Dialysis providers soon may have to retool their treatment practices to comply with new quality standards being considered for Medicare.
HCFA is reviewing standards being developed by a National Kidney Foundation project to see if they can be incorporated into its new "conditions for coverage" for the Medicare end-stage renal disease, or ESRD, program. In 1994, that program covered 92.3% of people who needed dialysis because of kidney failure.
Dialysis providers would have to meet the standards, which may include practice guidelines and outcomes measures, in order to receive reimbursement for services delivered to Medicare beneficiaries.
HCFA now makes dialysis providers meet professional standards for dialysis physicians and nurses and guidelines for patient-care plans and the quality of the care environment. It doesn't, however, mandate practice rules or outcomes goals.
But the times may be a-changin'. HCFA officials are reviewing draft reports of the National Kidney Foundation project-called the Dialysis Outcomes Quality Initiative, or DOQI-to determine whether they want to adopt any of those standards in new conditions of coverage expected to be released early this year, said Lynn Merritt-Nixon, a health insurance specialist in HCFA's ESRD division.
Garabed Eknoyan, M.D., president of the National Kidney Foundation and co-chairman of the DOQI, said if HCFA adopts any part of the initiative's work, it will be the outcomes measures he expects to be drafted "in some fashion" by the end of the year.
Although practice guidelines can help improve individual patient outcomes, Eknoyan said there are many factors outside dialysis providers' control-including patient compliance-that prevent them from following guidelines to the letter with each patient.
Outcomes standards, on the other hand, measure aggregate results, so they can account for variations in treatment for individual patients while still grading providers on their performance in caring for a larger patient population, he said.
Although dialysis patients on average are among the most costly of Medicare beneficiaries, the DOQI's goals appear to have some conflicting cost implications.
The project aims to "keep (dialysis patients) out of the hospital, keep them alive longer," Eknoyan said. Improving the efficiency of dialysis treatment is another of its goals.
According to HCFA estimates, the ESRD program will cover more than 243,000 people in fiscal 1997 at a cost of about $8.4 billion, or roughly $34,300 per patient. That's more than six times the $5,600 Medicare is projected to spend on the average beneficiary.
New quality standards are needed because dialysis patients have higher morbidity in the United States than in other countries and the mortality rates vary widely from facility to facility, Eknoyan said.
"People are not doing things uniformly," said Eknoyan, also a professor at Baylor College of Medicine in Houston.
Because that variability in practice patterns is contributing to premature deaths or otherwise unnecessary hospital admissions, the quality project's initial product will be practice guidelines. Chief among those will be procedures for both hemodialysis and peritoneal dialysis, the two main methods of cleansing the blood in cases of kidney failure.
To illustrate the practical implication of the guidelines, Eknoyan used the example of the timing of a provider's measurement of the dose of dialysis. If the measurement occurs too soon or too late, the provider can inadvertently provide too much or too little dialysis, resulting in a hospital admission or death. If the timing of the measurement is explicitly spelled out, that could prevent unnecessary hospital admissions and deaths, he said.
The prospect of HCFA adoption of some of the DOQI quality standards has some providers worried, however. They say the agency must ensure that its payment rates for dialysis providers account for the stricter quality standards.
Otherwise, they said, HCFA won't be able to implement the quality standards because providers won't be paid enough to cover the increased costs of quality monitoring.
An executive for one major dialysis provider said she was confident that her company would be able to comply with any standard HCFA adopts. LeAnne Zumwalt, chief financial officer of Vivra, the nation's second largest dialysis services provider, said that since the beginning of 1995, her company has spent "millions and millions of dollars that would ordinarily go to our bottom line" to improve patient outcomes.
The National Kidney Foundation convened the DOQI, consisting of providers, regulators and academic physicians, nearly two years ago. Work groups reviewed more than 3,000 articles to collect the data necessary to develop the practice guidelines.
Final draft guidelines are to be reviewed early this year, and a final version is expected to be published in April.