Clinical Trials & Health Insurance Coverage

ACA, Medi-Cal, Medicare & Medicare Advantage

If you have cancer or another serious illness, your doctor may suggest a clinical trial involving a new drug, immunotherapy, cell therapy, medical device, procedure, or combination of treatments.

One of the first questions is usually:
Who is going to pay for it?

• The experimental treatment may be paid for by the clinical-trial sponsor.
• Your health insurance may pay for the routine medical care you receive during the trial.
• You may still have normal deductibles, copays or coinsurance.
• Some research-only expenses may not be covered by insurance.
• Travel, lodging, meals and parking may or may not be paid by the study.

Do not assume that “the clinical trial is free” or that “insurance doesn’t cover experimental treatment.”

Those statements are both too broad. The answer depends on which expense is being discussed, the clinical trial, and the type of health coverage you have.

• Resources
  • Our Cancer & Health Insurance Coverage  webpage
  • Our Medicare Webpage
    • Medicare and You Publication  10050 

Who Pays for a Clinical Trial?

Clinical-trial expenses generally fall into two categories:

• routine patient-care costs and
• research costs.

Routine Patient-Care Costs

These are medical services that you might need even if you were not participating in the clinical trial. Depending on your coverage, they may be billed to your health insurance, Medicare, or Medi-Cal.

• Doctor and specialist visits
• Hospital care
• Laboratory tests
• CT, MRI, PET and other medically necessary imaging
• Standard chemotherapy, immunotherapy or other covered treatment
• Administration of treatment
• Monitoring necessary for your medical care
• Treatment of side effects or complications

Research Costs

These are expenses caused specifically by the research study rather than your ordinary medical care.

• The experimental drug, device or treatment being studied
• Tests performed solely to collect research data
• Additional scans required only for the research protocol
• Some additional research visits

These research expenses are often paid by the drug company, university or other sponsor conducting the trial, but you should verify this before enrolling.

• National Cancer Institute — Who Pays for Clinical Trials?
  

Does Obamacare Cover Clinical Trials?

Yes, the Affordable Care Act provides important clinical-trial protections — but clinical trials are not one of the ACA’s 10 Essential Health Benefits.
Clinical-trial protection is a separate provision of federal law.

For qualifying individuals enrolled in applicable non-grandfathered individual and group health coverage, the ACA generally provides that a health plan:

• Cannot prevent a qualified patient from participating in an approved clinical trial involving cancer or another life-threatening disease or condition.
• Cannot deny or impose additional conditions on coverage of routine patient-care costs merely because those services are connected with the clinical trial.
• Cannot discriminate against someone because they participate in an approved clinical trial.

What Doesn’t the ACA Require the Plan to Pay?

• The experimental item, drug, device or service itself.
• Services performed solely for research data collection that are not part of the patient’s direct medical care.
• Services clearly inconsistent with accepted standards of care.

HMO & Provider Networks Still Matter

The ACA clinical-trial rule does not automatically turn an HMO into a PPO.
If your plan normally does not provide out-of-network benefits, federal ACA clinical-trial protections generally do not require the plan to provide ordinary out-of-network benefits just because you participate in a clinical trial.

• Our Guide to the ACA’s 10 Essential Health Benefits
  
• U.S. Department of Labor — ACA Clinical Trial Coverage Rules
  
• California Department of Managed Health Care — Clinical Trials
  

Does Medi-Cal Cover Clinical Trials?

Yes. Medi-Cal covers routine patient-care costs associated with participation in qualifying clinical trials.

Federal Medicaid law now requires coverage of routine patient costs for qualifying clinical trials, and California added this coverage to the Medi-Cal State Plan.

• Medical services must otherwise be covered by Medi-Cal.
• The clinical trial must meet the requirements for a qualifying clinical trial.
• Routine medical care may include services needed to prevent, diagnose, monitor or treat complications associated with participation in the trial.
• The experimental treatment itself is not necessarily paid for by Medi-Cal.
• The clinical-trial sponsor may pay research-related expenses.
• Medi-Cal managed-care members should verify how services will be authorized and billed before treatment begins.

Before enrolling, ask the clinical-trial coordinator to identify which expenses will be billed to Medi-Cal and which expenses will be paid by the study sponsor.

• Our Medi-Cal Eligibility & Coverage Guide
  
• Our Medi-Cal & Cancer Coverage Information
  
• California DHCS — Medi-Cal State Plan Amendment 22-0017
  

Medicare & Clinical Trials

Medicare has its own clinical-trial coverage rules, separate from the Affordable Care Act.

Original Medicare covers routine costs of qualifying clinical trials and reasonable and necessary medical care used to diagnose or treat complications resulting from participation in a clinical trial.

