By Martine G. Brousse
"The Medical Bill Whisperer"
Patient Advocate, Certified Mediator
AdvimedPro
January 5, 2024
Watch the video:
There are a number of reasons why your insurance plan would reject payment of a lab test.
The two most common were explored here: https://www.advimedpro.com/post/denied-lab-tests-fix-it-part-1
But LDT tests (Lab-developed tests) are sometimes harder to get paid. Let’s see why.
A. WHAT IS A LDT TEST?
· It means “Laboratory developed test”
· These are tests designed and developed by one independent laboratory
· Usually only the creator lab can perform it
· Proprietary and sometimes protected by a patent
· Many such tests are used for specific and uncommon purposes
· Examples: genetic panels, mass spectrometry for drug testing, DNA testing, cancer genetic mutations, cell analysis, rare diseases, tumor genomic, COVID tests
· They use body fluids and other material such as cell cultures, DNA, serum, tissues, secretions etc
· They are “regulated” by the FDA (Food & Drug Administration) NOT by CMS (Center for Medicare & Medicaid Services) as are the more routine, common, widespread In Vitro Diagnostics (“IVDs” such as glucose, thyroid function, metabolic, blood count, ferritin, cholesterol tests)
B. VALUE & ADVANTAGES
· Meet diagnostic or therapeutic needs of a specific subset of the population
· Lead to more focused treatments, and avoid wasted time and costs of a “try-and-see” therapeutic method
· Can detect mutations or abnormalities that help direct and support a personalized course of therapy, and quickly establish its efficacy
· Because the FDA is NOT requiring trials, extensive data on research or oversight, tests are brought to market quickly
C. PROBLEMS AFFECTING INSURANCE COVERAGE
· Unlike CMS-monitored and regulated tests and laboratories where they are performed, the FDA has not established specific and mandatory regulations, whether bringing them to market, confirming their performance and safety, or even establishing their benefits.
· There is no requirement:
o To keep data base of results
o To show performance and safety through clinical trials
o To report how and when they are used, and even what for
o To prove accuracy or improvement of health outcomes
o To follow protocols to maintain approval
· While the actual facility is usually accredited by showing maintained quality and patient safety under federal and/or State standards, the actual tests are not subject to such scrutiny
· This leads to self-oversight, self-regulation, reliance by the FDA on the lab scientists and technicians, and on self-reporting of adverse events, false results, and their effects on patients’ health outcomes.
· Insurance companies can use this lack of controlled and verified data, and opacity of the process to reject tests as “experimental” and therefore deny them.
· Insurance companies can use the lack of verified benefits and better outcomes and therefore of medical (and financial) “value” to deny them as “not medically necessary” or “unproven” or “experimental”.
D. POSSIBLE FIXES
1. Question the ordering MD:
· Why the test necessary? Will it direct or affect my therapy or treatment, or is it only for informative purposes?
· Do insurances usually cover it?
· Will it improve my outcome?
2. Contact your insurance (with the lab code and diagnosis)
· Is there a special medical policy relating to it? Is it a covered benefit for my diagnosis or purpose?
· If not, why not? Is it a specific exclusion on my policy, or is the diagnosis not applicable?
3. Contact the lab
· If insurance does not cover, is there a lower cash price?
· Do you offer a financial assistance program?
· Can you provide documentation to help me file an appeal?
4. File an appeal
· With medical justification: physician’s record of use with other patients and benefits, medical necessity, clinical value, used as standard of care by other specialists
· With evidence of value: published articles, manufacturer’s data, reports of use and results, federal or state health agencies guidelines of use, proof that test is not experimental but routinely performed in your circumstances
· As medical policies are updated less rapidly than the course of medicine, point out other insurance companies’ published policies showing that they cover this test, proving that administrative delays are harmful to your welfare. The manufacturer/laboratory should be able to provide such evidence.
· Find out if Medicare covers it, and under what conditions. If so, that usually means that there is no good reason for your commercial plan to deny it.
E. Unwinnable cases
1. Some lab tests, unfortunately, are so unusual or uncommon that they may be restricted to a specific rare disease, condition or segment of the population. In such cases, strict adherence to the established protocol must be followed in order to be paid.
2. Example: an in-utero (fetal) test to rule out a genetic disease is performed on a woman who wants to know whether she is a carrier before getting pregnant. Because the test only is covered during pregnancy, her claim will be denied, with no way potential documentation or medical justification to appeal.
3. As tests are too new to be given a permanent CPT (billing) code, and therefore be rejected for lack of one, it may be useful to research its temporary code, show that it will be assigned a permanent code come next January, and argue
that this clerical matter should not be a valid reason for denial.
Martine Brousse was a long-time Billing Manager for Physicians before switching to the side of patients in 2013. The move has allowed her to apply her deep expertise and vast experience of the intricacies of resolving all types of medical bill and claim payment issues in ways that directly and positively impact her clientsʻ finances.
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@martine brousse 2024 @ the medical bill whisperer 2024