Mandated Insurance Coverage for Phase I and II Clinical Trials

At present the Missouri State Senate is considering new legislation (SB 365), which means to provide health insurance coverage for Phase I and Phase II clinical trials for cancer treatment. The law in the state of Missouri presently limits mandated insurance coverage to Phase III and Phase IV clinical trials.

Aside from the fact that this bill makes no sense whatsoever, it highlights the ignorance of what Phase I or Phase II trials are intended to accomplish. SB 365 seeks to force insurers, non profit health services plans, or health maintenance organizations to treat Phase I and II trials as if they are treatment – beneficial to the patient – which they certainly are not.  Since neither Phase I nor Phase II clinical trials are deemed treatment, or have any reasonable expectation of any real benefit to the patient, it makes no sense to compel payment for claims unrelated to actual health care treatment. 

Phase I trials are used solely to determine levels of toxicity of the drug being investigated. Phase II trial try to determine if the drug being investigated has any effect on the underlying disease, in this instance, cancer. Prior law in Missouri did make some sense by requiring insurance coverage for phase III and phase IV clinical trials would be covered because of, at least, the opportunity of benefit the patient i.e. actual therapeutic treatment. 

The bill then, in contradiction of the scheme of clinical trials, requires that “available clinical or preclinical data must provide a reasonable expectation that the treatment will be superior to the non-investigational alternatives.” This is outright stupidity because by the nature of phase I and phase II clinical trials there cannot be any clinical or preclinical data that provides any reasonable expectation that there is any treatment, actual therapeutic care, that will be gained. The bill seems to suggest that the patient will benefit from coverage for “routine patient care costs incurred for drugs…” The proposed legislation, however, defines “routine patient care cost” are the necessary costs needed to administer the drug under evaluation in the clinical trial, not actual care and treatment that will protect the patient. Accordingly, this proposed legislation is a sham, forcing insurers to pay for investigational drug research being performed by pharmaceutical companies, government, biotech companies, academia and privately run (outsourced) clinical trial programs.  

      All costs for Phase I and II trials should be born by the research investigators, including all necessary medical costs for the patient’s underlying condition as well as care during the clinical trial and thereafter to the degree that treatment is related to ill effects or adverse reaction to the drugs or medical devices being investigated.

This proposed legislation is unconstitutional by interfering in the right of freedom of contract because it requires payment for things outside the purview of the insurance contact for actual medical, therapeutic treatment.            

Many states are considering, or have passed, similar legislation. For example in Arizona (SB 1213 2000) requires cost for patient care associated with clinical trials phase I through 4. Yet coverage is limited when no clearly superior non-investigational treatment exists. California has passed the same legislation limited to , “when no clearly superior non-investigational treatment exists.” The confusion here is that neither Phase I or Phase II trials are “treatment.”

Colorado (HB 09-1059-2009) requires a similar coverage, but only when the physician believes that the patient may benefit from the clinical trial and when the patient has a disabling progressive or life threatening condition.

Connecticut (SB 325-2001) mandates coverage, but only in Phase III clinical trials and only if they involve “therapeutic intervention.” This legislation makes sense because it is limited to instances of “therapeutic intervention.”

Similarly Delaware (SB 181-2001) mandates coverage only when the clinical trial provides “therapeutic intent and where the trial is not designed exclusively to test toxicity or disease pathophysiology. This would, therefore, exclude coverage of Phase I and Phase II trials.

Indiana (HB 1382-2009) is similar to the confusion of the Missouri bill because it requires cost to be paid for Phase 1 through phase IV cancer clinical trials – but only when there is no clearly superior non-investigational alternative care available, and when the clinical data shows that the care method used in the research study is likely to work as well as approved care. This condition may make sense in Phase III or IV trials but not feasible in Phase I or II trials.

North Carolina (SB 199-2001) has some interesting additions. Patients who are suffering from life threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs and insurers do not have to pay for “investigative” clinical trials. Similarly Wisconsin (AB 617-2006) limits insurers’ responsibility for payments when trials are intended to improve the participants’ health outcome and not designed only to test toxicity or disease pathophysiology – thus eliminating mandated coverage in Phase I and II trials.

The level of misunderstanding (feigned or actual) of the purpose of Phase I and Phase II clinical trials will have to be dealt with by the Federal Court of Appeals and possibly the Supreme Court to provide constitutional clarity as well as uniformity throughout the various States.

In addition to the confusion is a significant problem of giving credence to recruiting efforts Phase I and II cancer patients by giving the impression that Phase I and II trials are therapeutic and “paid for by your insurance company.” Informed consent is especially important in Phase II and II trials. These laws summarized above should not tend to lessen the requirement of detailed and well documented informed consent.

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