Category: the business of health care

Transforming Mental Illness Diagnosis and Treatment with Biomarkers

In this article I discuss potential use of biomarkers to diagnose and treat psychiatric disorders, particularly depression. Research is underway to identify these which could improve diagnosis and treatment, though concerns about cost, insurance, and privacy persist. Adequate funding for research is crucial.

This information is current as of the date of original publication or update but may have changed by the time you read this. Do not use this information for diagnosis or treatment purposes. Before making health decisions, discuss with a qualified healthcare professional.

Imagine you consult a physician for a problem. The doctor asks you questions and examines you. Then you have blood tests, cultures, X-rays,a CT scan or MRI. You hope these tests show what is “wrong” so the doctor can treat you.

But what if all the tests are “normal”? Normal tests suggest that your symptoms may be due to a cause for which there is no biomarker.

A biomarker is a diagnostic test that indicates a specific disease or condition.

biomarker-A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

Both physicians and patients would like a biomarker for every disease. But many common conditions do not yet have a biomarker.

These include migraine, fibromyalgia, irritable bowel syndrome, Parkinson’s disease, many skin conditions, Alzheimer’s dementia, depression, and other psychiatric disorders.

a female physician talking to a male patient

For these disorders, physicians make a “clinical diagnosis”.

clinical diagnosis-The process of identifying a disease, condition, or injury based on the signs and symptoms a patient is having and the patient’s health history and physical exam

Much of medical research is devoted to finding biomarkers for these and other conditions. This article from KFF focuses on finding biomarkers for psychiatric disorders, especially depression. Such tests could be helpful not only for diagnosis but also for guiding therapy.

But there are potential downsides, like cost, insurance coverage, privacy, and potential discrimination, as explained in the article.

Psychiatrists’ Use of Biomarkers Could Open a New Window Into Mental Health Diagnoses

by Jamie Ducharme, March 17, 2026

Amanda Miller was 30 and pregnant with her second child in Hershey, Pennsylvania, when she developed depression. After she gave birth, her depression worsened. It was joined by a slew of unexplained health problems.

Miller, a neuroscientist, said she saw several psychiatrists and got prescriptions for drug after drug. Over two years, she tried four antidepressants and two antipsychotics. None of that helped — until her primary care doctor noticed high levels of an autoimmune marker in her blood.

A specialist then ran “every test in the book,” Miller said. Eventually, she was diagnosed with the autoimmune disease lupus and prescribed an inflammation-lowering steroid. Some of her symptoms let up within hours. Her depression subsided not long after.

“I was convinced it was a placebo effect,” Miller said, “but then it kept working.”

Had inflammation been contributing to her mental health problems all along? Miller thinks so, although she can’t know for sure. Her psychiatrists never raised that possibility, she said.

Laboratory vs Clinical Diagnosing

In most medical specialties, doctors can confirm whether to pursue a type of treatment through tests, such as blood work, imaging, and biopsies. Mental illnesses, however, have historically been diagnosed and treated based on outward symptoms. That could change.

The American Psychiatric Association in a January paper included ideas for how it might incorporate biomarkers — biological indicators of mental illness that could show up on diagnostic tests — into future versions of its Diagnostic and Statistical Manual of Mental Disorders.

Diagnostic and Statistical Manual of Mental Disorders.

The DSM, sometimes called “psychiatry’s bible” because of its influence in the field, provides criteria for diagnoses. It’s used by clinicians assessing patients and by insurance companies deciding whether to cover care.

‘Coordinated’ Research Needed

Psychiatric biomarkers are not ready for widespread use yet, the paper emphasized. Scientists have researched the topic for decades, with little to show for it.

More research is needed to prove these metrics are valid and reliable enough to be used in patient care, the APA’s paper said, and other researchers have raised questions about how their use could affect health care costs, insurance coverage, and patient privacy.

Adding biomarkers to the DSM would be “a very big deal,” said Jonathan Alpert, an author of the January paper and vice chair of the APA’s Future DSM Strategic Committee.

Access to test results, along with symptoms, could streamline insurance coverage decisions and help clinicians make faster and more accurate diagnoses and treatment recommendations, he said. If patients’ biology suggested they’d respond better to one treatment than another, their doctor could waste no time in starting there.

