On the Pap front: one victory, but
  a skirmish ahead

October 2005
Feature Story

Anne Paxton

With the recent approval of the CAP’s Pap program by the Centers for Medicare and Medicaid Services, cytology laboratory professionals may now use that program to meet gynecologic cytology PT requirements under CLIA for 2006. But the CMS endorsement has not derailed the College’s mission to reform the 13-year-old regulations.

“Everyone who is looking at Pap tests in the U.S. is required to be enrolled in a program sometime in 2005,” says R. Marshall Austin, MD, PhD, director of cytopathology at Magee-Womens Hospital of the University of Pittsburgh Medical Center and member of the CAP’s ad hoc committee on cytology proficiency testing. “The College’s Pap program is the first approved national program put together by a national pathology professional organization.”

The CAP’s program (formally called the Interlaboratory Comparison Program in Cervicovaginal Cytopathology) is one of three CMS-approved programs. The others are run by the state of Maryland and the Midwest Institute for Medical Education, or MIME, a nonprofit company in Indiana.

But the CAP still fears that the CMS requirement may drive some pathologists out of the field, and it continues to press its case that cytology proficiency testing should apply to the laboratory, not individuals.

Unlike those in other proficiency testing programs, the scores required by CLIA for cytology PT will be attached to individual pathologists and cytotechnologists at the nation’s 3,800 cytology laboratories, and could lead to sanctions against those individuals. While the College’s Pap program application was submitted to Medicare several years ago for approval, at the time it did not include any provision for individual scores, Dr. Austin explains.

“The application was always consistent with the CAP’s position that you should be testing the laboratory, not individuals, and the grading and scoring system should meet certain guidelines that should be validated along the lines of what the College was doing.”

A large contingent of the U.S. Congress has agreed with that position. In a September letter to the secretary of the Department of Health and Human Services, Mi chael Leavitt, 102 lawmakers asked that the CMS suspend the cytology PT requirement and review the program in the context of modern cytology science and practice.

That letter echoes a June missive from a coalition of 48 state and 10 national pathology societies, including the College, which charged that the regulation “overreaches the CLIA statute and has fallen far behind current gynecologic cytology practice.”

For now, however, the cytology PT requirement is in effect. The College only reluctantly decided to apply with an individually scored program when the MIME program was unexpectedly approved and cytology laboratories were faced with only one testing option.

The MIME program was actually given the nod last year in September, but MIME did not disclose the approval until mid-November. “The reason for the delay has never really been explained either by MIME or CMS,” Dr. Austin says. “One of the things we asked CMS for in late 2004 was a six-month period to educate people about the requirements, because MIME started out by saying you have to register by January 1, 2005.”

In response to this request, the CMS did allow a six-month period for educational conferences before enrollment by individuals and laboratories was required by June 30, 2005. The CAP quickly updated its existing proposal, with revisions completed and submitted by early December 2004. However, the CMS ruled that because the CAP’s proposal had changed significantly, it had to be reviewed as a new application.

“Because of that technical ruling by CMS, the College’s longstanding application could not be considered for 2005,” Dr. Austin explains, noting that that CMS ruling effectively gave MIME a year as a monopoly because it was the only approved national cytology PT program.

The College continues to maintain that the testing format and the scoring required by CMS, and CMS’ rationale, are flawed. “But the good news is, if we’re going to be tested under a flawed format, individuals will be better served by having a more transparent and accountable national professional organization to administer it,” Dr. Austin says.

With the CAP’s program, “Basically people are being asked to enroll in a combination program with both an educational component and a component that meets the requirements for regulatory testing,” he adds.

That educational aspect shouldn’t be discounted. “An enormous number of publications that come out of the Pap program have been published in the Archives of Pathology & Laboratory Medicine. And those articles about practice patterns in cytology have really been the deepest source of information about what’s happening in cytology in the U.S.,” Dr. Austin says. “They’ve been substantially based on information obtained through the Pap program.”

Cytology went from being almost a completely unregulated field to probably one of the most heavily regulated areas in medicine, and in the process Dr. Austin believes the federal government overstepped its bounds.

“The statutory language in CLIA ’88 actually never even mentions physicians,” he says. “The statutory language was for people involved in interpretation of Pap smear tests, and that could theoretically include gynecologists, nurses, and microbiologists. But there was nothing in the statutory language that referred to physicians, pathologists, or medical doctors.”

