Clinical Trials and Insurance Coverage

Patients should speak with their insurers in the early stages of finding a clinical trial in order to learn about the general coverage offered and which clinical trial phases it is offered for. Once a patient has been selected for, or chosen a trial, they should speak with members of the trial team as well as their insurance provider to determine which costs related to your participation are financed. Patients can also read through the “Experimental/ Investigational” or “Non-FDA Approved” section of their insurance documents for additional information.

Two major costs in a clinical trial are research and patient care. Research costs are often covered by the research institution or researchers. This can include the cost of testing the new treatment/device or conducting research. Patient care costs are often covered by the patient’s insurer or the patient, depending on the insurance provider. Patient care costs consist of routine care and ancillary careAncillary care – additional care a patient might require when participating in a clinical trial. This could include additional screening tests or hospital visits a patient may require after experiencing adverse side effects. . Routine care is the care a patient would receive even if they were not in a clinical trial. This can consist of regular doctor visits, screenings, and any other care a patient may need to properly manage their condition. Coverage of clinical trials are mandated under the Affordable Care Act (ACA), and as a result, insurers and health plans are not allowed to discontinue or increase the cost of routine care when a patient joins an approved clinical trial. Approved clinical trials tend to be trials that are funded by federal institutions or organizations, or are for an approved drug application by the FDA. Clinical trials from centers and groups founded or funded by federal organizations might also be approved clinical trials. 

Insurers cannot deny coverage or discontinue routine care when patients enroll in approved clinical trials; however, they are also not required to cover every cost. Coverage of ancillary care depends on the research institution and the patient’s insurance provider. Patients should be proactive in communicating with their health insurance provider for a clear understanding of their coverage should they enroll in a clinical trial. If you require more assistance and are already enrolled in a trial, the clinical trial coordinator should be able to facilitate communications with your insurance provider. Be sure to keep notes of these important conversations. Be sure to include dates and names of participants. Whenever unsure, ask the insurer to document all coverage eligibility determinations in writing.

Most insurers offer coverage for approved clinical trials, and coverage for unapproved trials are optional and rare. Again, approved clinical trials tend to be trials that are funded by federal institutions or organizations, or are an approved drug application by the FDA, or from centers and groups founded or funded by federal organizations.

Here is a list of organizations that have approved clinical trials:

  • National Institutes of Health
  • Agency for Health Care Research and Quality National Health Institute
  • National Cancer Institute
  • Department of Defense
  • Department of Veterans Affairs
  • Centers for Medicare and Medicaid Services
  • Centers for Disease Control 

Employer-based Insurance

Because coverage of clinical trials are mandated under the ACA, employers are required to cover the cost of routine care that is related to a patient’s participation in a clinical trial. The patient must be enrolled in an approved clinical trial to receive coverage. Employers are only required to cover routine costs that the patient normally receives. If a patient needs additional tests or care that is not covered under their routine care costs, it will not be covered by the employer-based insurance. Unless provided otherwise, patients must cover the cost of their travel, co-pays, and deductibles. The coverage a patient receives when enrolled in a clinical trial is a continuation of their existing coverage. For example, if a trial requires participation through an out-of-network provider and the patient’s plan does not cover the cost, this will be the responsibility of the patient. Unexpected, additional costs may arise if the patient fails to have adequate insurance coverage before enrolling in a trial.

Grandfathered Plans

For patients enrolled in a “grandfathered” plan (established prior to ACA enactment and exempt from ACA requirements), coverage in a trial may be denied. Unlike other health plans, the ACA mandate for clinical trials does not apply to grandfathered plans. Grandfathered plans do not have to comply with the regulations set by the ACA. This means they are not required to cover the cost of routine care for clinical trial participants, they have no limits for yearly out-of-pocket costs, and they can deny coverage based on a patient’s pre-existing condition. If a patient intends to participate in a clinical trial while enrolled in a grandfathered plan, they should first communicate with their insurer to verify responsibility for these costs.

Veterans Affairs

The Department of Veterans Affairs (VA) is in partnership with the National Cancer Institute (NCI) to ensure that veterans have greater access to clinical trials. In their partnership, the organizations have created a program called The NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). Historically, veterans have faced several barriers for trial enrollment such as lack of information about clinical trials, transportation, financial limitations, and narrow eligibility criteria. The NCI contributes funding and sets best practices, while the VA offers its facilities and coverage for the medical costs of clinical trials. As a result of the partnership, the number of clinical trials available for veterans has increased. The VA covers patient care costs if the patient participates in a trial located in a VA facility.

General requirements for coverage:

The veteran must be eligible (as determined by their primary care physician and trial investigator) to participate in the trial and

  • The trial must be an approved clinical trial

    OR

  • The trial must take place in a VA hospital/center (if the veteran is enrolled in a trial that takes place in a non-VA hospital/center it may still be covered if it is an NCI trial)
For information on how to navigate the clinical trials site as a veteran in search of VA-sponsored trials see here.

TRICARE

TRICARE is the health insurance program for active duty service members, military retirees, and qualified dependents. TRICARE has partnered with the NCI to cover the cost of clinical trials sponsored by the NCI. A beneficiary of TRICARE is not required to cover the cost of participating in an NCI-sponsored trial because it is an approved clinical trial. Research costs are the responsibility of the research institution. This coverage extends to family members of active and retired members. Participation in a trial may occur at civilian or military treatment centers. If the beneficiary is on active duty, participation must be in a military facility. TRICARE coverage includes:

  • Screenings that determine whether a patient is eligible for trial participation
  • Trials in Phases I-III
  • Routine and ancillary care
  • Inpatient and outpatient care (outpatient care is completely free if the trial is in a military hospital)
  • Out-of-network care (for patients with eligible out-of-network plans)

Clinical trials not sponsored by the NCI will not be covered. Although coverage is offered for patients enrolled in approved clinical trials, patients must continue to assume the cost of co-payments and cost-shares.

