It’s easy to criticize the regulation of medicine these days. No really, it is. There is so much material to choose from. And it frankly doesn’t much matter whether this regulation comes from the private sector or the government. Most of it is very, very poorly done. It defies logic. It defies common sense. It increases costs. It decreases quality. It makes people sick or sicker or even kills them. It disrupts clinicians and nurses who have actual work to do. And all for little or no benefit. You could get rid of it all tomorrow and no one – except the people doing it – would shed a tear.
Just before the recent holiday weekend a colleague of ours wrote a prescription for a diabetic patient for glucagon. Glucagon is a hormone that, when injected, raises blood sugar levels. Insulin-dependent diabetics will always want to have a syringe of glucagon around in case they either give themselves too much insulin, or are unable to eat on time after taking their usual insulin dose. If this happens their blood sugar can go too low and they can go into a hypoglycemic coma or even die. The advantage of glucagon is that it will raise blood sugar levels even if the patient is unconscious and unable to take food or a glucose tablet. It can be administered by someone else who happens to be around, but not in a coma. So a good, competent physician will always make sure that having a syringe of glucagon around is always an option for their insulin-dependent diabetics. It’s one of those true “quality” things, even though it’s not on any “quality of care” checklist that we’re aware of from the government or insurance companies.
As it happens so often these days, the private health insurance plan that the patient in question had requires that any brand-name medications be pre-authorized by the insurance company, and our colleague’s prescription for glucagon was rejected by the pre-authorization system. (As it happens, there really is no generic version of glucagon – just two brand-name versions made by Eli Lilly and Novo Nordisk. It’s not that the drug is patented; it’s just that the market isn’t big enough to support the research and manufacturing costs that a generic producer would have to incur to make it. It’s actually a fairly complex drug to produce, and is typically sold for about $100 per injection. That’s actually not so bad when one takes into account that patients just have to have one around for emergency use.)
Nonplussed, our physician colleague was forced to take the time to call the insurer to ask why the prescription request was rejected. The conversation went like this:
Physician: “I’m calling about a prescription for glucagon for Mr. Jones that you rejected. I’d like to know why this was denied. His name and policy number are blah, blah, blah.”
Insurance company denial officer: “You didn’t send a justification for why this patient needs this drug. We don’t know why it’s being used.”
Physician: “There is only one use for this medication. It’s to treat hypoglycemic in diabetic patients. Mr. Jones has had Type I diabetes for the past 20 years. There is no other possible explanation.”
Insurance company denial officer: “Okay. In that case it was probably denied because you prescribed it as an injection. We need you to try the oral or topical form first.”
Physician: “There is no oral or topical form of this drug. It only comes as an injection, and it’s to keep the patient from becoming brain damaged or dying.”
Insurance company denial officer: “In that case I’ll need you to send me the records so I can show them to the nurse, and she can decide whether to approve it or not.”
Physician: “A nurse needs to approve my request for this drug? Do you have any medical knowledge or training whatsoever?”
Insurance company denial officer: “No, but I follow the guidelines that the computer provides to insure that patient are receiving quality care at the lowest possible cost.”
Physician: “Please let me talk to the nurse.”
After spending roughly 30 minutes of uncompensated time trying to find someone with enough common sense and medical knowledge to approve the prescription, our colleague hung up the telephone angry, exhausted and in no mood deliver kind, appropriate and compassionate care. Or really any care at all. The prescription was approved, but it felt more like a defeat than a victory. Why do we bother training doctors if they have to justify their decisions to regulators who wouldn’t know a shot of glucagon if it poked them in the derriere? What the heck is all this hogwash about being licensed and certified, if the decision really is in the hands of a high school graduate who is simply reading instructions off of a computer screen? This isn’t “quality”. It’s a joke.
Just who is regulating the regulators? No one. And it’s destroying the efficiency, economy and quality of the healthcare that is being delivered every day. You might as well place plumbers in charge of air traffic control, or ballerinas in charge of military operations in Afghanistan and South Korea. It makes just as much sense. Just hand them computers that give them “guidelines” that they’ll use to keep airplanes apart and soldiers supported by air strikes.
Another endocrinologist, Dr. Richard Dolinar, recently wrote quite eloquently about this topic in the journal Endocrine Today.
Once upon a time, not so long ago, I used to be a doctor…
I used to order medications, therapies and hospitalizations for my patients.
Now, I request them, beg for them, cajole for them and often await prior approval authorizations from people at 1-800 telephone numbers. Some of them are doctors (although this is usually the exception), some are nurses, others are high school graduates and some, for all I know, might even be high school dropouts. Most are usually sitting in front of a computer screen as they attempt to determine the “appropriate care” for my patient, whom they haven’t ever seen, talked to or examined. As they attempt to dictate to me what drugs will be used on my patients, the exchanges can be telling. Today, for example, my office staff was told that I needed to use a lower dose of exenatide extended-release for injectable suspension (Bydureon, Amylin) or it would not be covered. How am I to use a lower dose of a medication that only comes in one dose?…
I used to go to the nurses’ station, and there actually was a time when nurses would offer their chair to the doctor. That was back in the days of the 8-hour nursing shift.
Now, many of those chairs are used by ex-nurses employed by third-party payers checking on the patient’s status. They sit, taking up critical space at nurse stations, which are often very cramped and crowded to begin with. They have “important” sounding names such as “insurance liaison,” etc. I call them “checkers,” and to this day, continue to wonder, “Who checks the checkers?”
I used to treat diabetic patients as their situations indicated, being careful not to use medications in “contraindicated” ways.
Now, I am told that hypoglycemic drugs are “not indicated” combined with each other unless clinical studies have been submitted to and approved by the FDA for such use. And third-party payers will not pay for them because they are not indicated, even if they are effective and not contraindicated. But what about using any hypoglycemic medication with any lipid-lowering medication or any hypertensive medication? Every time we use more than one medication on a patient, aren’t we usually using a combination that has not been evaluated or approved by the FDA and is, therefore, not indicated? Should we therefore not use it? Should we advise our chronic obstructive pulmonary disease patients to stop their inhalers because we want to start a hypoglycemic agent? Should we tell our cardiac patients to stop their cardiac meds because we want to start a statin? Why is it that only the glucose-lowering medications are held to this standard? Why aren’t various combinations of blood pressure pills or lipid agents held to the same?
It is, indeed, “Who checks the checkers?” is one of the key issues in American healthcare today. Who checks the regulators who make these idiotic and counterproductive rules? Who checks the Congressmen, who are (and we’re not making this up) less trusted by their constituents than telemarketers or car salespeople.
Because if these people are not honest-to-goodness experts in healthcare delivery, medical treatment and medical economics, they have absolutely no business being allowed to come within 50 miles of you, or your doctor, or your joint patient-doctor plan for managing your medical conditions or those of your family.
That’s a law/regulation that would be truly worth making.
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