Junkfood Science: “Will they be told the truth?”

July 21, 2008

“Will they be told the truth?”

Most consumers probably accept without question that the quality measures required of healthcare providers really are measures of quality care. As we’ve repeatedly seen, however, those quality measures aren’t always grounded on the best quality scientific evidence. A doctor and provider under Hawaii’s largest health insurer wrote a tell-all letter in the Honolulu Advertiser that received little national notice, but she felt her patients and everyone deserved to know what goes on behind the scenes. Those screening tests and prescriptions being ordered in increasing numbers may be influenced by more than the best science.

Dr. Catey Shanahan, M.D., with a Kalaheo clinic, wrote about the latest Quality of Care initiatives proposed by HMSA. The purported intent of this quality program, she said, is to identify and reward doctors “who provide ‘better’ care.” But, she asked, will patients be told the truth?

If you have diabetes, your doctor will be paid more if he or she convinces you to buy a cholesterol lowering pill. How much more? If I get all my diabetics on these pills, depending on how HMSA weights their payment scheme I may earn up to $8,000 more next year. Sounds great for me, and you might think I'd be an idiot to question such an easy cash gift.

But I don't think I'll go for it... I don't think there is enough scientific evidence that this practice will help all my diabetic patients. I can't justify writing prescriptions for unnecessary medications just because I'll earn more money if I do... But this new measure is not a good idea. Studies fail to prove that putting all diabetics on cholesterol pills is effective or even safe. So why is HMSA willing to experiment on Hawaii's diabetics?

How many patients know that their doctor is being paid more to get them on another prescription? How would this disclosure change their relationship and trust in their doctor?

Dr. Shanahan found it so disquieting, she went to the Vice President and Medical Director of HMSA, Hawaii’s Blue Cross insurer. While she went back and forth with him, she said “there really wasn’t anything I could say to change his mind.”

Before we look at the research that she and other doctors in her predicament find troubling and unsupportive of this Pay for Performance (P4P) measure, she made another disturbing disclosure on her blog. In discussing the outrage being expressed by the public over news reports of new statin recommendations for children, blaming “drug companies for taking over the minds of doctors,” Dr. Shanahan said:

Don’t blame doctors. We’re being threatened by insurance companies. If we don’t do exactly what drug companies want, we’ll be paid less. In some cases, some of us might loose [sic] our jobs. (OKay, we do deserve some blame for not standing up for ourselves!)

I went for a job interview in Portland and in a conversation with the medical director of a large group there, I was told that if I failed to get my patients LDL levels down to 100 “someone will sit down and talk with you.” This particular group was able to offer a better starting salary than average. I had assumed that the reason they could offer more was through efficiencies. During the interview, I learned there was more to it than that. They had special arrangements with drug companies called ‘incentive programs.’ The medical director told me with absolute glee “we keep asking them [meaning drug companies] for money and they keep giving it to us.” He sounded like a kid at Christmas!

This group’s policy is to get everyone’s LDL under 100, regardless of risk factors. Stratifying risk is “too complicated.” So they make it simple for their docs. How convenient for the drug companies. I suspect that because this organization has such an aggressive general policy, the drug companies reward them handsomely for taking such a progressive position. They can offer about $50,000 more per year than doctors working in their own, independent offices.

She also shared her concerns about HMSA planning to essentially begin fining doctors in 2009 who don’t put every one of their adult diabetic patients on statins. “No matter what your cholesterol, if you are a diabetic, your doctor will probably write you a prescription,” she wrote. “Even if you don’t have heart disease” [primary prevention]. In her discussion with the HMSA medical director, he said the new mandate “is well supported by extensive research.” She learned that wasn’t the case at all, writing:

[I]t appears he didn’t do the research himself, nor did anyone in HMSA. HMSA hired a company to outsource this decision making process. When I look at their package of supporting information, I see some very fishy writing. Two of the articles are based on the opinions of nine doctors, eight of whom are paid drug company consultants. One citation is a CDC web site that has disappeared.

The only article of any merit is about a study done on about 2,000 people with diabetes, half of whom took a sugar pill and half of whom took a cholesterol pill. Almost two hundred people had to stop the cholesterol pill due to side effects. This effectively weeds out the more sickly people and so, it is not surprising that in the group taking the pill there were fewer heart attacks — at least to start with. The study was stopped early, for reasons they don’t explain. What has me worried is that, when I look at the graph comparing death rates in the two groups, the first few years look pretty good for the group on the drug. But by the end of year three, people start dropping dead fast — so fast the line looks like its starting to go straight up. What is the real reason they stopped the study prematurely? Could it be that they saw where the line was heading, and decided to quit while they were ahead?

Remember, this line is the group of healthier people (b/c they could handle the side effects of the drug) and even they started to die after taking it for almost four years. HMSA wants diabetics to stay on it for life.

