At this point, employers may be intimately familiar with many of the provisions of the Affordable Care Act - coverage until age 26, no exclusions for pre-existing conditions and others. But one clause that may have escaped the attention of benefit managers relates to experimental treatments and medications - if you weren't covering clinical trials, odds are you might have to now.

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. While that by itself may not mean deep changes for most employer-sponsored health care plans, many of those medical studies say they will cover related expenses that aren't already taken care of by existing insurance - a convergence-of-care issue for even well-designed plans.

The firm Proskauer Rose's Ellen Moskowitz, a New York-based expert in health care law, and Stacy Barrow, a Boston-based employee benefits expert, spoke with EBN about what this ACA provision means for employers and their employees who may be seeking experimental care.


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 [and] 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.

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.

Barrow: The plan has to keep on providing the items and services it typically provides. What it can exclude is the item or device itself, and I think there's another exclusion for services that are not consistent with standards of care in the diagnosis.


Is it possible that clinical trials could try to reformat as a result of these changes and get insurance companies to cover more of the cost?

Moskowitz: I think that's unlikely. I think as a practical matter, many states already have guidelines to cover clinical trials. .... It's a very compelling situation; often you have extremely sick patients. A doctor will offer an opportunity to enroll in a clinical trial, and it's often the case that patients and their families will want to take advantage of whatever options are available. The other side of the coin, though, is that experimental treatments are experimental, which means that their benefit has not been proven. So, on the one hand, you want to support patients who have life-threatening illnesses, but ... there are ethical issues and issues of quality-of-life for patients involved in these trials. And then there is the basic issue of what is appropriate for an insurance company to cover.

I believe that many employers are already grappling with this issue. The practical question is going to be, first, am I grandfathered? And secondly, what do we do now? What are the benefits we're providing to our employees - which are insured, which are self-insured? Does our plan design cover access to benefits in the context of a clinical trial?

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 that 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. You don't see that kind of requirement in Medicare, for example, 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 as relates 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.

My own belief is this federal law may extend some coverage in places where there hasn't been coverage before, but it's going to be a complicated assessment by employers as to whether or not this is going to change what they now do. They're going to have to work closelyas with their third-party administrators and with their insurance companies to see if this affects them.

Barrow: This rule applies to all group health plans, the large and small, the insured and self-funded, with the exception of grandfathered health plans and other types of benefits that have been considered excepted. This is one of the reasons we were mentioning early on that a plan may want to retain grandfathered status, because it's really hard to estimate what the cost increase might be due to coverage of these clinical trials. The carriers have done a great job of letting their employer-clients know what some of these rules will result in in terms of premium changes, but I haven't seen any estimates into what kind of increase an average plan could expect to see based on this requirement.

Can a plan require that a participant go through a medical trial with a provider of their choice? Can they insist on naming the venue?

Barrow: To a certain extent a plan can require that a participant use in-network services, if there is an in-network provider that is willing to accept that individual as a participant. But if the plan also does provide coverage for out-of-network services, to the extent that there is not an in-network provider available, then they still have to cover the routine costs incurred out-of-network as well. ... One final other thing from the health plan standpoint is that the agencies don't intend to issue regulations on these rules - they're considered to be self-implementing, so basically the plan administrators are supposed to follow what could be seen as reasonable interpretation of that.

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