Mammography initiatives shape market prospects

December 15, 1993

Regulatory turbulence unsettled the mammography profession andindustry this month. The experience may provide a lesson for forecastersof health-care reform: Political winds are often unpredictableand usually intense. Federal agencies made two major

Regulatory turbulence unsettled the mammography profession andindustry this month. The experience may provide a lesson for forecastersof health-care reform: Political winds are often unpredictableand usually intense.

Federal agencies made two major pronouncements that could dramaticallychange the way mammography is practiced in the U.S.:

  • The National Cancer Institute (NCI) changed its guidelinesfor mammography screening in a way that limits recommended procedures;and

  • The Food and Drug Administration promised rigorousenforcement of the Mammography Quality Standards Act (MQSA), whichcould result in a spurt of equipment sales as facilities upgradetechnology.

The NCI withdrew its recommendation that women between theages of 40 and 49 receive screening mammograms every one to twoyears. The guidelines were withdrawn because mammography has notbeen proven to reduce mortality for women in this age group, accordingto the agency.

"Experts do not agree on the role of routine screeningmammography for women ages 40 to 49," the NCI said. "Todate, randomized clinical trials have not shown a statisticallysignificant reduction in mortality for women under the age of50."

The change surprised the mammography industry, which had expectedthe NCI to back off on the revision after its advisory board inNovember voted 14 to one in favor of recommending screening forwomen in the younger age group.

The NCI said its decision was based on the conclusions of anInternational Workshop on Breast Cancer Screening in February.The workshop was convened after the publication of the CanadianNational Breast Screening Study, which questioned the effectivenessof mammography for women aged 40 to 49.

Results from eight randomized clinical trials were reviewedat the workshop. While the efficacy of screening for women ages50 to 69 was confirmed, there was no such consensus for thosewho are 40 to 49, according to the NCI.

The NCI's recommendation puts its guidelines at odds with theAmerican College of Radiology, the American Cancer Society andmany women's advocacy groups, which recommend screening for the40 to 49 age group (SCAN 11/3/93). Many radiologists also disputethe new guidelines and the NCI's claim that there is no provenbenefit for screening women 40 to 49.

"What they overlook is that the randomized controlledtrials were not designed or executed in a way that a statisticallysignificant benefit could be shown at the level we think exists,"said Dr. Edward Sickles, chief of the breast imaging section atthe University of California at San Francisco. "The bulkof new evidence is in favor of doing more screening rather thanless. A trend has emerged showing mortality reduction. The onlything negative to come out is the Canadian trial, which is flawedin design and execution."

The NCI's recommendation, however, is in line with a proposalin President Clinton's health-care reform bill to reimburse mammographyonly for women aged 50 and over.

Reducing health-care costs is the motivating factor behindboth the Clinton reimbursement proposal and the NCI's new guidelines,according to Hal Kirshner, president of mammography vendor Loradof Danbury, CT.

"There is pressure from Washington to lower costs andthis is an attempt to succumb to that pressure," Kirshnersaid. "I think, though, that saving lives is more significantthan lowering costs."

TWO DAYS BEFORE THE NCI revealed its new guidelines, Food andDrug Administration commissioner David Kessler discussed the FDA'sMQSA regulations before a special plenary session of the RSNA.In a speech that emphasized the agency's intention to enforceMQSA zealously, Kessler gave a preview of the FDA's interim finalrules for implementing the law.

The FDA faces a daunting task in certifying over 11,000 mammographyfacilities in the country by October 1994, when all mammographycenters must have federal accreditation or cease operating. Theagency's efforts will build on the ACR's accreditation programto accomplish the task by the deadline, Kessler said.

Of the 11,162 facilities involved in the ACR's program as ofNov. 1, 7450 have completed the process and are accredited, accordingto Marie Zinninger, ACR senior director.

Under the new regulations, mammography facilities will be accreditedthrough state agencies and nonprofit groups like the ACR whoseaccreditation criteria meet FDA standards. The accrediting bodieswill supply the FDA with a list of facilities that meet federalstandards and the FDA will issue the required federal certificate.

The federal standards will not differ significantly from theACR's standards, Kessler said.

"ACR standards are substantially in compliance with thetough new rules published by FDA," Kessler said. "Withsome minor modifications, we expect ACR will be able to applyfor and receive approval from FDA as an accrediting body. Therefore,those facilities that are already ACR accredited--or that meetACR requirements and are accredited by states--could receive thefederal certificate in relatively short order."

To qualify for certification under the soon-to-be-publishedrules, mammography facilities must:

  • Use only dedicated mammography equipment;

  • Use equipment that does not deliver an average glandularradiation dose in excess of 0.3 rad during a single cranio-caudalview;

  • Be staffed by an interpreting physician certified byan approved professional body with continuing medical educationin interpreting mammograms;

  • Be staffed by an interpreting physician who reads anaverage of 40 mammograms a month;

  • Be subject to an annual on-site inspection by FDA staff;and

  • Collect clinical outcomes data such as biopsy resultsto follow up on the disposition of positive mammograms.

The rules will be published in the Federal Register some timethis month and will become law 60 days later, Kessler said.

In addition, the FDA is forming a new division of mammographyquality and radiation programs within the Center for Devices andRadiological Health (SCAN 8/25/93). Dr. Florence Houn will beprogram manager of the new division.

It remains to be seen what impact the MQSA and the NCI's recommendationswill have on mammography device purchasing. The new NCI guidelinescould reduce the number of procedures being conducted and thussuppress demand for equipment. That might be offset, however,by a mini-boom in equipment purchasing as mammography facilitiesupgrade equipment to comply with MQSA rules.

The size of that boom could be significant, though perhapsnot quite as large as vendors might hope. About 10% of the facilitiesthat have applied for ACR accreditation have been unable to meetthe college's standards for one reason or another, Zinninger said.

In addition, there are almost no facilities still using conventionalradiography to perform mammography, and nearly all mammographyunits of recent manufacture meet the ACR's guidelines providedquality control programs are in place, according to Zinninger.

"Dedicated mammography equipment should pass the test,"Zinninger said. "There are not a lot of devices that aregoing to have to be replaced."