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Archive for Hellth on Drugs

Aug
18

Exactly Who Are Hospitals Serving With Their Formularies?

by Dr. Doug Perednia

Here at the Road to Hellth, we’re normally all for letting the free market work whenever possible, but it’s important to remember that for markets to work properly there are certain pre-conditions.  First, the economic relationship between businesses and their customers has to be relatively clear.  For example, when a patient goes to a hospital, exactly who is the hospital supposed to be serving?  Is it the patient who has the disease or the insurance company paying the bill?  Second, working markets require that critical pieces of information, like prices, services and certain pieces of fine print, be relatively transparent.  It does no good to comparison shop for price, only to find that the goods and services you’re receiving aren’t equivalent. Third, there have to be enough competitors in the market to produce actual competition.  One reason American healthcare seems to be in such miserable shape is that one, two or even all three of these preconditions are absent in many cases.  This is generally bad news for all of us who happen to be patients at one time or another.  As the “little guy”, we’re typically the ones with the least information, the least amount of leverage and the most to lose during any brush with the healthcare system.

One example that came to our attention recently has its roots in the absurd amount of power that hospitals have come to wield over the patients and clinicians that, (at least back in the good old days), they are supposed to be serving.  Look at any advertisement these days for a hospital or healthcare system, and you’ll see these institutions portrayed as big teddy bears: all fuzzy and warm, caring for you as an individual and sporting the best doctors, equipment and procedures money can buy.  All of which makes it truly bizarre when they go ahead and screw us on the little things.

One of those little things is the hospital’s medication formulary; the assortment of medications that hospitals choose to carry in their inventory for use in treating patients.  It used to be that hospitals made an attempt to stock just about every drug that might reasonably be used for taking care of patients.  If you were admitted to the hospital on Chiquita Bananatol and your admitting doctor wrote that you were to get Chiquita Bananatol, the hospital pharmacy would send up exactly what the doctor ordered.  No pussyfooting.  No second guessing your doctor.  From a clinician’s perspective, it was nice to know that your patients would get exactly what they were supposed to get.  Actually, it was nice from a patient’s perspective as well.

Things began to change a bit around 20-30 years ago when money started to get tight, generics became more readily available and the cost of medications became increasingly important to insurance companies.  Instead of filling prescriptions as written, hospital pharmacies began to replace brand names with generics that were (supposedly) equivalent to the original drug.  Most of the time they were, but hospitals and pharmacies were never so pushy as to completely reverse a physician’s orders and replace one brand name medication for another.  At least until now.

Welcome to the Insulin Wars.  As many of you probably know, insulin is a hormone that is naturally secreted by the pancreas to regulate the amount of sugar in the bloodstream and allow individual cells to get the energy they need to live.  Diabetes is caused either by an inability to make insulin, or insulin resistance that makes a given amount of insulin considerably less effective.  In both situations excess amounts of sugar tend to stay in bloodstream.  Over the years this can cause considerable damage to the kidneys, eyes, heart, nervous system, and just about every other organ system.  All of these complications have made good blood sugar control a high priority for just about everyone involved.

For many years now, all Type I diabetics and a large percentage of Type II diabetics have been treated with injections of man-made human insulin.  One peculiarity of the insulin market is that there are essentially no generics; apparently the technical requirements for manufacturing human insulin are sufficiently complex that it can’t easily be knocked off by cut-rate generic producers.  Another interesting aspect of insulin is that it is continually being refined and improved to make dosing easier and more efficient.  Ordinary insulin made by the pancreas has a half-life of 4-7 minutes, (i.e., only half of a given amount secreted is still present after that time).  By manipulating the chemistry of how the insulin is formulated and packaged on a molecular level, it has been possible for drug companies to create varieties of insulin that range from very short-acting “meal time” insulin to long-acting “basal” insulins.  The invention of a long-acting once per day insulin called Lantus® by Sanofi-Aventis was a particularly important development because it allowed for much simpler and more efficient dosing in many people.  Most patients aren’t very sophisticated about how drugs work and how the various types of insulin should be combined, so it was a big deal to tell people that they could get one shot per day of a long-acting insulin, and then just cover their meals with small amounts of short-acting insulin.  Approved by the FDA in 2000, sales of Lantus® rapidly rose to $5 billion annually.