A Prescribing “Crapshoot”

Currently, prescribing psychiatric medications can be “a bit of a crapshoot,” with clinicians unable to predict whether they will work for a particular patient, said Matthew Eisenberg, director of the Center for Mental Health and Addiction Policy at the Johns Hopkins University Bloomberg School of Public Health.

In a seminal, early 2000s trial funded by the National Institute of Mental Health, about 30% of the study’s participants with depression saw symptoms disappear with their first antidepressant treatment. That study is still one of the most robust antidepressant trials conducted — although researchers have more recently argued that fewer people are cured by these medications than its results suggest.

9 different medication pills and capsules of various colors

Such a trial-and-error approach can lead to ineffective and unnecessary prescriptions, a topic of attack by proponents of the Make America Healthy Again movement, spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has been especially critical of antidepressants, having linked them to violence after a mass shooting without evidence and blaming doctors for overprescribing medications for children.

HHS is analyzing psychiatric diagnosis and prescription trends and evaluating alternative mental health treatment approaches, with a particular focus on children, spokesperson Emily Hilliard said in a statement. Hilliard did not respond to a question about Kennedy’s previous comments.

Biomarkers are already used to guide treatment in other medical disciplines, such as oncology. Arizona, Georgia, Kentucky, Texas, and more than a dozen other states require insurers to cover such testing. Blood and imaging tests are now used to help diagnose Alzheimer’s disease as well.

A Future for Psychiatric Biomarkers

The APA included in its article a variety of ways psychiatric biomarkers could be used in the future — such as testing for brain activity, genetic profiles, or immune markers associated with certain psychiatric conditions, including schizophrenia and substance use disorders.

In depression, for example, about a quarter of patients have elevated levels of an inflammatory protein, called C-reactive protein, that can be found through a blood test.

Research has shown that people with high levels of this protein seem to respond better when given drugs that alter dopamine levels in the brain, rather than using only selective serotonin reuptake inhibitors, or SSRIs, a common type of antidepressant.

C-reactive protein still needs to be “robustly validated” as a biomarker, but it’s among the most promising currently under investigation.

APA

A “coordinated, well-funded” research effort is needed to achieve such validation, the APA wrote — a tenuous prospect since the Trump administration slashed funding for research.

The National Institute of Mental Health alone had at least 128 grants, worth almost $173 million, canceled in 2025, according to a research letter in the journal JAMA. Though some grants have since been restored, researchers relying on federal money still fear their work is vulnerable to cuts.

“There’s a great need for continued, active funding of research related to mental health,” Alpert said, but scientists will have to grapple with “uncertainties of the funding landscape.”

Ripple Effects on Coverage, Costs

Health care costs tend to be higher among patients with poorly controlled mental illnesses, due to expenses like hospital visits, outpatient appointments, and prescriptions. Some research suggests biomarker testing could save money by landing on the right treatments faster and avoiding some of these costs.

One modeling study estimated that testing to look for genetic components that may influence a drug’s effectiveness could save the Canadian health system $956 million over 20 years if used among adults with major depression in British Columbia. Another study, by Spanish researchers, found that such testing reduced costs for most of the 188 participants with serious mental illness.

Whether the same would be true in the U.S. health care system is unknown. In the short term, Johns Hopkins’ Eisenberg said, an approach that uses biomarkers could raise health care spending due to the costs of testing.

Insurers may decline to cover pricey biomarker tests, It takes a while for new science to be proven safe and effective,
And once it is, insurance companies don’t cover it immediately.”

Matthew Eisenberg, Johns Hopkins

“The Beginning of a Revolution”

Some researchers have raised concerns that insurers or employers could discriminate against people whose biological profiles suggest they’re at risk of developing serious neuropsychiatric conditions.

It’s a “critical moment” to consider legislative approaches to protect patients and train clinicians about how to appropriately use these tools, said Gabriel Lázaro-Muñoz, a member of Harvard Medical School’s Center for Bioethics.

“I do not think that the field of psychiatry is currently ready to manage this,” he said.

The mental health system isn’t ready to “jump in with both feet,” said Andrew Miller, a professor of psychiatry and behavioral sciences at the Emory University School of Medicine, who studies inflammation-related depression. But the APA’s embrace of biomarkers signals “the beginning of a revolution,” he said.

