Clinical Trial Medical Claim Denial Investigation

Migliaccio & Rathod LLP is investigating whether certain employer-sponsored health plans improperly denied ordinary medical expenses simply because a patient was participating in an approved clinical trial.

Patients with cancer and other serious illnesses sometimes participate in clinical trials when standard treatments have failed or when a promising new therapy becomes available. Although a health plan may not necessarily be required to pay for the experimental drug or device itself, federal law provides protections for certain routine patient costs associated with participation in approved clinical trials.

We are investigating plans that may have automatically denied otherwise-covered hospital, physician, laboratory, imaging, chemotherapy, or other routine medical expenses because the treatment occurred in connection with a clinical trial.

You May Be Affected If:

  • You receive health insurance through your private-sector employer, or through a spouse’s or parent’s private-sector employer;
  • You participated in an approved clinical trial, including a qualifying cancer clinical trial;
  • Your health plan denied medical claims because they were “experimental,” “investigational,” or “clinical trial related”;
  • The denied bill involved ordinary medical care such as physician services, hospital care, laboratory testing, imaging, treatment of complications, or other services you would ordinarily receive even outside the trial; or
  • You paid substantial medical bills because your health plan classified all trial-related treatment as experimental.

We are particularly interested in patients whose plan appears to have denied all claims associated with the clinical trial, rather than separately determining which expenses were routine medical care and which expenses represented the investigational treatment itself.

Why This Matters

Participating in a clinical trial does not necessarily mean every medical service connected to that trial is experimental.

For example, a patient may still need ordinary:

  • hospital care;
  • physician visits;
  • blood tests;
  • imaging;
  • chemotherapy;
  • treatment of side effects or complications; or
  • other routine medical services.

If a health plan uses a blanket rule to deny everything associated with a clinical trial, patients may be left with substantial bills for care that otherwise would have been covered.

Does This Apply to Your Health Plan?

This investigation generally concerns ERISA-covered employer health plans, meaning health insurance obtained through a private-sector employer.

Both self-funded plans and plans purchased from insurance companies may qualify. Government employee plans and certain church plans generally do not.

If you do not know whether your plan is governed by ERISA, we can review your insurance card, denial letters, EOBs, and employer plan documents.

We Are Interested in Hearing From Patients Who:

  • participated in a cancer or other approved clinical trial;
  • had routine medical claims denied as “experimental” or “investigational”;
  • saw multiple claim lines denied simply because they were associated with a trial;
  • paid out of pocket for hospital, physician, imaging, laboratory, or complication-related care;
  • appealed the denial but did not receive payment;
  • were told that nothing connected to the trial would be covered; or
  • still have EOBs, denial letters, bills, trial paperwork, or appeal correspondence.

If your employer-sponsored health plan denied routine medical expenses because you were participating in a clinical trial, we would like to hear from you. Please complete the contact form on this page, send us an email at [email protected], or call us at (202) 470-3520.

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