Obamacare and the Supreme Court

This week the Supreme Court agreed to hear a legal challenge to the healthcare reform law, colloquially known as ‘Obamacare”. They have scheduled 5 1/2 hours for oral arguments, dividing the law into four parts, that they will hold over two days. According to a number of articles, this is pretty much unprecedented in modern history. Since 1970 the typical case is allotted one hour for oral arguments, with 30 minutes for each side.

I’m not a lawyer, but I was astounded by these numbers. I realize that the Supreme Court justices spend a lot of time reading written briefs, and probably have internal discussions, but only spending an hour listening to arguments for an issue that has hit the highest court of the nation does not sound like much time to me. If I have a complicated patient in my office, it’s not so unusual that I end up spending an hour on them, and unless they are going on Hospice, they always get a follow-up visit. The Supreme Court gets about 10,000 petitions a year, and only rules on a small fraction of them. Before it gets to that level, many lawyers and judges have already debated the issues, and if the answer was obvious, it would probably have been settled. It seems stingy to me to only giving one hour for oral arguments for cases at that level.

Even 5 1/2 hours doesn’t sound like much. The 12 members of the debt reduction super committee couldn’t come to an agreement on debt reduction after working on the issue for more than 3 months. That’s far more time than the Supreme Court will spend working on the health care law, and I’m not sure that it’s that much less complex than dealing with debt reduction. Of course the justices have the great advantage of not having to worry about getting re-elected.

Medicaid Documentation Nightmare

Washington State Medicaid has new requirements for ordering imaging tests. I ordered a dobutamine Cardiolite stress test for one of my patients. The coder in my office brought me the Cardiac Imaging Questionnaire – CarePlanner/iEX form. It had 41 questions which she gave to me because she can’t tell from the chart how to fill it out! As it turned out I didn’t have to answer all the questions, but it still took a while to figure out what questions I needed to answer and look up the information in the chart.

Physicians usually lose money when seeing patients on Medicaid since the reimbursement is less than the cost. Add in ridiculous paperwork burdens, and they may find that primary care doctors start referring their patients to specialists rather than do the test themselves. Then the Washington State Department of Social and Health Services (DSHS) can pay for the cardiology consult instead, to be followed by the test I wanted to do in the first place, or a more costly cardiac catheterization. If I think a patient needs a test, it’s pretty rare when the specialist does not agree that the patient needs that, or a more expensive test, done. Making it more cumbersome for primary care physicians will likely ultimately raise costs, not decrease them.

Let the Sunshine In, Let the Sunshine In

A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.

The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.

The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.

The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge Act  S.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.

The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.

Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.

Trouble Sleeping? – Is Intermezzo the Solution?

You may be feeling soporific after ingesting large quantities of tryptophan containing turkey, but the day before Thanksgiving, the Federal Drug Administration (FDA) announced the approval for zolpidem tartrate sublingual tablets, known as Intermezzo, by Transcept Pharmaceuticals Inc.

This is not a new molecule. It’s actually the same medication as Ambien, but it’s formulated to dissolve under the tongue, and the dose is lower. Ambien is dosed at 5 or 10 mg, but Intermezzo comes in 1.75 mg for women, and 3.5 mg for men. When Ambien is prescribed, it’s generally recommended that it only be taken if one can sleep for 8 hours afterwards, as otherwise one may still be sedated when driving, etc. Because the dose of  Intermezzo is lower, one only needs 4 hours. So if you wake up at 2 am and can’t get back to sleep, it might be a good option.

I have several concerns, however.

Because the name is completely different, there is some risk that patients might inadvertently take Intermezzo and Ambien thereby taking too much, though admittedly it would be at most only a 35% increase over the maximum dose.

My biggest problem with this is cost. Ambien was manufactured by Sanofi-Aventis, but went generic in April 2007 with multiple manufacturers, and is now pretty cheap. Around that time Sanofi-Aventis came out with Ambien CR, packaging zolpidem in a time release pill to make it last longer. It is probably a little better for some people, but I think it basically was a way to extend the patent. In addition, Sonata (zaleplon) works similar to Ambien, but it has a shorter half life. That means it gets out of your system faster. That’s bad if you take it at bed time and tend to awake in the middle of the night, but great if you only want to take it if you wake up in the middle of the night and get can’t back to sleep. That’s just like Intermezzo, only generic.

