Category: Government

Aspirin – Questioning Established Wisdom

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Bayer began selling aspirin (acetylsalicylic acid) in 1899, and the similar salicylic acid, derived from willow bark and other sources, has been used medicinally for thousands of years.  Since the 1960’s it has often been used for heart attacks and strokes. Studies showed that in patients who have had heart attacks, daily aspirin prevents another one. This is know as secondary prevention.

Doctors have assumed that it would also be good to prevent the first heart attack in patients at higher risk. This is know as primary prevention. The problem is that’s much harder to prove.  Even patients at higher risk might never have one, or maybe not for many years, so a research study can take many thousands of patients followed for many years, thus costing many millions of dollars, to tell if there is a benefit. Rare side effects can take many years to figure out. There have been studies done over the years, with inconclusive and sometimes with inconsistent results.

According to a trio of recent articles (Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly, Effect of Aspirin on All-Cause Mortality in the Healthy Elderly, and Effect of Aspirin on Disability-free Survival in the Healthy Elderly), aspirin use may cause more harm than benefit for primary prevention. They looked at patients >= 70-year-old (>= 65-year-old for blacks/hispanics in the US). A low proportion of participants regularly took low-dose aspirin before entering the trial, which did not directly address whether healthy older persons who have been using aspirin for primary prevention should continue or discontinue its use. Now 2019 guidelines from the American College of Cardiology and the American Heart Association recommend low dose aspirin for primary prevention only in limited patient populations at higher risk.

When it comes to medical treatments, it’s pretty much always a question of balancing benefit versus risk and cost. For aspirin, cost is pretty much not an issue. Although studies may look at thousands of patients, people are not homogenous, and any particular study may not apply to a particular patient. The guidelines listed above state that aspirin might be considered for primary prevention in adults age 40 to 70 at higher heart risk but who do not have a higher bleeding risk. They do not recommend it for routine use for those over 70-years-old. Note that it still may be warranted in some because of higher risk, and it’s still recommended for most older patient if they have known heart disease.

I think these new recommendations will eventually lead to less patients taking aspirin to prevent a first heart attack. This will lead to less bleeding, but it may increase other problems For example, aspirin may decrease the risk of colon and other cancers. It may help prevent deep venous thrombosis (DVT) blood clots in the legs, which could lead to a more serious pulmonary embolism (PE), so long distance air travelers may be at higher risk of a clot if they stop taking their aspirin. They could just take it before a trip, but will they remember? The FDA just added a block box warning for Uloric (febuxostat), a medicine used for gout, because of recently appreciated increased risk of cardiovascular disease. Surely there will be patients on that medication on aspirin for primary prevention who will stop aspirin, as a result of reading in the media that they should, but will then go on to have a heart attack because either they didn’t discuss it with their physician, or they did but their doctor didn’t know or appreciate the increased heart attack risk with Uloric. That medicine, by the way, should also be judged on benefits versus risks and alternatives, and is still appropriate for some patients, though not as many people as the drug reps would have had doctors believe. They’ve stopped promoting it as it’s almost generic, but that’s another story.

Medical Pricing Transparency via Non-Transparent Rule

copyright 2015 Daniel Ginsberg PhotographyHidden in a 700-page draft regulation to improve patient’s access to their electronic medical records is a proposal to require doctors, hospitals, and other healthcare providers to publicly reveal the prices they have negotiated with insurers. This rule, tied to the 21st Century Cures Act, would set the stage for eventually making prices publicly available. Although price transparency may be a good way to help lower medical costs, it’s ironic that there is a lack of transparency when it comes to the proposed rule. I challenge you to read the Title, Summary, or Actions section and realize that it includes such a major change (hint – in the PDF document it’s on page 7513 of the Federal Register under Price Information).

On the face of it, making prices readily available sounds like a no-brainer, but I think it’s more complicated than that, and there may be unforeseen consequences. The rule is long and complex, and I don’t have the few days it would probably take me to really understand it, but let me play devil’s advocate. Some of the comments posted say that medicine is the only industry that hides the cost. To a certain extent that’s true, but this rule could go beyond just saying the price consumers pay. If you go to a restaurant they won’t reveal how much they paid for the the ingredients. If you book through a 3rd party website, they don’t tell you how much, if any, they pay them for the referral. When you buy a car the dealer usually doesn’t tell you if the automobile manufacturer is giving them a rebate. From the point of view of a business, the consumer shouldn’t get to know their internal costs as that’s secret competitive information.