With that kind of money at stake it wasn’t long before a big league competitor entered the field in the form of Novo Nordisk, Inc.  Novo entered the field in 2005 with a competing basal insulin called Levemir®.  They then began aggressively selling to hospitals in an effort to displace Lantus®.  Specifically, Novo would frequently offer to give hospitals a good deal on Novo’s entire line of long and short-acting insulins, but only if those hospitals then agreed to dump all other brands of insulin from their formularies.

This is where the plot thickens.

Hospitals wanting to please insurers and protect their own bottom lines by saving on insulin costs soon began to take Novo up on their offer.  By changing their formularies they exiled Lantus® to the local outpatient market and substituted Levemir® for Lantus® whenever patients were newly admitted.  In institutions that employed hospitalists, this was as simple as telling their doctors to make the switch when they wrote their admitting orders.  Other hospitals would have their pharmacists call the admitting physicians and ask them to make the change, or else.  Or else what?   Or else their patients wouldn’t have a basal insulin to use during this admission, and they’d better not try to bring in their Lantus® from home.  “Hey,” the reasoning goes, “they’re both long-acting insulins.  If you don’t like Levemir®, switch ‘em for the period of the admission, and then switch ‘em back later when you discharge them.  Shut up and deal with it.”

But here’s the problem: Lantus® and Levemir® aren’t really interchangeable in the same way that a generic drug and its original brand name are simply version of the same compound made by different manufacturers using a similar production process.  Instead, Lantus® and Levemir® are completely different medications with different formulas, mechanisms of action, durations of action, dosages and side effects.  So when a patient who had previously been on Lantus® is discharged, someone (hint, someone other than the hospital) is going to have to go to a substantial amount of time and trouble re-adjusting their dose of Lantus®.  In effect, the hospital has changed the patient’s familiar drug for an unfamiliar one solely for monetary reasons, and then dumped the cost of changing them back on someone else in the healthcare system.

And then of course, there’s the issue of thoroughly confusing patients.  Many patients who have been on Lantus® for years have a hard time understanding that Levemir® and Lantus® are completely different drugs that do roughly the same thing.  There are any number of examples in which patients who have been discharged by the hospital on Levemir® dutifully re-started their Lanus® once they get home.  Needless to say, this resulted in very low blood sugars as a result of taking both long-acting insulins at the same time.  Once again this has to be sorted out and treated by the patient’s regular physician at a cost of time, money and potential complications that dwarfs any possible cost savings the hospital might have achieved in making the switch.

While some might claim that this sort of thing is exactly why the world needs Accountable Care Organizations to “coordinate” care between the hospital and outpatient clinics, this logic is rather disingenuous.  Fans of ACOs argue that when inpatient and outpatient facilities are controlled by essentially the same people, they’ll all standardize on the same medications.  This might be true, but completely misses the point with respect to patient care.  What happens when the makes of Lantus® come back with a better deal?  Are ACOs going to give all of their patients whiplash switching them back from Levemir®?  What happens to a new patient moving in from out of town?  Are they going to have to completely change their medical regimen and turn their lives upside down to please the bean counters and purchasing agents in the hospital administration?