“This is a recognition … that what we’ve done up to this point has not been good enough,” Miller said. “And we can do better.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Depression

Depression is common among people who have a chronic disease such as cancer or diabetes. Fortunately, depression is treatable even if you have another medical illness or condition. Learn more about chronic disease and depression: Caring for your mental health #shareNIMH

Biomarkers in Cancer Care

Biomarker testing is a way to look for genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer. Each person’s cancer has a unique pattern of biomarkers.

Some biomarkers affect how certain cancer treatments work. Biomarker testing may help you and your doctor choose a cancer treatment for you.

There are also other kinds of biomarkers that can help doctors diagnose and monitor cancer during and after treatment. To learn more, visit the Tumor Markers fact sheet.

Biomarker testing is for people who have cancer. People with solid tumors and people with blood cancer can get biomarker testing.

The FDA-approved blood tests for diagnosing Alzheimer’s disease

In May 2025, the U.S. Food and Drug Administration (FDA) approved the first blood test as a tool to help diagnose Alzheimer’s disease. The test is called Lumipulse.

The test measures certain proteins, including a specific form of the tau protein. This can indicate amyloid plaques in the brain, a protein that is considered the hallmark sign of Alzheimer’s disease.

This blood test, along with other diagnostic tools can help diagnose Alzheimer’s disease. While the blood test can detect changes even before memory problems begin, it is only recommended for use in people showing symptoms of Alzheimer’s disease.

The test is still being refined and can’t diagnose Alzheimer’s disease on its own. 

What to Remember from this Post

I learned from the KFF article and the references, did you? What are your takeaways from what you read? Here are some to consider.

  • Doctors use laboratory tests and imaging to supplement information gleaned from talking to and examining patients.
  • Biomarkers for common conditions make diagnosis easier and more precise, and help guide therapy.
  • Discovery of biomarkers for other serious conditions will help patients get earlier diagnosis and more effective treatment. More research is needed.
  • New medical discoveries introduce trade-offs in cost, payment, benefit, and potential misuse.

How will you use what you’ve learned? How may you apply this information to a current or future health concern?

What more information do you need and where will you find it?

a stethoscope, a red heart and a heart ekg tracing
exploring the HEART of HEALTH

Exploring the HEART of Health

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Dr. Aletha

How New Pain Drugs May Fight Addiction

I’m glad to learn that states are mandating insurance coverage for non-opioid pain medications. Advocates push for laws that eliminate higher copayments for non-opioids. Despite challenges, bipartisan support is growing, driven by healthcare concerns regarding opioid dependence and addiction.

This information is current as of the date of original publication or update but may have changed by the time you read this. Do not use this information for diagnosis or treatment purposes. Before making health decisions, discuss with a qualified healthcare professional.

Pain Treatment: A Problem for Doctors and Patients

When I was practicing medicine, pain was one of the most difficult problems to manage. I had to balance the need to relieve a person’s pain while not creating dependence or addiction.

Sometimes patients came to me already on chronic opioids for pain. I had to decide whether to continue them or change the person to another treatment, which can be hard to do. Sometimes patients came to me requesting “something” for pain. Only by checking the state pharmacy database did I learn they were already receiving prescriptions for opiates from other physicians, sometimes several.

In my long medical career, there have been few non opiate alternatives for severe pain. So I am pleased to learn of a new drug which is exactly that. Unfortunately, its use may be limited due to cost. This article explains how states are trying to circumvent that problem.

(For the purpose of this article, consider the terms narcotic, opiate, and opioid as referring to the same type of drug.)

More states are requiring insurers to cover non-opioid pain meds

by Nada Hassanein, Oklahoma Voice
February 16, 2026

(edited for readability and clarity, no change to content)

More states are requiring their Medicaid programs and health insurance companies to cover non-opioid pain medications as an alternative to opioids, which can be cheaper for insurers but also more addictive for patients.

Advocates, providers, medical associations, and state lawmakers are pushing for parity in coverage. That means prohibiting insurers from charging higher copayments for non-opioids than they do for opioids, and barring them from requiring prior authorization or step therapy — mandating that patients try other medications first — before they will cover non-opioid drugs.

At least eight states have enacted such laws: Arkansas, Illinois, Louisiana, Maine, Massachusetts, Oklahoma, Oregon, and Tennessee. In states that are still considering legislation, the efforts have been bipartisan, pushed by lawmakers in some Democratic-controlled states, Colorado and New York, and some Republican-leaning states, Kentucky and Missouri.

