Monday, August 28, 2006

No-Pay for Performance?

What would make a primary care physician say this?

Between September 22nd and October 1st, I will refuse to see Medicare patients in my office. If they need care urgently, they can go to the ER. I shall also tell them exactly why I am imposing a moratorium on caring for them. And if (when?) this happens again next year and the year after that, I'll just be that much closer to the brink of opting out of Medicare entirely.
Read all about it here. I had forgotten all about this little quirk in Medicare reimbursement, which came about as part of the bill that prevented a 5.2% decrease in payment from Medicare this year (which, incidentally, is back on the table for next year).

Thursday, August 24, 2006

Why I don't practice in Florida

This is an excellent example of why I get many offers of "great" practices to join in Florida --- sort of lurid sales pitches from snake oil salesmen sitting in a snake pit.

A jury has awarded $8.25 million to a Fort Myers woman who claims a Naples-based plastic surgeon botched a breast augmentation.....Aills' lawsuit said Dr. Luciano Boemi failed to inform her surgery could result in damage to her body. During the surgery, the suit contends, Boemi failed to ensure blood continued to flow in her breasts and caused a loss in sensation.....The jury of four men and two women awarded Aills $250,000 in actual damages to cover medical expenses and personal costs. The other $8 million was for pain and suffering.
Okey-dokey. Let's say, for argument's sake, that the plaintiff was correct, and that real malpractice occurred. The article states the patient went on to have a total of 13 surgeries, with what sounds like eventual loss of both breasts, and the $250K covers those expenses. But $8 milliion for pain and suffering? How did they settle on a figure of $4 million per breast? I doubt that even any of these ladies have Lloyd's of London insurance coverage that extensive for their cleavage.

Whenever I see an award in a malpractice case that is this high, I remind myself to continuously express to patients one of the basic tenets of life: Bad things happen. Sometimes, they happen despite the best efforts of everyone involved.

Surgery, like life, offers no guarantees.

Tuesday, August 22, 2006

Black Box Warning for ADHD Drugs

I don't see many children in my practice, but am often surprised at the number of kids out there that are being medically treated with stimulants for ADHD. Without getting into the debate (I'll leave it up to Flea, with whom I tend to agree), there is a new twist to the story: The FDA has slapped a "Black Box" warning on these drugs (from eMedicine; emphasis is mine):

Earlier this year, a FDA advisory panel voted 8–7 to add a black-box warning to the labeling of stimulants (eg, amphetamine mixtures, dexmethylphenidate, dextroamphetamine, methylphenidate), used to treat attention-deficit/hyperactivity disorder (ADHD) to alert prescribers about cardiovascular risks associated with use of the drugs. Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or other serious cardiac problems that may be exacerbated by sympathomimetic effects. In adults, sudden death, stroke, and myocardial infarction have been reported with use of stimulants for ADHD.

The Food and Drug Administration (FDA) has received reports of more than 20 deaths associated with use of ADHD drugs, reviewers said. But, said Kate Gelperin, a medical officer in FDA's Office of Drug Safety, cardiovascular signals in ADHD adverse events reported to the agency were "not conclusive."

About 1.5 million adults and 2.5 million children take ADHD medications, FDA safety reviewers told the panel. Use of ADHD medications is on the rise, especially in adults, said Andrew Mosholder, a medical officer in FDA's Office of Drug Safety. There was a 90 percent increase in adult use of the drugs over the past three years, he told the advisers. About 10 percent of adult users of ADHD medications are over age 50, Mosholder added. ADHD medication use in children peaks around ages 9–12, and then drops off, he said.

Methylphenidate products, marketed by Novartis under the brand name Ritalin, are the most frequently prescribed ADHD medications, Mosholder said. "Over the last decade or so, we've seen an enormous rise in the use of these drugs now to the point that 10 percent of 10 year olds are getting treated" for ADHD, said Steven Nissen, director of cardiovascular medicine at the Cleveland Clinic in Ohio—the panelist who proposed the black-box vote. "I have grave concerns about the direction we are going in with the mass use of these drugs and the potential for harm," he said.
10% of 10 year-olds are getting meds for ADHD? That seems like an awfully high number, and I wonder if that was an off-the-cuff remark or reflected actual data. (Illustration above © Joanna Walsh, found here.)

