Prior Authorizations Suck

"Suck" is a word I seldom use. It's a word I ask my children not to use.  However, in this case the word is appropriate. If as a patient, you have ever had a delay in getting a medication or a test your doctor ordered, it was probably due to a prior authorization.  A prior authorization is a bureaucratic hurdle (sometimes a phone call, sometimes a fax, sometimes a letter) that is required by your physician to get you the test or treatment he or she believes is right for you. A prior authorization is essentially a mechanism that insurance companies put in place to make ordering more expensive tests or medications more difficult for you to get. The decision maker on the insurance company's end who decides whether your doctor (regardless of specialty or years in practice) is justified in requesting the medication or test that your insurance company is obligated to provide for you is often a 20-something college grad with no clinical experience.  Prior authorizations are probably one of the most frustrating things about being a primary care physician. 


I am far from alone in this opinion.  My medical society, The Medical Society of the District of Columbia or MSDC actually did a survey of their members examining the impact of health insurance prior authorization protocols on patient care in Washington, D.C. The study reveals widespread concern among area physicians, with over 93% of respondents saying that insurance company requirements are having a negative impact on their ability to treat patients.

In their press release,  Dr. James Cobey, President of MSDC stated that “Doctors, not insurance companies, know best how to care for their patients, yet prior authorization and other insurer protocols are dictating how physicians provide treatment. Prior authorization requirements put D.C. patients at risk by causing unnecessary and potentially dangerous delays for medications and care while preventing doctors from providing the most appropriate forms of treatment.”


Specific findings of the MSDC survey include:  

• 93.1%  of D.C. physicians surveyed said that insurance company requirements such as prior authorization, pre-certification, therapeutic switching, and step therapy are having a negative impact on their ability to treat patients;

• Nearly 90% of those surveyed said that they have been forced to change the way they treated a patient, including changing prescription medications, due to restrictions imposed by an insurance company;

• Over 76% of physicians also reported that they have switched treatments in order to avoid dealing with prior authorization requirements;

• 94.8% of physicians surveyed said that insurance companies have delayed or denied treatments for their patients, such as prescription medications, diagnostic testing, or other services;

• 84.6% of physicians said that is it difficult to determine which prescription drugs or medical procedures require prior authorization;

• About half (47.2%) of MSDC members surveyed said that on average, prior authorization requests take several days or more to be resolved;

• 89.7% of respondents confirmed that completing and clarifying insurance requirements imposes “hidden” costs—such as extra staff time for the additional paperwork and phone calls—that have a negative impact on their medical practice.

Folks at the MSDC are trying to get laws passed to implement a standardized system across the District, with uniform requirements for filing and processing prior authorization requests which would expedite this onerous process and allow doctors to finally focus on what really matters—treating patients. Every medical society should follow their lead. 

Why OTC Lipitor is a Bad Idea

As reported by the Wall Street Journal, Pfizer, the maker of one the best selling drugs ever, is trying to get the FDA to approve an Over the Counter (OTC) version of their blockbuster Lipitor, not coincidentally on the eve of Lipitor going generic.
Readers of this blog know that I am a big proponent of cholesterol lowering medications like Lipitor (statins) for patients at moderate to high risk of cardiovascular disease.  In particular, I am a fan of the more potent statins like Lipitor and Crestor, because of their increased efficacy with fewer side effects (see Don't Take High Dose Simvastatin).  Finally having a generic version available of Lipitor will be a great thing for many patients.

That said, making Lipitor OTC is a bad move. First, there is a difference between medications like Prilosec and Claritin that have gone over the counter and Lipitor.  Diagnosis for GERD and allergic rhinitis for which those medications respectively treat are made mostly on symptoms alone.  Patients don't need to go to medical school to suspect that they may suffer from heart burn or allergies. Starting treatment without seeing a physician is actually medically sound because more often then not the medications will relieve symptoms avoiding a physician office visit.  In contrast, starting a patient on a statin is much more tricky.  Patients need to know their individual risk for cardiovascular disease.  Though there are tools available online to determine this (I use the NIH's risk calculator daily in my clinic), determining individual risk of disease, benefit of taking a medication and weighing this against potential side effects is best decided by a discussion between a doctor and patient. Secondly, before starting a statin medication, one needs to know their cholesterol levels.  Though there are other methods (health fairs, work screenings) of determining cholesterol levels, getting a blood test usually requires a visit to the doctor's office. In addition, follow up blood work (checking for medication efficacy, liver side effects) is warranted after starting treatment. Thus, the benefit of having a medication OTC is negated.  Finally, Claritin and Prilosec are very safe.  They are as safe or safer then other OTC medications.  Lipitor is also very safe, but is associated with rare, but serious side effects.  Taking Lipitor OTC without consultation with a physician creates the risks of patients developing these side effects without proper warnings and therefore potentially worse outcomes if attention is not sought.

