By: Liz Szabo — March 31, 2020

Michelle Kuppersmith feels great, works full time and exercises three to four times a week. So she was surprised when a routine blood test found that her body was making too many platelets, which help control bleeding.

Kuppersmith’s doctor suspected the 32-year-old Manhattanite had a rare blood disorder called essential thrombocythemia, which can lead to blood clots, strokes and, in rare cases, leukemia.

Her doctor suggested a bone marrow biopsy, in which a large needle is used to suck out a sample of the spongy tissue at the center of the patient’s hip bone.

Doctors examine the bone marrow under a microscope and analyze the DNA. The procedure allows doctors to judge a patient’s prognosis and select treatment, if needed. Kuppersmith had heard the procedure can be intensely painful, so she put it off for months.

The biopsy — performed by a provider in her insurance network, at a hospital in her network ― lasted only a few minutes, and Kuppersmith received relatively good news.

While a genetic analysis of her bone marrow confirmed her doctor’s suspicions, it showed that the only treatment she needs, for now, is a daily, low-dose aspirin. She will check in with her doctor every three to four months to make sure the disease isn’t getting worse.

All in all, Kuppersmith felt relieved.

Then she got a notice saying her insurer refused to pay for the genetic analysis, leaving her responsible for a $2,400 payment.

The patient: New York resident Michelle Kuppersmith, 32, who is insured by Maryland-based CareFirst Blue Cross Blue Shield. She works as director of special projects at a Washington-based watchdog group. Because she was treated in New York, Empire Blue Cross Blue Shield — which covers that region ― handled part of her claim.

Total amunt owed: $2,400 for out-of-network genetic profiling

The providers: Kuppersmith had her bone marrow removed at the Mount Sinai Ruttenberg Treatment Center in New York City, which sent her biopsy sample to a California lab, Genoptix, for testing.

Medical services: Bone marrow biopsy and molecular profiling, which involves looking for genetic mutations

What gives: The field of molecular diagnostics, which includes a variety of gene-based testing, is undergoing explosive growth, said Gillian Hooker, president of the National Society of Genetic Counselors and vice president of clinical development for Concert Genetics, a health IT company in Nashville, Tennessee.

A report from Concert Genetics, a company that helps clients manage genetic testing, found there are more than 140,000 molecular diagnostic products on the market, with 10 to 15 added each day.

The field is growing so quickly that even doctors are struggling to develop a common vocabulary, Hooker said.

Kuppersmith underwent a type of testing known as molecular profiling, which looks for DNA biomarkers to predict whether patients will benefit from new, targeted therapies. These mutations aren’t inherited; they develop over the course of a patient’s life, Hooker said.

Medicare spending on molecular diagnostics more than doubled from 2016 to 2018, increasing from $493 million to $1.1 billion, according to Laboratory Economics, a lab industry newsletter.

Charges range from hundreds to thousands of dollars, depending on how many genes are involved — and which billing codes insurers use, Hooker said.

Based on Medicare data, at least 1,500 independent labs perform molecular testing, along with more than 500 hospital-based labs, said Jondavid Klipp, the newsletter’s publisher.

In a fast-evolving field with lots of money at stake, tests that a doctor or lab may regard as state-of-the-art an insurer might view as experimental.

Worse still, many of the commercial labs that perform the novel tests are out-of-network, as was Genoptix.

Stephanie Bywater, chief compliance officer at NeoGenomics Laboratories, which owns Genoptix, said that insurance policies governing approval have not kept up with the rapid pace of scientific advances. Kuppersmith’s doctor ordered a test that has been available since 2014 and was updated in 2017, Bywater said.

Although experts agree that molecular diagnostics is an essential part of care for patients like Kuppersmith, doctors and insurance companies may not agree on which specific test is best, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society.

Tests “can be performed a number of different ways by a number of different laboratories who charge different amounts,” Nichols said.

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