What mitigates that argument is that the price of healthcare has gotten out of control. Despite being better educated about the matter than most, when it comes to getting healthcare for their own family I suspect most physicians struggle to understand their bills just like everyone else.

When it comes to pay, doctors are a commodity. For a given surgical procedure or office visit of a certain complexity, they are paid the same amount as mandated by Medicare or Medicaid, as negotiated with insurance companies, or their list price for the unfortunate cash patient. Just like any profession, some doctors are better than others. If you want to hire a top lawyer or an A list actor, you have to pay top dollar.  But that’s not so with much of healthcare. The price doesn’t necessarily reflect the quality of the care.

Hospital systems mitigate that somewhat. They can negotiate higher prices with insurance companies and with large employers by demonstrating that they provide higher quality care and/or lower cost care, or because patient perceive them as providing superior care and they demand that that can get care from them. What will happen if the rule goes into affect and patients can easily compare prices? I don’t know, but potentially they might choose the lowest cost without regard to quality. That could lead to systems competing on price, cutting corners to do so, and ultimately lowering quality.

The lowest price might actually not be the path to cost savings. Imagine two surgeons. One of them charges $5,000 for a knee replacement, and operates on 60% of the patients seen for knee arthritis, treating the rest successfully with injections and physical therapy, which on average costs $1,000. The other charges $7,000, and operates on 50% of the patients seen and treats the rest successfully with the same conservative measures. Besides the physician fee, the hospital system charges $10,000 for the surgery. In this example, treating 100 patients would cost $940,000 for the first surgeon, and $900,000 for second. So even though the second surgeon charges 40% more than the first, on average the doctor ends up being cheaper when it comes to managing knee arthritis.

I’m inclined to support more transparency in healthcare pricing, but I don’t know how much of an impact it will have, and there may be unintended consequences.

Don’t expect to see published prices anytime soon. Even if the proposal goes forward, following a public comment period that ends May 3, it’s likely to be tied up in legal challenges for quite a while.

National Guideline Clearinghouse Goes Kaput

Although the practice of medicine has existed for thousands of years, it substantially improved with the implementation of the scientific method. Experiments and research studies improved diagnosis and treatment. Now so much information is published that no person can read everything unless, possibly, it’s limited to an extremely narrow subspecialty.  In addition, different studies can come up with opposing results, and it can be difficult to make sense of all the available information.

To remedy that, various groups have published guidelines to help clinicians decide what to do. For example, new guidelines for high blood pressure were recently published. The American Diabetes Association just updated their guidelines for Standards of Medical Care in Diabetes.

So how does one find out about existing guidelines, other than doing a web search or coming across it in a journal? Well in 1998 the National Guideline Clearinghouse was created. It formed a collection of guidelines that met minimum quality criteria. By June 2018 there were more than 2000 guidelines listed that could be searched by specialty. In July of 2018 all of that information became unavailable on the website because of federal government budget cuts.

The website was originally created by the Agency for Healthcare Research and Quality (AHRQ), in partnership with the American Medical Association (AMA) and the American Association of Health Plans (now America Health Insurance Plans).

In the last year of operation, the National Guideline Clearinghouse’s budget was about $1.2 million dollars. This is only about 1% of the money spent globally on developing guidelines, and an even much lower percentage of the cost of medical care. The guidelines can improve care and save money, but only if people can find them. Both my company’s electronic health record and my county medical society’s website have the National Clearinghouse Guidelines integrated to reach them with a click. I’m sure we’re not the only ones who routinely used it.

Perhaps a better repository can and will be built, but in the meantime I think the government should fund the National Guideline Clearinghouse and bring it back online.  This was not a case of trimming fat from the national budget, but a self-inflicted stroke where the government cut off the blood flow (money) to a portion of our collective brain. We’re the worse for it.

Wasting Resources – A Day in the Life of Yours Truly

I’ve written before about some of the things that waste physicians time, and how trying to be a good steward of resources can be frustrating. As the saying goes, no good deed goes unpunished. So here are three such things I dealt with the day after April Fool’s Day.

I prescribed the diabetic medication alogliptin, the generic of Nesina, for one of my patients on a Medicare Advantage plan. I was told it wasn’t covered, but they would cover substitutes, including Januvia (sitagliptin). The cash price is a little over 4 times as much for Januvia! I don’t mind using Januvia from an efficacy point of view, but it was a waste of my time having to make the change, and tax payers are wasting money buying a more expensive drug. After any negotiated deals it may not be 4 times as expensive for the plan, but it’s hard to imagine it would be a cheaper option than what I prescribed.