Additional information see: 1-800-4-CANCER or https://www.tricare.mil/Plans/SpecialPrograms/CancerClinicalTrials

Medicaid

Medicaid is a health program administered by states according to federal requirements and provides health coverage to low-income adults, children, pregnant women, the elderly, and people with disabilities. States are often given the option on which forms of care they would like to cover. Under Medicaid, the coverage of clinical trials is not mandatory and is left to each state’s discretion. The ACA Clinical Trial Mandate does not apply to Medicaid. Most states have chosen to address this through laws and agreements that require insurers to offer coverage for the cost of routine care in clinical trials. Any states that have not adopted these requirements do not participate. You can find out whether your state has a law, agreement, or does not participate here (under “State Laws and Cooperative Agreements”). State-by-state information on clinical trial laws and individual state benefits/services can be found here (chart titled “Table One: Clinical Trials”).

General Requirements for coverage:

  • The trial must be federally funded and have an investigational new drug application (or be excused from the application).
  • The trial must be in an approved phase. Approved phases are usually Phases I-IV, however, their approved status varies by state. Early Phase I trials are not regarded as approved phases because they are not therapeutic.
  • Approval from primary care physician and trial investigator.
  • The patient volunteer must meet the eligibility requirements set by the trial investigators.

Medicare

Medicare is the federal health insurance program for eligible adults who are 65 or older, individuals with qualifying disabilities, and people with End-Stage Renal Disease. Medicare is mandated under the ACA to provide patients with routine care when enrolled in an approved clinical trial. For Medicare, an approved clinical trial is typically a Phase II or III trial that includes patient volunteers rather than healthy volunteers. If it is not a Phase II or III trial, it may still be approved if it is proven to be therapeutic, tests the toxicity of a drug, or studies the progression of the disease.

Medicare Parts A and B are the portions of Medicare that cover the cost of participating in a clinical trial. Medicare Parts A and B cover hospital costs and outpatient care costs, respectively, which are necessary for a patient’s routine care. Along with a patient’s routine care, Medicare also offers coverage for complications that may develop from participating in a clinical trial. If a patient is a beneficiary of Medicare Parts A and B (Original Medicare) prior to enrolling in a clinical trial, that coverage will remain when the patient participates in a clinical trial. In addition, most Medigap supplemental plans may offset trial participation costs to the individual for medical treatment.

For Medicare Advantage (MA) beneficiaries, a fee-for-serviceFee-for-service – each health service is separated. Health professionals are paid for the individual services they perform.  plan may be required to cover the cost of a clinical trial. Once an MA beneficiary has obtained a fee-for-service plan, they will receive the same coverage as an Original Medicare beneficiary. MA beneficiaries may also be eligible for reimbursement after submitting a clinical trial claim. Coverage of a clinical trial is also dependent on who funds the trial. Each trial is required to go through a qualification process.

Requirements for Medicare coverage

  • Trial must be a federally funded trial or a trial with automatic approval. Other trials may qualify but they must be approved by the Centers for Medicare and Medicaid Services
  • The beneficiary must be a patient volunteer to receive coverage
  • The trial should be therapeutic when studying the progression of the disease or toxicity of the new treatment. The primary focus of the trial should be to improve the patient volunteer’s health outcome
  • Trial must have submitted an Investigational New Drug (IND) application and gained approval from an IRB
  • Approval from primary care physician and trial investigator
Patient care costs are the only costs covered by Medicare – it does not cover the cost of research care. 

Uninsured/Underinsured

Underinsured and uninsured individuals have little to no representation in clinical trials. The cost of participating in a clinical trial can be overwhelming, especially for those who already face financial barriers to accessing care. There are many federally funded clinical trials where care associated with the research being done comes at no cost to patients. Unfortunately, participating in a trial requires receiving constant routine care. In addition to routine care, the number of tests or preventive care interventions a patient requires might increase due to side effects of the new treatment being tested. The burden of routine care costs, wages lost from time off, transportation, and childcare can deter the uninsured and underinsured from participating in clinical trials. However, there are organizations that offer financial and social support to alleviate some of the costs. For example, most tertiary care centers and larger health care institutions have trained health finance navigators and social workers on staff to assist prospective clinical trial volunteers in finding ways to reduce the economic burden to the individual. Consider the following resources if you need financial assistance for housing, travel, medications, or insurance payments:

Eligibility requirements may vary by organization.



Transamerica Center for Health Studies® (TCHS) – a division of Transamerica Institute ® (TI) – is focused on empowering consumers and employers to achieve the best value and protection from their health coverage, as well as the best outcomes in their personal health and wellness. TCHS engages with the American public through national surveys, its website, research findings and consumer guidance. TCHS also collaborates with healthcare experts and organizations that are equally focused on health coverage and personal health and wellness. TI is a nonprofit, private foundation funded by contributions from Transamerica Life Insurance Company and its affiliates, as well as unaffiliated third parties. None of the contributors are major medical insurers.

TCHS and TI and their representatives cannot give ERISA, tax, or legal advice, and TCHS is not an agent of any government agency including, but not limited to, state or federal health benefit Exchanges. This material is provided for informational purposes only. TCHS and its representatives are not registered brokers, navigators, applicant assistors, or promoters. Although care has been taken in preparing this material and presenting it accurately, TCHS disclaims any express or implied warranty as to the accuracy of any material contained herein ‘or cited as source material’, and any liability with respect to it.