When is unneeded care criminal?

Co-Authored by Juliet K. Mavromatis, MD, FACP, Personalized Primary Care Atlanta and Kreton Mavromatis, MD, Assistant Professor of Medicine, Emory University, Director of the Cardiac Catheterization Laboratory, Atlanta VA Medical Center

Recent media coverage has sensationalized the criminal investigation of several cardiologists for the possibility of performing fraudulent cardiac procedures.  Is this a case of individuals with unethical conduct? Or, does it point toward a more systemic problem in medical care, where Medicare dollars are wasted on unneeded care? As reported in Heartwire on July 27, 2011:

"A federal jury convicted McLean, 59, on six charges of healthcare fraud relating to insurance claims he'd filed for stents deemed to have been placed unnecessarily, as well as for ordering unnecessary tests and making false entries in patient medical records…evidence brought forward suggested that McLean had performed cardiac catheterizations and implanted unnecessary cardiac stents in more than 100 patients.  He then falsely recorded in the patients' medical records the existence or extent of coronary artery blockage, known as lesions, observed during the procedures in order to justify the stent and the submission of claims to healthcare benefit programs, including Medicare and Medicaid."

In a separate case the Senate Finance Committee investigated Dr. Mark Midei, an interventional cardiologist practicing in Towson Maryland, for the possibility of performing unnecessary stents and also for his relationship with Abbott Laboratories, the company that manufactures the stents that he used.
A prominent cardiologist commented in the New York Times report: 

“What was going on in Baltimore is going on right now in every city in America,” saying that he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”

Coronary artery disease affects a large proportion of people in Western civilization. The disease manifests as blockages in coronary arteries limiting blood flow to heart muscle, causing heart pain, heart  attacks, heart failure and/or sudden death. Heart disease kills 1 out of every 6 Americans. Coronary artery stents are metal mesh tubes that can be placed in blocked coronary arteries completely reopening them and improving blood flow to the heart muscle.   Many studies (PAMI, TACTICS-TIMI 18, etc.) have shown that when used appropriately, stents can be life-saving and improve quality of life by relieving heart pains (angina) and preventing heart attacks.

However, in 2007 the COURAGE  trial was published demonstrating that in some patients with coronary artery disease, there was no mortality or heart attack benefit associated with an initial treatment strategy of using stents, compared  with medication treatment.  The trial also found evidence that a strategy of using medications alone could potentially save money. In considering these results, several caveats must be kept in mind: patients included in the study were very select (< 1 in 15 patients considered were actually studied); they tended to have mild disease (78% had either no or only slight symptoms; patients with recent heart attacks were excluded);  ~1/3 of patients initially treated with medications alone eventually required stents for their blockages anyway.  In addition, patients who underwent initial treatment with stents had a quicker improvement in quality of life as compared to patients who initially were treated with medications alone. Nonetheless, this single study suggested that the need for coronary stenting is unnecessary in at least some patients with coronary artery disease, and that trying medication therapy alone in those patients is reasonable. There is ongoing investigation designed to confirm or refute the observations of the COURAGE trial.

In a New York Times editorial entitled Cut Medicare, Help Patients authors Ezekiel Emanuel and Jeffrey Liebman discuss the use of cardiac stents for treatment of symptomatic coronary artery disease suggesting that many stents are unneeded.

“Every year more than 1 million cardiac stents are placed in patients to open blocked arteries… many patients who receive stents paid for by Medicare are either experiencing no pain or have not tried medication first.”

In a review of national registry data published this year in JAMA by Chan et al. it was concluded that by current criteria 1 to 11.6 percent of stents placed may have been “inappropriate” based in part on the results of the COURAGE study.  

It is important to distinguish between “unneeded care” due to fraud and “unneeded care” due to less expensive but similarly effective alternatives. Fraud implies dishonest intent. Unneeded care due to fraud is universally considered to be wrong. In contrast, calling care unneeded because there are less expensive and similarly effective alternatives is subject to a broad range of opinion. In an article that I read recently Dr. Maneesh Patel  (Duke Clinical Research Institute, Durham, NC) made the important point:

"the majority of what we do in medicine is based on evidence that would fall into the category of 'uncertain' "—for example, guideline recommendations with level of evidence B or C.“

The Maryland cardiologists are accused fraud, or falsely recording the presence of significant coronary artery disease, and billing health insurance for placing stents in such patients. This is very different than choosing to treat significant coronary artery disease with a stent when medical therapy alone may also be a reasonable strategy in preventing death or myocardial infarction (heart attack).  

