The Obama Administration Gets Into the Pre-Approval Business: "Coming Between You and Your Doctor"

Unless you are a national T.V. reporter, vacuous socialite Paris Hilton or a leading official in the Obama Administration, you probably already know that health insurers do not deny coverage of medical services based on cost. Instead, payment (or non-payment) for healthcare services is based on an assessment of "medical necessity," which, in turn, is ultimately determined by published evidence, expert opinion, clinical guidelines and national standards of care (here's an example). Once what is covered is known, it's a matter of knowing the unit charge and expected utilization and rolling that up into the insurance benefit design and the price of the premium. From time to time, insurers may require knowing if the medical treatment fits the science. That can be complicated and can be a source of insurer mischief. Doctors and patients can get tangled up in differing interpretations of a policy. Ultimately, however, the often derided "insurers coming between you and your doctor" is typically a function of thought, not thievery.

Well, thanks to this summary, courtesy of the New England Journal of Medicine, we are now witnessing an intrusion of the Federal government into the decision-making between doctors and their patients. Aside from a problem with occasionally killing patients, Avandia remains an important option in the treatment of diabetes. It's possible for a doctor and a patient to weigh the benefits, risks and alternatives and correctly mutually decide to use it. Their problem now, however, is that they'll need to seek permission. According to the Journal, the Food and Drug Administration's "Risk Evaluation and Mitigation Strategy" (REMS) will require the following prior to obtaining approval to use the drug:

"Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns"

The Disease Management Care Blog points out that the FDA is doing this because of two reasons 1) it's science-based and 2) using that science to come between a doctor and a patient works. So, the DMCB says "welcome to the managed care club" to the FDA and the Obama Administration.

By the way, the better health insurers typically strive to streamline this kind of pre-approval process by making toll-free lines available 24-7 or using web portals with data entry fields that can be completed in minutes. The DMCB hopes the FDA sets up a similar process for Avandia. Doing this by paper promises to be a bureaucratic nightmare.