ARTS & FARCES internet

Peter Laird is an internist who also happens to be a dialysis patient. He writes regularly about the plight of dialysis patients from a unique perspective. In his most recent article, The dialysis industrial complex, he draws the parallel between Eisenhower’s military industrial complex and the current relationship between the US government and dialysis providers. “Despite the best intentions of the 1973 ESRD program, gross deficiencies in quality are rampant throughout the industry where profits continue to soar,” writes Laird.

Dialysis in the US started as a grand experiment to keep kidney failure patients alive, productive, and well but has devolved into the worst treatment program in the developed world. How that happened, as Laird notes, is subject to debate, but the fact it has is not in dispute.

As the provision of dialysis services in the US was commercialized, quality went down and mortality and morbidity rose in proportion to corporate profits. “Today, Davita and Fresenius dominate the American market with the most expensive dialysis population and the world’s worst outcomes,” Laird reports. Laird traces the qualitative shift in provision of dialysis services to the 1978 congressional testimony of Edmund G. Lowry, then vice president of National Medical Care, condemning “an entire generation of dialysis patients to short, violent sessions coupled with daily nausea, vomiting, severe fatigue, cramping and bouts of syncope.”

The dialysis community has known for quite a while that longer sessions combined with lower blood flow rates yields higher quality dialysis with fewer problems. But it’s not economically feasible in a system that rewards only the shortest treatment cycles.

Laird goes on to note the rarity of an academic nephrology study that makes an actual recommendation (other than that additional study is needed).

The Centers for Medicare & Medicaid Services (CMS) has published its final rule (.pdf; 872KB) of its 2012 End-stage Renal Disease (ESRD) Quality Incentive Program (QIP). As expected, the final rule includes the controversial decision to eliminate the minimum hemoglobin standard that’s been in place for years. It also increases the dialysis reimbursement in 2012 by 2.1 percent. While most ESRD hemodialysis patients are also Medicare beneficiaries, some of us remain on private insurance policies. It doesn’t matter, as the dialysis providers universally adhere to the minimal CMS guidelines as a matter of course.

Over the past 20 years, dialysis providers made a bundle of money by overusing erythroipoiesis stimulating agents (ESAs)—most commonly Erythropoietin (EPO)—to raise hemoglobin levels in dialysis patients. Pharmaceutical companies urged nephrologists to prescribe, and dialysis providers to deliver, recklessly high dosages of these drugs all in the name of outsized profits. As a result, Medicare now pays a flat fee for a “bundle” of services—known as the Dialysis Bundle (which took effect 1 January 2011)—rather than paying for each service separately. As I’ve written before, I’ve been a dialysis patient for almost 12 years and my hemoglobin level never rose to the levels of an anemic non-ESRD person in all that time. In fact it only rose above 12 g/dL two or three times, and then only for a day or two. That doesn’t mean that overuse of Epogen isn’t a problem—it absolutely was—just that it wasn’t a problem for me.

Under CMS’s final rule, two metrics will be used to determine treatment efficacy in dialysis patients in 2013: hemoglobin levels greater than 12 g/DL and a urea reduction ratio (URR) of at least 65 percent. Under the QIP, payments to dialysis providers are reduced if they don’t achieve an acceptable performance score with regard to these two metrics. In 2014, the efficacy metrics will be expanded to include the percentage of patients receiving dialysis through a arteriovenous fistula, whether or not the dialysis provider reports dialysis-related infections to the Centers for Disease Control & Prevention’s National Healthcare Safety Network, whether or not the dialysis provider administers a patient experience of care survey, and whether or not the facility monitors phosphorous and calcium levels on a monthly basis.

On 24 June 2011, the US Food and Drug Administration (FDA) announced that there is “no risk-free dosage level” of the most common ESAs, Epogen, Aranesp, and Procrit and that these drugs should be used only to reduce the need for blood transfusions. Oh, joy.

Three years ago, when kidney transplants were failing at twice the normal rate and at least five transplant patients died at the University Medical Center in Las Vegas, the Centers for Medicare and Medicaid Services moved to decertify the hospital’s kidney transplant program. US Representative Shelley Berkley (D-Nevada) intervened, along with two other members of the Nevada delegation.

The difference, according to Eric Lipton, writing for the New York Times, is that Berkley’s strong-arm tactics directly benefitted Larry Lehrner, her nephrologist husband. Lehrner “directs medical services at the hospital’s kidney care department—an arrangement that expanded after her intervention and is now reflected in a US$738,000-a-year contract with the hospital,” reports Lipton. “Ms. Berkley’s actions were among a series over the last five years in which she pushed legislation or twisted the arms of federal regulators to pursue an agenda that is aligned with the business interests of her husband, Dr. Larry Lehrner. In addition to the hospital contract, he operates a dozen dialysis centers in Nevada and has played a central role in an industry campaign to lobby members of Congress—including his wife—on behalf of kidney care providers.”

This illustrates exactly why the Stark Law was written: To prohibit physician self-referral (when a physician refers a patient to a medical facility in which he has a financial interest. Dialysis services are specifically excepted from the Stark Law under the “safe harbor” provisions of the law.

For an excellent analysis of the high stakes involved in the Stark Law exception for dialysis services, see Jennifer Brown’s excellent article for the Denver Post in 2009—just as dialysis provider giant DaVita was moving its headquarters to Denver—about sharp-elbowed approach to dealing with competitors.