I ordered a head MRI for one of my patients. A week ago I called Molina insurance after receiving a message that they required a peer to peer phone conversation with another physician. After 10 minutes on hold I left a message explaining why I had ordered the MRI (which I had already explained in my note and on the MRI request). As they still hadn’t approved it, I called back again today. I spent 3 minutes on hold, then 8 minutes talking to a staff member before she transferred me to a physician, then 3 minutes with him as he gathered the basic information then approved it. I did not give him any more information than I had provided in the first place. He said he didn’t have any information on why I had ordered the test or he would have approved it right away.

And the third thing? I can’t remember. No fooling!

Trying to Destroy Healthcare the Ostrich Way

Copyright: <a href='https://www.123rf.com/profile_andreykuzmin'>andreykuzmin / 123RF Stock Photo</a>Ostriches reportedly stick their heads in a hole if they see something they fear. If they can’t see it, then it must have gone away. President Trump, with most republicans lawmakers going along, is trying that same tactic on the public. Despite 7 years of promises, and multiple attempts, Republicans have been unsuccessful overturning the Affordable Care Act, otherwise know as ObamaCare. So Trump has been doing everything he can to destroy it, with the hopes that it will wither and die, then he can blame Democrats on it’s demise, claiming it was bad legislation. This despite not having a good alternative.

One of the efforts have been to keep people from signing up for coverage for next year. The Trump administration has cut the advertising budget by 90%, shortened the enrollment window, and will close the site on some Sundays for, “maintenance.” They figure that if people can’t see it, they will think it must not be there.

Well sign up just started. If you don’t otherwise have coverage, such as through work, sign up right away, while you still can.  You must sign up by 12/15/17. Don’t wait until the last minute as you might not be able to get on the site. Don’t be scared off by reports of premiums going up. Although true, subsidies also go up per the law, and it costs nothing to find out what it would cost for coverage. Go to healthcare.gov.

ICD-10 Keeps Getting More Painful

As I previously discussed,  a year ago we transitioned from the disease classification ICD-9 to ICD-10. That has been painful, but they keep making tweaks that require more work.

I guess the powers that be decided that more than 155,000 diagnoses were not enough when they recently changed many diabetes diagnoses (a day or two ago, at least, my organization implemented the latest edition). Now it’s no longer sufficient to say that someone has Type 2 Diabetes Mellitus with Diabetic Neuropathy [E11.40], for example, but I now have to specify in addition whether it’s with or without long term insulin use, or if it’s unspecified. That means all my carefully constructed Problem Lists on my patients no longer work. Every diabetic medication I reorder will have to be changed as they are associated with a diagnosis.

Across all my patients I’d estimate that’s close to 1000 changes I will need to make. Assuming it takes me 30 seconds each time (I’m probably a lot faster than most of my colleagues) that’s over 8 hours, so a full work day. Multiply that across all the primary care doctors and that’s a lot of time – about 1000 people working years! We have a shortage of primary care physicians and I think there are many better ways to spend our time.

I typed “type 2 diabetes mellitus” into my electronic medical record. I eventually scrolled to the bottom to see a message that there were 3158 diagnoses loaded, but that the results had been limited due to it being a common phrase! Many of these were synonyms, and one can save favorites, but I think it’s ludicrous that we have so many codes for just one disease. Those who promulgated moving to ICD-10 claimed the higher specificity would lead to all kind of advantages by being more precise, but in reality physicians can’t spend all day just to pick a diagnoses and they are going to pick something close that will satisfy the billing system. For many diagnoses you can’t even get precise agreement. There are various codes for uncontrolled diabetes, for example, but if you ask different doctors what that means, you’ll get different answers.

Patients with diabetes have to suffer from complications of their disease, increased medical costs, and being stuck more often for blood or injections. It’s too bad their physicians have to suffer more as well.

Trump the Bureaucracy

About 6 weeks ago I referred a patient of mine with a knee problem to an orthopedic surgeon in my group. He ended up seeing someone else in the same group about 3 1/2 weeks later, and the doctor prescribed a knee brace.

A few days ago my patient said his insurance company wanted me to do a new referral, because I had referred him to a different physician than the one he ended up seeing. Even worse, he still did not have the brace because they required his primary care physician (that’s me) to write them a letter saying the brace was necessary.

