THE FATAL contamination of drugs at the New England Compounding Center last year showed that the US Food and Drug Administration and state agencies must do a better job monitoring the manufacturing of compounded drugs — medications mixed for patients who need formulations or doses generally not available off the shelf. Nonetheless, insurer Harvard Pilgrim Health Care’s decision to end coverage for compounded drugs for adults as of Wednesday could impede patients’ access to drugs they need. The categorical nature of the move should be reconsidered.
Children’s drugs will be excluded from the ban; most compounded drugs prescribed to patients under age 18 are FDA-approved medications in smaller doses or liquefied form. But that’s not true for the compounded drugs used by adults: A Harvard Pilgrim report found that most compounded drugs prescribed to its adult patients were more discretionary — such as anti-aging treatments or cosmetic remedies that lack FDA approval. Thus, Harvard Pilgrim argues, patients won’t suffer medically from no longer having such medicines covered, especially given the inherent risks of compounded drugs.
But Harvard Pilgrim’s move doesn’t seem to be based entirely on safety. From 2011 to 2012, the insurer saw a 171 percent jump in claims for compounded drugs and a threefold rise in costs, according to its own study. Clearly, it hopes to put a stop to the spiraling outlays. But not every compounded drug is medically unnecessary: Having an overall ban, in the name of safety but also to cut costs, goes too far.
Harvard Pilgrim has said it will make sure medically necessary treatments will be covered, through an appeals process that, the insurer vows, will be clear cut and take no more than one business day. Harvard Pilgrim is right to make generous exceptions to its new policy. But it would make better sense to set more nuanced rules to begin with.
quoted from here
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