Applied Radiology

At the time of submission, Dr. Lee was Medical Director of HealthHelp, Inc., a radiology MSO. He is now Chief Medical Officer/Health Care Manager with the California Department of Corrections, Salinas, CA.

Screening mammography, the only screening procedure recommended by the American College of Radiology, has been shown to decrease the mortality in women from breast cancer. ¹ To meet this challenge, guidelines have been developed recommending screening exams beginning at age 40. ² Because of this need, screening facilities began springing up all over the nation. It was soon realized, however, that not all these facilities performed diagnostic-quality mammograms.

In 1992, the Mammography Quality Standards Act (MQSA) ³ was enacted to ensure that only facilities that had passed rigorous standards would perform those exams. Not only would the facilities and equipment be reviewed, but the technologists and interpreting physicians would be as well. In 1994, the first facilities were certified. Since then, more than 9,000 facilities have been reviewed annually. However, if every eligible woman were to get a screening mammogram as recommended, there still might not be enough facilities, manpower, or money to meet this need. ⁴

From 1995 to 1997, the number of facilities increased from 8803 to 9448. Then in 1998, the number decreased to 9297, only to rise to 9537 in 1999. In September 1999, there were 9968 fully certified facilities. This number may now be decreasing. As of April 28, 2000, there were 9570 certified facilities, a decrease of 398 facilities. ⁵

If there is a decrease in the number of offices providing mammograms, fewer women will be screened, fewer early cancers will be detected, and the mortality rate will rise. This may have become a serious matter, possibly to the level of a public health problem. The basis for any decrease in the number of facilities are threefold: (a) the high medical liability risk associated with mammography; (b) the low reimbursement for screening mammograms; and (c) the rigorous and costly governmental regulations.

Disincentives of mammography

High mammography liability risk

One of the areas of medicine with the most malpractice litigation and liability is the interpretation of mammograms. ⁶ Misdiagnosis of breast cancer is the most common condition for which claims are generated against physicians. ⁷ An informal survey of local radiologists suggests that more than half have been involved directly or indirectly in malpractice litigation relating to mammography. Radiologists are named in one-quarter of all breast cancer malpractice claims. ⁸ The average judgment award in cases where there was a jury verdict is $869,766. ⁸ Malpractice suits are extremely disruptive to physicians and their practices, involving time and expense, as well as an emotional toll on the doctor. Without question, women have been injured by negligent physicians, and there should be compensation for the harm done. But there should be a correlation between the harm done, the act of the doctor, and the compensation received. The risk of being sued is, without a doubt, a reason that some qualified, competent physicians will discontinue performing mammograms.

The low reimbursement for screening mammograms

As of January 2001, the standard reimbursement, based on Medicare, allowable for a screening mammogram in Florida, localities 1 & 2, was $69.23. ⁹ Other payers, such as Medicaid, provide even lower reimbursements. A survey of 21 radiology facilities showed that their average cost to do a mammogram is $65. This cost is dependent on volume, and most facilities are not operating at their maximum efficiency for mammography. In fact, some facilities regard performing mammograms as a loss leader. It is difficult to measure the effect of performing mammography on the other areas of the imaging business, however. The general consensus among radiologists is that unless they do a significant amount of ancillary breast procedures, such as ultrasound, diagnostic follow-up, and localizations with biopsies, they do not make money on screening mammograms, and may in fact lose money. Some facilities that are losing money performing mammograms have decided to discontinue providing this service. ¹⁰ In our survey, the average reimbursement was $5 less than it cost to do the exam.

The rigorous and costly governmental regulations

The MQSA is a federal law intended to ensure that women undergoing screening for breast cancer get that screening only at a facility where quality is assured. The MQSA imposes high standards on mammography facilities, technologists, and physicians. The facilities must undergo a rigorous application and inspection process under the auspices of the Federal Drug Administration. Those not meeting the standards are prohibited by law from performing mammograms, both screening and diagnostic. Detailed records of the equipment and processor must be maintained. The training, experience, and continuing education of the technologists and physicians must be verified and maintained in accordance with the Act. The purpose and goals of the Act are without question.