“The intention of the regulations was to address the fact that cytotechnologists were being forced in some laboratories to read too many slides. The idea of it evolving into a testing program for physicians was something that happened really after the law was written and regulations put together, and many of us hope this authority can be legally challenged,” Dr. Austin says.

Virtually no other subspecialty in medicine is subjected to a requirement that individuals be tested annually under a federally prescribed testing format. “It’s virtually unprecedented across all medical professional areas,” he says.

“It’s really a template for federal usurpation of authority to license and certify professionals, since it overrides the long historical traditions of state licensure and professional organization recertification examination in determining who is allowed to practice the medical subspecialty of gynecologic cytology.”

College leaders hoped that in the short term, the so-called educational phase of testing could be lengthened so there would be no penalties. “CMS had said it was traditionally their approach to have the initial phase of the testing program be not punitive, so it would be considered educational,” Dr. Austin says.

“What they failed to realize is that the way the program is being played out, it still has significant penalties and punitive aspects, and they basically chose not to address those concerns.”

Dina Mody, MD, chair of the CAP’s Cytopathology Committee, says that the College’s program is the oldest of all such programs and has the strictest standards.

“I must preface this by saying there’s nothing that shows passing a 10-slide proficiency test that tests you on some outdated algorithm qualifies you to practice cytology compared with someone who doesn’t pass. But since we’re stuck with this ridiculous exercise, we wanted the test to be fair.”

“We started grading slides in 1996, so we’ve been at this for a while, and we have very stringent validation criteria. We not only have three experts agree with the submitting diagnoses, but we’ve had them out in the field and had them validated,” says Dr. Mody, director of cytopathology at The Meth o dist Hospital, Houston.

“We’re the only ones who have that kind of data.”

“We wanted the test to be set up so the people who deserve to pass, pass, and people who do not pass at least know they have been tested on well-validated slides. It’s unlike what’s happening now, which is that many people are failing not because they’re bad pathologists or cytopathologists, but because there are defective test sets out there.”

“I think we’ll be offering a very fair and equitable test, and if people do not pass on this, we have procedures where they can appeal. It’s not just some three unknown pathologists deciding you failed or passed based on how they picked slides.”

The fears that cytology laboratories would migrate to another program before the CAP’s Pap program won formal approval have not been realized. “Initially, when the MIME program was approved, we were afraid we’d see a big dip in the program,” Dr. Mody says. “We decided to give our participants the opportunity to take a mock proficiency test using the grading scheme that CMS wants us to use.”

The CAP has been pleased with the results. “We did it as a service to the people who stayed with us in the Pap program, and we’ve actually seen an increase in our enrollment. People are still enrolling because of mock PT. So we’re at least even and maybe slightly ahead in number of participants.”

Nevertheless, the cytology PT requirement is like being “stuck with a ghost from the past,” Dr. Mody says. CLIA ’88 was adopted in 1988, 17 years ago. “Really, Congress made this law and it came down heavily on cytology because of what happened back in 1987, when there were a lot of problems.”

“Yes, some of the regulations were really onerous, but they have been implemented, and the problems that existed in those days no longer exist. There are very stringent quality improvement and quality assurance requirements enforced, and inspection for cytology laboratories is very stringent.”

“In the meantime,” she says, “we’ve had location–guided screening, automated screening, HPV testing, and changes in the management of patients based on our reporting system from Bethesda 2001 and ASCCP guidelines.” Those have changed the need for regulation, she contends.

For example, in the letter to HHS secretary Leavitt, the CAP noted that current evidence-based management guidelines have reduced the emphasis on determination of low-grade vs. high-grade lesions.

When the cytology PT regulation was written, patients with low-grade squamous intraepithelial lesions often received repeat cervical cytology, whereas high-grade lesion patients were triaged for colpos copy and biopsy. Now, however, colposcopy is recommended for both types of lesions, in part because of the difficulty of reliably distinguishing between the two categories and findings from the ALTS trial.

“Despite this acute evolution in treatment, the regulation’s grading scheme used to make proficiency judgments simply does not take this into account and mandates severe penalties for the inability to distinguish between the two,” the CAP’s letter says.
In form, the CAP and MIME programs are similar. “The form is very specifically spelled out by CMS regulations,” says David Wilbur, MD, the incoming chair of the Cyto pa thol ogy Committee.

