Medicare Coverage of Clinical Research
Medical Research Studies, also known as Clinical Trials, determine whether a medical treatment or device is effective and safe (common studies are cancer treatment effectiveness). As well as, these studies explore which groups will benefit the most from the treatment. Now that Medical Research studies are defined, are you covered by Medicare? The answer isn’t simple.
Starting in 2014, private insurance companies were required to pay for routine costs of care delivered in clinical trials. A number of states have already passed similar legislation. The Patient Protection and Affordable Care Act, describes "routine patient costs" in clinical trials that health insurers must cover as "all items and services consistent with the coverage provided in the plan that is typically covered for a qualified individual who is not enrolled in a clinical trial." This includes items such as hospital visits, imaging or laboratory tests and medications.
Analysis becomes more complicated when considering Local Coverage Determination, the policies written by local or regional fiscal intermediaries representing CMS and Medicare. This is where many of the pitfalls occur and where many institutions get lost, and also where state Medicare contractors make the majority of coverage decisions. A procedure or test may be covered in New York, but not California.
Does Medicare cover Clinical Research Studies?
In recent years, Medicare has issued several national coverage determinations providing coverage for services and procedures of a complex nature, with the stipulation that the facilities providing these services meet certain criteria. This criterion usually requires, in part, that the facilities meet the minimum standards to ensure the safety of beneficiaries receiving these services in order to be considered as a provider with the ability and expertise to perform the procedure. Being certified as a Medicare approved facility is required for performing the following procedures: carotid artery stenting, VAD destination therapy, certain oncologic PET scans in Medicare-specified studies, and lung volume reduction surgery.
Medicare partially covers certain qualifying clinical research studies. You’ll have to check with Medicare and CMS whenever you doctor or hospital thinks you would be a good fit for a clinical trial to make sure Medicare approves the study. While, Medicare Part A (hospital costs) and Part B (doctors’ visits and out-patient care) can partially cover your cost, you’ll still owe your Part A deductible and your Part B deductible, copays, and coinsurance. Having an adequate Medicare Supplement Insurance plan will significantly help pay for these gaps in original Medicare.
Remember Medicare does not cover all clinical research studies, but will pay toward these Clinical Trial Services:
- A hospital stay, even if you weren’t in a covered clinical research study.
- An operation to implant a device that is being tested.
- The care of side effects and complications resulting from the clinical trial.
Medicare Won’t Pay for these Clinical Trial Services:
- A new service or device, unless Medicare would cover the service or device if you weren’t in the study
- Services designed to only collect data and not used for your specific health needs.
Does Medigap Cover Clinical Research Studies?
Medigap plans fill in the gaps of Original Medicare; however, if Medicare does not cover the clinical trial, neither will Medigap. So, the answer is that Medigap will ONLY cover clinical research studies approved by Medicare. Most Medigap plans will cover all or part of your Part A deductible, and all will cover all or part of your Part B copays and coinsurance.
Does Medicare Advantage Cover Clinical Research Studies?
Medicare Advantage may cover a clinical research study. You will have to contact your Medicare Advantage provider to see how it and if it is covered.