I did write a letter saying that I’m not qualified to say whether or not the brace is necessary, and that if they wouldn’t approve it, then their medical director should contact the orthopedic surgeon to explain why not.

Physicians have far better things to do with their time than waste it on unnecessary paperwork. If we could only channel our collective anger and frustration with the system, as Donald Trump has been doing in the realm of politics, maybe we could spend more of our time treating patients, rather than placating the government and insurance companies.

Gluteus Maximus

I ordered atorvastatin (generic Lipitor) for one of my patients with high cholesterol and Medicare Part D coverage. It was denied. We then appealed it (prior authorization). A fax from Maximus Federal Services said their decision was, “UNFAVORABLE.” They said the patient had not tried and failed one of the preferred generic statins (lovastatin or simvastatin). They did note that we could appeal to an Administrative Law Judge.

In fact the person had tried simvastatin, which I had noted on the prior authorization. However the cost savings is minor. According to Goodrx, a 90 day supply of atorvastatin is as low as $19.25 around where I work.  For the equivalent dose of simvastatin it’s $10.06.

Yes, it’s almost half the price, but it’s still a pretty small amount, especially in my patient who had already had a heart attack, and the difference will only get smaller as Lipitor has not been generic for all that long. Contrast that with the staff time wasted dealing with this on both ends. Dealing with this is a pain in the Gluteus Maximus!

Disabled Parking and Needless Paperwork

Date and Place SignedIn Washington State, if you want a disabled parking permit you need your doctor to fill out a form. Effective 7/1/15, a new law also requires a written prescription to help combat forgery. Physicians already have to deal with far too much paperwork. Their latest form ridiculously asks us to write down the place signed. As the photo above shows, I made up a stamp that has the latitude and longitude of my office. They want to know where I signed it? They got it!

An ICD-9 Story

Medical billing and epidemiology relies on a classification of diseases maintained by the World Health Organization. On the first of October, 2015, we will transition from ICD-9 to ICD-10, a major change that increases the number of available diagnoses from some 17,000 codes up to more than 155,000. In a strange cosmic twist, that’s the same day that most retails need to install readers for credit cards with chips or be liable for bad purchases.

With that in mind, I present a short story in ICD-9, with a translation into English.

It was E900.0. That, combined with E904.1 and E904.2, not to mention V69.4, is what led to 780.2. I admit it, I have V69.0 and V69.1. I usually sleep well, but that night was different, thanks to 780.55 due to 780.92. That morning I understandably drank 969.7, leading to 785.1. During E924.2 while E013.0 I felt 780.4. Stepping out I had 368.45 before I 780.2.When I was V49.89 after my E884.9. I had a 784.0, as if I had a 305.00. I used my E011.1 to call work to say I’d be late and hoped to avoid V62.1. He greeted me with a 784.42 indicating 300.4.

Last year I V49.89. The flights are arduous, subjected to E918 or being in V01.9 with a 780.92 E979.6 at E902.0. After landing I’m 780.79 due to V69.4 and 780.55, leading to excessive 786.09.

I was in 309.29. At least, thank to the ubiquity of E849.6, I didn’t have to suffer from 292.0.

If you think this makes for 315.00 and is a 729.1 to read, just wait for ICD 10! Ever see a V91.07XA?!

It was too hot. That, combined with lack of food and water, not to mention lack of sleep, is what led to my fainting. I admit it, I don’t exercise or eat right. I usually sleep well, but that night was different, thanks to interrupted sleep from my son’s crying all night. That morning I understandably drank one too many cups of coffee, leading my heart to skip a beat. During a hot shower I felt lightheaded. Stepping out my vision narrowed before I passed out. I awakened after my fall to the floor. I had a headache, as if I had a hangover. I grabbed my cellphone to call my work to say I’d be late and hoped I wouldn’t be in trouble with the boss. He greeted me with an edge to his voice, indicating he was wasn’t completely happy.

Last year I traveled to foreign countries. The flights are arduous, subjected to being squeezed in with other passengers, or being next to a crying, germy child at altitude. After landing I’m worn out due to lack of sleep and jet lag, leading to excessive yawning.

I was in culture shock. At least, thank to the ubiquity of vendors, I didn’t have to suffer from caffeine withdrawal.

If you think reading this is difficult and is a pain in the butt to read, just wait for ICD 10. Ever see a burn due to water-skis on fire?!

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