What we have here is clearly the result of a market failure, combined with what we would characterize as some questionable patient care ethics on the part of the hospitals involved.  Consider the following:

  • Clearly there is not enough competition among hospitals if administrators can afford to take such a cavalier attitude toward patients and the clinicians who refer them.   Given the choice between two otherwise equal hospitals, who the heck would put up with this kind of hassle?
  • If competition in the hospital world is limited, transparency is all but absent.  Aside from a few endocrinologists and the patients who have suffered from this “we’re not about to carry the drugs you want to use” policy, who in the healthcare market even knows that this issue exists?  Still worse, how would they find out?  It’s not the sort of thing that newspapers – if your town still has a newspaper – tend to report on these days.  If you expect to find it in those hospital advertisements, don’t hold your breath.
  •  Exactly who are hospitals really serving with policies that deprive patients of the specific drugs they’re used to and happen to work for them?  This is clearly one of the biggest problems with the existing insurance system: providers aren’t working for patients; they’re working for the various public and private insurance companies who pay them.  Apparently insurers don’t care how many patients or providers’ lives are disrupted by formulary manipulations as long as hospitals promise them “savings”.
  • Finally, while everyone can applaud the innovation and competitive spirit portrayed by Sanofi-Adventis and Novo Nordisk, it strikes us as being just plain wrong that hospitals should choose to offer only one product or another, when doing so is clearly not in the best interest of a population of patients that routinely uses both drugs and benefits from both of them.  They are completely different compound; this is not a case of “six of one, half dozen of the other”.

The healthcare market needs to work better than this.  Much better.

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Categories : Ethics, Healthcare Policy, Hellth on Drugs
May
11

This Is Your Insurer On Drugs

by Dr. Doug Perednia
Sign of Denial

I am hereby declaring this the international symbol for denying public and private health insurers the right to make stupid coverage denials. God knows we need one.

I get far more absurd stories of healthcare system screw-ups than I have time to write up and post.  This is a shame.  As Joseph Stalin once said, “quantity has a quality all its own.”  If it were somehow possible to publish every story about stupidity, politics and incompetence in the funding and administration of healthcare services, the sheer size of the document would become a modern Wonder of the World.  It might even motivate our political Leaders to take some useful action to simplify and streamline the rules and regulations that are currently overwhelming patients and providers.

Which leads us to ask of the health insurance administrators who are making up these rules: “What are those guys smoking?”

Our story this week comes from a colleague whom we’ll call “Dr. Despair”, because that’s how he felt after going around and around with the medical guidelines-keepers at Providence Health Plan here in the Pacific Northwest.

One fine day last month, Dr. Despair got it into his head that a patient of his might do better and avoid the expensive long-term complications of diabetes (which include such attention-getters as blindness, kidney failure, heart attacks, amputations, leg ulcers and strokes just for starters) with a non-generic drug.  Good control of a diabetic’s blood sugars is one of the key “quality” measures that politicians and healthcare administrators like to mandate for doctors.  They generally do this by offering to punish physicians who don’t regularly check a key measure of blood sugar control called hemoglobin A1c (Hgb A1c).  Some day they’ll probably get around to punishing doctors for not having the Hgb A1c measurements within the normal range of 4% to 6%, but that would require the physician to be accountable for patient compliance.  However this is probably still a few years away under the our nation’s new healthcare reform law.

This particular patient (whom we’ll call Myrna), had been working very hard with Dr. Despair to achieve good blood sugar control for a long time.  She had been checking her blood sugars regularly, and was giving herself multiple doses of insulin each day in an attempt to keep her sugars down.  Despite all of their best efforts, it wasn’t working.  Her blood sugars were still high after dinner, but when she increased her insulin to reduce them her blood sugars would fall too low.  She went on an insulin pump.  This gave her very fine control of her insulin usage by allowing her to adjust it five or more times each day, but her Hgb A1c  still would not go below 7.5%.  After lots of calls and consultation with Dr. Despair (who happens to be an expert of some note on the treatment and control of diabetes), Dr. Despair decided that she would benefit from a modern diabetes drug called Symlin.