The issue has gained momentum in recent years, as leading medical associations such as the American Society of Regional Anesthesia and Pain Medicine have urged providers not to prescribe opioids as the first-line treatment for pain.

Meanwhile, bipartisan legislation introduced in Congress last year aims to increase Medicaid Part D enrollees’ access to non-opioid pain medications. It’s been referred to a committee.

Dr. Patrick Giam, president of the American Society of Anesthesiologists, said the organization “believes it is important that insurance plans make non-opioid therapies as accessible to patients as opioid-based therapies.”

drugs to treat pain

The U.S. Food and Drug Administration has encouraged non-opioid pain relief alternatives.

Non-opioid pain medications include

  • prescription-strength non-steroid anti-inflammatory NSAIDs such as naproxen and ibuprofen,
  • nerve-blocking injections,
  • certain antidepressants,
  • anticonvulsant medications,
  • acetaminophen , such as Tylenol and other brands, and
  • other medications.

(affiliate links)

Opioids include

  • oxycodone,
  • codeine,
  • morphine and
  • fentanyl.

suzetrigine-Journavx

Last year, the agency approved a new drug called suzetrigine, under the brand name Journavx, the first non-opioid pain relief medication in a new class of analgesic drugs. The drug, which is available in tablets, can be prescribed for acute pain after surgery or injury. Vertex Pharmaceuticals, the manufacturer, is one of the funders of Voices for Non-Opioid Choices, which has been lobbying for the bills.

In Missouri, where GOP-sponsored legislation would prohibit insurance companies from denying coverage of a prescribed non-opioid or requiring a higher copayment for a non-opioid, the Missouri Insurance Coalition has argued that the measure would increase health care costs and effectively create “a monopoly” for Journavx. Each tablet can cost around $15 per tablet out-of-pocket. But lawmakers pointed to non-opioid alternatives.

Why non-opioids often cost more

Newer non-opioid drugs entering the market are more expensive than opioids because there isn’t yet a generic alternative, explained Sterling Elliott, an Illinois clinical pharmacist and lecturer at Northwestern University’s Feinberg School of Medicine and a board member of Voices for Non-Opioid Choices.

Generic opioids are amongst the cheapest medications that you’ll find flowing through the American pharmaceutical supply,

Sterling Elliott, clinical pharmacist

“The price is so high for a lot of things because the price for generic opioids is so low. Generic opioids are amongst the cheapest medications that you’ll find flowing through the American pharmaceutical supply,” Elliott said. “When you get a new entrant into the pain market, the marketplace factors are set up to drive the price up.”

Elliott added that some insurance plans don’t cover prescription-strength NSAIDs such as ibuprofen because they’d rather people pay out-of-pocket for lower strength, over-the-counter versions of those drugs.

In New York, Democratic Assembly member Phil Steck, the cosponsor of a bipartisan bill that hasn’t received a hearing, said challenging the insurance companies isn’t easy.

“You’re trying to tell insurers what to do,” Steck said. “Those are usually difficult undertakings. … Our experience is that the [legislature’s] insurance committee is very difficult to deal with, and so it hasn’t been pursued as much as we would like.”

Coverage of non-opioids can vary widely across insurance plans, explained clinical pharmacist Emma Murter, who co-chairs the advocacy committee of the Society of Pain and Palliative Care Pharmacists.

“There are so many [non-opioid] medications that can be used for chronic pain,” Murter said. “It isn’t gut-instinct obvious, what is and isn’t covered. It’s very Wild West, chaotic.”

When it comes to filling prescriptions, Murter said, she often has to “fight and appeal for some of these non-opioid therapies” with insurance companies.

Dima Qato, associate professor of clinical pharmacy at the University of Southern California, said non-opioid pain prescription meds are less common on insurance companies’ “preferred” drug lists. Because insurers may favor the less expensive opioids, that can result in higher copayments or consumers paying more out-of-pocket.

That was the case for Chris Fox, the Washington lobbyist who serves as executive director of Voices for Non-Opioid Choices. Fox has traveled to state capitals around the country to lobby for the bills. Recently, he had a personal experience with pain medications following oral surgery.

“For everything but the non-opioid, my out-of-pocket expectation was $0,” he said. He was charged $30 out-of-pocket for the non-opioid.

