Following additional studies that raised further concerns, an FDA-approved 2010 guideline regarding the drug now states patients “may die sooner” when they are “treated with Epogen to a hemoglobin level above 12.”
But the FDA’s action does not carry the force of law, and DaVita, until December, continued to have a corporate protocol that called for halting doses of the drug only when a patient’s hemoglobin level rose above 14. Doses were started again when the patient’s level dropped below 13.
DaVita officials said the 2006 studies did not cause “an overnight revolution.” And they point out that Medicare policy has permitted Epogen reimbursement payments for patients with hemoglobin levels above 13 as long as the level doesn’t stay that high for more than three months.
Government scrutiny of Epogen has been “active, detailed and vigorous,” said William Myers, DaVita’s vice president of corporate communications. “In turn, our adherence to government guidelines has been strict, meticulous and transparent.”
Asked about the high hemoglobin levels of its patients, DaVita countered that it has focused on maintaining a low percentage of patients with hemoglobin levels under 10, and in order to do that, its levels have been at the higher end of the curve. Scientific research has shown allowing a patient’s hemoglobin level to slip below 10 is extremely dangerous and even deadly.
Indeed, just 3 percent of DaVita patients in 2003 and 2.8 percent in 2008 had hemoglobin levels below 10, according to the U.S. Renal Data System. But 56.3 percent of DaVita patients had levels 12 and above in 2003 and 38.3 percent had levels 12 and above in 2008.
Other companies had similarly low percentages of patients on the low end of the hemoglobin spectrum and significantly fewer patients on the higher end than DaVita. Fresenius, for example, had 3 percent of patients with hemoglobin levels under 10 in 2008, while 24 percent had levels 12 and above.
Unrelated to payment system
DaVita’s leading anemia-management expert, Dr. David Van Wyck, said the Epogen protocol initiated in December is not related to the new bundled-payment system.
Rather, he said, it’s a combination of evolving science, the additional Epogen guidelines approved by the FDA in 2010 and new Medicare quality-improvement measures that reward dialysis companies for having more patients’ hemoglobin levels within the 10-12 range.
Van Wyck said the latest protocol marked the first time DaVita figured out how to cut off Epogen when patients reach level 12 without causing too many patients to slip below level 10. “It was a huge accomplishment,” he said.
Besides, Nissenson said, there was “massive scientific disagreement from 2000 to 2006” about the use of Epogen. And, he said, “within the scientific community still, this is an unresolved debate.”
Dennis Cotter, president of the Medical Technology and Practice Patterns Institute, home to some of the country’s often-cited kidney-care researchers, said there was no new scientific discovery that would have prompted DaVita’s change in protocol in December — just ahead of the new reimbursement policies.
Cotter estimated DaVita’s new protocol could cut the company’s use of Epogen in half, saving millions of dollars in drug-purchasing costs, now that the government isn’t reimbursing the company for each dosage.
DaVita executives discounted Cotter’s criticism, saying he is not familiar with the company’s internal research, which is used to design protocols.
Another kidney expert said he believes the 2007 FDA warning about the dangers of Epogen at high levels had little effect on the drug’s use at for-profit clinics when they should have cut back.
Instead, use remained high in those clinics until the changes in government reimbursement were on the horizon, said Dr. Ajay Singh, an associate professor at Harvard Medical School.
“You could argue that the stimulus for that was the financial stimulus,” said Singh, who headed the clinical trial in 2006 that showed anemia drugs might be unsafe for kidney patients at higher doses.
Dr. Melissa Yanover, formerly associated with DaVita and now at a Fresenius clinic, said the medical community, not just for-profit clinics, has pushed for higher hemoglobin at times because many doctors believed research would prove the benefit. Even after studies showed risks at higher hemoglobin levels, doctors have differed in their own target levels and how much to cut back Epogen dosages, Yanover said.
And she said the for-profit system deserves credit for bringing high technology and efficiency to renal care in a way government never could.
Efforts to curb dialysis companies’ use of Epogen might not be over.
Medicare is currently reviewing the dosing limits of Epogen and is accepting public comments.
Cotter wants Medicare to adopt stricter per-patient dosage limits in line with FDA guidelines.”How can (Medicare) continue to ignore the risks that FDA has already recognized and deemed sufficient to take action?” he asked in a letter last month to Medicare.
The nation’s system to pay for dialysis during the past decade was not designed to optimize patient care, the independent Medicare Payment Advisory Commission has reported to Congress. Still, Dr. David Spiegel, a professor and director of the University of Colorado’s chronic hemodialysis program, said he does not believe for-profit dialysis companies intentionally harmed anyone for the sake of making money.
“The mission of corporations is really for their bottom line and their stockholder. The mission of a health care company is to do what’s in the best interest of the patient,” Spiegel said. “When you merge those two worlds, you are potentially asking for and setting up situations of conflicts of interest and maybe misaligned incentives.”
Jennifer Brown: 303-954-1593 or jenbrown@denverpost.com
Christopher N. Osher: 303-954-1747 or cosher@denverpost.com
About DaVita
Kent Thiry became chief executive of the struggling Total Renal Care in 1999 and renamed the company DaVita in 2000.
Key numbers:
•35,000 “teammates”
•$6.5 billion in annual revenue
•1,612 dialysis centers in U.S.
•125,000 patients
Tell us
The Post is interested in your tips. You can reach our investigative reporters at 303-893-TIPS (8477), toll-free at 866-748-TIPS or at TIPS@denverpost.com.
|
|
|
3