However, the Act places a severe burden on screening facilities. This burden is not only one of time and labor, but also of an out-of-pocket expense. Facilities have had to hire additional personnel to keep up with MQSA-related paperwork. In keeping with the intent of the regulations, once a facility is certified, that facility must maintain its certification by: (a) having an annual physics survey of the equipment performed by a private radiation physicist certified by the American Board of Radiology; (b) undergoing periodic audits and reviews by their accreditation body; (c) permitting and undergoing an annual MQSA inspection; (d) paying an inspection fee; and (e) correcting any deficiencies found during inspections. ¹¹

The annual MQSA inspection fee is $1500. ¹² The average cost to reach MQSA compliance has been estimated to be as high as $18,000. ¹³ A facility may have to perform more than 20 mammograms just to pay for the inspection fee, and more than 250 to cover the cost of initially being compliant. In addition, the services of a physicist must be obtained, which may cost more than $500. These additional financial burdens are a disincentive to performing mammography.

Proposed solutions

Lessen the malpractice risk

Precedents have been established where no-fault liability is allowed in cases in which medical malpractice litigation has interfered with adequate delivery of healthcare. ¹⁴ In these settings, any patient injured in a documented medical experience is awarded compensation without assigning fault to the healthcare provider. This eliminates the stigma, time, and the administrative and legal cost associated with a lawsuit, but still provides the injured patient with appropriate compensation.

Another mechanism to lessen the malpractice effect is a scheme such as the Florida Birth-Related Neurological Injury Compensation Association, which is funded by a combination of state funds, physician fees, and hospital assessments. ¹⁵ If a doctor (whether a family practitioner or an obstetrician) performs obstetrical services and wishes to be covered by the association, the fee is $5000 per year. In addition, all physicians, regardless of specialty, must pay a mandatory fee of $250 and hospitals pay $50 per live birth. This fund is to be used for compensation, which lessens the medical malpractice insurance costs to the providers.

This type of plan would have to be followed on a national level to provide consistency throughout the states. One possibility would be its amendment to the MQSA. The resultant lessened liability would not create a sense of immunity in the radiologists; there would still be the requirement of their being certified by the FDA. If repeated negligence were identified, expulsion from the program would be an option. Physicians don't become lackadaisical simply because the risk is lessened. Physicians still have their pride and reputation as well as the desire to provide to best care for the patient.

Increase reimbursement

Any business that offers its services or products to the public should be allowed to receive a financial gain from that service or product. This is fundamental to the American capitalist system. At the minimum, one should not be expected to suffer from offering that service. The American College of Radiology has been looking at the reimbursement for imaging procedures and has had mammography at the top of its list for evaluation. ¹⁶ The reimbursement for screening mammograms should cover the full and complete costs of doing the exam and still allow a reasonable profit. This reimbursement should also cover the added expenses of compliance with the MQSA. A survey of 21 mammographic facilities in our network indicated that they felt average reimbursement should be $95, with a range from $67 to $150. The Health Care Financing Administration sets the standard for reimbursement in its Medicare program. The private insurance payers frequently follow suit and adopt the Medicare fee schedules.

Revisit the regulatory controls

The accreditation standards have continuously become more stringent and may have reached the point of overkill. Inman ¹³ suggests that the FDA look for ways to perform more cost-effective inspection. Two suggestions he offers are that: (a) inspections be unannounced with higher fines for noncompliance; and (b) implementation costs be more realistic and paperwork be decreased. ¹³ Others suggest streamlining the process for those with good track records and few negative findings at inspection. ¹⁷ The MQSA should be reviewed to determine if a lesser degree of regulation would accomplish the same goal of ensuring quality. The MQSA is a federal law, and Congress should be petitioned to amend the law to make it workable.

Conclusion

There may be a public health problem looming in the future of mammography. Women may not be able to avail themselves of screening mammograms to the extent they deserve. Public health problems require innovative solutions. Three solutions have been suggested to preserve the availability of screening mammography with the goal of saving lives. AR