ductal carcinoma or invasive carcinoma is found in 25% of those subsequent surgical biopsies,” he says. “Therefore it is mandatory to do open biopsy after a diagnosis of atypical ductal hyperplasia. Lobular carcinoma in situ is a risk factor for future cancer, and some believe that open biopsy should be done in those cases to check for potential adjacent, higher-grade lesions. However, not everyone agrees that surgical biopsy is necessary after a core biopsy showing lobular carcinoma in situ. So obviously there are some nebulous areas that are not resolved yet in terms of what types of lesions should still be surgically biopsied.

“The primary issue remains that the majority of cases turn out to be benign and core needle biopsy simply does not have some of the morbidity that you have with open biopsy, plus no scarring and no impact on future mammograms,” he continues. “With this procedure, we can get an adequate answer without putting the patients through that.”

Patient Issues

As core needle biopsies are a relatively new procedure, patients who have elected to undergo the procedure will need information about its risks and benefits.

“Science writers advocate that patients be assertive in their requests for needle biopsies,” Leung says. “While it can be dangerous to have lay journals advising patients about things that they can’t understand, patients should hear about needle biopsies in case the option is not made available to them.”

At the Iris Cantor Center, patients are informed that core needle biopsy brings with it no scarring, a relatively fast process, and an avoidance of surgery if the biopsy is definitively benign and concordant with the imaging findings.

“It also won’t affect future mammograms,” Bassett says. “The procedure will not be considered successful if the lesion doesn’t show up well enough on the image or is in a difficult location, or if the patient can’t lie on the stereotactic table for 30 minutes. If the results are not definitive, then they still may need an open biopsy.”

“From the patient’s point of view, core needle biopsies provide a rapid diagnosis, spare a wait of 2 weeks to see a surgeon, and have a lower cost, and greater ease and comfort,” Sadowsky says. “Doing a needle biopsy under ultrasound is virtually 100% accurate.”

Even with the relative ease and efficacy of the procedure, Bassett is quick to point out that there are some downsides to core needle biopsy.

“I try to get away from the idea that it’s just a core biopsy,'” Bassett says. “Core needle procedures are not without morbidity, it is just more likely to be psychological morbidity. Patients are pretty upset regardless of how we do breast biopsies, so we don’t just do them randomly.”

In fact, Bassett notes that anxiety for breast procedures is higher than it is for usual surgical procedures. In a study of three groups of patients at Iris Cantor Center, one group received no pre-medication, one group was taught some relaxation techniques, and the third group was given diazepam.

“We found that anxiety levels were extremely high prior to the procedure, but in those patients with no intervention, anxiety went up another 8% during the biopsy,” Bassett say. “However, for those trained in relaxation techniques, it came down 8%, and for those who were given diazepam, the level dropped 47%.”

Another issue with core needle biopsies is the potential of centers for lowering the threshold of patient criteria. The Joint Task Force of the ACR, ACS, and CAP noted in its report that “indications for diagnostic biopsy, based on a careful assessment of level of mammographic suspicion, should not be altered simply because new technology is available. Stereotactically guided core needle biopsy should not be a substitute for poor or inadequate imaging workup,” it said, noting that it still is not uncommon for patients to be referred for stereotactic needle biopsy of an abnormality that has been seen in one view only.1

“We have not eliminated the serious workup stage just because we have an easier way to do the biopsy,” Bassett says. “Core needle biopsy is a major advance for us and for the patient, but we still take a biopsy seriously. I don’t want to get carried away so much by the procedure that I forget it is still serious for the patient.”

Furthermore, the Joint Task Force notes, “lowering the biopsy threshold to include probably benign findings would significantly increase the number of biopsies performed, yield very few additional carcinomas, and possibly eliminate the economic advantages of stereotactically guided core needle biopsy.”1

The ACR and the ACS likewise recommend parameters for radiologists doing the procedure. They stipulate that surgeons must do 12 core needle biopsies per year and have been proctored for 3 years before starting to do needle biopsies.

“Those are the ‘official’ numbers, but to do core needle biopsies exceedingly well, the radiologist should do a lot more than that,” Parker says. “We have three radiologists on staff and we do a total of 15 biopsies per day, so we each are doing about 12 procedures per week.

“Patients should get funneled to the place where the people have the most experience, because when you do something a lot, you become good at it,” he says.

Clinics also need to take into account what people are comfortable with, and how accepting they are of a new procedure. “For a core needle biopsy program to be successful, it really has to be a team effort on the part of the surgeons, the pathologists, and the radiologists,” Leung says. “As far as Brigham and Women’s is concerned, there is no financial incentive here. We are working as a team to provide what is best for the patients.”

Elizabeth Finch is a contributing writer for Decisions in Axis Imaging News.


  1. Bassett L, Winchester DP, Caplan RB, et al. Stereotactic Core-Needle Biopsy of the Breast: A Report of the Joint Task Force of the American College of Radiology, American College of Surgeons, and College of American Pathologists. March 1998. Jacksonville Medicine. Available at: htm.
  2. Martinez B. How insurance payments can work against less-invasive biopsies. Wall Street Journal. March 28, 2001.
  3. Smith DN, Christian C, Meyer JE. Large-core needle biopsy of nonpalpable breast cancers. The impact on subsequent surgical excisions. Arch Surg. 1997;132:256-259.
  4. Core needle biopsies can reduce unnecessary surgical breast biopsies. For release: May 1, 2001; release by the American Roentgen Ray Society. Available at:
  5. Ohio?Medicare Carrier 16360?FSY2001 Locality Fee Schedule. Available at: schedule/Ohio%20FY2001%20Fee%20Schedule.PDF.