My experience jibes with Brown’s reporting. My nephrologist group is closely-linked with DaVita and I’ve been told that if I moved outside of DaVita clinics no one in the practice would be able to see me. I have strong history with just about every partner in the group, and they’re individually and collectively the best in town, but they’re joined at the hip with a corporation where, as Brown cites in the Pikes Peak nephrologist group’s countersuit against DaVita, “‘cost-cutting measures and administrative bureaucracy’ were taking precedence over patient care.”

I’ve been a patient at two Saint Paul DaVita-owned dialysis clinics since 2000. I have excellent relationships with my nephrologist and DaVita staff and feel that I get excellent care. But I did switch clinics several years ago because the quality of care at my original clinic had degraded each year. The only competing option in the Twin Cities metro area is the second-largest dialysis provider in the US, Fresenius. As a non-Medicare patient, I’d really like to see competition for providing dialysis services in this market. And I’d just about kill for one of those heated massage chairs they have out in Denver.

DaVita—one of the two biggest providers of dialysis services in the US—is being accused by a former clinic nurse and doctor of intentionally wasting expensive medicine (.pdf; 365KB) in order to defraud Medicare. According to Andrew Pollack, writing for the New York Times, “The lawsuit says that the company, DaVita, used larger than necessary vials of medicine knowing that Medicare would pay for the unused portion of each vial if it were deemed unavoidable waste.”

Under the new Medicare rules, dialysis providers are paid a single, “bundled” fee for dialysis services, including all necessary intravenous drugs. But before January, when the new rules took effect, Daniel Barbir (the former DaVita nurse) and Alon Vainer (a doctor and former DaVita medical director) allege the company required nurses to use a 10 mcg vial of Zemplar, intravenous vitamin D, for a 6 mcg prescription (instead of three 2 mcg vials), billing Medicare for the 10 mcg vial and throwing away the unused 4 mcg. Similar practices were employed with Venofer, an iron drug.

Medicare has long paid only for the exact amount of Epogen actually administered, but Barbir and Vainer allege DaVita used and billed Medicare for every bit of Epogen, including excess amounts, called “overfill,” for which it did not pay.

DaVita spokesperson Bill Meyers tells Pollack, “the larger but fewer vials for Zemplar helped minimize needle sticks and protect patients and nurses from possible infection.” That would be plausible if it were true, but it’s not. All intravenous drugs administered during dialysis are given in the dialysis line, not the patient. Pollack could have easily researched this, but didn’t.

Meyers goes on to cite Pollack as telling him that small doses of Venofer “were thought to be better for the patient.” This is simply not true. Venofer (and similar iron drugs) must be administered slowly to some patients who are sensitive to the drug (myself included), but there is absolutely no evidence supporting the efficacy of smaller doses. With a simple Google search Pollack could have found this out, but failed again.

Barbir and Vainer provide documentation indicating a DaVita dialysis center in Georgia wasted twice as much Venofer as its patients received.

Disclosure: I’ve been a DaVita dialysis patient, carrying private insurance, for more than 11 years.

US dialysis providers have overused Epogen, the expensive drug for treating anemia. There’s no question whatsoever of that. While it hasn’t happened to me in more than 11 years of dialysis, I know it’s a problem—the dialysis providers were using it as a profit center, plain and simple.

Last week, the US Food and Drug Administration (FDA) announced there were “no risk-free doses of Epogen, Aranesp, and Procrit” and changed the drugs’ labels calling for lower dosing.

This week, Medicare proposed rescinding its requirement (.pdf; 500KB) that dialysis providers maintain patients’ hemoglobin levels above a mandatory minimum, hoping to lower use of Epogen. Currently, Medicare requires dialysis patients’ hemoglobin levels to be maintained above 10 g/dL. As I’ve written—repeatedly and consistently—I’m in trouble when my hemoglobin falls below 11.5 g/dL and almost totally incapacitated when it falls below 11 g/dL. In more than 11 years on dialysis, I’ve never had Epogen overprescribed. Ever. I know overuse of Epogen is a problem; hell, there’s money to be made in it. Or, rather, there was.

“Clinicians should use the lowest dose of ESA (erythropoiesis stimulating agent) sufficient to reduce the need for red blood cell transfusions,” Patrick Conway, chief medical officer at the Centers for Medicare and Medicaid (CMS) said in a media release.

On 1 January 2011, Medicare’s final rule for dialysis patients—the “bundling” arrangement (.pdf; 1.3MB)—took effect. No longer would dialysis providers be allowed to bill separately for dialysis and drugs like Epogen. There would be a single “bundled” payment made. Previously, Medicare paid a predetermined fee for dialysis services, but some drugs—like Epogen—were reimbursed separately. That system gave dialysis providers a financial incentive to overuse Epogen which increased the patients’ risk of heart attacks and strokes. Under the new rule, Medicare pays a single, predetermined fee for each dialysis treatment, covering the entire “bundle” of services (dialysis, supplies, drugs, and lab tests).

Take the Medicare “bundle” (which applies to non-Medicare patients with private insurance, like me) and add in the proposal to rescind mandatory minimums for dialysis patients’ hemoglobin levels, and this very bad. Blood transfusions are sufficiently risky to make this incredibly bad policy.