Here’s an example:  a 50 year old man was found to have calcifications in his coronary arteries on a chest CT done for follow up of cancer (presumed cured). On questioning, the patient, who has high blood pressure, high cholesterol, and a family history of heart disease, noticed some shortness of breath with exertion, potentially due to obstructive coronary artery disease.  An exercise treadmill test was ordered and was positive after ten minutes.  An exercise echocardiogram was ordered and showed a possible small area of reduced blood flow after ten minutes.  A cardiac catheterization was ordered and an 80 percent blockage of one artery was found. A stent was placed and the patient was started on blood thinners.  The patient also had 30 to 50 percent blockages in other locations and was advised to take more cholesterol and blood pressure medication.

Which of the tests/treatments in this case were unnecessary? If the coronary blockage was 40 percent and not 80 percent, the stenting here would be universally considered to be unnecessary. (Furthermore, if the physician knowingly reported this 40 percent blockage as 80 percent, stented it, and billed for it, then it would constitute fraud). If the coronary artery blockage was truly 80 percent then according to the results of the COURAGE trial, first trying medical therapy alone could be as effective as immediately using stents for the purposes of minimizing the cardiovascular mortality in this patient (but perhaps not from the point of view of immediately relieving his symptoms).  In this situation, the immediate stent placement could also be considered “unnecessary.”

With a proposal to add “cost-conscious care and stewardship of resources” as one of the ACGME’s core competencies for medical trainees, and with Medicare aggressively tightening its belt in order to remain fiscally solvent, determining “unnecessary care” will depend on developing a consensus on the value of life, suffering, and the validity of extrapolating scientific data analysis to a multitude of individual specific patient situations.   As health professionals and policy makers appropriately engage in this discussion about what represents effective care that health insurance should pay for, they should be careful not to equate outliers, such as doctors facing criminal charges for fraud, with accepted variation in standard practice that might encompasses care that some deem “unneeded.”  Equating unneeded care with dishonest intent is bound to elicit a highly emotional response from most doctors, who are deeply committed to their professional obligation to do what they believe is best for their patients.

  

Are you at risk for an adverse medication reaction?

Many patients express concern about being on long term medications. In my view, their concerns are well-founded.  At times the treatment can be worse than the disease.  According to CDC statistics 82 percent of adults are on one or more medications, and 29 percent are on five or more.  Polypharmacy (the use of many drugs together, or excessive medications) is a significant problem of the elderly, and of those with chronic illness.  These populations are at increased risk for drug-related adverse reactions.   How can a patient assure the safety of his or her medication? Many turn to alternative medicine, under the false impression that these substances are somehow safer than those that are brought to market by the pharmaceutical industry.  Others rely on medical professionals—doctors, nurses, and pharmacists-- to warn them about the possibility of drug interactions and toxicity. Electronic prescribing has improved drug safety by automating cross-checking and alerting prescribers when two drugs interact.  However, in my experience electronic systems can establish such low filters for reporting drug interactions that virtually every drug prescribed may cause an alert to pop up. Which of these interactions is clinically relevant? Often clinicians must use their best guess as to whether two or more drugs in combination will be safe for a particular patient.

The cytochrome P450 enzymatic system is involved in the metabolism of many drugs. Although there are more than 50 of these enzymes, only six of them are responsible for the metabolism of 90 percent of drugs. Many significant adverse drug events result from issues that involve this pathway. Ingested substances, whether it’s grapefruit juice, a cup of coffee, an herbal product, or a prescribed medication, can alter metabolism by inducing or inhibiting the activity of the P450 enzymes. Moreover, research has revealed that there is significant genetic variation in their activity from one individual to the next.  I’ve had many a patient tell me of his or her unique sensitivity to drugs.  These circumstantial observations may well be founded in science, and pharmacogenetics is an emerging field that describes the genetic variation in responses to medication while one patient may have particularly efficacious P450 enzymes, another may have P450s that are slower to operate. Two or more drugs that are metabolized by the same P450 may compete and one drug may reduce the metabolism of another, causing high levels of the “substrate” drug to accumulate, and potentially cause toxicity.  Other drugs may up-regulate the digestive enzyme and cause a drug to be cleared more rapidly than normal, reducing its concentration and therapeutic efficacy.

