Advocacy Update

• CAP Opposes Proposal to Change Profession Name ‘Cytotechnologist’ to ‘Cytologist’
• Proposed FDA Rule on LDT Oversight Under Review by OMB
• Texas Governor Enacts Network Adequacy Law Supported by TSP, CAP
• CDC: Autopsy Rates Reached New Low in 2020
• Take Our News Quiz for June

A proposal to change the professional title of cytotechnologist to “cytologist” would occur under new guidelines currently under review of an allied health accreditation body. The CAP has strongly opposed the name change for several reasons but the proposal has moved forward despite the CAP’s objections.

The CAP, as a sponsor of the Cytotechnology Programs Review Committee (CPRC), has worked with CPRC for several years on upcoming proposed changes to the standards for cytotechnology programs. Over CAP objection, the new standards currently under consideration by the Commission on Accreditation of Allied Health Programs (CAAHEP) include a name change for the profession from cytotechnologist to “cytologist”.

Of greatest concern is that the name change from cytotechnologist to cytologist will create confusion throughout the health care system. Some, including patients, might mistake cytotechnologists using the “cytologist” name to be physicians. The term cytologist is indeed used by physicians in Europe to describe the practice of non-gynecological cytopathology.

The CAP also represents pathologists’ concerns on scope of practice issues. The AMA and the CAP have both prioritized fighting scope creep that tries to expand the scope of non-physician providers, which can confuse and ultimately endanger patients. The AMA recognizes across the house of medicine that name changes are often the first step in scope of practice expansions.

Other societies with blended memberships of pathologists and cytotechnologists such as the American Society for Clinical Pathology and the American Society of Cytopathology are supporting the title change.

Since August 2020, the CAP has communicated its opposition to the name change due to lack of baseline data that independently validated the necessity for the change. Furthermore, the impacts of the name change on the medical community have not been evaluated. Although CAP is listed as a sponsor for changes concerning the cytotechnologist program the CAP does not endorse the name change issue.

The Commission on Accreditation of Allied Health Education Programs is seeking public comments on the proposed change by July 3, 2023. There will also be an in-person open hearing in Bloomington, Minnesota, on July 21, 2023. Virtual attendance is also allowed but registration is required: https://us02web.zoom.us/meeting/register/tZ0vdOqvrTsjGtZXmMWIFNzg3A8BtfAdEW8L#/registration.

The CAP is calling on its members to oppose the professional title change of cytotechnologists to cytologists. CAP members should take immediate action to provide public comments to the Commission on Accreditation of Allied Health Education Programs. Follow these steps:

1. Click the link Access the Comment Collection Survey Tool here
2. Check the circle for Description of Profession (listed third) and click next
3. For the line number section, enter “50”
4. You can then copy and paste this comment and click next:
   As a pathologist I am concerned about the proposed cytology professional titles new designation of cytologist. I believe we need a strong cytotechnology workforce, but the name change is not a necessary step to achieve this objective. In this proposed change there are still outstanding questions about the standards and guidelines that have not been addressed or agreed to by all parties. Until there is baseline data independently validated regarding this change, I question the need to move forward. No action should be taken without the data to thoroughly evaluate the impact of this proposed change on the current and future medical community. Time would be better spent focusing on standardizing the cytotechnologist curriculum to ensure a sustainable supply of cytotechnologists. Moreover, consideration needs to be given to the costs associated with federal and state regulatory changes. Given the current reimbursement climate any additional cost will be detrimental to laboratory operations. For all of these reasons I oppose the proposed name change and strongly recommend you reconsider your decision.
5. Then click the first button for “I have completed my comments” and click next
6. Click done

On June 14, the US Food and Drug Administration (FDA) filed a notice of proposed rulemaking for the oversight of laboratory-developed tests (LDTs) with the White House Office of Management and Budget (OMB). To regulate LDTs, the FDA is following the formal rulemaking process, which the CAP will analyze, engage, and advocate for minimizing burden on laboratories and ensuring patient access to tests.