Symlin is an man-made version of a hormone that the body makes called amylin.  Amylin is released by the pancreas, and has the triple effect of making one feel full (thus reducing the amount patients tend to eat), reducing the amount of sugar released by the liver and slowing the release of food from the stomach.  These affects tends to even out blood sugar levels after meals, and is exactly the sort of thing that Myrna needed.

Cue the administrators.

Because Symlin is a relatively new drug with no generic equivalent, Dr. Despair had to submit a prior authorization request to Providence in order for them to cover the medication for Myrna.  He dutifully wrote up the request and sent it to the Pharmacy Unit of Providence Health Plan, along with a description of the problems that that patient had that justified the use of Symlin, a copy of Myrna’s medical records and her laboratory results.

Five days later,  Providence Health Plan (their featured advertising catch-phrase: “Your Health, Your Health Plan, Together!”), faxed Dr. Despair the following missive:

PHP Simlin Denial Fax

Say what?

Dr. Despair, who gets dozens of these sorts of responses from health insurers each week, took time off from seeing his patients to go over each point of the rejection and make the notes that you see along the bottom.

  • The patient needs to be on multiple adjustments of insulin each day?  Check.
  • The patient has to have a Hgb A1c greater than 7% and less than 9%?  Check.
  • The drug request is still denied?  It figures.

Dr. Despair wrote and asked Providence to reconsider in light of all of their requirements being met.  Soon after, the good doctor received another letter saying that the drug request had again been denied because Myrna did not meet the insurer’s criteria for allowing its use.  He was offered the opportunity to take yet more time to file a grievance protesting the decision.

Obviously when your health and your health plan get together, it means that your health is going to take a beating.

Of course Dr. Despair is not being paid for any of these efforts on his patient’s behalf.  Quite the opposite.  He is incurring lost revenues and additional administrative overhead expense in exchange for the privilege of trying to ensure that her patient receives appropriate care, and has the best possible chance of avoiding all of those expensive complications that insurers and the government claim that they would like to stamp out.  Undaunted, Dr. Despair called the phone number listed for to reach a “clinical reviewer” at Providence.  After spending roughly 25 minutes in a phone tree and on hold, he finally gets to speak with a person.

“Hello,” said Dr. Despair.  “I’m calling about a denial of Symlin for patient Myrna Crabtree.  Her record number is 123456798”

“How can I help you?”, asked the voice on the phone.

“Well I can’t understand why this drug has been denied.  She seems to meet all of your criteria for approval.”

“You’ll have to send her records.”  Dr. Despair knew that one was coming.  Insurance folks always ask for more records.  It saves them the trouble of making a decision.

“I DID send her records.  She’s on an insulin pump.  She’s tried many different does of basal and bolused insulin, but is still running high after meals.  Her Hgb A1c is 7.5%.  She’s a perfect candidate for this drug.  What’s the problem?”

Dr. Despair was met with silence on the phone for almost a minute.

“May I put you on hold?”.  This was followed by elevator music and advertisements for the excellent attributes of Providence Health Plan.  Dr. Despair wondered how she was going to see any of the patients who were scheduled for that afternoon.  Finally, after ten minutes, the voice returned.

“Okay.  I guess we’ll approve it.”  No explanation.  No apologies.  No nothing.  You’d get more customer service out of a turnip.

And the government is developing programs to punish physicians for not providing “quality” care?  Who are they kidding?

Stalin was right.  When it comes to insurance denials, quantity has a quality all its own.

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Categories : Hellth on Drugs
Jan
26

Mail Disorder Pharmacy

by Dr. Doug Perednia

Robert is a pleasant, 47 year old gentleman with short red hair and a winning smile. Except he hasn’t been smiling much these days. Neither has his doctor.

Mailman

Got a problem with your medications? Don’t bother your doctor or local pharmacist – ask this guy to straighten it out!