Take the popular cholesterol lowering medication simvastatin (Zocor).  Simvastatin is used to lower cholesterol and has been associated with important clinical outcomes in patients who are treated with it-- including a reduction in cardiovascular death. However, its use has also been linked with an adverse drug reaction--myopathy, or muscle damage.  At its extreme myopathy is known as “rhabdomyolysis,” a process that can lead to kidney failure and even death.  Rhabdomyolysis occurs at a rate of 4.4 cases per 100,000 patients exposed to a “statin”-type medication (also including atorvastatin, rosuvastatin, pravastatin). The risk of myopathy is dose related and recently the FDA has warned against using the 80 mg dose of simvastatin for treatment of elevated cholesterol. 

Simavastatin’s metabolism occurs in the liver with the P450 enzyme CYP3A4.  Numerous other medications affect the activity of this enzyme.  The calcium channel blocker amlodipine (Norvasc) is processed by the same enzyme. Patients who take amlodipine and simvastatin simultaneously may have reduced clearance of simvastatin, and may be more prone to muscle damage from the drug.  Consequently the FDA advises limiting simvastatin dosing in this population to the 20 mg dose. However, enzymatic activity of CYP3A4 is genetically determined.  Within the population certain individuals may be rapid or poor metabolizers of the drug, impacting the generalizability of the FDA recommendations from one person to the next.

Genetic testing for cytochrome P450 enzyme polymorphisms is not yet recommended. Yet, we are moving in that direction, and no doubt the genetic polymorphisms may prove to provide valuable insight into why particular patients may not respond to standard treatments.  For example the drug Plavix (clopidogrel) is an important blood thinner that effects platelet activity and is indicated in patients who have had a stroke, or who have had stents placed for coronary artery disease.  Clopidogrel is a pro-drug-- it must be converted in the liver to its active form and CYP2C19 is the predominate enzyme responsible for this conversion. Patients who are poor metabolizers of Plavix do not effectively convert the drug to its active form. In these patients, the drug is less effective at preventing heart attacks, strokes, and cardiovascular death.  It is estimated that 2 to 14% of the population are poor metabolizers of Plavix; the rate varies based on racial background.  With this finding, some have advocated genetic testing of all patients who need Plavix for its important indication.

Another P450 issue has emerged with Clopidogrel.  The popular, and now over the counter, proton pump inhibitor (PPI) omeprazole is metabolized by the same hepatic enzyme and is an inhibitor of the enzyme, blocking the conversion of clopidogrel to its active form.  However, not all PPIs have the same degree of inhibitory effect on the enzyme (CYP 2C19). The drug pantoprozole (Protonix) may be a less strong inhibitors, and therefore safer for concomitant use with Plavix.

These two examples demonstrate the complex determinants of drug metabolism—genetic and environmental—and highlight the importance of using individualized treatment plans in order to optimize therapy and reduce the risk of medication related toxicity. 

*The FDA website offers a drug Index of Postmarket Safety Information for Patients and Providers. I found the website useful for specific drug information.

Should Doctors Stop Using PSA to Screen for Prostate Cancer?

The United States Preventive Services Task Force (USPSTF) says yes. 

Recently the influential Task Force gave the PSA (prostate specific antigen) screening test a “D” level rating, meaning that doctors should recommend against using the test for the purpose of early detection.  Prostate cancer is the second leading cause of cancer death in men after lung cancer.  Early detection of prostate cancer through screening with PSA  was introduced into clinical practice in 1986.  Over the past several decades prostate cancer mortality has fallen by approximately 30%. Statistical modeling suggests that this might correlate with the advent of screening with PSA.  In addition, over the past several decades there has been an increase in prostate cancer incidence and a shift toward the detection of earlier stage cancers—likely also a result of PSA screening.