A "Black Box" warning is a pretty big deal, and can seriously change prescribers' activity. My only experience with this kind of warning came when the FDA similarly labeled Droperidol, which had been in wide use since the 1970s primarily to treat perioperative nausea.
Tony Gerlach, a pharmacist and medication safety specialist for the Ohio State University Medical Center (OSUMC) in Columbus, said his health system’s medication-use improvement team, a P&T subcommittee, decided to "phase out" droperidol use over the coming months. Gerlach said OSUMC had previously used droperidol as a first-line antiemetic drug for surgical patients "mostly as a cost-saving measure." But, he said, after the addition of the boxed warning to droperidol’s labeling, the health system’s head of anesthesiology recommended against using the drug. "He said that, although he has never seen an adverse event, the black-box warning is too hard to ignore," Gerlach said.

I was involved with our P & T committee at the time, and we felt our hand was forced to severely restrict access to the drug, even though the decision by the FDA was exceedingly controversial and based on very skimpy data. In addition to increasing overall costs for antiemetics, that particular "Black Box" warning also has prevented us from using Droperidol to calm the heavily intoxicated, agitated trauma patient to allow safe evaluation (with CTs, X-rays, etc.); now, they all have to be intubated, increasing risk and costs.

With this new warning, I wonder how many pediatricians will be willing to continue to prescribe Ritalin and its cousins. Will they screen all such patients with echocardiograms, at a considerable cost, to try to prevent a lawsuit? Or will they continue to prescribe these drugs at their current rate?

UPDATE: I know this may come as a surprise to a grand total of 3 of you, but guess what type of professionals have also noticed this black box warning?

Sunday, August 20, 2006

C(hicago) M(edical) E(ducation)

Chicago beckons. It's time for me to get some CME hours, and there's no better way to get a big chunk of them than to go to the American College of Surgeons annual meeting. I hate going to meetings; I prefer to read my journals, but need to get some CME hours for a variety of meetings. So, I just registered for the meeting in October, but I was unable to get SWIMBO to come with me. Chicago? What about the Magnificent Mile does she not understand?! Oh, well. What will she miss? Perhaps a shopping trip here?

Plus, since I read about Chicago's famous architect Daniel Burnham in Devil in the White City, I was excited to find out that I will be staying at the Hotel Burnham -- housed in the Reliance Building designed by Burnham's firm (by Charles Atwood, who also designed the Museum of Science and Industry). The Reliance Building is felt to represent the "first direct predecessor to today's modern skyscrapers," built in the "Chicago School" of architecture. It has been renovated recently:

.... complete renovation and restoration work began. The result -- portions of the interior replicated from the original building. Renovation included meticulously reconstructing the mosaic floor, multi-colored marble ceiling and walls, and ornamental metal elevator grills, stairways and archways to resemble the lobby as it once existed.


Cool. I like it already. So, although I don't like to go to national meetings, it looks like a fun place to stay. Maybe I need to check into some CME where I would like to go next time. Anyway, this time I'll do a little meeting, do a little talking to old friends. Eat a little steak, maybe catch some music, and enjoy a neat old hotel. Anybody else going? I'll buy you a martini.

Friday, August 18, 2006

Pain Relief & Iontophoresis

I get jazzed when I see new ideas that get implemented in innovative ways. Years ago, the idea of transdermal admininstration of medications was a new approach; it became widely used with estrogen patches and the like, along with fentanyl patches for pain management.

Some smart guys decided that if fentanyl patches worked, why not use the same technology with a patient-controlled delivery system --- sort of a fentanyl patch with an on-demand component. We have had for many years patient controlled IV narcotic delivery systems (PCAs), and a transdermal delivery system would theoretically be similar. The FDA has approved the first such device, the Ionsys:

IONSYS is the first and only product to incorporate the proprietary E-TRANS® iontophoretic transdermal drug delivery system developed by ALZA. E-TRANS utilizes iontophoresis - a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. IONSYS securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl.
The idea is to use this once patients have been titrated to their appropriate level of analgesia, and replace it every 24 hours (or whe 80 doses have been delivered). There is a "lockout" feature that prevents administration of more than one dose every 10 minutes.

Cool! No needles, and each unit is self-contained and disposable. I'm not a nurse, so I am not sure how much easier this little gizmo would be to use than PCA pumps, but I suspect it would alleviate at least a few hassles. My only concern is that there is no method of adjusting the dose -- some patients, particularly the postop LOL, may need a smaller dose than the unit is designed to deliver. Obviously, these are to be used only in the hospital setting; if the same technology was to be applied with much lower doses, there could theoretically be a role in the outpatient setting (postop inguinal hernia repair, for example), but a whole lot of safety testing would have to be undertaken first.