The second main reason that OTC Lipitor is a bad idea is that it will hurt more patients than it will help.  The reason for this is that when a medication goes OTC, insurance companies usually will not pay for them.  Now that Allegra is over the counter, it is virtually impossible for any of my patients to get a prescription version antihistamine.  Though they can easily get this OTC, not having a prescription means they need to pay for it out of pocket.  The cost of an OTC medication, even if the generic OTC version is used, is generally more than the co-pay for a generic prescription.  It is unlikely that generic Lipitor will make the $4 Walmart or Target list, but after six month, the co-pay for generic Lipitor would still likely cost a lot less for most patients then paying for OTC Lipitor out-of-pocket. 

Bottom Line: The reason why Pfizer wants Lipitor OTC is for one reason: to make more money.  They can argue that cardiovascular disease is the number one killer in the US, and by having Lipitor OTC, it will be available to more patients.  However, because statins require blood work and medical consultations, the risk of harm to patients outweighs the potential benefits of greater availability.  In addition, this will result in cost-shifting to patients in order to boost Pfizer's profits. Hopefully, the FDA will say what they said when Merk tried to pull this off: "No."

Boston Doctors Getting Paid to Switch Patients to Generics

Interesting video from WCVB in Boston about doctors getting kick backs from the insurance company to switch patients from branded medications to generic medications. New Rules To Protect Prescription Drug Customers

If people were concerned about undue influence when drug companies used to give physicians pens and other novelties (now currently banned by most companies), they should really be concerned about actually monetary payments. The patient interviewed in the Boston piece stated his doctor wanted to switch him from Lipitor to generic simvastatin (cholesterol lowering medications) but did not mention that he was being payed by his insurance company to do so.

Though this is the first case I have heard of doctors being incentivized to switch patients to generics, it happens in pharmacies all the time. What is horrible is that some pharmacies may switch patients to alternative medications even if that switch costs the patient more money. The example I am familiar with is albuterol inhalers (see FDA Announces End for CFC-Propelled Inhalers).

Switching to generics is itself not a bad things. I have blogged before that, for most medicines, generics are just as good as brand name medicines. For example, if the patient were on Zocor, a switch to the generic simvastatin would probably make a lot of sense, since the medications are basically equivalent and it would likely save the patient some money. However, in some cases, the small differences may actually make a difference. Back in November, I discussed this in more detail (see Generic and Therapeutic Substitutions ).

In this particular case, the therapeutic switch from Lipitor to simvastatin might have been devastating since Lipitor is a much stronger medication. The piece does not say what dose the patient was on, but if the patient required Lipitor 40mg or 80mg, no dose of simvastatin would have given him the cholesterol lowering he needed.

What should you do?
1. If you are on a branded medication, ask your doctor if there is a generic equivalent of the exact same medicine, or one that works just as well.
2. If you are on a branded medicine and asked to switch to a generic by your doctor, find out why he or she wants to switch.
3. If you are on a branded medicine and asked to switch to a generic by your pharmacy, find out why they want you to switch. Is your insurance company asking for the switch? Is the medicine the same (generic substitution) or slightly different (therapeutic substitution)? Regardless, make sure that you check with your doctor before switching any medicine.

How can a psychiatrist write 100,000 prescriptions a year, and why this matters to Primary Care?

The Miami Herald is reporting an investigation of a psychiatrist who wrote almost 100, 000 prescriptions a year. Sen. Grassley and the feds have halted payment to this Miami psychiatrist who stated that "he prescribes only what is medically necessary" and "works long hours, seeing patients for 10 minutes at a time and many of his patients need four or five medications."

I have no personal knowledge, interaction, acquaintance with psychiatrist Dr. Mendez-Villamil. However, though this sounds fraudulent (which is why the fed likely pulled payment), how could this doctor personally benefit from all of these scripts? Doctors do not get paid by how many prescriptions they write (unless you count docs like oncologists who collect fees for administering chemotherapy). Drug companies are now forbidden to wine and dine doctors, so it is highly unlikely that some pharmaceutical rep is incentivizing this psychiatrist. Besides, these patients areMedicare and Medicaid, so they are likely getting generics in the first place.

So if there is no wrong doing or even an incentive to write all those scripts, is this even possible and why does it happen? If the good doctor is seeing patients every 10 minutes, and each patient needs 4-5 prescriptions (assuming an 8 hour day); that's 46 patients a day needing about 3 prescriptions on average to yield the 150 prescriptions a day that Dr. Mendez Villamil is "accused" of writing. Though this may not be good medicine, with that volume of patients, the numbers sound pretty reasonable, espescially since many chronic psychiatric patients are on multiple medicines. So it it possible that one psychiatrist sees almost 50 Medicare and Medicaid patients a day in 10 minute visits? If the psychiatrist accepts Medicare and Medicaid, then this is actually quite likely the case (and probably not the exception but the rule).

