While employers are busy today taking into account the delay for mandatory employee coverage, another Affordable Care Act provision is still set to take effect Jan. 1. Starting next year, the health care reform act holds that a “qualified individual” cannot be denied coverage by a plan for “related services” from an “approved clinical trial.”

Ellen Moskowitz, a health care expert with the law firm Proskauer Rose, tells EBN that, while most insurance already covers medical trials for life-threatening conditions, there may be issues with convergence of care, and that benefits leaders should carefully review their policies.

EBN: What changes are coming to clinical trials in employer-sponsored health plans?

Moskowitz: As of Jan. 1, the Affordable Care Act is requiring employers with self-insured plans — that in the past were not affected by state insurance laws dealing with mandated benefits — to cover certain routine costs associated with certain clinical trials. The law sets a floor, not a ceiling, so the numerous state insurance laws that address coverage of routine costs for clinical trials still apply to the extent their coverage is more generous than the coverage described in the federal law. Those state insurance laws don’t touch self-insured plans, but many employers will have a combination of insured benefits, self-insured benefits, so again, the bottom line is that there’s a new requirement to think about when employers are considering their plan designs, and it reaches certain routine costs of clinical trials that in the past may not have been covered by applicable laws.

EBN: What kind of routine costs are we talking about? What’s covered now that wasn’t before?

Moskowitz: That is a very complicated question. Most states have laws mandating the routine costs of clinical trials or in other ways touching on coverage for clinical trials, and these laws are sometimes voluntary agreements for insurance providers. For example, New Jersey has an agreement in place with insurance providers to cover certain costs associated with cancer treatments, depending on your diagnosis. Other states don’t have specific laws covering clinical trials, but if a particular treatment or course of care has benefit for a patient, it ought to be covered by insurance companies. For example, New York is a state like that.

One of the questions is, what’s a routine cost? The easier question is, what isn’t a routine cost? And that is usually the cost of the study, drug or device – that wouldn’t be considered something that an insurance company would pay for.

EBN: Has guidance been issued for standards of qualification? Do these trials have to be measures of last resort?

Moskowitz: The federal law is interesting in that it says in order to have access you have to have a life-threatening condition, and that’s a condition for which the likelihood of death is probable unless the course of the disease or condition is altered. That kind of requirement, for example You don’t see [that requirement] in Medicare, which allows coverage for disabling conditions. [Many state plans follow Medicare on clinical trials.] The types of trials are very similar to what you would normally see – some kind of standards relating to the results of the trial, some way to know things are being handled scientifically….

Where this gets more complicated, and where the federal government has started to grapple with this more, is what about when a study sponsor agrees to cover subject injuries? If the protocol was followed, but the subject was injured – does the study sponsor cover that cost? Many clinical trials will say: ‘Study sponsor will cover the cost only if insurance doesn’t cover it.’ … Medicare has made it very clear that they’re only going to cover it to the extent that the study sponsors don’t. Well, does that mean that study sponsors are now going to not agree to cover subject costs? That raises ethical issues.

Watch the August issue for more on what changes to clinical trial coverage mean for employer-sponsored health care plans.

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