Does the Current LCD Process Jeopardize Patient Care?

As a practicing pathologist, I spend far too much time fighting insurance coverage decisions that impede my pathology practice and patients’ access to care. These external decisions run counter to my years of training and those clinically accepted best practices of how to diagnose and treat patients. This issue is particularly acute among our senior citizen population which relies on Medicare for health care coverage. As all physicians treating senior citizens have experienced, Medicare local coverage determinations may use data that is not clinically sound or does not comport with the standards of practice based on clinical practice guidelines to make coverage policy decisions.

Instead, Medicare Administrative Contractors, the private health care insurers who contract with Medicare to administer Part A/B claims and establish LCDs for a defined geographical region, have been replacing physician judgment with arbitrary and, in some cases, unsubstantiated coverage rules that have the potential to prevent or inhibit adequate patient care. Pathologists and many other physician organizations have united with patient advocacy groups in an attempt to fix this problem.

Advocates opposed to the current LCD process and the unwillingness to reinforce accepted standards of care have asked Congress to step in and reform the MAC-LCD process. Currently, the Local Coverage Determination Clarification Act of 2017 in the Senate, S. 794, and House, H.R. 3635, is gaining traction to remedy the current dysfunctional process. I urge my fellow doctors as well as patient organizations and professional societies concerned about the LCD process to review the legislation and become active supporters.

I advocate thoughtful decision making when it comes to additional testing and agree that providers throughout the health care system have a responsibility to be cognizant of reducing overall system expenditures when possible. However, I disagree with the approach taken by some MACs to limit or deny coverage or to challenge the standards of practice through their LCDs. As physicians we are tasked with being the patient’s advocate. When a pathologist looks at a biopsy of a malignancy of unknown origin, their job is to try to determine the primary site of the tumor so that treatment can be specifically targeted — not to worry about whether or not they have reached a threshold for providing certain tests that day. Different cancers have different characteristics, and they must make a decision based on the consensus evidence and their judgement as to which testing is most helpful to the patient.

Pathologists are physicians who diagnose disease — we’re experts at viewing a slide under a microscope and then deciding what, if any, additional testing is appropriate. But, practicing in a regulatory environment where I may or may not be allowed to exercise my medical judgement, despite supporting evidence, means patient care suffers.

One example of this is an LCD that establishes thresholds for the number of special testing stains that can be used to evaluate cases of chronic gastritis, which is associated with increased risk of ulcers and lymphoma. In this instance, the MAC is ignoring opposition by the College of American Pathologists and the evidence submitted by more than 40 pathology experts that found the LCD used published studies in a highly selective fashion and misrepresented the opinions of the study authors. This LCD, which suggests that only 20 percent of gastric biopsies require special stains or immunohistochemistry, ignores instances of individual pathology practices where there are increased rates of H. pylori infection and a greater than 20 percent rate of special stain use would be typical and expected. Increased use of these stains would not just be limited to GI specialty or consultant practices as some general pathologists practice in settings where infection with H. pylori is prevalent. On any given day a pathologist may find that 50-75 percent of stomach biopsies have microscopic evidence of chronic gastritis, which may or may not be related to H. pylori. What happens to our patients if we are strictly held to the LCD’s 20-percent testing threshold?

Once a pathologist meets the 20-percent threshold for testing, should he or she worry about conducting more specific confirmatory testing on remaining patients who have clinical symptoms of gastritis and microscopic evidence suggesting H. pylori infection? Sadly this LCD has spread to 26 states with large populations of Medicare patients.

We should devise a better system for coverage determinations.

If our goal is to try to provide the best care for our patients, let’s create a system that allows for fair, unbiased input from all stakeholders. Let’s create a system for LCDs based on transparent communication in open and public meetings—one that ensures a MAC bases its coverage decisions on sound, sufficient, and relevant evidence and that clearly defines the rationale for denying coverage in its LCDs.


Dr. Richard C. Friedberg is the immediate past president of the College of American Pathologists.

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