Clinical laboratory work including cytology is a highly regulated profession. This being generally the case, and true to what we all expect, inspection and accreditation of cytology can be exhaustive. This is fueled in part by the nature of our profession: the onset of advanced technologies; the availability of human pappilomavirus (HPV) vaccines; and powerful healthcare legislation. The most significant factors to date are newer recommendations and as it become more evident, insurance payment structures.
As stakeholders in Cytology, one can't help but wonder how our jobs relate to newer Pap smear frequency requirements; and how costs, payments, and reimbursements will be affected. It is true that advances related to our profession have somehow initiated these corresponding changes in women's gynecologic health care policy.
The most important principles that determine daily laboratory practice are those outlined in the Clinical Laboratory Improvement Amendments (CLIA) as provided by the federal government and regulated by the Centers for Medicare and Medicaid Services (CMS).1
As cytotechnologists, this is where our part of history comes in. It is worthwhile and very interesting to note that the CLIA '88 regulations were put into place in response to allegations of improper performance of cytology testing, and how mandatory external quality control (proficiency testing) eventually came to be a common but very critical requirement.
Standards of laboratory practice stem from numerous agencies, including but not limited to federal and state government; The Joint Commission (TJC), and the College of American Pathologists (CAP). Laboratory inspection and accreditation of TJC and CAP, including other state and private organizations are recognized by the federal government through an arrangement known as "deemed status." TJC and CAP have the authority to inspect laboratories and accredit those laboratories that demonstrate standards equivalent or more stringent than those of CLIA regulations -- these findings are then reported to CMS.
Although these agencies have traditionally provided the guidelines for which professional standards of laboratory practice are derived, it is becoming more relevant that CMS and its structure of payment policies is becoming the distinctive trend-setter. One will not argue about the need to curtail healthcare spending and the reality of current spiraling costs in maintaining a viable Medicare and Medicaid program. The Health and Human Services (HHS) oversees CMS and as it continues to become the major player in payment and reimbursement practices, this shift of policy also sets the standards of how private insurance plans are formulated. As HHS (and CMS) becomes more involved in healthcare policy making, their reach will continue to determine what can and cannot be charged.
Screening Frequency and Insurance Coverage
Last year in October, the American College of Obstetricians and Gynecologists (ACOG) passed the new guidelines for Pap screening, the highlight of which recommends less frequent screening intervals providing certain guidelines are met, including the attention given to HPV testing results.2
As of August this year, the Health and Human Services (HHS) issued a detailed guideline mandate addressing women's health care services that group health plans and health insurance policies must cover without cost-sharing expenses.3 Note that HPV DNA testing is listed as a type of preventive service and in addition to the age criteria, the frequency for health insurance coverage is only every 3 years.4 Quite efficiently, the release and effective date coincides with insurance plans that cover college students, which commonly begin new year policy plans in August to accommodate the 2012-2013 school year.
Clearly the recommended frequency of screening will be reinforced by how often health insurance policies will cover the procedure. There are obvious exceptions to this approach, again, provided that in certain cases the clinician sees reason to prescribe an otherwise more frequent screening program. HHS understands the unique health needs of women throughout their lifespan. 4
The newer technologies governing gynecologic care do provide great added benefit to the patient but the healthcare provider must still address how these extended testing and follow up periods will affect the patient's return for routine screening or abnormal follow up. This is important when considering that the other types of preventive services are still covered on an annual basis.
Changes in the Cytology Laboratory
As cytotechnologists, we continue to adhere to work under set rules to assure accurate and reliable results and at the same time comply with regulatory requirements, but molecular testing has indirectly changed the scope of our profession.
HPV testing is for the most part is still a reflexive (and confirmatory) testing package, but is it conceivable that such can be utilized as the first line approach to gynecologic care? Yes and no, again to the discretion of the healthcare provider. Both Pap screening and HPV testing have their merits but now there are more pressing considerations, well beyond laboratory inspection and accreditation.
Changes in the provision and financing of healthcare do show that test volume has begun to decrease and less screening in the future is probably expected, but we should include with this conclusion of less testing and personnel the assurance that the need to process, screen, and report these smears will continue. It is reasonable to expecting an increase of insured women as a result of the Affordable Care Act (ACA) and until the female patient population can be reasonably defined and the true effect of these less frequent screening intervals are fully realized, only then can a better anticipation of gynecologic cytology workload can be foretold.
We must remember that these workload adjustments have been the result of numerous changes all factored in: the onset of automated screening; the introduction of molecular testing; the availability of HPV vaccinations; and now the realization of the major changes brought by the new healthcare policy and the cost-effective solutions it deems necessary.
CLIA '88 was only the beginning and a lot has transformed in cytology since then. The solutions for which the government initiated to meet those needs have led to the customary practices we follow today. The reasoning was clear and required standards were suitably implemented, similar to what the ACA has begun to do with healthcare policy. The changes affecting cytology is just one of many but considering the circumstances, our situation is quite unique.
Nelson Barayuga is lead medical technologist, Syosset (N.Y.) Hospital (North Shore Long Island Jewish Health System); and cytotechnologist, LabCorp.