The notice of proposed rulemaking filing was expected after legislation concerning the oversight of LDTs stalled in 2022. The FDA said it would move forward with the formal regulatory process in the absence of congressional action. Once the OMB will likely conclude its review by mid- to late August or early September, after which the proposed regulation would be released for public comment. Most public comment periods last 60 days but the CAP anticipates it being extended beyond that time period. As prescribed by the statute, the FDA would then have two years to finalize the regulation for implementation. As the VALID Act was not enacted in 2022, the FDA will not be implementing provisions outlined in the legislation.

The CAP will keep its members updated with the latest information on regulatory action as news develops.

On June 12, Texas Gov. Greg Abbott signed into law health plan network adequacy legislation (House Bill 3359) supported by the Texas Society of Pathologists (TSP) and the CAP, working with the Texas Medical Association. The new law requires preferred provider organization health plans to meet state requirements so that their enrollees can access in-network physician services, including pathology and laboratory services, at in-network facilities and geographically accessible services within the network based upon time and distance standards as expressly prescribed.

For in-network facilities, the new law will “require a sufficient number of preferred providers of emergency medicine, anesthesiology, pathology, radiology, neonatology, oncology, including medical, surgical, and radiation oncology, surgery, and hospitalist, intensivist, and diagnostic services, including radiology and laboratory services, at each preferred hospital, ambulatory surgical center, or freestanding emergency medical care facility...”

The insurance commissioner will be required to develop rules to review a preferred provider benefit plan before it is offered to insureds to ensure the plan’s provider network meets the quality of care and network adequacy standards. With the enactment of this law, Texas became the third state this year (in addition to Tennessee and Georgia) to enact a health plan network adequacy statutory requirement that includes clinical laboratory and pathology services. The law takes effect September 1, 2023.

Autopsy rates in the United States reached a new low of 7.4% in 2020, reflecting an ongoing decline since 1972 when the rate was 19.1%, according to a May 24 National Vital Statistics Report from the Centers for Disease Control and Prevention’s (CDC) Division of Vital Statistics.

As would be expected, the autopsy rate varied by age, cause and place of death. The rate for those aged 15-24 years was 62.6% and then decreased with increasing age. Deaths occurring in settings such as hospital inpatient, hospice facility and nursing home or long-term care were lease likely to be autopsied compared with other locations.

The rate was highest for decedents where place of death was recorded as being dead on arrival at hospital (30.5%), followed by other place (28.9%) and unknown place (25.9%). The rate at hospital outpatient settings or emergency room was 20.9%.

External causes, such as assault (homicide) were among the most frequently autopsied causes of death (98.7%) while the rate for deaths due to illness was 3%. Among diseases, the autopsy rate for the leading causes of death – heart disease, cancer and COVID-19 – was 6.5%, 0.8% and 0.9%, respectively.

Changes in the autopsy rate over time have changed the profile of those being autopsied. In 1972, 79% of autopsies were performed for deaths due to diseases and 19% for deaths due to external causes. By 2020, 37% of autopsies were performed for deaths due to diseases and 60% due to external causes.

In 2020, although the number of deaths increased with age after 1 year of age, autopsy rates peaked for those aged 15-24 years and declined for decedents as they aged. The autopsy rate was 31.6% for those under 1 year of age, 55.4% for those aged 1-4 and 46.8% for those aged 5-14. The rate fell to 56.1% for those aged 25-34, 41% for 35-44, 22.1% for 45-54, 10.3% for 55-64, 3.9% for 65-74, 1.5% for 75-84 and 0.6% for those 85 and over.

The report did not make a direct connection between the low autopsy rate in 2020 and COVID-19 although it did acknowledge that autopsies typically were not done for those who died of COVID. In fact, the autopsy rate has been consistently falling over the past 50 years, it said.

“Most of this report focuses on 2020,” states the DVS. “However, 2020 was also the first year of the COVID-19 pandemic, which changed the environment in which people were living and dying. Aside from introducing a large number of deaths from a new cause of death that was infrequently autopsied, the findings in this report are consistent with previous findings.”

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