With Intermezzo you can pay more for less! This is not the first time pharmaceutical companies have done this. Recently Somaxon Pharmaceuticals came out with the sleep medication Silenor. This is doxepin in a 3 or 6 mg pill, and supposedly works better than the higher dose generic pills. At Drugstore.com, 10 mg doxepin costs $28.99 for 90 capsules (note you can’t just split them), or about $10 per month. Silenor is more than ten times the price for about half as much medication.

Transcept Pharmaceuticals, Inc. is also attempting to do the same thing with TO-2061, a low dose form of ondansetron (Zofran) for obsessive-compulsive disorder. Wouldn’t you know it, but ondansetron is generic now.

Penny Wise, Pound Foolish

A patient of mine has been on cyclobenzaprine, a muscle relaxer, intermittently for over a year. Now her insurance, a Humana, Medicare plan, said they will no longer cover it. I pointed out to them that the medication is generic and at Costco one could purchase 100 pills for $9.93 without insurance. That would be enough to last her over 3 months. The Costco price for tizanidine they suggested I switch her to costs even more. They told me to check their website for what they cover, which I did. It said cyclobenzaprine is covered, though on some of their plans it requires prior authorization, which is what I tried to obtain. Besides the risk of switching a medication to something new, Humana wasted the time of my nurse and I for what would be a minuscule, if any savings. They would not budge other than saying she had to first try and fail tizanidine.

I understand the need to control costs, but forcing doctors to change from one cheap medication to another cheap one is not the way to do it. It doesn’t save significant amount of money, and it frustrates their customers (the patients) and their physicians.

Insurance companies such as Humana place no value on physicians time. I hope other physicians join me contesting such things from time to time. Don’t just accept the first no. Make them deal with extra phone calls and faxes when they are unreasonable. If enough of us protested, I think we could force them to change their ways. Occupy Medical Insurance Companies Movement, anyone?

Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.

An Apple A Day

You’re familiar with the first part, or a variation of it, but did you know the rest of this Mother Goose nursery rhyme?

An apple a day
Sends the doctor away.

Apple in the morning,
Doctor’s warning.

Roast apple at night
Starves the doctor outright.

Eat an apple going to bed,
Knock the doctor on the head.

Three each day, seven days a week,
Ruddy apple, ruddy cheek.

100-Year-Old Marathoner

Fauja Singh completes Toronto marathon.

According to the Wall Street Journal, on 10/16/11 Fauja Singh completed the Toronto marathon, finishing the 26.2 mile race in over 8 hours. I hope that will inspire my patients to exercise. I’ve started telling my octogenarians to start training for a half marathon. Heck, I’m letting them off easy.

How Primary Care Docs Became Assistant Shoe Salesmen

Nurse practitioners, physician assistants, pharmacists and naturopaths have gained the right to prescribe medications traditionally only done by a physician. But the Medicare Therapeutic Shoe Bill requires that the physician managing the diabetic condition certify the need for footwear and inserts.

So although the podiatrist truly has the expertise in this arena, it falls on the patient’s primary care physician or endocrinologist to do the paperwork. Congress might have been concerned that because podiatrists profit from selling inserts or shoes, that someone else should determine whether it’s really needed. In fact, though, us primary care docs are overworked and don’t have much time to deal with such paperwork. If we deny that the patient needs it, especially after their podiatrist already told them they do, the patients get mad at us.

I think the best way to minimize fraud would be to have patients pay a portion of the cost, say 25%. That way they are less likely to get a shoe or insert unless they feel they really need it. Actually Medicare pays 80% of the allowable amount so patients pay up to 20% if they don’t have secondary insurance. Since most patients are going to buy a pair of shoes in any case, I think they should pay what a similar non-medical shoe would cost, and Medicare would pick up the difference. That way there would be no financial incentive for patients to get shoes they don’t really need, and doctors could stop being the watchdog.

At the very least, Congress should allow nurse practitioners and physician assistants to do the paperwork.