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Clinical Laboratories and Pathology Groups

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US Preventative Services Task Force Study Finds Evidence of Benefits to Vitamin D Screening in Asymptomatic Adults is ‘Inconclusive’

New USPSTF guidelines suggest reducing the volume of Vitamin D deficiency testing in the general population, which could reduce revenue for clinical laboratories

From 2005 to 2011, the volume of clinical laboratory tests for Vitamin D soared nationally as more doctors tested more patients for Vitamin D deficiency. This became a major source of revenue growth for many clinical laboratories performing those tests. But at least a portion of lab revenue associated with Vitamin D testing may be in jeopardy.

In a recommendation statement published in JAMA Network, titled, “Screening for Vitamin D Deficiency in Adults,” the United States Preventive Services Task Force (USPSTF)—following up on its 2014 recommendations—stated “that the current evidence is insufficient to assess the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults.”

The USPSTF’s new recommendations concerning Vitamin D testing came after the federal task force performed an extensive review of the benefits and potential harm of screening for Vitamin D deficiencies in non-pregnant adults who displayed no symptoms of a deficiency. Symptoms of a Vitamin D deficiency include fatigue and tiredness, bone and back pain, depression, impaired would healing, bone loss, hair loss, and muscle pain.

After completing its research, the USPSTF concluded “the overall evidence on the benefits of screening for Vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults cannot be determined.”

The USPSTF published its new guidelines online in the Journal of the American Medical Association (JAMA Network) on April 13.

Are USPSTF Conclusions Contrary to Current Deficiency Testing Practices?

“Among asymptomatic, community-dwelling populations with low Vitamin D levels, the evidence suggests that treatment with Vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the JAMA Network article states.

Other studies have linked low Vitamin D levels with some health conditions and risks, however, the USPSTF review found no studies that directly evaluated any perks associated with Vitamin D screening in otherwise healthy individuals.

 Everyday Health listed 10 illnesses linked to low Vitamin D deficiency. They include:

mary-byrn-phd-rn-layola-university-at-podium
“We see a lot of associations between Vitamin D deficiency and poor health outcomes,” Mary Byrn, PhD, RN, an associate professor at Loyola University in Chicago who studies Vitamin D, told Everyday Health. “Although these are relationships and we are unable to conclude cause and effect, taking Vitamin D supplements or exposing yourself to the sun in a safe manner to increase Vitamin D naturally are easy ways to improve your health and try to reduce your risk of multiple diseases,” she said. (Photo copyright: Midwest Nursing Research Society.)

Can Vitamin D Supplementation Be Harmful?

The USPSTF study also stated that Vitamin D supplementation appears to be safe and that toxicity from too much Vitamin D would be rare. One of the USPSTF’s key concerns of screening for Vitamin D in asymptomatic individuals was the potential for misclassification and inaccurate diagnoses.

The study also revealed that more research is needed to determine what serum levels are optimal when diagnosing a Vitamin D deficiency, and whether those levels vary by subgroups, such as race, ethnicity, or gender.

The JAMA Network article states that “the evidence is inconclusive about the effect of treatment on physical functioning and infection.”

The amount of Vitamin D individuals need each day depends upon their age. The National Institutes of Health (NIH) recommends that adults between the ages of 19 and 70 get 15 micrograms or 600 International Units (IU) of Vitamin D daily.

According to an NIH fact sheet, people can receive Vitamin D through sun exposure, supplements, and some food, such as fatty fish, mushrooms, beef liver, cheese, and egg yolks, plus foods that are fortified with Vitamin D, such as some milk products and breakfast cereals.

Vitamin D and COVID-19

It has been widely reported that approximately 42% of Americans are Vitamin D deficient. And Vitamin D deficiency has been linked to an increased risk of contracting the SARS-CoV-2 coronavirus and how well patients recover after COVID-19 treatment.

A study published in the Journal of Clinical Endocrinology and Metabolism that examined 216 COVID-19 hospitalized patients in Spain found that over 80% of those individuals were deficient in Vitamin D. The study also found that COVID-19 patients who had lower Vitamin D levels also had a higher number of inflammatory markers that have been associated with poorer COVID-19 outcomes. The results of this study were in March.

For several decades, experts have recommended avoiding sun exposure and using sunscreen to avoid skin cancers. This may have caused people to get less Vitamin D from sun exposure. It may also have contributed to an increase in the number of Vitamin D deficiencies and increased COVID-19 infections.

Pathologists and clinical laboratory managers should keep in mind that the USPSTF recommended less testing for Vitamin D deficiencies in asymptomatic individuals. This proposal may affect test volume in clinical laboratories, as Vitamin D testing has been a common and lucrative assay for many years.

JP Schlingman

Related Information:

Don’t Screen for Vitamin D in General Population, Says US Task Force

Screening for Vitamin D Deficiency in Adults

The USPSTF 2021 Recommendations on Screening for Asymptomatic Vitamin D Deficiency in Adults

How Much Sun Do You Need for Vitamin D?

Vitamin D Fact Sheet for Consumers

Vitamin D Deficiency

Vitamin D Status in Hospitalized Patients with SARS-CoV-2 Infection

10 Illnesses Linked to Vitamin D Deficiency

The A-to-Z of Vitamin D: Why It’s Today’s Hottest Lab Test

Why Vitamin D Continues to Be the World’s Fastest-Growing Clinical Laboratory Test

Exact Sciences Sues Humana Over Cologuard Coverage in Spat over How Insurer Reimburses for This Clinical Laboratory Test

Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states

Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.

Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.

Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.

They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)

Proposed Expansion of Screening for HIV and Hepatitis C Could be Good News/Bad News Stories for Clinical Pathology Laboratories

Expanded universal screening would increase costs to the healthcare system; would the healthcare system shortchange clinical labs inadequate reimbursement for the increased number of screening tests?

Separate recommendations that call for widespread, regular screening for HIV and hepatitis C can be considered to be good news/bad news stories for the clinical laboratory testing industry. That’s because the benefits in patient health are likely to incur additional costs for which the healthcare system is not likely to fully reimburse the medical laboratories performing these screening tests.

To improve detection and diagnosis of HIV, a story published in Reuters reported that the U.S. Preventive Services Task Force (USPSTF) will issue a new recommendation to make human immunodeficiency virus (HIV) screening a standard practice. Experts believe that such a strategy would fundamentally change how the virus is detected and treated. (more…)

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