In a piece I wrote for KevinMd a year an a half ago, I described how there are two kinds of mental health care in the US: care for those who pay with insurance and care for those who pay out of pocket. The kind of care that you see in TV and movies where a patient talks to a psychiatrist and possible gets medication; that kind of care happens, but only if you are willing to pay out of pocket. In many cases fees for a regular sessions run over $200. For those paying with insurance, the experience is quite different. If a patient sees a psychiatrist, it is usually only for medication management and usually only in short (10 minute) visits. Any "talk therapy" is relegated to a psychologist or psychiatric social worker. I mean no disrespect to some of the excellent and well qualified non-physician therapist we have in the US. I am not even stating that having a short visit with a psychiatrist for medication management and counseling done by non-MD's is bad medicine. However, the public must be aware that this is how psychiatry is practiced in the US.

In the case of Dr. Mendez-Villamil, he probably is one of only a handful of psychiatrists in Miami that accepts Medicare and Medicaid. Patients probably wait months to see him. The Miami Herald makes him look like a criminal. However, think about the majority of his colleagues who only see patients who can pay $200 or more out of pocket per visit? Dr. Mendez-Villamil is probably a hero, and if he writes 100,000 prescriptions per year this should be seen not as a crime, but a sign of a broken system.

The piece I wrote for KevindMD was entitled, "As psychiatry goes, so will primary care." The reason why so many psychiatrist stopped taking insurance and the reason why those psychiatrist who accept insurance cram patients into 10 minute visits is because the reimbursement rate from insurers is ridiculously low. Many psychiatrist realized that accepting insurance just didn't make sense. The same thing is happening right now in primary care. More an more primary care physicians have stopped taking new Medicare or Medicaid patients, or any insurance altogether. Some have even gone beyond cash only, and started "concierge" practices which charge patients a retainer fee (sometimes well over the usual $1500 a year) in exchange for easy access to their primary care doctor.

Health care reform has focused on how to cover the uninsured and how to pay for this, but it has not focused on how to change the current reimbursement system that rewards "proceduralists" and punishes "congnitivists." If health legislation that covers the uninsured does eventually pass without addressing this fundamental crack in our health care system, there will likely be no primary care physicians to see all these newly insured patients (see what happened in Massachuesetts). The few primary care physicians that do accept the newly insured will likely have limited access and see more patients in less time....kind of like the good Dr. Mendez-Villamil. Whereas the typical psychiatric patient might be on 3-4 meds, the typical Medicaid and Medicare patient is on a great deal more medications. Primary care physicians, get your pens ready! 100,000 prescriptions a year will seem like nothing.

Generic and Therapeutic Substitutions

I was on the local DC news today regarding generic substitution.

Generic substitution is when your doctor writes for a prescription medication, but the pharmacists substitutes this with a generic medication. This is perfectly legal and, in general, a good thing for patients. For the most part, and for most drugs, the generic is just as good as the brand drug. However, as the news piece points out, there are some instances where the small difference between the generic and the brand name medication may make a difference. These are usually medicines where doses are very small such as hormones (thyroid medications, birth control pills) and medicines that have to be closely monitored. This does not necessarily mean that the generic is worse than the branded medication, but that switching from one to the other could have potential adverse effects.

One of the things that I spoke with the reporter about that is not in the above video (I have control over what I say, but not what they choose to sue), and only got a brief mention by the new anchor after the video was shown was about therapeutic substitution. This is a completely different ball game and a major concern of mine.

Therapeutic substitution is when your doctor writes a prescription for a branded drug and the pharmacist substitutes it not with the generic equivalent, but with a completely different generic drug in the same class. In this case, you are getting a totally different medication. For example, let's say your doctor writes a prescription for Crestor or Lipitor, both very potent cholesterol lowering drugs. You bring this prescription to the pharmacist, but instead of getting Crestor or Lipitor, you get simvastatin, a generic cholesterol medication. The difference here is that where the brand and generic equivalent will work about the same, this is not the case with a therapeutic substitution. Simvastatin will work in many patients but is not nearly as good as lowering cholesterol as Crestor or Lipitor. Thus, if the patient got switched and needed more cholesterol lowering than the simvastatin could provide (which is why I would write Crestor or Lipitor in the first place), that patient's cholesterol levels could be too high despite medication, potentially leading to heart attack and strokes. This is just one of many examples.

The practice of therapeutic substitution is currently illegal, but this could change. In Washington, DC where I practice, there is current legislation pending that would not only allow, but might compel a pharmacist to switch patients to cheaper medication, whether or not they were the same. In the case of DC, this is designed to save the government money from the millions of dollars its spends on prescription medications for our Medicaid patients.

