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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Alberta’s Next Round of Clinical Laboratory Consolidation Alarms Pathologists

Plans are to centralize all cervical cancer screening in just two Alberta medical laboratories


Ongoing efforts to further consolidate clinical laboratory testing in the Canadian Province of Alberta caused local pathologists earlier this year to go on record to specifically oppose a proposed consolidation of Pap Smear testing. Over the past 15 years, the Alberta government has never been timid in its efforts to use consolidation of clinical pathology laboratory testing as a way to achieve cost savings.

During the past winter, more than 30 pathologists in Alberta signed letters to Health Minister Gene Zwozdesky to protest the consolidation of all the province’s Pap Smear testing into just two clinical laboratories—one in Edmonton and one in Calgary. As a result of the government’s decision to consolidate this medical laboratory testing service, cytology laboratories in Lethbridge, Medicine Hat, Red Deer, and the University of Alberta Hospital would no longer perform Pap smear testing.
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Is New Cervical Cancer Test Better Than a Pap Smear?

Intense research into cervical cancer detection and treatment has yielded significant progress in the past decade. One common cause of such cancer is the human papillomavirus (HPV). New developments involving HPV have produced thin-layer Pap smears, HPV testing, and HPV vaccines. Now, researchers in Italy are reporting a new twist in HPV screening and detection. In research published in the journal Lancet Oncology, Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, reported that a new way to test for cervical cancer is more accurate than a pap smear alone and identified more dangerous lesions.

Clinicians can improve the specificity of DNA tests for HPV by testing for the presence of a protein that is over-expressed in cervical cancer cells, the new research shows. The molecular test tends to give more false positives, increasing the number of unneeded referrals for colposcopy, Ronco and colleagues reported online in the journal Lancet Oncology. (Carozzi F, et al “Use of p16-INK4A overexpression to increase the specificity of human papillomavirus testing: a nested substudy of the NTCC randomised controlled trial” Lancet Oncology 2008; DOI: 10.1016/S1470-2045(08)70208-0.)

DNA tests for HPV are more likely to pick up cases of high-grade cervical intraepithelial neoplasia (CIN) than conventional cytology, Ronco and colleagues reported. Since the molecular method gives more false positives, it tends to increase the number of unneeded referrals for colposcopy, Dr. Ronco and colleagues reported. To improve specificity, the researchers considered the cyclin-dependent kinase inhibitor p16-INK4A (p16), which is considered to be a marker of HPV infection, according to a report on the findings at www.medpagetoday.com.

Since only a small percentage of women who have an HPV infection actually develop cancer, the challenge for researchers is to identify those who have the highest risk for developing the disease. By testing for a the presence of P16, the researchers said they had identified a biomarker showing cell changes that indicated whether a woman was likely to have pre-cancerous lesions, Ronco and colleagues reported. “The marker shows there was some sort of disruption by the HPV virus,” Ronco said.

“Our data show that in HPV-positive women, p16-INK4A over-expression is strongly associated with the presence of histologically confirmed CIN2+, suggesting that it actually is a marker of progression,” Dr. Ronco said. “This study supports the application of triage by P16INK4A immunostaining in HPV-positive women,” he added.

Data from the U.S. National Cancer Institute show that an estimated 11,000 women in the United States would be diagnosed with this type of cancer and nearly 4,000 would die from it last year. Cervical cancer strikes nearly half a million women each year worldwide, claiming a quarter of a million lives. Studies show 26% of women aged 14 to 59 will contract HPV.

For More Information:

Dark Daily’s List of Anatomic Pathology’s 10 Most Costly Coding Errors Costly Coding Errors

Coding Error #1: Not Insisting on Complete Requisition Forms for Pap Tests

Lab administrators and pathologists often fail to realize how frequently this error results in lost revenue to the laboratory. Incomplete information on the requisition can also impact the clinical service the laboratory provides to the referring physician. It may be timely to do audit current workflow to determine the error rate on Pap smear requisitions. If your lab team doesn’t know the precise number, it is likely to be higher than anyone imagines.

CLIA regulations clearly state that, for Pap smears, laboratories need to indicate “whether the patient had a previous abnormal report, treatment, or biopsy.” Unfortunately, Pap smears are often completed without proper information from the patient’s referring physician and without first documenting the patient’s prior Pap smear results. These costly mistakes can lead to reimbursement disputes and lack of reimbursement from Medicare.

Medicare will reimburse for 3 types of Pap tests:

1) Type 1 is a Pap test that is medically necessary for diagnosis. These tests must be based on qualifying diagnosis (LCD).

2) Type 2 is a high-risk screening Pap test. Medicare will reimburse for high-risk Pap test every year assuming definition criteria are properly met.

3) Type 3 is a low-risk screening Pap test. Medicare will reimburse for low-risk Pap tests every 2 years. If a Pap test is not reimbursable by Medicare, laboratories must have a signed ABN (Advance Beneficiary Notice) and use the proper modifier in order to bill the patient.

An anatomic pathology laboratory’s requisition form for Pap tests should be designed to capture all of the following information:

  • Patient, insurance, and testing information
  • Clinical information and patient history
  • ICD9 code or a narrative description

• Whether the pap test is for diagnostic or screening purposes
• If a screening, whether the Pap test is a high-risk or low-risk screening
• ABN (form R-131-L)

There are several effective secrets to ensure that your laboratory avoids the trap of having incomplete requisition forms for Pap smears. First, monitor requisitions on the front end, in the laboratory. Second, laboratories should keep up with code changes and continually update requisition forms. Third, referring physicians and office staff should be educated as to the importance of the requisition forms so they do their part to fill them out as completely as possible. Finally, a laboratory should never default to an ICD9 code simply because information was not provided by a referring physician. This goes along with our third point – educate the physician, your office staff, and, if necessary, the referring physician’s office staff to let all parties know that incomplete information about patients will not be tolerated!

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