Clinical trials, experimental or investigational services - Chapter 7, 2022 UnitedHealthcare Administrative Guide

Experimental items and medications have limited coverage. We do not delegate utilization management for experimental or investigational services or clinical trials.

Commercial

Members with cancer may have coverage for routine costs related to the cancer clinical trial. It depends on the state. You should consider recommending the clinical trial if there is a potential for the member to benefit.

Medicare Advantage (MA)

Experimental and investigational procedures, items and medications are not a covered MA benefit. Call us at 1-877-842-3210 or 1-888-478-4760 (Individual Exchanges) for a clinical coverage review.

Certain clinical trials are a benefit of MA plans. You should bill Medicare directly. Members can get additional information on clinical trials by calling 1-800-MEDICARE.

Approval or denial of clinical trials

After a clinical review, we send a determination notice to the member and health care provider. An experimental/investigational denial requires a disclosure of additional rights. It also requires information regarding the independent external review process. This includes:

  • An Independent Medical Review (IMR) packet.
  • Physician certification form (commercial only).
  • One-page application form and addressed envelope that the member returns to the Department of Managed Health Care to request the IMR (CA only).

Evaluations prior to entry into a clinical trial

Evaluations, tests, and consultations are benefits of both the commercial and MA plans. Coverage for these does not change if the member does not qualify for a clinical trial. For capitated health care providers, the member’s health care provider is responsible for these tests, unless stated differently in your contract.

You can find more information on clinical trials and experimental procedures in:

  • Commercial: The Coverage Determination Guideline for Clinical Trials available on uhcprovider.com/policies > Commercial Policies > Medical & Drug Policies and Coverage Determination Guidelines.
  • MA: The Coverage Summary for Experimental Procedures and Items, Investigational Devices, and Clinical Trials is available on uhcprovider.com/policies > Medicare Advantage Policies > Coverage Summaries for Medicare Advantage Plans.
  • Individual Exchange Plans: The Coverage Determination Guideline for Clinical Trials is available on uhcprovider.com/policies> For Exchange Plans > Medical & Drug Policies and Coverage Determination Guidelines for UnitedHealthcare Individual Exchange Plans > [search for] Clinical Trials.