You see it’s been the beginning of a new calendar year, and Robert has been spending an inordinate amount of time trying to get his prescriptions in order yet again. Like millions of Americans, Robert is being encouraged to use mail order pharmacies by his insurance company. In exchange for sending his prescriptions to the other side of the country to be filled, the insurance company will allow him to obtain three months worth of medicine at one time. In addition he’ll only have to provide a single co-pay for the entire three month supply instead of a co-pay for each month of prescriptions – a provision that saves him roughly $100 every three months.

The question that’s plaguing him is whether it’s worth it.

This year Robert’s employer changed insurance companies, which means that all of his mail order prescriptions need to be completely re-written and sent to a different mail order pharmacy from the one he’s been using. That might not be so bad except that changing mail order pharmacies isn’t as easy as, say, changing a tire in a snowstorm. For Robert, two things are making this a particularly onerous process.

First, despite having plenty of refills left on his old mail order prescriptions, he now has to have entirely new prescriptions written to send to the new pharmacy. So he called his doctor’s offices to request them. (Of course, so did every other patient in the country.) Since his old prescriptions were ending and it would take 2-3 weeks to receive the new ones, he had to ask his doctors for two prescriptions for everything – one that would be filled by the mail order pharmacy in a few weeks, and a second that would be filled at a local pharmacy immediately. With patients everywhere asking for duplicate prescriptions, his doctor’s offices were completely swamped with prescription requests. This sort of burden is not something that the average clinic can hire up for. With overhead rates already high, office staffing levels can’t be adjusted quickly or easily – especially since medical offices can’t bill for the time or staff costs involved with doing everything even once, let alone twice.

His doctor’s offices should theoretically be able to call in the prescriptions to the mail-order pharmacy, but they can rarely get through. When they do they’re placed on terminal “hold”.

So Robert’s been doing a lot of calling and running around to try to pick up prescriptions, finding and printing the forms needed by this new mail order pharmacy, and trying to pick up what he needs locally. Not an easy task for a working single father. In fact, when you consider his lost time he would have earned over $100 if he wasn’t screwing around with all of his prescriptions.

The second big problem is that the insulin Robert takes for his diabetes has run out, and the local pharmacy won’t give him any more until the end of the month. This is a real problem. If you’re diabetic, insulin is not one of those medications you can do without. You can become very sick or die if you don’t take enough of it, and at the right times.

The irony is that he ran out because the State of Oregon wants to protect him.

You see, a few years ago the state of Oregon passed a law that says that every prescription has to be written with a specific dose. It’s not okay to write a prescription for “Insulin, 3 bottles, use as directed”. That doesn’t satisfy the kindly bureaucrats who are so intent upon looking after your health. Instead, the doctor has to write something like: “Insulin, 40 units injected subcutaneously two times per day.” With this additional and specific information, the pharmacy calculates a month’s supply as being 80 units per day x 30 days = 2,400 units. And that’s how much they give him. No more. No less.

This sounds good on paper, but in practice it’s impossible for anyone – even the legislators and regulators of the State of Oregon – to know how much insulin a diabetic should take on a given day. The correct amount depends upon a dozen different variables, ranging from what they’re eating that day to how much exercise they’ve done to whether they’re sick with the flu. So any dosage of insulin that the doctor may put down on a prescription is nothing but a wild guess, and has nothing to do with how much insulin the patient will need to last the month.

So it’s been a bad week for Robert. First he and his doctors have to shoulder the administrative overhead that has been transferred to them by his insurer and its mail-order pharmacy. The least these pharmacies could do is adequately answer their phones and use a common, standard order form. After all, they’re the ones making the money. Why can’t doctors bill these pharmacies for the privilege of writing the additional prescriptions? Any real business would.

Then the State of Oregon adds to his Robert’s with a well-intentioned, but overly broad law that forces doctors to write dosing instructions that don’t make any sense at all for patients like him, and actually makes it more difficult for him to manage his prescriptions.

You know, it doesn’t have to be this hard. If we devoted as much time to simplifying healthcare processes as we do mucking them up, most things would fix themselves.

Really.

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