His oral surgeon wasn’t familiar with the availability of the new first-in-class non-opioid suzetrigine, Fox added. When he asked the doctor for a prescription for it, the surgeon wrote it but also prescribed an opioid along with an antibiotic.

“He prescribed me hydrocodone to go along with it, just in case, because he wasn’t as familiar with [suzetrigine],” Fox said.

Preventing addiction

As he spoke with Stateline by phone, Fox was driving to the local sheriff’s office to drop off the hydrocodone, which he didn’t take following his surgery.

“We’ve neglected the opportunity, I would say, to prevent opioid addiction where we can, which is in those patients that will develop a newly persistent opioid use pattern following exposure to an opioid that they get for medical reason,” Fox said.

Although opioid overdose deaths have declined, the drugs still kill about 200 Americans a day.

Health care professionals at hospitals also run into issues with lower reimbursement rates for some non-opioids.

Dr. Joseph Smith, an anesthesiologist at a Virginia surgical center who has practiced for three decades, pointed to a nerve-block pain pump as an example. Administering a brand-name version of the drug could cost up to $400 for all the equipment, he said. Smith, like Elliott, sits on the board of Voices for Non-Opioid Choices.

“So the hospital is like, ‘Well, I can spend $400 or I can spend 25 cents on a narcotic pill,’” Smith said.

Smith treats many young teen athletes with sports injuries. Research has shown post-surgery narcotic use can increase risk of addiction.

“My goal when I get a 14-year-old or 15-year-old in here is to never have them try a narcotic, never have them exposed to narcotics,” he said.

Stateline reporter Nada Hassanein can be reached at nhassanein@stateline.org.

This story was originally produced by Stateline, which is part of States Newsroom, a nonprofit news network which includes Oklahoma Voice, and is supported by grants and a coalition of donors as a 501c(3) public charity.

It is shared here under a Creative Commons License.

Tolerance vs. Dependence vs. Addiction

Long-term use of prescription opioids, even as prescribed by a doctor, can cause some people to develop a tolerance, which means that they need higher and/or more frequent doses of the drug to get the desired effects.

Drug dependence occurs with repeated use, causing the neurons to adapt so they only function normally in the presence of the drug. The absence of the drug causes several physiological reactions, ranging from mild in the case of caffeine, to potentially life threatening, such as with heroin. Some chronic pain patients are dependent on opioids and require medical support to stop taking the drug.

Drug addiction is a chronic disease characterized by compulsive, or uncontrollable, drug seeking and use despite harmful consequences and long-lasting changes in the brain. The changes can result in harmful behaviors by those who misuse drugs, whether prescription or illicit drugs.

Source:

NIDA. Prescription Opioids DrugFacts. National Institute on Drug Abuse website. https://nida.nih.gov/publications/drugfacts/prescription-opioids. June 1, 2021 Accessed February 19, 2026.

Images in this Post

The infographics in this post were created by the NIH, National Institutes of Health, and used with permission.

The cover photo is by Towfiqu Barbhuiya and used courtesy of Pexels.com.

Get Help with Substance Use at FindTreatment.gov

While the initial choice to use a drug is often voluntary, the powerful effects of addiction makes it very hard to stop, even if someone wants to.

When drugs or alcohol are used so often that they have significant negative effects on your life, this is called a substance use disorder.

It causes intense cravings for alcohol or drugs, and can include:

  • Using illegal drugs like heroin or cocaine, or excessive alcohol drinking.
  • Using prescription drugs in ways other than prescribed, or using someone else’s prescription.

Using drugs repeatedly changes the brain, including the parts that help exert self-control. That’s why someone may not be able to stop using drugs, even if they know the drug is causing harm, or want to stop.

FindTreatment.gov lists facilities across the country. It gives guidance on what to expect from treatment,  different kinds of treatment, and how to pay for treatment.

If you live outside the United States, contact your local source of medical care or search online for substance use treatment in your country.

Exploring the HEART of Health

I’d love for you to follow this blog. I share information and inspiration to help you transform challenges into opportunities for learning and growth.

Add your name to the subscribe box to be notified of new posts by email. Click the link to read the post and browse other content. It’s that simple. No spam.

I enjoy seeing who is new to Watercress Words. When you subscribe, I will visit your blog or website. Thanks and see you next time.

Search this blog for related posts on this topic or other issues you care about.

Dr. Aletha