Smart folks, figuring out better ways to do things; ain't America great? Any day now, I fully expect one of you smart people out there to outfit me and all the staff at my hospital with a spanking new tricorder --- just like Dr. McCoy --- and all of our diagnostic dilemmas will disappear!

Thursday, August 17, 2006

Rested

Remeber my recipe for R&R? Here's the real result:

The Cheetos Factor

Nutritional status
&
Weight
While on the surface it would appear that these two issues are inextricably linked, that is not necessarily the case. The average person, observing a gaunt, malnourished denizen of a poor third world country would accurately assume that person's nutritional status is extremely poor, going along with his "under-healthy" weight. But what about the obese person? Once again, the average person would assume that the obese patient is, while certainly not healthy, clearly not malnourished in any meaningful way.

Actually, that is not always true --- the morbidly obese patient in the United States has a very good chance of having demonstrable deficits in nutrition. This has been shown previously, but there is a good study published in the July issue of the Journal of Gastrointestinal Surgery that really illustrates this point nicely. The study, entitled Preoperative Nutritional Status of Patients Undergoing Roux-en-Y Gastric Bypass for Morbid Obesity, comes from the Dept. of Surgery at North Shore Univ. Hospital in New York. They retrospectively reviewed a series of preoperative nutritional markers in a consecutive series of 379 patients undergoing gastric bypass surgery for morbid obesity; these were not patients that were "a little" overweight, as the average BMI for the group was 51.8 ± 10.6.
Preoperative values of serum albumin, serum calcium, 25-OH vitamin D, serum iron, ferritin, hemoglobin, vitamin B12, and thiamine (vitamin B1) were examined and the prevalence of deficiencies noted. Values for serum albumin, serum calcium, serum iron, ferritin, and hemoglobin were available for all patients. Thiamine and 25-OH vitamin D levels were available for patients undergoing surgery after July 2003 (n = 141 and n = 144, respectively). Data were also stratified based upon age, gender, and race.
From the table in the results section, here are the percentages of patients with demonstrable deficiencies in the values tested; those that reached statistical significance are highlighted:
Albumin 1.1%
Calcium 3.2%
25-OH Vitamin D 68.1%
Iron 43.9%
Ferritin 8.4%
Hemoglobin 22%
Vitamin B12 0%
Thiamine (Vitamin B1) 29%
These patients do not suffer from protein-calorie malnutrition (as exemplified by normal albumin levels), but exhibit the effects of poor dietary habits. What is particularly striking to me is the fact that a large proportion of these patients were found to have significant deficits in Vitamin D and Thiamine stores, which can compound their risk for the development of postoperative neurological complications (Thiamine) and metabolic issues (Vit. D). The predominant focus in vitamin supplementation for these patients postoperatively has been to supplement with Vitamin B12 and iron, due to the known effects of this procedure on absorption of those important nutritional components. Most programs also recommend multivitamins and extra calcium as well. Given the risk for neurologic problems associated with thiamine deficiency, it would seem prudent to ensure proper thiamine supplementation.

For many non-clinicians, the question remains -- why do these people, who appear to be more than supplemented with nutrition, have such deficits? While there are many compounding etiologies, I like to call this the end result of the Cheetos Factor. Most truly morbidly obese patients not only consume large volumes of food, a significant proportion of that intake is lacking in basic nutritional requirements. Ever look at the nutrition label on a bag of Cheetos? It makes the idea of going into the backyard and eating weeds seem a bit healthier.

We can all eat in a healthier manner, and certainly I am no stranger to the inside of a Cheetos bag. It behooves clinicians, however, to not make assumptions about the nutritional status of morbidly obese patients. Just as we are well aware of the effects of obesity in causing diabetes, sleep apnea, heart disease, DJD, etc., we need to be very cognizant of the potential for nutritional deficits in these patients who outwardly appear to have no capacity for them.

Thursday, August 03, 2006

R&R Recipe for Me

Imagine the Tetons:

Add one Aggravated DocSurg and one surgling. Stir in two mountain bikes, and a bike tour with Western Spirit Cycling.

The result?


Back to the grind on the 14th!