The purpose of health screening is to detect disease in an earlier stage so that preventive measures can be initiated to improve health outcomes related to that condition.  However, in order to justify population level screening, the benefit associated with early detection must outweigh the harm that it potentially causes.  Healthy Americans and their physicians have embraced the practice of early detection, particularly with respect to cancer, which along with Alzheimer’s disease, is the most feared illness in our population.  The USPSTF analyzed available data on prostate cancer screening and treatment, including the results of the two largest clinical trials—one done in the United States and the other in Europe.  The American study (PLCO)  found no mortality benefit with PSA screening after a 7 to 10 year period of follow up.  Its results have been criticized with the possibility that findings were “contaminated” with too many men in the control group who received screening before and during the study, reducing the apparent efficacy of PSA screening.   In contrast, the European ERSPC study showed a statistically significant, but small reduction in prostate cancer mortality (20%), in men who were screened every 4 years over 9 years. Researchers found that 1,410 men would have to be screened and 48 additional cancers would have to be detected to prevent one death from prostate cancer.  This efficacy is similar in magnitude (slightly greater) to the effectiveness of using mammography to screen women in their forties for breast cancer.  A potential shortcoming of these studies is that the study time could have been too short to detect benefit given that prostate cancer may be very indolent. 

Needless to say urologists as a professional group object to the USPSTF’s recommendation, stating on the American Urologic Association website: 

The Task Force is doing men a great disservice by disparaging what is now the only widely available test for prostate cancer, a potentially devastating disease. We hold true to our current position as supported by the AUA's Prostate-Specific Antigen Best Practice Statement that, when interpreted appropriately, the PSA test provides important information in the diagnosis, pre-treatment staging or risk assessment and monitoring of prostate cancer patients. But not all prostate cancers are life-threatening. The decision to proceed to active treatment or use surveillance for a patient's prostate cancer is one that men should discuss in detail with their urologists.

The argument against using PSA to screen, itself an inexpensive blood test, is that it leads to over-diagnosis of clinically insignificant prostate cancer.  Postmortem data indicate that approximately one third of men between the ages of 50 and 65 have microscopic evidence of prostate cancer. This percentage increases to over 50 percent for men in their 70s and 80s. Analysis of data suggests that early detection leads to over-zealous treatment—including radiation and radical prostatectomy.  Over-treatment puts men in harm’s way with side effects related to treatment --loss of continence (ability to control urination) and erectile dysfunction.  I recently read a nice discussion the magnitude of risk associated with screening by Dr. Albert Fuchs. Both physicians and patients are participants in opting for aggressive interventions for early stage cancer.

Active surveillance or “watchful waiting” is an acceptable strategy for managing elevated PSA or even biopsy proven prostate cancer.  In practical terms this means that once cancer is detected it may be reasonable to do nothing aside from monitoring for evidence of prostate cancer progression. In some, this might entail monitoring the PSA velocity (or rate of increase) to help determine an appropriate time to treat.  Or, in others, it might include waiting to treat until the cancer becomes symptomatic with urinary symptoms or symptoms related to prostate cancer that has spread to the bone.  However it’s very difficult for patients and their doctors to sit tight with the knowledge that they might be living with cancer.  I’ve discussed the difficulty with watchful waiting with respect to breast cancer in the blog: “Is Watchful Waiting too Difficult?” 

As for me, I tend to find the USPSTF’s PSA screening recommendation a little too reactionary.  As stated in a recent New England Journal of Medicine editorial a “C” level rating for this test might have been more appropriate.   I am not completely ready to jump onto the anti-PSA bandwagon that many of my fellow internists seem to be espousing and go back to the 1970s.  However, I do see that a more cautionary approach to prostate cancer detection and treatment is warranted.  This will require discussion, courage, and culture change on the part of primary care physicians, urologists, and their patients alike as we try to effectively convey and accept the message that early detection of cancer is good, but that not all early cancer, or “pre-cancer,” needs early and aggressive intervention.