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Lab Tests: Basic 411

By Martine G. Brousse

"The Medical Bill Whisperer"

Patient Advocate, Certified Mediator

AdvimedPro

 

January 3, 2024

 

 

There are 2 kinds of lab tests.

How do their differences affect your insurance coverage and your bottom line?

Let’s explore some more:

 

A.    Terminology clarification

 

The term “lab” in healthcare can mean 2 things:

1.     The actual laboratory, structure, place, facility that handles and processes your samples and issue a report on its findings

2.     The actual test that is processed in a laboratory

For the sake of clarity, I will use “lab” as the facility and “test” as the process in this article.

 

B.    Two kinds of tests:

 

1.     In Vitro Diagnostics (IVDs)

·      These are the widespread, routine, often basic tests

·      performed and processed at countless labs (LabCorp or Quest draw stations, medical offices, hospitals, laboratories etc)

·      they are readily available and ordered for preventive, therapeutic, diagnostic or risk-measuring purposes

·      examples: CBC, CMP, lipid panel, TSH, ferritin, prothrombin time, A1C, hemoglobin…

·      They use human samples (blood, urine..) to detect the presence or risk of a certain disease

·      They are regulated by CMS (Center for Medicare and Medicaid services), and the labs where they are performed can be subject to inspections, accreditations, and other strict protocols of safety, accuracy and reporting

 

2.     Laboratory-developed Tests (LDTs)


·      These are tests designed and developed by one independent laboratory

·      Usually only performed at the one creator lab

·      Proprietary and sometimes protected by a patent

·      Meet diagnostic or therapeutic needs of a specific subset of the population

·      Often 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 and of course COVID testing

·      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). More on this topic below

 

C.    Value and Coverage

Insurance companies cover tests loosely based on 2 criteria: cost and value. By “value” I mean the financial advantage of paying for the test now vs. that of future costs if not covered now.

 

1.     In Vitro Diagnostics (IVDs) have a certain advantage. 

·      Low cost due to widespread competition

·      Wide use over years has proven efficacy, safety and benefits

·      The value of early detection and prevention far outweighs any (small) cost

·      Vast medical reward in investing now

·      For patients, a plus too as outcomes will be better, costs smaller and impact on health lower as tests done now are cheap or free

·      Can be considered the “generic” version of lab tests

 

2.     Laboratory-developed Tests (LDTs)

·      Although a fair number are done at multiple or widespread facilities, those only performed at one lab are expensive

·      Even if their medical benefits are established (focused treatment, detection of rare diseases, better faster outcomes) the lack of competition inhibits lower pricing

·      Can be considered “brand-name” lab tests

·      From a medical point of view, they can be dismissed or labeled as “unproven, informative-only, without added benefits to existing protocols, experimental” if too new or without supportive data

 

D.   The FDA problem for LDTs

 

1.     Unlike CMS-monitored and regulated lab tests and laboratories, the FDA has no established specific and must-follow regulations regarding LDTs, whether bringing them to market, confirming their performance and safety, or even establishing their benefits.

2. There is no requirement:

·      To keep data base of results

·      To show performance and safety through clinical trials

·      To report how and when used, and the results

·      To prove accuracy (COVID tests as an example) or improvement of health outcomes

·      To follow protocols to maintain approval

3.     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

4.     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.

5.     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.

6.     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”.

 

E.    Remedies

 

1.     Ask questions to the ordering physician

·      Is this test necessary?

·      Is it covered by my insurance?

·      How will it improve my outcome?

2.     Contact your insurance

·      Is it a covered benefit for my diagnosis or purpose?

·      If not, why not?

3.     Contact the lab

·      If insurance does not cover, is there a lower cash price?

·      Is there a financial assistance program?

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 physicians

·      With evidence of test value: published articles, manufacturer’s data, reports of use and results, federal or state health agencies reports, proof that test is not experimental

·      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, therefore proving that administrative delays are harmful to your welfare. The test  manufacturer/laboratory should be able to provide such evidence.

 

 


Lab Tests: the basics
Lab Tests: the basics

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.

 

(424) 999 4705 - F (424) 226 1330

@martine brousse 2024 @ the medical bill whisperer 2024

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