Medicare fraud, hot health topics, and FDA activity top most read in 2023

Top 10 Gold Social

Early-onset colorectal cancer, type 2 diabetes, and long COVID clinical laboratory research took the top three spots in LabPulse.com's top 10 most read articles of 2023. Perhaps the reason for the colorectal cancer (CRC) story's popularity was the fact that it used a large database of longitudinal claims data, or it may have been the fact that CRC is starting to affect millennials at near-alarming rates.

Beyond health conditions, revised Molecular Diagnostic Services Program (MolDX) guidance around molecular testing in post-transplant care stirred emotions enough to land Medicare administrative contractor (MAC) business within our top five most read articles, along with discoveries of new genetic causes of rare diseases.

Rounding out LabPulse.com's top 10 stories were three significant fraud cases and two U.S. Food and Drug Administration (FDA) decisions. Read on for more details.

1. Red flags signal early-onset colorectal cancer
Colorectal cancer landed No. 1 for audience popularity in 2023 at LabPulse.com.The May story out of the Washington University School of Medicine pointed out important signs and symptoms of early-onset CRC between three months and two years prior to a CRC diagnosis. The study used longitudinal claims data from a large, real-world claims database, and the authors suggested that although diagnostic strategies may not be required for every event of abdominal pain or diarrhea, for example, close clinical follow-up to assess symptom resolution or fecal immunochemical testing for endoscopic triage could be beneficial.

2. Blood sugar maintenance mechanism revealed in DNA study
Coming in at No. 2, a June story revolved around University of Cambridge findings that may have opened a potential new avenue for the development of treatments to stop the progression of type 2 diabetes. Researchers used genomewide association studies. What was notable was that researchers investigated candidate genes at a subset of associated loci in cultured cells and identified nine genes they associated with the expression or "trafficking" of GLUT4, the key glucose transporter to fat and muscle cells that regulates insulin.

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3A closer look at long COVID symptoms 

In May, evidence showed widespread immunological and autonomic nervous system changes tied to long COVID. The study published in Neurology: Neuroimmunology and Neuroinflammation involved deep phenotyping and an extensive evaluation of patients with persistent neurological symptoms after SARS-CoV-2 infections. The results showed that people with long COVID had lower levels of CD4+ and CD8+ T cells-immune cells involved in coordinating the immune system’s response to viruses. Researchers also found increased numbers of B cells and other types of immune cells, suggesting that immune dysregulation may play a role in mediating long COVID.

4. UPDATE: Patients concerned about Medicare policy that limits coverage of noninvasive post-transplant tests
Concerns about the MolDx making coverage changes to molecular diagnostic testing in post-transplant care came to light also in May. At issue was a Medicare billing article revision that became effective March 31, 2023. Four transplant organizations pushed out a survey for voicing patient concerns. The uproar led to the U.S. Centers for Medicare and Medicaid Services (CMS) confirming in September that neither CMS nor the MACs made changes that affected patients’ ability to have the tests -- if the tests were ordered by their physicians in medically appropriate circumstances. CMS said the MACs issued the revised billing instructions to help providers, suppliers, and other interested parties better understand the intent of the existing (since 2021) local coverage determination criteria language. In addition, based on interested parties’ feedback, on August 10, 2023, the MACs released a new proposed local coverage determination, seeking comment and evidence from the public pertaining to proposed changes made for clarity. CMS issued a statement in late September.

5. Genetic causes identified for three rare diseases
In March, researchers at Mount Sinai Icahn School of Medicine announced they had identified 260 associations between genes and rare-disease classes, including 19 previously unknown and 241 known associations. The work helped to identify previously unknown genetic causes of three rare conditions: primary lymphedema, thoracic aortic aneurysm disease, and congenital deafness. The Mount Sinai team built a compact database, called "Rareservoir," that contained the rare variant genotypes and phenotypes of 77,539 participants sequenced by the 100,000 Genomes Project. The work established statistical methods and a computational framework for potentially finding new genetic causes of rare diseases.

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6. Labcorp to pay $19M to settle kickback, false claims lawsuit

A $19 million Labcorp settlement announced in February raised a spotlight on blood testing services, lab processing and handling fees, and two whistleblowers who alleged for years that Labcorp violated the False Claims Act. Two smaller labs were also implicated in the alleged schemes in which it was alleged that Labcorp knew Health Diagnostic Laboratory (HDL) and/or Singulex were paying healthcare providers fees as an inducement to refer patients to their laboratories. Labcorp denied the allegations but was ordered by the U.S. Department of Justice (DOJ) to pay the U.S. to resolve them. HDL and Singulex previously settled their civil liability with the U.S. for a combined $48.5 million. As part of the resolution, the whistleblowers were to receive approximately $5.6 million of the federal settlement amount, according to the U.S. Attorney's Office for the District of South Carolina.

7. FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Even though we were reaching "post-COVID" conditions, COVID-19 continued making headlines. In this example, the FDA approved Pfizer’s Paxlovid. The FDA said Paxlovid significantly reduced the proportion of people with COVID-19-related hospitalization or death from any cause through 28 days of follow-up compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. More recently, evidence was updated concerning Paxlovid and a new worry, COVID rebound. The U.S. Centers for Disease Control and Prevention (CDC) examined SARS-CoV-2 rebound studies but reported on December 22, 2023 that there was no consistent association with viral rebound. 

8. Michigan residents charged in $61.5M Medicare fraud
More DOJ news in February highlighted a $61.5-million wave of conspiracy, fraud, kickbacks, money laundering, and bribes in Michigan. This case involved 23 people who took part in illegal schemes of home health (visiting physician) services and unnecessary drug testing. Among key points made about the case were that ownership interests were concealed, actions violated the U.S. Anti-Kickback Statute, and illegal payments were made to patient recruiters.

9. T2 Biosystems seeking FDA breakthrough device designation for Candida auris test
Following a CDC warning about increased drug-resistant Candida auris (C. auris) infections, news came in July that T2 Biosystems applied for and received breakthrough device designation from the FDA for its C. auris molecular diagnostic blood test. The test is designed to detect sepsis-causing fungal pathogens from a blood sample within three to five hours without the need for a positive blood culture. The CDC said in March that people who are very sick, have invasive medical devices, or have long or frequent stays in healthcare facilities are at increased risk for acquiring C. auris. The CDC deemed C. auris to be an urgent antimicrobial-resistance threat because it is often resistant to multiple antifungal drugs, spreads easily in healthcare facilities, and can cause severe infections with high death rates. 

10. Texas, Louisiana lab executives charged in $107 million genetic-testing kickback scheme
A third fraud case rounded out LabPulse.com's top 10 mostread articles in 2023. This case implicated two Texas men and one Louisiana man to the tune of $107 million in fraudulent genetic testing claims originating with Trinity Clinical Laboratories, in Lewisville, TX. The claims sent to Medicare and Medicare Advantage were part of a sophisticated nationwide healthcare kickback scheme, according to the details.

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