“The major issue in preparing a program for CMS approval is setting up the administrative structure. The second is getting all the slides you need and having them reviewed by expert cytopathologists. I guess the MIME program managed to do this, although they haven’t been completely forthcoming as to who the individuals are that reviewed these slides, so there’s no transparency.”

“The main difference between CAP and MIME is that CAP is starting out with field-validated slides,” Dr. Wilbur says.

“The College has contended all along that field validation of slides is an important component of any quality cytology PT program. The barest bone standard, according to CLIA, was to have three expert pathologists on the diagnosis, then make the slide available for PT.”

The College has long said that’s not enough. “And we’ve published a number of papers looking at the data in the Pap program, and there is a big difference between field-validated vs. CLIA standard-validated slides. Slides that met CLIA qualifications don’t always test particularly well,” says Dr. Wilbur, director of cytopathology at Massachusetts General Hospital and associate professor of pathology, Harvard Medical School.

The CAP’s Cytopathology Committee, which meets four times per year, spends two of the four days of each meeting reviewing new slides from the previous quarter.

“We’re constantly adding new slides,” Dr. Wilbur says. “At each meeting, we review over 1,000 new slides into the program so it’s constantly being updated, because glass slides break, they get lost, or the stains fade, making them unusable. So we have to have a constant source of replenishment. “

In addition, he notes, while MIME this year is offering PT as an isolated event, the CAP has educational mailings that will continue in the Pap program format, with supplemental mailings for gynecologic cytology.

“What proficiency testing is doing is supposedly testing the manual screening capability of each individual,” Dr. Wilbur says. “However, there are several things, some related to automation, that make this a relatively artificial situation in the laboratory.”

“Many laboratories, although not all, are using new devices, either Cytyc ThinPrep imaging or TriPath’s focal point system, that actually pre-screen slides, then essentially give the reviewer additional information in the form of a slide score, or location-guided screening.”

“In those laboratories it’s now the standard of practice, so to test somebody purely on their manual screening capabilities would not necessarily be a true assessment of how the laboratory is actually functioning.” It gets back to the issue, he says, of testing individuals versus testing laboratories.

“All other proficiency tests look for the laboratory response, and that would be more valid for cytology too, because we show the slides around and refer them to colleagues. This is the way cytology is actually practiced,” Dr. Wilbur says.

New York State’s cytology PT program, he adds, does not have deemed status with the CMS because, like the CAP, New York has always tested laboratories rather than individuals.

But the response to the letter that the CAP and the coalition of groups sent to HHS secretary Leavitt has not been encouraging, Dr. Wilbur says. “They were interested in reviewing the features of the regulations, but they were not willing to suspend this year’s testing program, even though CLIAC voted unanimously to have CMS review these regulations. However, CLIAC is an advisory committee only.”

Clinical laboratories have not shied away from accountability, Dr. Wilbur stresses. “Quite frankly, other PT programs have been in place for a long time, and I haven’t heard anybody complain about them. The type of proficiency testing done routinely in pathology in most clinical laboratories really consists of getting a sample in the laboratory that has a known result, putting it on an instrument or running it through routine processes, and seeing whether you get the same result.”

“That’s the way it should be done. It’s entirely appropriate, so why shouldn’t cytology do it that way?”

The bottom line, Dr. Wilbur says, is that the current PT program as mandated by CLIA and regulated by the CMS is “actually an outdated PT exercise, based on what we know about field validation of slides, and what we know about the biology of screening for cervical cancer and the way cytology is currently practiced in the laboratory.”

All of which makes it an inappropriate test. “I don’t think any of us are against PT intrinsically,” he says. “No one, I think, has any qualms with PT per se. But we do have qualms with being tested in such a way that it can deprive us of the ability to practice and the ability to deliver gynecological services, based on an invalid exercise.”

The step to alter the program was taken with great reluctance by the CAP and the Cytopathology Committee, and it was intended to give people doing cytology a more scientifically sound alternative as an interim step, Dr. Austin says. “We believe that regulatory proficiency testing should be on the laboratories, and not individuals, and that may require a legislative change. Also, the grading scheme needs to be updated and modified.”

Says Dr. Wilbur, “Clearly the onus is on CMS to prove this is a valid test, and more importantly, to actually get back into the regulations and start changing things to make sure it is valid going forward.”