Patient, Doctor, and Government – Who Decides?

Patient, Doctor, and Government – Who Decides?

How will the newly enacted health care legislation’s emphasis on comparative effectiveness research (CER) affect patient choice, and the future of America’s health?

Last week, Congress enacted a nearly $1 trillion health care program – claiming it would reduce the cost of care and even lower the deficit by more than $100 billion over the next decade.  But how exactly will such a costly government program cut costs? Here’s one major way: by cutting your medical treatment options.  And no, that’s not just conservative rhetoric. It’s a simple case of actions (and money) speak louder than words.   

The aim of comparative effectiveness research (CER) is to measure the outcomes of different treatments and medications and decide which is most effective.  The information is then passed along to doctors, patients and consumers.  According to a CBO report, before 2007 CER consumed less than $15 million of the total government budget for research funding.¹   In the past two years, however, the government has poured a tremendous amount of money into CER, allotting $1.1 billion in funding CER through the American Recovery and Reinvestment Act (ARRA). 

Now under the health care bill passed by Congress last weekend, it will create an agency to carry out this type of research – the Patient Centered Outcomes Research Institute.  The Institute, a nonprofit organization, was meant to be an independent entity; however the agency’s “board of experts” in charge of leading the research is appointed by the Health and Human Services Secretary. 

Here in North Carolina, the Legislature met on March 16 for a joint legislative study on comparative effectiveness.  Legislators are setting plans to move quickly with support for comparative effectiveness research provided with funds from the federal government – which is allocating more than $200 million a year nationwide for this research in the health care bill.  According to the legislature’s report, $12 million has been allotted to North Carolina so far this year, and another $25 million is expected in the next months.  The work will be done by organizations like the North Carolina Healthcare Quality Alliance (NCHQA) – a largely government-backed organization. 

But what does this mean for patients? Certainly the government will now have a greater and more permanent role in deciding best treatment options.  Although most of the research conducted is meant to focus on the clinical benefits of different treatments, some have also focused on measuring cost-effectiveness.  This will lead to less patient choice and greater constraints on doctors, as has already been seen with Medicaid and Medicare, where doctors are not reimbursed if they don’t prescribe the government-approved treatment.  It’s easy to envision a similar scenario in which the federal government will force private insurers to only reimburse providers for the CER-recommended treatments as a way to cut costs.

There are some, however, who argue that CER is just a means to disseminating better information about medical treatments.  The problem with this claim is that comparative effectiveness research lacks any discernable benefit to the treatment of the individual.  CER is dependent on expensive clinical trials and compounded observational data sets that often produce negligible differences between treatment options. Further, in contrast to research that measures the efficacy of a certain treatment or medication – in other words whether it works or not – CER is focused on finding a treatment that works “better” and proves cost effective.  This comparative measure is often more difficult to pinpoint and subject to error.  For example, if you are attempting to measure the better of two treatments that are both relatively ineffective to begin with, what exactly is being accomplished?

There are other problems that arise with CER.  For example, these tests are usually too expensive to use for measuring long term effects, which are often imperative in deciding which treatment a patient will choose.  Also, clinical trials are often limited to a relatively homogenous population as not everyone has an equal probability of becoming a participant, so the result may not be applicable to the entire population and will certainly miss important outliers.   

Often different patients respond to treatment in very different ways.  Patient’s choice of treatment depends on a wide variety of circumstances. Take prostate cancer for example – a man diagnosed in his 40’s with an aggressive cancer is more likely to opt for surgery, which is a highly tech-involved and expensive procedure.  However, an older man with a less aggressive form of cancer might opt out of a surgical alternative because it will more than likely not be deadly.  However, this choice should always be left up to the patient, and not the government or any “board of experts.”

Another supporting claim is that this move is a necessary counter to powerful drug companies pushing products that often turn out to have adverse effects or prove ineffective. This is certainly not the case.  Patients today have a wealth of resources available to them in deciding treatments.  Not only do they have the recommendations of their doctor and the ability to seek a secondary or even tertiary opinion, they also have the ability to pull information from a growing network of patients.  The Internet – yes the Internet – and health care blogs provide a space where patients can share their experiences, discuss treatments, and provide advice to other patients recently diagnosed with similar conditions.  Although not an "official” source for information it gives patients a greater amount of control over their health care decisions.  Many times patients who have often gone years without an accurate diagnosis find their answers with the help of others like themselves, which provides them with a starting point where they can initiate an informed conversation with their doctor. 

A greater amount of information for patients and doctors seems like a step in the right direction. The problematic aspect of comparative effectiveness research, however,  is when the government decides what type of medications and treatments are best, and provides funds for research that bolster these claims, it often limits or controls the information available to patients and choices for doctors.   It is inevitably the perfect recipe for rationing care, making decisions based on cost, and giving patients less choice and less control over their health.