The study she is referring to is the Collaborative Atorvastatin Diabetes Study (CARDS). It was a primary prevention study similar to the Scandinavian Cardiac Outcomes Trial (ASCOT). Both of these randomized, placebo-controlled clinical trials included type 2 diabetics who already had notable cardiac risks and nearly all had hypertension, were well into their 60s, were mostly men and high numbers of smokers. The ASCOT found no significant reduction in cardiovascular-related incidents or deaths with statins as compared to a placebo. The type 2 diabetics in the CARDS study had advanced disease and been on diabetes medications for about eight years, and while none had diagnosed heart disease, most all had hypertension. The trial had been stopped two years early and reported a 37% reduction in risks for cardiovascular events.

But a review of this trial published in the Canadian Medical Association Journal shared her concerns about this trial being used to recommend statins for all diabetics. The author, Dr. Daniel G. Hackam from Sunnybrook and Women's College Health Sciences Centre in Toronto, noted that the patients had had poor control of their diabetes, hypertension and other risk factors, lending caution to generalizing these results. “At first glance, the data appear to support the authors' conclusion that most, if not all, patients with type 2 diabetes should be considered for long-term statin therapy,” said Dr. Hackam. “However, the average participant had long-standing diabetes with multiple additional risk factors that were substantially undertreated. Thus, it remains to be seen whether the benefits would be realized in diabetic patients who did not have similar risk factors or who were optimally treated for their comorbidities.” Are statins of any benefit for generally healthy patients or among high-risk patients receiving good clinical care?

A number of studies have supported doctors’ arguments that medical care should be individualized and that universally putting every diabetic on statins isn't supported by the evidence. It’s not only expensive, but could needless expose many patients to side effects. A German randomized controlled clinical trial, for example, evaluated statins for primary prevention among type 2 diabetics on hemodialysis, who might be expected to be at especially high risk for heart problems. With clinical care of their condition, the authors found no benefit of statins. Cardiovascular deaths, heart attacks and strokes were no different in those on statins compared to a placebo after four years.

Treatment guidelines, such as those issued by the American Diabetes Association recommending statins in most everyone with diabetes, have otherwise been extrapolated from secondary analyses done of diabetics who’d been participants in larger studies. However, according to a review in the American Journal of Health System Pharmacology by authors from the School of Pharmacy at the University of Mississippi in Jackson, these trials suffered from design flaws and some nonsignificant results.

The only other randomized placebo-controlled clinical trial conducted exclusively on diabetics (meaning, it could control for other diabetes treatment effects and risks) without pre-existing heart disease, to evaluate the use of statins for primary prevention was the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN).

As the University of Mississippi authors wrote, ASPEN found that a statin (atorvastatin) was no better than a placebo in reducing cardiovascular events or improving outcomes. They concluded that the available evidence suggests the use of pharmaceuticals should be based on individual diabetic patients, not solely on the diagnosis of type 2 diabetes, as in those P4P measures being imposed by third party payers.

The ASPEN trial results had been published in the July 2006 issue of Diabetes Care. Two years into the secondary prevention arm of the study, it enrolled type 2 diabetics without a history of cardiac events to evaluate statins for primary prevention. Participants were followed for an average of 4 years. Two-thirds of the participants were men, with an average age of 61 and BMI of 28.8. Half had a history of hypertension. The study found no statistical difference between the group receiving the statin and the placebo group in their first cardiovascular event or death. The ASPEN authors had also concluded that for primary prevention, the risk for heart disease is low and diabetics are best managed on an individualized basis.

Is this important for you?

Regardless of whether you feel a third-party payer or government agency can know better than your doctor what’s the best care for you, most of us would be uneasy to learn of the increasingly heavy-handed influence payers are having over our doctors and the care they provide. The importance of this example goes far beyond just this one health index. Think of all those health numbers for which there is controversial evidence that screening or prescriptions to reach lower thresholds actually improve clinical outcomes. With the 74 clinical quality measures recently launched by the Centers for Medicare & Medicaid Services with its P4P program, which would encourage doctors to prescribe some 15 different prescriptions for adults over age 50 in order to meet the requisite health indices, this is more than just about cholesterol.

This past fall, HMSA announced it had spent more than $113 million over the past ten years on its P4P incentive programs for doctor and hospital providers. Dr. Shanahan’s letter to the editor this past week put a face and a reality to the study of the effectiveness of the BCBS of Hawaii’s P4P incentive program in changing doctors’ practices [covered here]. Since 1998, the insurer has been giving doctors financial rewards for meeting its quality indicators. The first six-year results of the program were surprising. Not only was there no tenable increase in the percentage of patients actually getting the insurer’s treatment recommendations, but for patients seeing doctors both in and out of the network, rates actually dropped. The study authors felt certain that adherence to their guidelines would increase when patients aren’t given the ability to see providers outside the network, as with medical home managed care, which also requires mandatory disease management and monitoring.

As the science behind P4P measures being applied to everyone is, at the very least, still being debated and controversial; should guidelines be written and enforced by those who stand to profit on them, suddenly these financial incentive programs feel more onerous. Most troubling are the findings of unintended consequences, especially for older, sicker or “noncompliant” patients.

