This website provides information about the authority and exclusion activities of the OIG. The OIG has the authority to exclude individuals and entities from federally funded health care programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Excluded individuals cannot receive any payment from federal health care programs for the items or services they provide, order, or prescribe. This includes those that provide health benefits funded directly or indirectly by the United States (other than the health benefits plan for federal employees).
The Office of the Inspector General (HHS OIG) of the U.S. Department of Health and Human Services may exclude a health professional or entity from participating in Medicare, Medicaid, or other federally funded health care program by virtue of the authority granted to HHS in the Social Security Act. Exclusions can be mandatory or permissive. Participating in a clinical trial to treat a potentially fatal disease may offer a treatment option when other treatments have failed.
However, the routine costs of clinical trials are not services covered by Medicare Advantage plans. If you participate in an approved clinical trial for a condition, such as cancer, that meets Medicare criteria, the plan will not pay for any services or items that are provided solely for the trial. These excluded costs may include doctor visits, hospitalizations, tests and medications related to the trial. You will be responsible for any routine care costs that are not covered by the clinical trial sponsor. With Original Medicare, these clinical trial costs would be covered. However, with Medicare Advantage, you may incur significant expenses that aren't covered.
When Medicare makes national coverage decisions that qualify a certain procedure or technology as experimental or under investigation, Medicare Advantage plans also deny coverage for experimental services, as does Original Medicare. This could include some cutting-edge interventional techniques, medical devices, and diagnostic tests that are still undergoing clinical trials and approval processes by the FDA.
