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Proposed Obamacare regulation could limit approved drugs to one per class

10:39 pm by | 3 Comments

Imagine being sick with a life-threatening disease. Most of us would want access to as many medicines as possible — including the full range of proven treatment options.

But under the Affordable Care Act, some people may see their drug choices severely restricted.

A draft regulation proposed by the Department of Health and Human Services would require insurers participating in the law’s new exchanges to cover only a single drug in each class of pharmaceuticals.

That could be a disaster for both patients and doctors. Those living with chronic conditions — think serious mental illness, HIV-AIDS, epilepsy, or kidney disease — would be hit particularly hard. “One-size-fits-all” may work for baseball hats, but medication requires a far more individualized approach. Doctors know that each patient responds differently to treatment. Patients need all the options they can get.

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That’s part of the reason Medicare’s prescription drug benefit has been so important. Medicare Part D requires participating plans to cover at least two different drugs in most every class of pharmaceutical — and nearly all drugs in six important classes: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics.

Medicare Part D’s requirements were designed to ensure continuity and access for vulnerable patients. Its rules should be a model for the new regulation.

Similar drugs within the same category can have dramatically different results among patients. A drug that works for your neighbor might not work for you

Choice works in tandem with innovation to give patients the best chance of recovery. Requiring insurers to cover just a single drug in each class would likely cause many to skip covering new drugs, even if they represent clinical improvements in efficacy and/or safety.

This issue is especially important for the mental health community. Diagnoses in serious mental illness remain imprecise. It is not uncommon for a patient to receive multiple inaccurate diagnoses over several years before being correctly diagnosed and receiving effective treatment.

Persons with depression, bipolar disorder, or schizophrenia don’t always respond to their first or second rounds of treatment — and often require multiple attempts with multiple combinations of medications before something finally succeeds. There’s no way of knowing in advance exactly what will work. This is why doctors and patients need all available options.

Research into drug access for Medicaid beneficiaries starkly illustrates the problem of restrictions on medicines. According to one recent study, psychiatric patients with medication access issues had three times the rate of suicidal thoughts and behavior. When these patients were forced to switch drugs because of a lack of coverage, they reported far higher rates of hospitalization, homelessness, and incarceration.

When it comes to prescription drug coverage, what patients need most is access and choice.

The Department of Health and Human Services understands this issue. Indeed, this same draft regulation about the healthcare law’s exchanges contains strong language ensuring “mental health parity,” which requires insurers to cover both mental and physical health equally. Prescription drug coverage should not fall short of this standard for equitable coverage.

The Department of Health and Human Services is expected to make its final ruling on drug access in the insurance exchanges within the next two weeks. Between now and then, it’s imperative that Department officials revise this regulation to protect patients.

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By Michael Fitzpatrick, MSW

Michael J. Fitzpatrick is executive director at NAMI, the National Alliance on Mental Illness. Prior to taking that role in January of 2004, he served both as the director of NAMI's Policy Research Institute and as NAMI's national director of policy
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