Medicare May Cover

• Doctor visits
• Hospital care
• Covered laboratory tests
• Medically necessary scans and imaging
• Conventional cancer treatment
• Services necessary to administer the investigational treatment
• Appropriate medical monitoring
• Treatment of side effects and complications

Medicare Generally Doesn’t Pay For

• The investigational item or treatment itself when it would not otherwise be covered by Medicare.
• Items or services supplied free by the clinical-trial sponsor.
• Tests performed solely to collect research data and not used in the patient’s direct medical care.

For Part B-covered clinical-trial services, the normal Medicare deductible and coinsurance rules can apply.

What About a Medicare Supplement / Medigap?

If Original Medicare approves and pays its share of a covered clinical-trial service, a Medicare Supplement policy generally pays according to the standardized benefits of that Medigap plan.

• A Plan G generally covers applicable Part B coinsurance after the Part B deductible.
• Other Medigap plans pay according to their particular standardized benefits.
• Medigap does not make an expense covered if Medicare itself does not approve the expense.

• Our California Medicare Supplement / Medigap Guide
  
• Medicare.gov — Clinical Research Studies
  

Medicare Advantage Clinical Trials — An Important Exception

If you have a Medicare Advantage HMO or PPO, do not assume that you cannot participate in a clinical trial simply because the research doctors or cancer center are outside your plan’s normal network.

Qualifying Medicare clinical trials have special rules.

• You may participate in a Medicare-qualified clinical trial available to people with Original Medicare.
• For qualifying clinical-trial services, Original Medicare generally pays for the covered routine services rather than your Medicare Advantage plan paying the provider in the usual way.
• The clinical-trial provider does not ordinarily have to be part of your Medicare Advantage plan’s provider network for these qualifying trial services.
• Your Medicare Advantage plan generally must reduce your ultimate cost sharing to the plan’s applicable in-network cost sharing for the same category of service.
• You may need to submit your Medicare Summary Notice or other documentation to the Medicare Advantage plan to receive the appropriate reimbursement.
• Your Medicare Advantage plan generally cannot prevent you from entering a Medicare-qualified clinical trial.

What If I Have Kaiser Medicare Advantage?

These Medicare rules also apply to Medicare Advantage HMOs such as Kaiser. A Kaiser Medicare Advantage member should therefore not automatically assume that an outside cancer-center clinical trial is prohibited merely because the research center is outside Kaiser’s normal network.

However, medical care that is not part of the qualifying clinical trial generally remains subject to the Medicare Advantage plan’s normal network, referral, authorization and coverage rules.

Tell your Medicare Advantage plan about the clinical trial before treatment begins and ask how to submit the Original Medicare cost-sharing documentation.

• Our Medicare Advantage Guide
  
• Medicare — Medicare & Clinical Research Studies
  

Before Joining a Clinical Trial — Get These Answers

Before agreeing to participate, ask the research center for the information you need to determine exactly who will pay each expense.

• What is the NCT number?
  • Most registered clinical trials have an identification number beginning with “NCT.”
  • You can use it to look up the study on Clinical Trials.gov.
• Who is sponsoring the trial?
  • Drug company?
  • University?
  • Government agency?
  • Hospital or research organization?
• Which treatment is experimental?
  • Drug?
  • Immunotherapy?
  • Cell therapy?
  • Surgery?
  • Medical device?
• Which expenses does the study sponsor pay?
  • Experimental treatment
  • Research-only laboratory work
  • Extra scans
  • Research visits
• Which expenses will be billed to insurance, Medicare or Medi-Cal?
• How often will treatment be required?
• How long is the treatment expected to continue?
• Is hospitalization required?
• What happens if there are serious side effects?
• Are travel, hotel, meals or parking expenses reimbursed?
• What happens if I leave the trial early?

Ask for a copy of the informed-consent document and financial-responsibility information before treatment begins. Do not rely only on a verbal statement that “insurance covers it.”

Research the Clinical Trial

If you have been offered a clinical trial, start by getting the complete trial name and NCT number. You can then review the official listing and discuss the financial details with the research coordinator and your health plan.

• ClinicalTrials.gov — Search for Clinical Trials
  
• National Cancer Institute — Cancer Clinical Trials
  
• National Cancer Institute — Who Pays for Clinical Trials?
  
• Medicare.gov — Clinical Research Study Coverage
  
• California Department of Managed Health Care — Clinical Trials
  

Related Coverage Guides – Our Webpages 

• Cancer Treatment & Health Insurance Coverage
  
• ACA Essential Health Benefits
  
• Medi-Cal Eligibility & Coverage
  
• Medicare Enrollment & Coverage
  
• Medicare Supplement / Medigap
  
• Medicare Advantage
  

Important: Clinical-trial eligibility and medical treatment decisions should be discussed with your physicians and research team. Insurance coverage varies by the particular trial, medical services provided, health plan and applicable coverage rules. Verify coverage before receiving services.