With health care costs so high, physicians should do their best to try and write generic medications when possible. In additions, our pharmacist colleagues can be a tremendous help in figuring out ways to lower the costs of medications by using generics, whether it be a direct generic substitution or even therapeutic substitution. Pharmacist and blogger Mr.Medsaver has been doing this for quite some time, and I routinely read his helpful posts. However, pharmacists are not trained clinicians and do not know (and can not know) all the details of the patient's history or the rationale for the doctor choosing one drug over another. Though the pharmacist's suggestions are always welcome, I do not believe the should be allowed, and certainly not compelled or heaven forbid incentivized, to switch medications within the same therapeutic class. This could be very dangerous for patients.

Prescription Drugs: Risk vs. Benefit vs Cost- The Chantix Example

When a physician prescribes a medication, a patient generally wants the most effective medication, with the least amount of side effects, that won't cost a lot of money. Unfortunately, this is often not the case. When determining which medication is right for you, all things need to be balanced. Obviously, for people with good prescription coverage and/or substantial wealth, cost likely does not play into the picture. However, for most patients, decisions need to be made. Should a patient take a generic medication that might not work as well or have potentially more side effects, but will cost substantially less than the branded medication? The choice is not always easy.

The Chantix example

I have posted several times about Chantix here, here, here, and here. The main reasons for these postings was due to the fact that the media (and some organizations) in my opinion were blowing out of proportion the risk of side effects of a very useful medication for the single leading preventable cause of death in our country.

Now, we have data in that seems to confirm that Chantix is the most effective agent available in the United States for smoking cessation. For those of you not familiar with the Cochrane group, they are international and free of any commercial bias. They review all data available in a systematic way, and are considered by most as some of the most unbiased and highest level of evidence available for therapeutics. The Cochrane review for Chantix (varenicline) is now in, and states that compared to placebo, nicotine replacement or bupropion (Wellbutrin, Zyban), that Chantix is the most effective agent, essentially doubling to tripling your chances of successfully quitting cigarettes.

Soon after Chantix had been on the market, reports of worsening of neuropsychiatric symptoms (depression, anxiety, suicidal ideation) surfaced, and the FDA took notice. Unfortunately, they went very public with this and the media had a field day scaring a lot of patients. In the original studies, patients with underlying depression and anxiety were purposefully excluded. Yet, patients with mental health disorders are much more likely to be smokers. We also know that stopping smoking, even without medication, can cause a worsening of these symptoms. In their final analysis, the FDA stated that it was not entirely clear whether Chantix was responsible for some of these adverse events. They appropriately added language to the drug information (package insert) to warn doctors and patients to look out for these side effects. This is a good thing, because even if Chantix is not the causative agent, it serves as a reminder that stopping smoking can cause worsening of neuropsychiatric symptoms.

Thus, the issue becomes efficacy vs. safety. Should you take a medication that is the most effective agent to help you stop smoking and risk a potential side effect that you could become depressed or even suicidal? One also has to consider the risks of NOT taking the drug. If I don't take Chantix, for example, and continue smoking, I am at risk for a lot of major problems! Given that it is unclear that Chantix has any more or less risk than other agents or no agents at all, in my opinion, since smoking increases risks for things like cancer, heart attack and stroke; in this case risk is outweighed by benefit.

Probably more troublesome is efficacy vs. cost. Chantix trumped bupropion (wellbutrin, zyban) and nicotine replacement (patch, gum, etc.). However, bupropion is generic and for most patients with prescription coverage, a relatively low out of pocket expense. Nicotine replacement is not covered by insurance, and thus the patch, gum or lozenge is a high out of pocket expense. Finally, many insurances still do not cover Chantix, and when covered the co-pay can be high. Thus, do you take the medicine is that is likely to be the most effective, but pay more, or do you try the generic which will likely work, though possibly not as well?

It would be great if all medicines were covered and at low costs to patients, worked incredibly well with virtually no side effects. However, in general this is just not the case. Many generics work just as well if not better than newer more expensive drugs. However, this is not always the situation. Furthermore, sometimes more effective drugs come to market but with increased risk. Doctors and patients must weigh cost, benefit, and risk with each prescription. Every patient's situation will be different. Thus, when being prescribed a new drug you need to take all of these into account.

Here are some questions to ask:
1. What are the side effects of the drug, and what is the chance that I will get these side effects?
2. What are the benefits of this drug, and how much and how likely will I benefit if I take this drug?
3. What are the risks if I don't take this drug, and how likely am I to get these consequences?
4. Are there alternatives available for this drug? If so, what would my out of pocket costs be for each one?
5. What are the differences in risk and benefits between all my options, including not taking any medication?