A recent article in Medical Economics took a hard look at some of the ethical dilemmas for doctors when financial concerns come between doctors and patients. The article was even more important for consumers. For people who believe that their bodies are their own and they have the right to make the final choices about what treatments they will consent to, then sound P4P measures matter. Can people be forced to undergo unnecessary, costly or dangerous tests and interventions and take prescription drugs to make someone else more money?

The most serious unintended consequence of P4P measures is what happens should consumers or doctors choose not to comply with insurer mandates. What happens when you are labeled as “noncompliant?”

We’ve already looked at what happens to doctors. Healthplans use profiling systems to rank doctors by their performance data. “Physicians designated as ‘good performers’ in both P4P measures and efficiency receive increased rate of reimbursement. Physicians who fail to meet designated status may be excluded from participation with the health plan,” according to BCBS of Michigan. Health plan rankings of doctors, based on their compliance with P4P measures, are also given to members and patients who seek care from these non-designated doctors are subjected to increased out of pocket expenses.

Could doctors be influenced by those financial incentives, whether intentionally or unintentionally, and be more apt to drop patients or refuse to take care of those who don’t go along and agree to take their medicine? Will doctors increasingly refuse to care for patients when their reimbursements are lower, such as Medicare and Medicaid patients? Doctors may want to put patients first, author Gail Garfinkel Weiss said, but they’re also small businesses and need to be profitable to stay afloat. Her thought-provoking article titled, “Patients’ needs versus maximizing income,” is worth reading in its entirety.

Her discussion of “noncompliant” patients most highlighted concerns of one-size-fits-all P4P measures. She wrote:

Physicians have always wrestled with the quandary of how to deal with problematic patients. Over time, organized medicine and the legal system have developed guidelines that physicians are expected to follow when a "divorce" becomes inevitable because, say, patients won't pay their bills, follow treatment regimens, or treat the office staff appropriately... Dropping patients for noncompliance, long considered a last resort, has become more tempting in recent years with the introduction of pay-for-performance initiatives. If physicians are to be financially rewarded for successful outcomes, dropping a patient who can't or won't keep appointments or follow medical advice makes sense financially. But does it meet ethical obligations?...

FP Charles Davant III of Blowing Rock, NC ... currently has no P4P insurance payers, but he maintains that if he did, these noncompliant patients would be out the door. "It would be a matter of running the numbers," he says. "If treating them brings in, say, $115 a year for three office visits, and they reduce my other payments by 10 percent, they can be someone else's problem."

The ethical ground gets shaky, however, when physicians try to improve their P4P numbers by ridding their patient roster of people who don't take their medicine, follow a prescribed diet, or get recommended tests because their lives are complicated and taking care of themselves isn't a top priority. Perhaps they're working two jobs or are otherwise overwhelmed with responsibilities...

[P]erformance-based reimbursement [also] has the unintended consequence of penalizing physicians who take the ethical high road by seeing the sickest and most vulnerable patients — and rewarding those who cherry-pick the patients who are most likely to yield good results....

Last month’s issue of Medical Economics published the responses from doctors. They probably deserve reading with a critical eye, as we have no way of knowing if these letters were representative of the letters sent in by doctors or trying to convince physician readers that most of their colleagues were on board with P4P measures. How many doctors are like Dr. Shanahan and protesting P4P measures that lack the best evidence or may not be in the best interests of their patients? And how many are pressuring their patients to comply? We don’t know. Still, these provide troubling insight into how free patients may actually be to refuse to undergo tests and take prescriptions they don’t believe will offer sufficient benefits over risks for them.

One doctor in Hawaii said he took a hard line with his patients who didn’t go along with the insurer mandates:

I have dropped patients for noncompliance in the past and will continue to do so, not for pay-for-performance issues but for liability reasons. As a rural solo pediatrician, I have neither the time nor the desire to try to convince parents about the importance of childhood immunizations, follow-up with specialists, or medications. I tell parents that I have to be able to trust them to carry out the treatment plan, just as they must trust me to prescribe the proper therapy...

An osteopath said his family practice office:

[We’ve] taken an aggressive approach toward noncompliant patients. We've done this for two reasons: First, the impact on the patient and the associated liability of noncompliance; and second, the financial effect on the practice. For the past two years, we have been flagging the charts of patients who haven't complied with health maintenance issues such as annual mammograms, gynecology visits, bone density tests, lab screens, baseline ECGs, eye examinations, colonoscopies, prostate exams, and so forth... Those who remain noncompliant over a period of time are asked to sign an informed refusal or to find another physician.

In other words, some patients already appear forced to choose between submitting to tests and prescriptions or not having a doctor! And when medical homes are put into place, will that mean no medical care at all until patients comply?

It’s never been more critical that those issuing clinical care guidelines be free from conflicts of interest and able to objectively and carefully evaluate the clinical evidence. And it’s never been more critical that clinical care guidelines again be guides for healthcare providers to use along with their clinical judgment in prescribing what’s best for each individual patient, rather than mandates that must be followed, or else.

© Sandy Szwarc. All rights reserved.

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