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Experimental / Investigational

By December 3, 2013 No Comments

In a previous blog (April 23, 2013) the multiple definitions of “Medically Necessary” were discussed.

In this blog some of the various definitions of “Experimental/ Investigational” will be reviewed.

The relationship between “Experimental/ Investigational” and “Medical Necessity“ is crucial since many definitions of medicinal necessity, as noted in the past blog,  exclude medications, procedures, or devices which are considered Experimental /investigational.

Just as the meaning of “Medical Necessity” varies, there are multiple specific definitions of “Experimental/Investigational.”

An Internet search will reveal multiple definitions. The AMA website has no specific definitions of Experimental /Investigational.

Many insurance plans have their own definitions,

Here are a few excerpts:

“Surgical procedures or medical procedures, supplies or devices, or drugs which at the time provided, or sought to be provided, are in the judgment of The Plan not recognized as conforming to accepted medical practice or the procedure, drug, or device:

  • Has not received the required final approval to market from appropriate government bodies;
  • Is one about which the peer-reviewed medical literature does not permit conclusions concerning its effect on health outcomes;
  • Is not demonstrated to be as beneficial as established alternatives;
  • Has not been demonstrated to improve the net health outcomes; or
  • Is one in which the improvement claimed is not demonstrated to be obtainable outside the investigational or experimental setting.
  • Phase I, II, or III clinical studies are considered investigational and are not covered.”

Another plan defines “Experimental, or Investigational,”

As “services, supplies, care, and treatment that do not constitute accepted medical practice.”

“When determining whether or not a procedure is Experimental or Investigational, the Plan will take into consideration appropriate medical practice under the standards of the case and by the standards of a reasonably substantial, qualified, responsible segment of the medical community or government oversight agencies at the time the services were rendered.

The Plan must make an independent evaluation of the Experimental/ non-Experimental standings of specific technologies.  It will be guided by a reasonable interpretation of the Plan provisions. The decision will be made in good faith and rendered following a detailed factual background investigation of the claim and the proposed treatment.”

This specific plan then goes on to list several guiding principles:

“The drug or device cannot be legally marketed without approval of the FDA, and such approval has not been given

The drug, device, medical treatment or procedure or the patient informed consent document was reviewed and approved by the treating facilities Institutional Review Board.

Reliable Evidence shows that the prevailing opinion among experts regarding the drug, device, medical treatment or procedure is that further studies or clinical trials are necessary to determine its efficacy compared with a standard means of treatment or diagnosis.”

Like so many issues in medicine, “Medical Necessity” and “Experimental/ Investigational” are difficult to define.

Not everything, which is considered “Non-Experimental/ Investigational”  has been proven by double blind, controlled, randomized studies.

Consider the case of the diagnosis of acute appendicitis. In the past this was a clinical diagnosis. However in recent years it has become largely a radiologic diagnosis. It’s treatment with an appendectomy is not considered “Experimental/Investigational” in the United States.  And yet there have never been controlled studies in the U.S. to validate this treatment.

Although this treatment will probably never be studied in randomized, controlled studied in the United States, it has recently been studied and validated in Scandinavia.

A number of plans each have their own specific definition of Experimental/ /Investigational. Some are more specific than others. Some are more exclusive than other plans. Therefore we ask our reviewers to review the cases according to the specific plan definitions of E/I if relevant. It is very important to make it clear if specific treatment is excluded from being “Medically Necessary” if it is considered “Experimental/ Investigational” by the plan.

If no plan language definitions of Experimental/ Investigations are provided, the following generic definition may be provided to our reviewers.

“If no policy language is submitted, base your review on the following generic experimental / investigational language. Experimental or Investigational means;
1. The treatment is not commonly recognized in the medical profession as proper care or treatment; and
2. The usefulness of the treatment has not been recognized by the appropriate technological assessment body established by the state or federal government having jurisdiction.”

Since plans vary, it is very important to for our reviewers to pay close attention to the plan language and plan definitions of the plan in question. It is also important for our clients to supply specific definitions of Experimental/ Investigational by which they would like the specific treatment, procedure, device or medication to be evaluated.

 Bennion D. Buchanan, MD, MBA, FACEP

 MRIoA Medical Director

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